MRI COMPATIBLE BIOPSY NEEDLES by MANAN MEDICAL PRODUCTS, INC.

MRI Chiba Needle, MRI Spinal Needle, MRI Automatic Cutting Needle, MRI General Purpose Introducer Needle, MRI Techna-Cut Biopsy Needle, MRI Super-Core Biopsy Needle, MRI Breast Localization Needle, and MRI Simon Breast Localization Needle

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a set of MRI-compatible needles. It states that the devices are substantially equivalent to devices marketed prior to May 28, 1976. This type of clearance does not require the submission of clinical study data demonstrating specific performance criteria or a study proving the device meets those criteria.

Therefore, based solely on the provided text, the following information cannot be extracted:

A table of acceptance criteria and the reported device performance: Not provided. The 510(k) clearance simply asserts substantial equivalence, not specific performance metrics.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
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: Not applicable. This is for medical devices, specifically needles, and not an AI or imaging diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for medical devices, specifically needles, and not an AI or imaging diagnostic device.
The type of ground truth used: Not applicable, as there's no study described for performance evaluation.
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Summary based on the provided document:

The document is an FDA 510(k) clearance letter confirming that the listed MRI needles are substantially equivalent to predicate devices already on the market. It does not contain information about specific acceptance criteria, performance studies, or clinical trial data that would be relevant to evaluating new performance claims for an AI or diagnostic device. The clearance is based on the devices being comparable to existing ones, rather than demonstrating novel performance against defined criteria through a study.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Michael Plishka ·New Product Development Manan Medical Products, Inc. 2200 Carlson Drive Northbrook, Illinois 60062

OCT - 9 1997

Re: K962977

Trade Name: MRI Chiba Needle, MRI Spinal Needle, MRI Automatic Cutting Needle, MRI General Purpose Introducer Needle, MRI Techna-Cut Biopsy Needle, MRI Super-Core Biopsy Needle, MRI Breast Localization Needle, and MRI Simon Breast Localization Needle Regulatory Class: II Product Code: KNW Dated: August 26, 1997 Received: September 2, 1997

Dear Mr. Plishka:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions

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Page 2 - Mr. Michael Plishka

does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

S. - Galix M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K962977 510(K) Number (if known):

Device Name:

MRI Chiba Needle MRI Spinal Needle MRI Automatic Cutting Needle MRI General Purpose Introducer Needle MRI Techna-Cut Biopsy Needle MRI Super-Core Biopsy Needle MRI Breast Localization Needle MRI Simon Breast Localization Needle

Indications For Use:

Needles can be used in MRI, Flouroscopic, CT and Mammographic procedures for obtaining biopsies of various tissues.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
(Per 21 CFR 801.109)

Over-The-Counter Use	_________________
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(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices	K2162977
510(k) Number

page I V

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.