(25 days)
The dS Knee Coil 8ch 1.5T is to be used in conjunction with Philips 1.5T Magnetic Resonance Scanner to produce diagnostic images of Knee that can be interpreted by a trained physician.
The dS Knee Coil 8ch 1.5T is an 8 channel phased array, receive only coil with a rigid volume and designed to be used in conjunction with 1.5T Magnetic Resonance Scanner for high resolution imaging of the left or right knee. The split design and single handle allows easy setup. The coil can be slightly rotated relative to its base plate to ease coil setup and enhance patient comfort. The coil conforms snugly to the anatomy for excellent signal-to-noise ratio. This coil is used independently and cannot be combined with any other coil and is available for Philips 1.5T Prodiva and MR 5300 MR Systems.
The provided text K242879 is a 510(k) summary for the Philips dS Knee Coil 8ch 1.5T. It describes the device, its indications for use, and a summary of performance data. However, this document does not contain the detailed clinical study results or acceptance criteria in the format requested, particularly for an AI/software-based medical device performance evaluation.
The document states:
- "Acquired Image quality was assessed by a U.S. Board Certified radiologist to confirm images produced on the subject coil are sufficient quality for diagnostic use."
- "Substantially equivalent performance is demonstrated by meeting all criterion in the quidance "Magnetic Resonance (MR) Receive-only Coil –Performance Criteria for Safety and Performance Based Pathway" issued on December 11, 2020."
This indicates that the performance evaluation for this hardware device (a medical coil) focused on image quality for diagnostic use, rather than the performance of an AI algorithm or software. Therefore, many of the requested elements, such as MRMC studies, standalone algorithm performance, ground truth establishment for training, and sample sizes for AI model development, are not applicable or detailed in this document because it's not an AI/ML device submission.
Based only on the provided text, I can infer some information relevant to the intent behind your questions, but I cannot provide the specific details of an AI/ML study.
Here's how I can interpret the provided text in the context of your request, filling in with "Not Applicable" or "Not specified" where the document does not provide the information for an AI/ML device:
Study Type: This is a performance study for a hardware medical device (MRI coil), not an AI/ML software device. The evaluation focuses on assuring the generated images are of diagnostic quality.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from guidance) | Reported Device Performance (Inferred) |
|---|---|
| Images sufficient quality for diagnostic use | Confirmed sufficient quality (per radiologist assessment) |
| Compliance with FDA guidance "Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway" | All criteria met |
| Safety (IEC 60601-1, ISO 10993-1, etc.) | Met (implied by 510(k) clearance) |
| Performance (NEMA-MS-1, IEC62464-1 for image uniformity, SNR) | Met (implied by 510(k) clearance and "sufficient quality") |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the clinical image quality assessment. The document only mentions "Acquired Image quality was assessed."
- Data Provenance: Not specified. It's likely prospective imaging data acquired with the device for validation, but the document doesn't explicitly state this.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Singular ("a U.S. Board Certified radiologist").
- Qualifications: "U.S. Board Certified radiologist." Specific experience level (e.g., 10 years) is not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/not specified. The assessment appears to be a single read. This is a hardware image quality assessment, not an AI diagnostic study usually requiring complex adjudication.
5. 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
- MRMC study: No, this was not an MRMC study. It was an assessment of the image quality produced by the coil, not a study comparing human reader performance with or without AI assistance.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This is not an AI algorithm. The performance being evaluated is the image generation capability of the MRI coil.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Expert assessment by a U.S. Board Certified radiologist to confirm "sufficient quality for diagnostic use." This is a form of expert consensus on image utility, rather than a clinical ground truth for a specific diagnosis (like pathology).
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a hardware device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
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October 18, 2024
Philips Medical Systems Nederland B.V. Asha Jacob Senior Manager Regulatory Affairs & Compliance Veenpluis 6 Best, 5684 PC Netherlands
Re: K242879
Trade/Device Name: dS Knee Coil 8ch 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: July 18, 2024 Received: September 23, 2024
Dear Asha Jacob:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
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(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
D.R. King
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
dS Knee Coil 8ch 1.5T
Indications for Use (Describe)
The dS Knee Coil 8ch 1.5T is to be used in conjunction with Philips 1.5T Magnetic Resonance Scanner to produce diagnostic images of Knee that can be interpreted by a trained physician.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
The 510(k) Summary was prepared in accordance with 21 CFR §807.92(c).
| Preparation date: | Sept 22, 2024 |
|---|---|
| 510(k) Owner: | Philips Medical Systems Nederland B.V. |
| Veenpluis 6 | |
| 5684 PC Best | |
| The Netherlands | |
| Contact person: | Establishment Registration # 3003768277Asha Jacob (primary) |
| Senior Manager Regulatory Affairs & Compliance | |
| Philips Medical Systems Nederland B.V. | |
| Phone: +31 626764825 | |
| Trade Name: | dS Knee Coil 8ch 1.5T |
| Classification Name: | Coil, Magnetic Resonance, Specialty |
| Regulation Number: | 21 CFR 892.1000 |
| Review Panel: | Radiology |
| Device Class: | Class II |
| Product Code: | MOS |
| Predicate Device Trade Name: | Model HRK-63-8 PMS Knee Array Coil (K033567) |
| Predicate Classification Name: | Coil, Magnetic Resonance |
| Predicate Regulation Number: | 21 CFR 892.1000 |
| Predicate Device Class: | Class II |
| Predicate Product Code: | MOS |
Device description
The dS Knee Coil 8ch 1.5T is an 8 channel phased array, receive only coil with a rigid volume and designed to be used in conjunction with 1.5T Magnetic Resonance Scanner for high resolution imaging of the left or right knee. The split design and single handle allows easy setup. The coil can be slightly rotated relative to its base plate to ease coil setup and enhance patient comfort. The coil conforms snugly to the anatomy for excellent signal-to-noise ratio. This coil is used independently and cannot be combined with any other coil and is available for Philips 1.5T Prodiva and MR 5300 MR Systems.
Indications for use
The dS Knee Coil 8ch 1.5T is to be used in conjunction with Philips 1.5T Magnetic Resonance Scanner to produce diagnostic images of Knee that can be interpreted by a trained physician.
Fundamental Scientific Technology:
The subject dS Knee Coil 8ch 1.5T is considered substantially equivalent to the primary predicate device Model HRK-63-8 PMS Knee Array Coil (K033567) in terms of its indications of use, technological and design characteristics:
- Similar Indications for use .
- Prescription Use Only ●
- Anatomy of interest is the knee. ●
- Receive only, phase array, 8 channel. .
- Magnetic field strength (1.5T) ●
- Rigid housing design contoured for knee anatomy. ●
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- . Split housing design and closing mechanism.
- Dimensions and housing thickness .
- Energy source from the MR scanner .
The following technological differences exist between the subject and predicate device:
- The design of the housing is more simplified than the marketed primary predicate ● device for conforming better to the new patient couch.
- The subject device is compatible with Philips Prodiva and MR 5300 MR systems, whereas the . predicate is compatible with Philips Intera 1.5T MRI System.
Clinical and non-clinical testing demonstrates that the safety and effectiveness requirements as outlined in FDA quidance Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020 were met. No new safety or efficacy concerns are raised because of these differences.
Summary of Non- Clinical and Clinical Performance Data:
The subject dS Knee Coil 8ch 1.5T has undergone the following testing in accordance with FDArecognized consensus standards and as recommended in FDA guidance documents Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 18, 2016 and Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020:
Performance Testing - Non-Clinical:
- IEC 60601-1 General electrical/mechanical safety -
- IEC 60601-1-2 EMC Immunity, electrostatic discharge testing -
- IEC 60601-2-33 Particular requirements for the basic safety and essential performance of । magnetic resonance equipment for medical diagnosis
- NEMA-MS-1. 3. 9. 14 Image uniformity and signal-to-noise ratio testing -
- -IEC62464-1 International Standard: Magnetic resonance equipment for medical imaging – Part 1: Determination of essential image quality parameters
- ISO 10993-1 Biological safety evaluation -
- ISO 17664 Cleaning and disinfection validations to support reprocessing instructions -
Performance Testing - Clinical:
Acquired Image quality was assessed by a U.S. Board Certified radiologist to confirm images produced on the subject coil are sufficient quality for diagnostic use.
Substantial Equivalence Conclusion:
Substantial equivalence of the dS Knee Coil 8ch 1.5T is demonstrated through the Safety and Performance Based Pathway for magnetic resonance (MR) receive-only coils.
The subject device has the similar indications for use and similar technological characteristics as the predicate device. Substantially equivalent performance is demonstrated by meeting all criterion in the quidance "Magnetic Resonance (MR) Receive-only Coil –Performance Criteria for Safety and Performance Based Pathway" issued on December 11, 2020.
The summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device according to 807.92(b)(3).
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.