(66 days)
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.
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
The provided text is a 510(k) summary for the MD Tech Tru-Core™ I Reusable Biopsy Instrument. It does not contain information about acceptance criteria, a specific study proving the device meets criteria, sample sizes for test sets or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.
Instead, the document focuses on:
- Device Description: Explaining the operation and components of the reusable biopsy instrument.
- Substantial Equivalence: Comparing the new device to previously cleared devices (K962969 and K982960) by the same company. The core claim is that it has the "same operation and firing cycle" as the disposable gun and is "intended to be reusable, as in the gun submitted under K962969."
- Indications for Use: Defining for what medical purposes the device is intended (obtaining multiple core samples from soft tissue like liver, kidney, prostate, breast, and various soft tissue lesions, but not bone).
- FDA Clearance: An FDA letter confirming the review of the 510(k) notification and a determination of substantial equivalence to legally marketed predicate devices.
Therefore, I cannot provide the requested information as it is not present in the given text. The 510(k) process for this type of device typically relies on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific performance metrics and acceptance criteria in the manner requested.
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MAY 20 1933
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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 AvenueGainesville, FL 32608 |
|---|---|
| CONTACT: | Karl SwartzQuality Assurance Manager |
| TELEPHONE: | (352)338-0440fax (352)338-0662 |
| TRADE NAMES: | Medical Device Technologies, Inc. Tru-Core™ IReusable Biopsy Instrument |
| COMMON NAME: | Reusable 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 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.
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20FZ
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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.
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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
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3600 SW 47th Avenue 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™ 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
§ 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.