MODIFICATION TO HRW-127 WRIST ARRAY COIL

• K Number: K040349
• Device Name: MODIFICATION TO HRW-127 WRIST ARRAY COIL
• Manufacturer: MRI DEVICES CORP.
• Date Cleared: 2004-03-09 ( 26 days)
• Product Code: MOS
• Regulation Number: 892.1000
• Type: Special
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician.

Device Description

Model HRW-127 Wrist Array Coil

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "Model HRW-127 Wrist Array Coil." This letter confirms that the device is "substantially equivalent" to legally marketed predicate devices.

Crucially, this document is an FDA clearance letter and does not contain the detailed study information, acceptance criteria, or performance data that would be found in a submission dossier or a scientific publication. The FDA letter is the result of the review process, not the detailed content of the review itself.

Therefore, based solely on the provided text, I cannot answer most of your questions as the information is not present.

Here's what I can and cannot infer from the given text:

What can be inferred from the text:

• Device Name: Model HRW-127 Wrist Array Coil
• Regulation Number: 21 CFR 892.1000 (Magnetic resonance diagnostic device)
• Regulatory Class: II
• Product Code: 90 MOS
• Indications for Use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician."
• Type of Use: Prescription Use
• 510(k) Number: K040349
• Clearance Date: March 9, 2004

What cannot be inferred from the text (and why):

1. A table of acceptance criteria and the reported device performance: This information would be in the device manufacturer's 510(k) submission, not the FDA clearance letter. The letter simply states that the FDA found the device "substantially equivalent."
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs. without AI assistance: This device is a "Wrist Array Coil," which is hardware for an MRI scanner. It's not an AI algorithm. Therefore, an MRMC study comparing human readers with/without AI assistance is not applicable to this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as it's not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
8. The sample size for the training set: Not mentioned (and likely not applicable in the same way an AI model has a "training set," as this is a hardware device).
9. How the ground truth for the training set was established: Not mentioned.

To get the answers to these questions, you would need to access the original 510(k) submission documentation for K040349, which often contains performance data, bench testing results, and potentially clinical data depending on the device and predicate. This information is typically proprietary or only available in heavily redacted forms through FOIA requests.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 2004

Mr. Thomas Schubert President MRI Devices Corporation 1515 Paramount Drive WAUKESHA WI 53186

Re: K040349 Trade/Device Name: Model HRW-127 Wrist Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: February 11, 2004 Received: February 12, 2004

Dear Mr. Schubert:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section C - Statement of Indications for Use:

Indications for Use

510(k) number (if known): $ 0 4 0 3 49 Model HRW-127 Wrist Array Coil Device Name:

Indications for use:

To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Hodgson

(Division Sign-Off) Division of Reproductive. A and Radiological Devices 510(k) Number

Regulation Number and Section

§ 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.