MANAN LIVER BIOPSY KIT by MEDICAL DEVICE TECHNOLOGIES, INC.

The provided text describes a 510(k) premarket notification for the Manan™ Liver Biopsy Kit, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the way an AI/ML medical device submission would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are not applicable to this type of device and submission.

Here's a breakdown of the available information based on your request, highlighting what is not applicable:

1. A table of acceptance criteria and the reported device performance

For a traditional medical device like a biopsy kit, acceptance criteria are generally related to its physical characteristics, functionality, material compatibility, and sterile packaging. The provided document, a 510(k) summary, does not detail these specific criteria or their performance validation tests. Instead, it relies on demonstrating substantial equivalence to a predicate device already on the market.

Acceptance Criteria Category	Reported Device Performance (as implied by 510(k) submission)
Functionality	"used for obtaining liver biopsies or for other biopsies of soft tissue" (Indications for Use). Assumed to function similarly to the predicate device Manan Medical Products Liver Biopsy Kit (K943650).
Device Design	"composed of a cutting biopsy needle based upon the Menghini cutting tip geometry that is fitted to a locking syringe." Assumed to be sufficiently similar to the predicate device.
Materials	Not explicitly stated, but implied to be suitable for medical use and substantial equivalence.
Sterility	Not explicitly stated, but expected for a biopsy kit. Compliance with "general controls provisions of the Act" and "Good Manufacturing Practice requirements" (21 CFR Part 820) implies sterility considerations.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This 510(k) submission does not describe a clinical study with a test set of data in the context of an AI/ML device. Substantial equivalence for this type of device is typically demonstrated through engineering tests, biocompatibility assessments, and comparisons of physical characteristics and intended use to a legally marketed predicate device, rather than performance on a clinical "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. There is no "ground truth" establishment in the context of a clinical test set for this device as it's not an AI/ML diagnostic tool.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set or expert adjudication in this context.

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

Not Applicable. This is a physical biopsy kit, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. Not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No ground truth in the context of an AI/ML evaluation. The "ground truth" for a device like this is its physical and functional attributes meeting design specifications and being suitable for its intended use, which is assessed through bench testing and often comparison to an already approved predicate.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so no training set is involved.

9. How the ground truth for the training set was established

Not Applicable. No training set or associated ground truth.

Summary

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AMD

K980452

FEB 1 8 1998

4445-310 S.W. 35th Terrace Gainesville, Florida 32608 Gaillosvillo, FAX: 352/338-0662

510(k) SUMMARY
APPLICANT:	Medical Device Technologies, Inc.4445-310 SW 35th TerraceGainesville, FL 32608
CONTACT:	Karl SwartzQuality Assurance Manager
TELEPHONE:	(352)338-0440fax (352)338-0662
TRADE NAMES:	Manan™ Liver Biopsy Kit
COMMON NAME:	Menghini type biopsy needle with a locking syringe
CLASSIFICATION NAME:	§878.4800-Manual Surgical Instrument for General UseDisposable Aspiration and Injection Needle
SUBSTANTIAL EQUIVALENCE:
Company Name	Product Name	510(k) No.
Manan Medical Products	Liver Biopsy Kit	K943650

DESCRIPTION OF DEVICE:

The Manan Liver Biopsy Kit is composed of a cutting biopsy needle based upon the Menghini cutting tip geometry that is fitted to a locking syringe.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 1998

Mr. Karl Swartz Quality Assurance Manager Medical Device Technologies, Incorporated 4445-310 SW 35th Terrace Gainesville, Florida 32608

Re: K980452 Trade Name: Manan™ Liver Biopsy Kit Regulatory Class: II Product Code: KNW Dated: February 4, 1998 Received: February 5, 1998

Dear Mr. Swartz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 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 (Premarket Approval), 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 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 device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for

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Page 2 - Mr. Swartz

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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 device, 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,

Authority, years,

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

Enclosure

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4445-310 S.W. 35th T Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Manan™ Liver Biopsy Kit

Indications for Use:

The Manan™ Liver Biopsy Kit is used for obtaining liver biopsies or for other biopsies of soft tissue.

(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_

cotter

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980452

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.