(60 days)
Not Found
No
The description focuses on the hardware (receive-only coil) and its performance metrics (SNR, uniformity) for image acquisition, with no mention of AI/ML for image processing or interpretation.
No
The device is described as a receive-only coil for producing diagnostic images, not for treating any condition.
No
Explanation: The device is a receive-only coil for an MRI system, which produces images. It is not an image analysis device that interprets or diagnoses. The diagnostic interpretation is performed by a trained physician.
No
The device description explicitly states it is a "receive-only, 12-channel phased array coil," which is a hardware component used in MRI systems.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Contour Knee is an MRI coil. Its function is to receive radiofrequency signals from the body during an MRI scan to create images of the knee. It does not analyze biological specimens.
- Intended Use: The intended use is to "produce diagnostic images of knee anatomy." This is a function of an imaging device, not an IVD.
- Device Description: The description clearly states it's a "receive-only, 12-channel phased array coil designed for magnetic resonance imaging (MRI)."
The information provided describes a component used in an imaging system (MRI), which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Contour Knee is intended for use with Siemens 0.55T MR systems to produce diagnostic images of knee anatomy that can be interpreted by a trained physician.
Product codes
MOS
Device Description
The Contour Knee is a receive-only, 12-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 0.55T MR systems. The Contour Knee is intended to be used for imaging knee anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
knee anatomy
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
The signal-to-noise ratio (SNR) and image uniformity of the Contour Knee were measured on a 0.55T Siemens MR System, manufactured by Siemens Healthineers. The SNR and uniformity of the Contour Knee were analyzed per NEMA MS-9 (using alternate method 2.5 from MS-6) and uniformity was analyzed using NEMA MS-9 (primary method from MS-6) and was found to conform to predetermined acceptance criteria.
In accordance with the FDA Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, clinical images from volunteer scanning of knee anatomy were obtained from a Siemens 0.55T MR system. These images were used to demonstrate that the Contour Knee produces diagnostic quality images of the intended anatomy. No adverse events were reported or recorded.
The electrical safety and electromagnetic compatibility data support the safety of the Contour Knee and the bench testing per the IEC standards and diagnostic quality sample clinical images demonstrates the performance and the device under the specified use conditions. This testing demonstrates that the Contour Knee performs as well as or better than the predicate device.
Key Metrics
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 acronym along with the full name of the agency on the right. The FDA acronym is in blue, and the full name of the agency, "U.S. Food & Drug Administration," is in a smaller font size below the acronym.
January 13, 2023
Quality Electrodynamics, LLC Eric Yeh Senior Regulatory Affairs Specialist 6655 Beta Drive Suite 100 Mayfield Village, Ohio 44143
Re: K223429
Trade/Device Name: Contour Knee Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: November 11, 2022 Received: November 14, 2022
Dear Eric Yeh:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
D. G. K.
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 Quality Center for Devices and Radiological Health
Enclosure
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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
Contour Knee
Indications for Use (Describe)
The Contour Knee is intended for use with Siemens 0.55T MR systems to produce diagnostic images of knee anatomy 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| K223429 | 510(k) Summary | Prepared on: 2023-01-12 | |
|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | Quality Electrodynamics, LLC | ||
| Applicant Address | 6655 Beta Drive, Suite 100 Mayfield Village OH 44143 United States | ||
| Applicant Contact Telephone | 440-484-2940 | ||
| Applicant Contact | Mr. Eric Yeh | ||
| Applicant Contact Email | eric.yeh@qualedyn.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | Contour Knee | ||
| Common Name | Magnetic resonance diagnostic device | ||
| Classification Name | Coil, Magnetic Resonance, Specialty | ||
| Regulation Number | 892.1000 | ||
| Product Code | MOS | ||
| Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K183111 | Contour 24 | MOS | |
| Device Description Summary | 21 CFR 807.92(a)(4) | ||
| The Contour Knee is a receive-only, 12-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 0.55T MR systems. The Contour Knee is intended to be used for imaging knee anatomy. | |||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | ||
| The Contour Knee is intended for use with Siemens 0.55T MR systems to produce diagnostic images of knee anatomy that can be interpreted by a trained physician. | |||
| Indications for Use Comparison | 21 CFR 807.92(a)(5) | ||
| The Indications for Use statement for the Contour Knee is not identical to that of the predicate device (Contour 24); however, the differences do not affect the safety or effectiveness of the device relative to the predicate device. Both Indications for Use statements for the proposed Contour Knee and predicate Contour 24 indicate that the device is intended to be used in conjunction with a MR system to produce images of human anatomy and that the images can be interpreted by a trained physician. The indications for use statements differ only in that the proposed Contour Knee is intended to be used with 0.55T Siemens MR systems instead of 1.5T Siemens MR systems, and intended for use to image knee anatomy instead of general human anatomy. | |||
| Technological Comparison | 21 CFR 807.92(a)(6) | ||
| At a high level, the proposed and predicate device are based on the following same technological elements: Receive-only phased array RF coilActive PIN diode switching blocking circuitry. Passive blocking circuitry. |
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· Materials used for flame retardancy and biocompatibility: Polycarbonate and aramid felt with a polyurethane coated nylon fabric cover
The following technological differences exist between the proposed and predicate device:
· Number of channels (12 (proposed device) versus 24 (predicate device))
· Intended for use (knee anatomy (proposed device) versus general human anatomy (predicate device))
· Flexible blanket-like enclosure for anterior coil elements, rigid plastic housing for posterior coil elements (proposed device) versus flexible blanket-like enclosure (predicate device))
· Compatible with Siemens 0.55T MR systems (proposed device) versus compatible with Siemens (predicate device)
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The signal-to-noise ratio (SNR) and image uniformity of the Contour Knee were measured on a 0.55T Siemens MR System, manufactured by Siemens Healthineers. The SNR and uniformity of the Contour Knee were analyzed per NEMA MS-9 (using alternate method 2.5 from MS-6) and uniformity was analyzed using NEMA MS-9 (primary method from MS-6) and was found to conform to predetermined acceptance criteria.
In accordance with the FDA Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, clinical images from volunteer scanning of knee anatomy were obtained from a Siemens 0.55T MR system. These images were used to demonstrate that the Contour Knee produces diagnostic quality images of the intended anatomy. No adverse events were reported or recorded.
The electrical safety and electromagnetic compatibility data support the safety of the Contour Knee and the bench testing per the IEC standards and diagnostic quality sample clinical images demonstrates the performance and the device under the specified use conditions. This testing demonstrates that the Contour Knee performs as well as or better than the predicate device.