(60 days)
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.
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.
The document K223429 outlines the Contour Knee, a 12-channel phased array coil designed for magnetic resonance imaging (MRI) of knee anatomy using Siemens 0.55T MR systems.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Signal-to-Noise Ratio (SNR) | Conform to predetermined acceptance criteria (specific quantitative criteria not provided in the document, but implicitly met for diagnostic quality). Method: NEMA MS-9 (using alternate method 2.5 from MS-6). | The SNR of the Contour Knee was measured and found to conform to predetermined acceptance criteria, implicitly demonstrating adequate signal quality for diagnostic purposes. |
| Image Uniformity | Conform to predetermined acceptance criteria (specific quantitative criteria not provided in the document, but implicitly met for diagnostic quality). Method: NEMA MS-9 (primary method from MS-6). | The uniformity of the Contour Knee was measured and found to conform to predetermined acceptance criteria, implicitly demonstrating consistent image quality across the scanned area for diagnostic purposes. |
| Diagnostic Image Quality | The Contour Knee must produce diagnostic quality images of the intended knee anatomy that can be interpreted by a trained physician. | 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. The images were presumably interpreted by trained physicians (implied by the "intended for use" statement in the Indications for Use). No adverse events were reported or recorded during this testing. |
| Electrical Safety | Compliance with relevant electrical safety standards. | Electrical safety data support the safety of the Contour Knee. Bench testing was performed per IEC standards, demonstrating compliance. |
| Electromagnetic Compatibility (EMC) | Compliance with relevant EMC standards. | Electromagnetic compatibility data support the safety of the Contour Knee. Bench testing was performed, demonstrating compliance. |
| Comparison to Predicate Device | The Contour Knee performs as well as or better than the predicate device (Contour 24). | The testing performed (bench testing and diagnostic quality sample clinical images) demonstrates that the Contour Knee performs as well as or better than the predicate device. This is based on the technical changes and the successful fulfillment of functional and performance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "clinical images from volunteer scanning of knee anatomy were obtained."
- Sample Size: Not explicitly stated for the "volunteer scanning." It refers to "sample clinical images," implying a limited but representative set, rather than a large cohort. It does not provide specific numbers of volunteers or images.
- Data Provenance: The data was obtained from "a Siemens 0.55T MR system." The country of origin is not specified but is implied to be where Quality Electrodynamics, LLC conducts its testing. The data is prospective in nature, as it involves active "volunteer scanning" with the device for the purpose of demonstrating diagnostic quality.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The indication for use states that the images "can be interpreted by a trained physician." This implies that the images demonstrating diagnostic quality were assessed by at least one, and likely more, trained physicians. No specific specialties (e.g., radiologist) or years of experience are provided, but "trained physician" is a general qualification required for interpreting medical images.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The assessment of diagnostic quality appears to be based on the general ability of the images to be interpreted by a trained physician, rather than a multi-reader consensus process.
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
- No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was reported or indicated.
- The Contour Knee is a hardware device (an MRI coil) and not an AI/software device. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable to this product. The study focused on the coil's ability to produce diagnostic quality images compared to a predicate device, not on diagnostic accuracy improvements for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No standalone (algorithm-only) performance was done.
- As noted above, this is an MRI coil, not an algorithm or AI. Its performance is inherent in the quality of the raw images it produces.
7. The Type of Ground Truth Used
The ground truth for the device's performance was established via:
- Bench Testing: For SNR, uniformity, electrical safety, and EMC, the ground truth was based on objective measurements against established engineering standards (NEMA MS-9, IEC standards).
- Expert Interpretation: For diagnostic image quality, the ground truth was based on the ability of "trained physicians" to interpret the images of knee anatomy, implying a subjective assessment of diagnostic interpretability by medical professionals. This is a form of expert consensus/opinion, though a formal consensus process is not detailed. There is no mention of pathology or outcomes data being used as ground truth.
8. The Sample Size for the Training Set
No information about a "training set" is provided. Since this is an MRI coil and not an AI or machine learning algorithm, the concept of a training set is not applicable. The device's design and engineering would be based on physical principles, not data-driven training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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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| 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.
§ 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.