The Tru-Core™ Disposable Automatic Biopsy Instrument is intended for use in obtaining multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.

Device Description

AI/ML Overview

This document is a 510(k) summary for the Tru-Core™ Disposable Automatic Biopsy Instrument and does not contain information about acceptance criteria or a study proving device performance against acceptance criteria.

The 510(k) summary focuses on the device's substantial equivalence to previously marketed devices and its intended use. It does not include details on:

A table of acceptance criteria and reported device performance.
Sample size or data provenance for a test set.
Number or qualifications of experts for ground truth establishment.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
Type of ground truth used in a performance study.
Sample size for a training set.
How ground truth for a training set was established.

Therefore, I cannot provide the requested information based on the provided text.

Summary

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SEP 2 3 1998

Image /page/0/Picture/1 description: The image shows the logo for MD Tech Medical Device Technologies Inc. The logo is in black and white and features the letters "MD TECH" in a bold, sans-serif font. The words "MEDICAL DEVICE TECHNOLOGIES INC" are printed in a smaller font below the letters "MD TECH". The logo is simple and modern.

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

1982960

510(k) SUMMARY

Medical Device Technologies, Inc. APPLICANT: 4445-310 SW 35th Terrace Gainesville, FL 32608 CONTACT: Karl Swartz Quality Assurance Manager (352)338-0440 TELEPHONE: fax (352)338-0662

TRADE NAMES:Medical Device Technologies, Inc. Tru-Core™ Disposable Automatic Biopsy Instrument

COMMON NAME:	Disposable handle gun for use with disposable biopsyneedles.
CLASSIFICATION NAME:	Instrument, Biopsy, No. 78KNW
SUBSTANTIAL EQUIVALENCE:
Company Name	Product Name	510(k) No.
Medical Device Technologies	Tru-Core	K962969
Medical Device Technologies	Tru-Core Semi-Automatic	K982085

DESCRIPTION OF DEVICE:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 1998

Mr. Karl Swartz Quality Manager Medical Device Technologies, Inc. 4445-310 S.W. 35th Terrace Gainesville, FL 32608

Re: K982960

Tru-Core™ Disposable Automatic Biopsy Instrument Dated: August 20, 1998 Received: August 24, 1998 Regulatory Class: II 21 CFR 876.1075/Procode: 78 KNW

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 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 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 (OS) 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 vour premarket notification submission does not affect any obligation you might have under sections 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 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) 594-4613. 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/cdrb/dsmaldsmamain.html".

Sincerely yours.

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image is a logo for MD Tech Medical Device Technologies Inc. The logo is black and white and features the letters "MD TECH" in a bold, sans-serif font. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC" in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to represent the company's brand.

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

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: MD Tech Tru-Core™ Disposable Automatic Biopsy Instrument

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K982960

Prescription Use (Per 21 CFR 801.109)
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Over-The-Counter Use
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(Optional Format)A member of The

Group of companies

(Optional Format 1-2-96) .

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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.