Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T

K232021 · Philips Healthcare (Suzhou) Co., Ltd. · MOS · Sep 1, 2023 · Radiology

Device Facts

• Record ID: K232021
• Device Name: Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
• Applicant: Philips Healthcare (Suzhou) Co., Ltd.
• Product Code: MOS · Radiology
• Decision Date: Sep 1, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Smart Fit TorsoCardiac 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the torso (including chest, abdomen, pelvis), head and neck and heart that can be interpreted by a trained physician. The Smart Fit Shoulder 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the Shoulder that can be interpreted by a trained physician.

Device Story

Phased-array receive-only RF coils for 1.5T MRI systems. Inputs: magnetic resonance signals from hydrogen nuclei in patient anatomy. Operation: coils receive RF signals, which are amplified and transmitted to the MRI system for image reconstruction. Used in clinical settings by trained physicians/technicians. Output: diagnostic cross-sectional images of torso, head, neck, heart, or shoulder. Assists physicians in diagnosis and therapy planning. Benefits: high-resolution imaging of specific anatomical regions.

Clinical Evidence

No clinical study was required. Substantial equivalence was established through non-clinical bench testing and comparison to predicate devices. Clinical images obtained using the coils were evaluated by qualified radiologists, confirming sufficient image quality for diagnostic use.

Technological Characteristics

Phased-array receive-only RF coils. Materials: PU foil, flexible PCB, EVA foam. Sensing: RF signal reception via phased-array elements. Energy: derived from MR scanner (no internal source). Connectivity: analog connector to dS Interface boxes. Standards: IEC 60601-1, IEC 60601-2-33, ISO 10993-1, NEMA MS series. Biocompatibility: ISO 10993-1 compliant for limited contact (<24h) with intact skin.

Indications for Use

Indicated for patients requiring MR examination of the torso (chest, abdomen, pelvis), head, neck, heart, or shoulder, where the coil provides diagnostic benefit in terms of Field of View or Signal-to-Noise ratio. Contraindications include physical characteristics (circumference, mass) exceeding system/coil capabilities and standard MR safety contraindications.

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

• dS TorsoCardiac 1.5T (K212864)
• 1.5T 16 CH GE Shoulder Coils (K162001)

Submission Summary (Full Text)

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September 1, 2023

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

Re: K232021

Trade/Device Name: Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: June 12, 2023 Received: July 7, 2023

Dear Li Sherry:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,

D

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

Submission Number (if known)

K232021

Device Name

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T

#### Indications for Use (Describe)

The Smart Fit TorsoCardiac 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the torso (including chest, abdomen, pelvis), head and neck and heart that can be interpreted by a trained physician.

The Smart Fit Shoulder 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the Shoulder 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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K232021

510(k) Summary of Safety and Effectiveness

[As required by 21 CFR 807.92(c)]

| [As required by 21 CFR 807.92(c)] | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Date<br>Prepared: | July 04, 2023 | | | |
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd.<br>No. 258, Zhongyuan Road, Suzhou Industrial Park, Suzhou Jiangsu, CHINA, 215024<br>Establishment Registration Number: 3009529630 | | | |
| Primary<br>Contact<br>Person: | Sherry Li<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>E-mail: [e-mail] | | | |
| Secondary<br>Contact<br>Person | Erhong Wang<br>Senior Manager Regulatory Affairs<br>Phone: [phone]<br>E-mail: [e-mail] | | | |
| Device Name: | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | | | |
| 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<br>TorsoCardiac<br>1.5T | Trade name: | dS TorsoCardiac 1.5T | | |
| | Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. | | |
| | 510(k) Clearance: | K212864 | | |
| | Classification Regulation: | 21CFR 892.1000 | | |
| | Classification name: | Magnetic Resonance Diagnostic Device | | |
| | Classification Panel: | Radiology | | |
| | Device class<br>Product Code: | Class II<br>MOS | | |
| Predicate<br>Device for<br>Smart Fit<br>Shoulder 1.5T | Trade name: | 1.5T 16 CH GE Shoulder Coils | | |
| | Manufacturer: | InVivo Corporation | | |
| | 510(k) Clearance: | K162001 | | |
| | Classification Regulation: | 21CFR 892.1000 | | |
| | Classification name: | Magnetic Resonance Diagnostic Device | | |
| | Classification Panel: | Radiology | | |
| | Device class<br>Product Code: | Class II<br>MOS |…