Smart Fit Knee 3.0T

K233600 · Philips Healthcare (Suzhou) Co., Ltd. · MOS · Feb 5, 2024 · Radiology

Device Facts

• Record ID: K233600
• Device Name: Smart Fit Knee 3.0T
• Applicant: Philips Healthcare (Suzhou) Co., Ltd.
• Product Code: MOS · Radiology
• Decision Date: Feb 5, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system to produce diagnostic images of the Knee that can be interpreted by a trained physician.

Device Story

16-element phased-array receive-only RF coil; used with Philips 3.0T MR systems for high-resolution knee imaging. Device comprises base plate, anterior/posterior parts, and positioning pads; allows slight rotation for patient comfort. Operates by receiving MR signals from hydrogen nuclei while blocking RF fields applied by the scanner; signals are amplified and transmitted to the MR system for image reconstruction. Used in clinical settings by trained physicians/technicians. Output consists of diagnostic images interpreted by radiologists to assist in diagnosis and therapy planning. Benefits include improved image quality (SNR/FOV) for knee anatomy.

Clinical Evidence

No clinical study required. Bench testing only. Performance verified against NEMA standards (MS 1, MS 3, MS 9, MS 14) and electrical safety standards (IEC 60601 series). Qualified radiologists evaluated clinical images to confirm sufficient diagnostic quality.

Technological Characteristics

16-channel phased-array receive-only coil. Materials: PC and PU (biocompatible per ISO 10993-1). Frequency: 127.728 MHz +/- 0.75 MHz. Decoupling: Overlap, pre-amp, and active/passive PIN diode. Energy: Derived from MR scanner. Dimensions: 538 x 280 x 293 mm. Connectivity: Analog connector mating with dStream Interface. Standards: ANSI AAMI ES60601-1, IEC 60601-2-33, IEC 60601-1-2, IEC 60601-1-6, ISO 14971, IEC 62366-1, NEMA MS 1, MS 3, MS 9, MS 14.

Indications for Use

Indicated for patients requiring MR examination of the knee where the coil provides diagnostic benefit (FOV or SNR). Intended for use on the order of a physician in conjunction with a 3.0T MR scanner to produce diagnostic images.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• HRK-127-8 KNEE ARRAY COIL (K033567)

Submission Summary (Full Text)

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February 5, 2024

Philips Healthcare (Suzhou) Co., Ltd. Sherry Li Regulatory Affairs Specialist No. 258, Zhongyuan Road, Suzhou Industrial Park Suzhou, Jiangsu 215024 China

Re: K233600

Trade/Device Name: Smart Fit Knee 3.0T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: November 3, 2023 Received: November 9, 2023

Dear Sherry Li:

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.

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).

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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 OS 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.

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 (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

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## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

Device Name

Smart Fit Knee 3.0T

Indications for Use (Describe)

The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system to produce diagnostic images of the 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

| Date<br>Prepared: | November 09, 2023 | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. | | | |
| | No. 258, Zhongyuan Road, Suzhou Industrial Park, Suzhou Jiangsu, CHINA, 215024 | | | |
| | Establishment Registration Number: 3009529630 | | | |
| Primary<br>Contact<br>Person: | Sherry Li | | | |
| | Regulatory Affairs Specialist | | | |
| | Phone: [phone] | | | |
| | E-mail: [e-mail] | | | |
| Secondary<br>Contact<br>Person | Leo Louis | | | |
| | Regulatory Affairs Director | | | |
| | Phone: [phone] | | | |
| | E-mail: [e-mail] | | | |
| Device Name: | Smart Fit Knee 3.0T | | | |
| Classification: | Classification name: | Magnetic Resonance Diagnostic Device | | |
| | Classification Regulation: | 21CFR 892.1000 | | |
| | Classification Panel: | Magnetic Resonance Diagnostic Device | | |
| | Device Class: | Class II | | |
| | Primary Product Code: | MOS | | |
| Predicate<br>Device for<br>Smart Fit 3.0T | Trade name: | HRK-127-8 KNEE ARRAY COIL | | |
| | Manufacturer: | MRI Devices Corporation, 1515 Paramount Drive,<br>Waukesha, Wisconsin 53186, U.S.A. | | |
| | 510(k) Clearance: | K033567 | | |
| | Classification Regulation: | 21CFR 892.1000 | | |
| | Classification name: | Magnetic Resonance Diagnostic Device | | |
| | Classification Panel: | Radiology | |…