(30 days)
No
The 510(k) summary describes a mechanical biopsy instrument and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is used to obtain tissue samples for diagnostic purposes, not to treat a disease or condition.
No
Explanation: The device is a biopsy instrument used for obtaining tissue samples. While these samples are then used for diagnosis, the instrument itself is a tool for sample collection, not for performing the diagnostic analysis or interpretation.
No
The device description clearly identifies it as a "Disposable Automatic Biopsy Instrument," which is a physical, hardware-based device used for obtaining tissue samples. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro) to analyze these samples.
- Device Function: The Tru-Core™ Disposable Automatic Biopsy Instrument is used to obtain the tissue samples from the body. It is a tool for collecting the sample, not for analyzing it.
- Intended Use: The intended use clearly states it's for "obtaining multiple core samples from soft tissue." This is a sample collection function, not a diagnostic test performed on a sample.
The device is a surgical instrument used for biopsy, which is a procedure to collect tissue for later diagnostic testing (which would involve IVDs).
N/A
Intended Use / Indications for Use
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.
Product codes
78 KNW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 biopsy
needles. | |
|-----------------------------|------------------------------------------------------------------|------------|
| 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:
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.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three human profiles incorporated into its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
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
2
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
Page_1_of_1_
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MD Tech Tru-Core™ Disposable Automatic Biopsy Instrument
Indications for Use:
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.
(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) | |
|---|---|
| --------------------------------------- | -- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format)A member of The
Group of companies
(Optional Format 1-2-96) .
}