HRH-63-8 HEAD ARRAY COIL

• K Number: K013159
• Device Name: HRH-63-8 HEAD ARRAY COIL
• Manufacturer: MRI DEVICES CORP.
• Date Cleared: 2001-10-16 ( 25 days)
• Product Code: MOS
• Regulation Number: 892.1000
• Type: Special
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: K022669 , K060758 , K091546 , K110591

Intended Use

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

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text only contains an FDA 510(k) clearance letter for the "HRH-63-8 Head Array Coil." It states that the device is substantially equivalent to legally marketed predicate devices and is intended to "produce diagnostic images of the head, that can be interpreted by a trained physician."

However, the document does NOT contain information about:

1. Acceptance criteria and reported device performance: These details are typically found in the 510(k) submission summary, not the clearance letter.
2. Sample size for the test set and data provenance: Not mentioned.
3. Number of experts and their qualifications for ground truth: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. MRMC comparative effectiveness study: Not mentioned.
6. Standalone (algorithm-only) performance: Not applicable as this is a hardware device (coil).
7. Type of ground truth used: Not applicable as this is a hardware device.
8. Sample size for the training set: Not applicable as this is a hardware device.
9. How ground truth for the training set was established: Not applicable as this is a hardware device.

The FDA clearance letter primarily confirms that the device is legally cleared for marketing based on substantial equivalence, not a detailed performance study with specific metrics and methodologies as requested.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2001

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

Re: K013159

Trade/Device Name: HRH-63-8 Head Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: September 14, 2001 Received: September 21, 2001

Dear Mr. Schubert:

ﻣﺔ ﺗ

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 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 (OS) 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 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 this 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" (21 CFR Part 807.97). 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:

Applicant: MRI Devices Corporation Kol 3159 510(k) number (if known): Model HRH-63-8 Head Array Coil Device Name:

Indications for use:

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

Nancy C Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013159

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

Over-The-Counter Use_

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

3159

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.