Month: September 2026

Decoding FDA 510(k) Clearance K260667 | Interactive Case Study RegIntelligence Case Study: K260667 Decoding FDA 510(k) Clearances for Regulatory Professionals 19-Field Decoder 5-Step Guide Device Matrix Quiz FDA Cleared (SESE) June 29, 2026 AI-Enabled Device Philips Alturion Series Diagnostic Ultrasound System Dissecting FDA 510(k) submission K260667 line-by-line. A real-world masterclass in platform refreshes, transducer hardware changes, and non-clinical AI algorithm validation. Applicant Philips Ultrasound Predicate Affiniti (K243794) Primary Reg # 21 CFR 892.1550 PCCP Status Not Authorized Interactive 510(k) Summary Metadata Inspector Click on any field on the simulated clearance document below to inspect its official definition, plain-language breakdown, and regulatory implications. Filter Field: All 19 Metadata Fields Administrative & Ownership Classification & Reg Codes Timelines & Submission Type Special Features (AI & PCCP) FDA 510(k) Summary Sheet — K260667 Public Document (21 CFR 807.92) Select a Field to Inspect Click any entry on the left to unpack its regulatory meaning, CFR citations, and specific context for the Alturion filing. Field 01 Device Classification Name Classification Regulatory Meaning Official FDA definition and regulatory scope. Application in K260667 (Alturion) How Philips applied this specific field in this filing. Pro-Tip for Regulatory Writers Key insight or pitfall to avoid in your own 510(k) submissions. Reference Document Philips Alturion K260667 Summary FDA Database How to Dissect a 510(k) Clearance Like an FDA Reviewer A step-by-step masterclass analyzing K260667 across predicate selection, hardware comparison, AI validation, PCCP strategy, and post-market duties. Step 1: Predicate Step 2: Table Step 3: AI Validation Step 4: PCCP Step 5: Post-Market 1 Predicate Selection Strategy Everything Starts with the Predicate The entire 510(k) pathway hinges on proving that a new device is **Substantially Equivalent (SE)** to a legally marketed predicate device. In submission K260667, Philips selected their own previously cleared **Affiniti Series Diagnostic Ultrasound System (K243794)** as the primary predicate. Pro Tip: Own Predicate vs. Competitor Predicate Citing your own prior cleared device (as Philips did) generally leads to a smoother review process because the manufacturer possesses all underlying design histories, raw safety test reports, and transducer calibration files. Citing a competitor device is permitted, but requires proving equivalence through public specs or bench testing without access to the competitor's proprietary design history file (DHF). Role of Reference Devices in K260667 Philips also cited three **reference devices**. Reference devices are not predicates used to claim SE directly, but serve as supporting evidence that specific sub-technologies are already cleared and standard in the market: K231190 Philips Epiq Series Establishes baseline ultrasound console architecture. K253595 Philips Epiq (Auto Measure) Establishes prior acceptance of Auto Measure Abdomen algorithm. K231966 GE LOGIC E10 Competitor reference confirming industry standard for transducer design. Device Lineage Tree Submission Lineage Map Primary Predicate Affiniti Series (K243794) Core acoustic engine & console platform Reference Features Epiq Series (K253595) Shared AI Auto-Measure codebase NEW SUBMISSION Alturion Series (K260667) Console refresh + eV14-2v probe + Auto Measure AI Substantial equivalence does not require identity — only equivalent safety & effectiveness profile. 2 Side-by-Side Scrutiny Read the Comparison Table Like an FDA Reviewer The heart of any 510(k) summary is the comparative analysis. In K260667, Philips compared the new **eV14-2v transducer** against the predicate **3D9-3V transducer** across nearly 20 design parameters. "Same as Predicate" Rows Parameters like intended use, acoustic output display indices, and materials in patient contact matched directly. These require minimal reviewer intervention. "Different Than Predicate" Rows This is where reviewer scrutiny focuses! Philips proactively framed every design change as either an anatomical benefit or ergonomic improvement without introducing new risks. How Differences Were Defended in K260667: • 436 elements vs. 128 elements: Framed as improved spatial resolution, contrast, and clutter reduction. • 180° FOV vs. 155.5° FOV: Framed as clinical enhancement allowing visualization of larger anatomical structures in a single view. • Smaller tip dimensions & shorter length: Framed as patient comfort and operator tip maneuverability optimization. 3 AI Performance Validation Strategy Validating AI Software Without a Clinical Trial A major highlights of K260667 is how Philips cleared the **Auto Measure Abdomen** feature. They did NOT conduct a prospective randomized clinical trial. Instead, they performed a rigorous **non-clinical algorithm performance study**. 150 Subjects & 3 Sites Retrospective dataset collected across 3 independent clinical sites to ensure demographic and operator diversity. Expert Ground Truth 3 ARDMS-certified sonographers with 10+ years experience established manual measurement baselines independently. Train/Test Independence Validation images were completely isolated from the training set, sourced from Epiq and Affiniti consoles. Statistical Methodology Bland-Altman Limits of Agreement (LoA) Simulation Select Parameter: Kidney Sagittal Length (mm) Kidney Transverse Width (mm) Spleen Length (mm) Bland-Altman plots quantify agreement between AI automated measurements and human expert ground truth by plotting the difference against the mean of the two measurements. All 4 organ parameters met pre-specified limits of agreement. MEAN BIAS +0.12 mm UPPER LIMIT (+1.96 SD) +2.45 mm LOWER LIMIT (-1.96 SD) -2.21 mm 4 Strategic Analysis What's NOT There — The Missing PCCP A critical detail in field #19 of the clearance summary is: PCCP Authorized: No. What is a Predetermined Change Control Plan (PCCP)? A PCCP is an FDA regulatory mechanism that allows medical device manufacturers to pre-specify future post-market AI algorithm updates (such as retraining on expanded demographic datasets) and obtain advance authorization. With an authorized PCCP, minor algorithm retrainings do not require a new 510(k) submission. Strategic Impact for Philips Post-Clearance Because K260667 does not include an authorized PCCP, Philips must evaluate any future updates to the Auto Measure Abdomen algorithm using FDA's standard guidance: "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (21 CFR 807.81) If Philips updates the neural network architecture or retrains the model in a way that significantly alters performance or clinical output, they will be required to file a new 510(k). 5 Post-Market Compliance Never Skip the "Standard" Boilerplate Text Junior regulatory professionals often skip the standardized closing paragraphs of an FDA clearance letter. However, these paragraphs represent binding legal duties triggered upon market entry. 21 CFR Part 820 / ISO 13485 QMSR & Design Controls Clearance is granted under the condition that design controls (7.3), nonconforming product procedures (8.3), and CAPA systems (8.5) are maintained during manufacturing. 21 CFR Part 803 Medical Device Reporting (MDR) Mandatory reporting obligations kick in immediately upon clearance. Any device malfunction that could cause death or serious injury must be reported to FDA. 21 CFR Part 830 Unique Device Identification (UDI) Proper labeling and electronic submission of device identifiers to FDA’s Global UDI Database (GUDID) prior to commercial distribution. 21 CFR Part 807 Subpart E Annual Registration & Listing Philips Ultrasound, LLC must maintain active establishment registration and list the Alturion platform under product code IYN. Interactive Technical Comparison Matrix Comparing New eV14-2v Transducer vs. Predicate 3D9-3V Transducer (K260667 Filing Data) Toggle Mode: Show FDA Reviewer Lens Parameter New Device: eV14-2v Predicate: 3D9-3V Comparison Status FDA Reviewer Justification Analysis Interactive Assessment 510(k) Regulatory Mastery Quiz Test your ability to read and evaluate 510(k) clearance letters based on the K260667 case study. Quiz Completed! 0 / 5 Correct Retake Quiz RegIntelligence Educational Module Based on public FDA CDRH 510(k) clearance summary data for K260667 (Philips Ultrasound, LLC). 21 CFR 807 Subpart E | For Regulatory Training Purposes