(32 days)
The Tru-Core™ Disposable Semi-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.
The Tru-Core™ Disposable Semi-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.
The provided document is a 510(k) summary for the MD Tech Tru-Core™ Disposable Semi-Automatic Biopsy Instrument. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of the device's performance against specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in the given text.
The document states: "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...". This signifies that the regulatory approval was based on a comparison to existing devices, not on a new, comprehensive performance study with the details requested.
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445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
JUL 17 1998
982085
510(k) SUMMARY
APPLICANT:
CONTACT:
TELEPHONE:
TRADE NAMES:
COMMON NAME:
Medical Device Technologies, Inc. 4445-310 SW 35th Terrace Gainesville, FL 32608
Karl Swartz Quality Assurance Manager
(352)338-0440 fax (352)338-0662
Medical Device Technologies,Inc. Tru-Core™ Disposable Semi-Automatic Biopsy Instrument
Disposable handle gun for use with disposable biopsy needles.
Instrument, Biopsy, No. 78KNW
SUBSTANTIAL EQUIVALENCE:
CLASSIFICATION NAME:
| Company Name | Product Name | 510(k) No. |
|---|---|---|
| Manan Medical Products | Pro Mag 2.2 | K914874 |
| Medical Device Technologies | Tru-Core | K962969 |
DESCRIPTION OF DEVICE:
The Tru-Core™ Disposable Semi-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.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 1998
Mr. Karl Swartz Quality Assurance Manager Medical Device Technologies, Inc. 4445-310 SW 35th Terrace Gainesville, Florida 32608
Re: K982085 Trade Name: Medical Device Technologies, Inc. Tru-Core ™ Disposable Semi-Automatic Biopsy Instrument Regulatory Class: II Product Code: KNW Dated: June 12, 1998 Received: June 15, 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 mayor 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 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.
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Page 2 -- Mr. Karl Swartz
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,
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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4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
Page 1 of 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: MD Tech Tru-Core™ Disposable Semi-Automatic Biopsy Instrument
Indications for Use:
"
The Tru-Core™ Disposable Semi-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.
(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 General Restorative Devices | |
| 510(k) Number | K982085 |
| Prescription Use | OR | Over-The-Counter Use_ |
|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
§ 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.