(245 days)
The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler (PWD), and M modes.
It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric,Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ,Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung, Ophthalmic.
The Lumify system is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.
The Philips Lumify Diagnostic Ultrasound System (Lumify) is a mobile, durable, and reusable, software-controlled medical device, which is intended to acquire high-resolution ultrasound data and to display the data in B mode (2D), Pulsed Wave Doppler, Color Doppler, Combined (B+ Color), and M modes. The Lumify system is compatible with iOS and Android operating systems.
The Lumify Diagnostic Ultrasound System (iOS) utilizes:
- A commercial off-the-shelf (COTS) iOS mobile item (smart phone or tablet)
- The Philips Ultrasound Lumify software running as a medical device application on the COTS device
- The Philips C5-2 Curved array USB transducer
- The Philips L12-4 Linear array USB transducer
- The Philips S4-1 Sector array USB transducer
- Lumify Micro B Transducer Cable
- Lumify Micro C Transducer Cable
- Lumify USB-C to USB-C Transducer Cable
- Lumify Power Module
The purpose of this Traditional 510k pre-market notification is to add Ocular preset to currently commercialized L12-4 transducer available with Lumify Diagnostic Ultrasound System. Addition of Ocular preset will be available under newly added Ophthalmic clinical indication, as part of this 510k submission.
The Ocular Preset is an imaging setting to image the eye. It supports 2D (B Mode) and Color Doppler Mode and is available under "Ophthalmic" clinical indication.
The ocular preset is available to download with the Lumify 5.1 software and is available with the previously commercialized L12-4 Lumify transducer.
Based on the provided FDA 510(k) clearance letter for the Philips Lumify Diagnostic Ultrasound System (K242670), here's an analysis regarding acceptance criteria and the study that proves the device meets them:
It's crucial to understand that this 510(k) application is for an addition of an "Ocular preset" to an already cleared device (Lumify Diagnostic Ultrasound System, K192226), utilizing an already cleared transducer (L12-4). The core technology and device itself are established. Therefore, the "study" described focuses on validating the new Ocular preset and Ophthalmic indication against existing standards and a reference device, rather than a full de novo clinical trial for a completely new device.
Key takeaway: The document explicitly states, "The proposed Lumify Diagnostic Ultrasound System with Ocular preset did not require clinical data for determination of substantial equivalence" and "For testing, all pre-determined acceptance criteria were met." This suggests the acceptance criteria were primarily met through non-clinical performance testing and substantial equivalence arguments based on technical similarity to a predicate and reference device that already had the Ophthalmic indication.
Acceptance Criteria and Device Performance
Since no specific quantitative acceptance criteria or clinical study results are detailed in the provided document (as it was deemed unnecessary for this 510(k)), we infer the acceptance criteria from the information presented:
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Inferred from regulatory requirements and submission context) | Description (Inferred) | Reported Device Performance (From K242670) | Proving Study/Method |
|---|---|---|---|
| Safety | Device must not introduce new or significantly modified risks to patients or users with the addition of the Ocular preset. | "The changes made to the subject device do not affect the use of the device, nor do they introduce any new or significantly modified risks." | Risk Analysis and Management Review (Non-clinical), Compliance with IEC 62304, IEC 62366-1, ISO 14971. |
| Effectiveness/Performance (Non-Clinical) | The Ocular preset must function as intended for diagnostic ultrasound imaging of the eye (2D and Color Doppler Modes). Image quality and performance metrics for Ocular imaging should be comparable to established standards and the reference device. | "The proposed modification... was tested in accordance with Philips internal procedures." "Non-clinical verification testing was conducted to address the system level requirements according to system and design specifications, and risk control measures." "All pre-determined acceptance criteria were met." | Requirements Review, Product Specification Review, Design Reviews, Internal Non-clinical verification testing. Comparison to Sparq Diagnostic Ultrasound System (K162329) with L12-4 transducer and Ophthalmic indication. |
| Substantial Equivalence | The device with the Ocular preset must be substantially equivalent to a legally marketed predicate device (K192226) and/or a reference device (K162329) for the Ophthalmic indication. | "The proposed device is substantially equivalent to the predicate and reference devices in terms of indications for use, design, technological characteristics, modes of operations, safety, and effectiveness." | Comparison of design features, indications for use, fundamental scientific technology, non-clinical performance testing, safety and effectiveness. (Table 6.1: Technological Comparison) |
| Compliance with Standards & Guidance | The device must comply with relevant medical device standards and FDA guidance documents. | "The proposed Lumify Diagnostic Ultrasound System with Ocular preset is Track 3 device and comply with the reference standards and with FDA ultrasound guidance document, 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Guidance for Industry and Food and Drug Administration Staff, February 21, 2023'." | Internal verification of compliance. |
Study Details (Based on the supplied document)
Given that the submission category is a "Traditional 510(k)" for an addition to an already cleared device, and not a de novo submission or one requiring extensive clinical data, the "study" primarily consists of non-clinical performance testing and a technological comparison to establish substantial equivalence.
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Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of cases or images. The testing conducted was "non-clinical verification testing" to address system-level requirements, design specifications, and risk control measures. This implies testing against engineering specifications and possibly phantom studies rather than a clinical dataset of patients.
- Data Provenance: Not applicable in the context of a clinical test set from patients. The testing was internal to Philips Ultrasound, conducted according to their internal procedures.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as no clinical test set requiring expert ground truth establishment was deemed necessary for this 510(k) submission. The substantial equivalence argument relies on the prior clearance of the predicate and reference devices for similar indications.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None is explicitly described. As no clinical test set was required for human review with an established ground truth, adjudication methods are not applicable here.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This 510(k) is for a diagnostic ultrasound system and its imaging preset, not an AI/CADe/CADx device that assists human readers. Therefore, the concept of human readers improving with AI assistance is not applicable to this submission.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a diagnostic imaging system, not an algorithm. Its performance is inherent to its ability to acquire and display ultrasound data.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance testing, the "ground truth" would be the engineering and performance specifications the device was designed to meet. For the substantial equivalence argument, the effective "ground truth" is the demonstrated safe and effective performance of the predicate and reference devices for similar imaging capabilities. No clinical ground truth (e.g., pathology, outcomes) was required for this specific 510(k) submission.
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The sample size for the training set:
- Not applicable. This is a traditional diagnostic ultrasound system, not an AI/machine learning product that requires a "training set" in the conventional sense. The "training" of the system refers to its design and engineering to meet diagnostic imaging requirements.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the machine learning context for this device. Ground truth for the underlying ultrasound technology would be established through physics principles, engineering design, and prior clinical validation of similar devices.
In summary, the provided document explicitly states that clinical data was not required for this 510(k) submission. The acceptance criteria were primarily met through non-clinical performance testing (design reviews, risk analysis, system requirements verification) and demonstrating substantial equivalence to existing, cleared devices (the predicate Lumify system and the Sparq system which already has an Ophthalmic indication for the L12-4 transducer), ensuring the new Ocular preset did not introduce new safety or effectiveness concerns.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.