(32 days)
Not Found
No
The 510(k) summary describes a mechanical biopsy instrument and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
This device is described as a "biopsy instrument" used for obtaining tissue samples, which is a diagnostic procedure, not a therapeutic one. It is used to aid in diagnosis rather than to treat a condition.
No
The device is described as an instrument for obtaining tissue samples, not for diagnosing. It is a tool for sample collection, which is a precursor to diagnosis, but not a diagnostic device itself.
No
The device description clearly states it is a "Disposable Semi-Automatic Biopsy Instrument," which is a physical, hardware device used for obtaining tissue samples. There is no mention of software as the primary or sole component.
Based on the provided information, the Tru-Core™ Disposable Semi-Automatic Biopsy Instrument is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The Tru-Core™ instrument is used to obtain the tissue samples from the body. It is a tool for collecting the specimen, 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.
Therefore, the Tru-Core™ Disposable Semi-Automatic Biopsy Instrument is a medical device used for sample collection, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
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.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows a 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 letters are stacked on top of each other, with the "MD" on top and the "TECH" below. Below the letters, the words "MEDICAL DEVICE TECHNOLOGIES INC" are written in a smaller font.
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.
1
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 symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
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.
2
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
3
Image /page/3/Picture/0 description: The image shows a logo with the letters "MD" in white against a black background. The letters are bold and stylized, with horizontal lines running through them. The logo has rounded corners, giving it a modern appearance.
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)