(66 days)
Not Found
No
The description focuses on the mechanical operation of a reusable biopsy instrument and its similarity to predicate devices. There is no mention of AI or ML in the intended use, device description, or any other section.
No.
The device is used to obtain tissue samples for evaluation and diagnosis, not to treat a disease or condition.
No
The device is used to obtain tissue samples for "laboratory evaluation and diagnosis." It is not performing the diagnosis itself.
No
The device description clearly outlines a physical, reusable biopsy instrument with a spring-powered handle and disposable needle sets. It describes mechanical actions ("cocked", "fired", "advances forward") and the physical components involved in obtaining tissue samples. There is no mention of software as a component of the device itself.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body to provide information for diagnosis. This device is used to obtain the specimen (tissue sample) from the body.
- The intended use clearly states it's for obtaining core samples from soft tissue. The subsequent laboratory evaluation and diagnosis of the tissue specimen is where an IVD device might be used, but the biopsy instrument itself is a surgical/sampling tool.
- The device description focuses on the mechanical process of tissue acquisition. It describes how the needle set works to cut and retrieve tissue.
- There is no mention of analyzing or testing the tissue within the device. The tissue is retrieved for "laboratory evaluation and diagnosis," which happens after the device has been used.
In summary, this device is a biopsy instrument, which is a tool used to collect a sample for later diagnostic testing, but it does not perform the diagnostic testing itself.
N/A
Intended Use / Indications for Use
The Tru-Core™ I Reusable 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)
78 KNW
Device Description
Our company is presently authorized by the Food and Drug Administration to manufacture a reusable handle gun K962969 that utilizes the same disposable soft tissue biopsy needles as the disposable version of this gun, K982960. This new device has the same operation and firing cycle as the disposable gun, but is intended to be reusable, as in the gun submitted under K962969. This new device will also utilize the same disposable soft tissue biopsy needles.
The biopsy needle is guided into position utilizing external guidance (Ultrasound, Mammography, etc.). The device consists of a spring powered, reusable handle, and a disposable needle set. To operate, the needle set is loaded into the reusable handle, the device is "cocked", then "fired" into the appropriate site, and tissue (specimen) is retrieved from the needle set for laboratory evaluation and diagnosis. Specifically, when "fired", the inner part of the needle set (stylet) moves forward first, penetrating the biopsy site. Tissue fills a "slot" at the tip of the stylet. Then the outer part of the needle set (cutting cannula) advances forward slicing off the tissue in the slot and enclosing it during removal from the patient. The tissue specimen is removed from the stylet slot after placing the device in the sample retrieval position. The procedure is repeated for additional biopsies, if dictated by the physician
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, Mammography, etc.
Anatomical Site
soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.
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
MAY 20 1933
Image /page/0/Picture/1 description: The image contains a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the number '9', another '9', the number '0', the number '8', the number '3', and ends with the number '9'. The characters are written in a dark ink, and the handwriting style appears somewhat cursive.
Image /page/0/Picture/3 description: The image shows a logo for MDTECH MEDICAL DEVICE TECHNOLOGIES INC. The logo is black and white and features the letters "MDTECH" in a stylized font. The letters are stacked on top of each other, with the "MD" on top and the "TECH" on the bottom. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC" in a smaller font. The logo is surrounded by a black border.
3600 SW 47th Avenue Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
510(k) SUMMARY
| APPLICANT: | Medical Device Technologies, Inc.
3600 SW 47th Avenue
Gainesville, FL 32608 |
|--------------------------|-----------------------------------------------------------------------------------|
| CONTACT: | Karl Swartz
Quality Assurance Manager |
| TELEPHONE: | (352)338-0440
fax (352)338-0662 |
| TRADE NAMES: | Medical Device Technologies, Inc. Tru-Core™ I
Reusable Biopsy Instrument |
| COMMON NAME: | Reusable 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 Reusable | K962969 |
| Medical Device Technologies | Tru-Core Automatic Disposable | K982960 |
DESCRIPTION OF DEVICE:
Our company is presently authorized by the Food and Drug Administration to manufacture a reusable handle gun K962969 that utilizes the same disposable soft tissue biopsy needles as the disposable version of this gun, K982960. This new device has the same operation and firing cycle as the disposable gun, but is intended to be reusable, as in the gun submitted under K962969. This new device will also utilize the same disposable soft tissue biopsy needles.
The biopsy needle is guided into position utilizing external guidance (Ultrasound, Mammography, etc.). The device consists of a spring powered, reusable handle, and a disposable needle set. To operate, the needle set is loaded into the reusable handle, the device is "cocked", then "fired" into the appropriate site, and tissue (specimen) is retrieved from the needle set for laboratory evaluation and diagnosis. Specifically, when "fired", the inner part of the needle set (stylet) moves forward first, penetrating the biopsy site. Tissue fills a "slot" at the tip of the stylet.
1
20FZ
Image /page/1/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".
3600 SW 47th Avenue Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
510(k) SUMMARY(Cont.)
Then the outer part of the needle set (cutting cannula) advances forward slicing off the tissue in the slot and enclosing it during removal from the patient. The tissue specimen is removed from the stylet slot after placing the device in the sample retrieval position. The procedure is repeated for additional biopsies, if dictated by the physician
Indications for Use:
The Tru-Core™ I Reusable 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.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1999
Mr. Karl Swartz Quality Manager Medical Device Technologies, Inc. 3600 SW 47th Avenue Gainesville, Florida 32608
Re: K990839
MD Tech Tru-Core™ I Reusable Biopsy Instrument Dated: March 5, 1999 Received: March 15, 1999 Regulatory Class: II 21 CFR §876.1075/Product Code: 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 legally marketed predicate 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 Requlations, 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 requlation (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 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 requlation (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/cdrh/dsma/dsmamain.html".
Sincerely yours.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the logo for MDTech Medical Device Technologies Inc. The logo is black and white and features the letters "MDTECH" in a bold, sans-serif font. The words "MEDICAL DEVICE TECHNOLOGIES INC" are printed in a smaller font below the letters. The logo is simple and modern.
3600 SW 47th Avenue 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™ I Reusable Biopsy Instrument
Indications for Use:
The Tru-Core™ I Reusable 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)
Prescription Use
(Per 21 CFR 801.109)
1
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
David A. Segeen
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dey 510(k) Number