(25 days)
Not Found
No
The description focuses on the hardware components and physical design of the coil, with no mention of AI or ML for image processing or analysis. The performance studies are standard safety and image quality tests for MR coils.
No.
The device is used to produce diagnostic images, not for therapy or treatment.
Yes.
The device's intended use is to produce diagnostic images that can be interpreted by a trained physician, and clinical performance testing confirmed that the acquired image quality is sufficient for diagnostic use.
No
The device description clearly states it is a physical coil (hardware) used in conjunction with an MRI scanner, and the performance studies include hardware-specific testing (electrical/mechanical safety, EMC, biological safety, cleaning/disinfection).
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to produce diagnostic images of the knee within the patient using Magnetic Resonance. It does not involve analyzing samples like blood, urine, or tissue outside the body.
- The device description and intended use clearly indicate it's an imaging coil for an MRI scanner. This is a piece of medical imaging equipment used for in-vivo (within the living body) diagnosis.
Therefore, this device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanner
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
2
(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
3
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 # 3003768277 |
| Asha 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).