(94 days)
The Contour Hand/Wrist is intended for use with Siemens 0.55T MR systems to produce diagnostic images of hand and wrist anatomy that can be interpreted by a trained physician.
The Contour Hand/Wrist is a receive-only, 12-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 0.55T MR systems. The Contour Hand/Wrist is intended to be used for imaging hand and wrist anatomy.
The provided text describes a 510(k) premarket notification for a medical device called "Contour Hand/Wrist (Q7000232)," which is a magnetic resonance (MR) diagnostic device. The documentation focuses on demonstrating substantial equivalence to a legally marketed predicate device, the "Contour Knee." However, it does not contain the detailed information required to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them, particularly for a software-based AI device.
The device described, "Contour Hand/Wrist," is a hardware component (a receive-only, 12-channel phased array coil) for an MRI system, not an AI software. The performance testing mentioned (SNR, uniformity, image quality) is typical for MR coils, not AI algorithms.
Therefore, many of your specific questions, especially those related to AI algorithm performance (e.g., MRMC study, standalone algorithm performance, AI assistance effect size, training set details, ground truth for AI) cannot be answered from this document.
However, I can extract information relevant to the device's performance assessment as described:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, the acceptance criteria are related to the physical characteristics and imaging performance of the MRI coil. The document states:
| Criteria Category | Acceptance Criteria (Stated) | Reported Device Performance (Implied/Stated) |
|---|---|---|
| Signal-to-Noise Ratio (SNR) | Pre-determined acceptance criteria per NEMA MS-9 (using alternate method 2,5 from MS-6) | "The SNR... were measured... and analyzed per NEMA MS-9... This testing demonstrates that the Contour Hand/Wrist performs as well as or better than the predicate device." |
| Image Uniformity | Pre-determined acceptance criteria per NEMA MS-9 (primary method from MS-6) | "Uniformity was analyzed using NEMA MS-9... This testing demonstrates that the Contour Hand/Wrist performs as well as or better than the predicate device." |
| Diagnostic Image Quality | Produce diagnostic quality images of the intended anatomy (hand/wrist) | "Clinical images from volunteer scanning of hand/wrist anatomy were obtained... These images were used to demonstrate that the Contour Hand/Wrist produces diagnostic quality images of the intended anatomy." |
| Electrical Safety | Compliance with IEC standards | "The electrical safety... data support the safety of the Contour Hand/Wrist and the bench testing per the IEC standards..." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC standards | "The... electromagnetic compatibility... data support the safety of the Contour Hand/Wrist and the bench testing per the IEC standards..." |
| Biocompatibility | Compliance with standards (implied) | "The... biocompatibility data support the safety of the Contour Hand/Wrist..." |
| Adverse Events | No adverse events reported/recorded | "No adverse events were reported or recorded." |
2. Sample size used for the test set and the data provenance:
- Test Set (Clinical Images): The document states "clinical images from volunteer scanning of hand/wrist anatomy were obtained." It does not specify the sample size (number of volunteers or images).
- Data Provenance: The images were obtained from a Siemens 0.55T MR system in an unspecified location (likely the manufacturer's facility or a collaborating site). The document does not explicitly state if it was retrospective or prospective, but "volunteer scanning" implies prospective collection for the test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in the AI Sense: This device is an MRI coil, not an AI algorithm that produces interpretations needing expert ground truth. The "diagnostic quality images" verification is implicitly against the expectation that a "trained physician" can interpret them.
- The document states the images "can be interpreted by a trained physician," implying the assessment of 'diagnostic quality' is based on the inherent ability of the images to be interpretable by medical professionals, rather than a comparison to a pre-established ground truth for specific pathologies. No explicit number of experts or their qualifications for assessing image quality are provided.
4. Adjudication method for the test set:
- Not Applicable: There is no indication of an adjudication method as would be used for clinical endpoints or AI algorithm performance assessment. The "diagnostic image quality" evaluation seems to be a qualitative assessment based on the technical characteristics of the images produced by the coil.
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: This is not an AI device. No MRMC study was conducted or is applicable for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is a hardware component. It does not perform as a standalone algorithm.
7. The type of ground truth used:
- Implied Technical / Interpretability Ground Truth: For the "diagnostic image quality," the ground truth is the inherent quality, clarity, and detail present in the images that allows a "trained physician" to make a diagnosis. It's not a ground truth for specific disease presence, but rather for imaging capability. For SNR and Uniformity, the ground truth is the NEMA MS-9 standard.
8. The sample size for the training set:
- Not Applicable: This is not an AI device. There is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable: As above, no training set for AI.
In summary, this document is a 510(k) for an MRI hardware coil, not an AI diagnostic software. Therefore, most of the detailed questions regarding AI acceptance criteria and study design are not addressed and are not relevant to this specific premarket notification. The study described focuses on demonstrating the technical performance (SNR, uniformity) and diagnostic image quality of the MR coil itself.
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February 16, 2024
Quality Electrodynamics Jovanna Boudreaux Quality/Regulatory Engineer 6655 Beta Drive, Suite 100 Mayfield Village, Ohio 44143
Re: K233652
Trade/Device Name: Contour Hand/Wrist (07000232) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: January 18, 2024 Received: January 18, 2024
Dear JoVanna Boudreaux:
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 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.
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 (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 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: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
| Contour Hand/Wrist (Q7000232) | |
|---|---|
| ------------------------------- | -- |
Indications for Use (Describe)
The Contour Hand/Wrist is intended for use with Siemens 0.55T MR systems to produce diagnostic images of hand and wrist 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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510(k) #: K233652
510(k) Summary
Prepared on: 2024-02-16
| Contact Details | 21 CFR 807.92(a)(1) | |
|---|---|---|
| Applicant Name: | Quality Electrodynamics | |
| Applicant Address: | 6655 Beta Drive Suite 100 Mayfield Village OH 44143 United States | |
| Applicant Contact Telephone: | 4404842340 | |
| Applicant Contact: | Mrs. JoVanna Boudreaux | |
| Applicant Contact Email: | jovanna.boudreaux@qualedyn.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name: | Contour Hand/Wrist (Q7000232) | |
| 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 |
| K223429 | Contour Knee | MOS |
Device Description Summary
The Contour Hand/Wrist is a receive-only, 12-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 0.55T MR systems. The Contour Hand/Wrist is intended to be used for imaging hand and wrist anatomy.
Intended Use/Indications for Use
The Contour Hand/Wrist is intended for use with Siemens 0.55T MR systems to produce diagnostic images of hand and wrist anatomy that can be interpreted by a trained physician.
Indications for Use Comparison
The Indications for Use statement for the Contour Hand/Wrist is not identical to that of the predicate device (Contour Knee); however, the differences do not affect the safety or effectiveness of the device relative to the predicate device. Both Indications for the proposed Contour Hand/Wrist and predicate Contour Knee 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 Hand/Wrist is intended for use to image hand and wrist anatomy instead of knee anatomy.
Technological Comparison
At a high level, the proposed and predicate device are based on the following same technological elements:
- Receive-only phased array RF coil
- · Active PIN diode switching blocking circuitry. Passive blocking circuitry.
- 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:
- Intended for use (hand and wrist anatomy (proposed device) versus knee anatomy (predicate device))
21 CFR 807.92(a)(4)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
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• The posterior coil elements are enclosed in a rigid polycarbonate housing with a flexible nylon and aramid fabric (proposed device) versus flexible blanket-like enclosure for anterior coil elements, rigid plastic housing for posterior coil elements (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 Hand/Wrist were measured on a 0.55T Siemens MR System, manufactured by Siemens Healthineers. The SNR and uniformity of the Contour Hand/Wrist 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) using pre-determined acceptance criteria.
In accordance with the FDA Guidance for Industry: Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, clinical images from volunteer scanning of hand/wrist anatomy were obtained from a Siemens 0.55T MR system. These images were used to demonstrate that the Contour Hand/Wrist produces diagnostic quality images of the intended anatomy. No adverse events were reported or recorded.
The electrical safety and electromagnetic compatibility and biocompatibility data support the safety of the Contour Hand/Wrist and the bench testing per the IEC standards and diagnostic quality sample clinical images demonstrates the performance and effectiveness of the device under the specified use conditions. This testing demonstrates that the Contour Hand/Wrist 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.