(93 days)
Not Found
No
The summary describes a passive hardware component (an MR coil) and does not mention any software or algorithms that would utilize AI/ML for image processing or analysis.
No
The device is described as producing "diagnostic images" and is used for "imaging Shoulder anatomy," indicating its purpose is for diagnosis, not treatment.
No
The device is a receive-only coil for MRI systems, designed to produce diagnostic images. It is not the diagnostic device itself but rather a component used in the diagnostic imaging process.
No
The device description explicitly states it is a "receive-only, 12-channel phased array coil" with physical components like a rigid plastic housing and flexible wing coil elements, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Contour Shoulder is a receive-only coil for Magnetic Resonance Imaging (MRI). It is a component used in an imaging system to produce diagnostic images of the shoulder anatomy. It does not analyze samples taken from the body.
- Intended Use: The intended use is to "produce diagnostic images of shoulder anatomy," which is a function of an imaging device, not an IVD.
- Device Description: The description details a physical coil used in an MRI system, not a test kit or analytical instrument for biological samples.
Therefore, the Contour Shoulder falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Contour Shoulder is intended for use with Siemens 0.55T MR systems to produce diagnostic images of shoulder anatomy that can be interpreted by a trained physician.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The Contour Shoulder is a receive-only, 12-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 0.55T MR systems. The Contour Shoulder is intended to be used for imaging Shoulder anatomy.
The Contour Shoulder is a reusable, non-invasive device with regard to duration of contact with the body. The central coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and has been tested for biocompatibility. The flexible wing coll elements are encapsulated in polycarbonate and aramid felt which is fire-rated, has impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Shoulder anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The signal-to-noise ratio (SNR) and image unifornity of the Contour Shoulder were measured on a 0.55T Siemens MR System, manufactured by Siemens Healthineers. The SNR and uniformity of the Contour Shoulder 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.
Clinical images from volunteer scanning of shoulder anatomy were obtained from a Siemens 0.55T MR system. These images were used to demonstrate that the Contour shoulder 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 Shoulder 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 Shoulder performs as well as or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Signal-to-noise ratio (SNR) and image uniformity.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains 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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 15, 2024
Quality Electrodynamics JoVanna Boudreaux Quality/Regulatory Engineer 6655 Beta Drive Suite 100 Mayfield Heights, Ohio 44143
Re: K233656
Trade/Device Name: Contour Shoulder 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).
1
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,
signature
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
Submission Number (if known)
Device Name
Contour Shoulder
Indications for Use (Describe)
The Contour Shoulder is intended for use with Siemens 0.55T MR systems to produce diagnostic images of shoulder 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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3
| 510(k) #: | K233656 |
|---|---|
| ----------- | --------- |
510(k) Summary
| Prepared on: 2024-01-17 | |
|---|---|
| Contact Details | 21 CFR 807.92(a)(1) |
| Applicant Name | Quality Electrodynamics |
| Applicant Address | 6655 Beta Drive Ste 100 Mayfield Heights 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 Shoulder (Q7000222) |
| 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
| 21 CFR 807.92(a)(4) | |
|---|---|
| -- | --------------------- |
The Contour Shoulder is a receive-only, 12-channel phased array coil designed for magnetic resonance imaging (MRJ) using the Siemens 0.55T MR systems. The Contour Shoulder is intended to be used for imaging Shoulder anatomy.
The Contour Shoulder is a reusable, non-invasive device with regard to duration of contact with the body. The central coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and has been tested for biocompatibility. The flexible wing coll elements are encapsulated in polycarbonate and aramid felt which is fire-rated, has impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.
Intended Use/Indications for Use
The Contour Shoulder is intended for use with Siemens to produce diagnostic images of shoulder anatomy that can be interpreted by a trained physician.
Indications for Use Comparison
The Indications for Use statement for the Contour Shoulder is not identical to that of the predicate device (Contour Kne); however, the differences do not affect the safety or effectiveness of the predicate device. Both Indications for Use statements for the proposed Contour Shoulder 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 intended for use is to image shoulder anatomy instead of knee anatomy.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
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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 (shoulder anatomy (proposed device) versus knee anatomy (predicate device))
· Flexible wing coil elements are encapsulate, polyimide and aramid felt (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 unifornity of the Contour Shoulder were measured on a 0.55T Siemens MR System, manufactured by Siemens Healthineers. The SNR and uniformity of the Contour Shoulder 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. See attached bench testing results.
In accordance with the FDA Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, clinical images from volunteer scanning of shoulder anatomy were obtained from a Siemens 0.55T MR system. These images were used to demonstrate that the Contour shoulder produces diagnostic quality images of the intended anatomy. No adverse events were reported or recorded. The parameters used to obtain the clinical images for the Contour Shoulder, clinical images for the Contour Shoulder, and images also provided in the native DICOM format are attached.
The electrical safety and electromagnetic compatibility data support the safety of the Contour Shoulder 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 Shoulder performs as well as or better than the predicate device.