(47 days)
The Medical Biopsy Automatic Cutting Needle is intended for use in obtaining samples of tissues or lesions.
Medical Biopsy's Automatic Biopsy Needle is intended for use in obtaining samples of tissues or lesions from the Breast, Kidney, Prostate and Liver.
The Medical Biopsy Automatic Cutting Needle is a two-piece design consisting of a cannula and an obturator (stylet). The needles are made of 304 Stainless Steel. Etched markings have been incorporated along the shaft of both the cannula and the obturator, at intervals of 1cm, to guide depth of insertion. The distal end of the stylet is notched for tissue retention. The proximal end of the Automatic Cutting Needle incorporates a plastic fitting for attachment to the "gun" portion of the Biopsy System, which houses, guides and manipulates the Automatic Cutting Needle during use. This "gun" component is sold separately by another company and is not covered within this 510(k) Premarket Notification.
This document is a 510(k) summary for the Medical Biopsy Automatic Cutting Needle, intended for use in obtaining tissue samples. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria, device performance studies, or ground truth establishment in the context of AI/ML evaluation.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is a summary of what information could and could not be extracted:
Acceptance Criteria and Study Details
| Information Item | Found in Document |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Not found. The document is a 510(k) summary demonstrating substantial equivalence to a predicate device (Manan Pro-Mag Automatic Biopsy Device). It lists characteristics (two-piece design, intended use, sizes, material, etched markings) that are similar to the predicate device but does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or report quantitative device performance data against such criteria. |
| 2. Sample size used for the test set and data provenance | Not found. The document does not describe any clinical study or test set for evaluating the device's performance against specific criteria. It only references a predicate device for comparison of characteristics. |
| 3. Number of experts used to establish ground truth and their qualifications | Not found. No ground truth establishment is described as there's no performance study detailed. |
| 4. Adjudication method for the test set | Not found. No test set or adjudication method is mentioned. |
| 5. MRMC comparative effectiveness study and effect size | Not found. This document predates common AI/ML applications in medical devices and does not describe any AI/ML components or MRMC studies. |
| 6. Standalone performance study (algorithm only) | Not found. This document predates common AI/ML applications in medical devices and does not describe any AI/ML components or standalone algorithm performance. |
| 7. Type of ground truth used | Not found. No ground truth is described. |
| 8. Sample size for the training set | Not found. The device is a physical instrument, not an algorithm that requires a training set. |
| 9. How the ground truth for the training set was established | Not found. The device is a physical instrument, not an algorithm that requires a training set. |
Key takeaway from the document:
The 510(k) summary demonstrates that the Medical Biopsy Automatic Cutting Needle is substantially equivalent to the Manan Pro-Mag Automatic Biopsy Device (K914874) based on shared design characteristics, intended use, available sizes, materials, and features (etched markings). The document focuses on showing that the new device is as safe and effective as the predicate device without providing detailed performance metrics or clinical study data that would be typical for many AI/ML-driven device approvals today.
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JUN 1 0 1998
K 981477
510(K) SUMMARY
1. SUBMITTER:
Medical Biopsy, Inc. 10800 Lyndale Avenue South Suite 110 Bloomington, MN 55420 Telephone: 800-714-7788 Contact: Stephen M. Page, Regulatory Consultant Date Prepared: April 23, 1998
2. DEVICE:
Classification Name: Instrument, Biopsy Trade Name: Medical Biopsy Automatic Cutting Needle Class II per 21 CFR 876.1075 The Product Code is 78 KNW
3. PREDICATE DEVICE:
The predicate device used to determine substantial equivalence for the Medical Biopsy Automatic Cutting Needle is the Manan Pro-Mag Automatic Biopsy Device (K914874).
4. DEVICE DESCRIPTION:
The Medical Biopsy Automatic Cutting Needle is a two-piece design consisting of a cannula and an obturator (stylet). The needles are made of 304 Stainless Steel. Etched markings have been incorporated along the shaft of both the cannula and the obturator, at intervals of 1cm, to guide depth of insertion. The distal end of the stylet is notched for tissue retention.
The proximal end of the Automatic Cutting Needle incorporates a plastic fitting for attachment to the "gun" portion of the Biopsy System, which houses, guides and manipulates the Automatic Cutting Needle during use. This "gun" component is sold separately by another company and is not covered within this 510(k) Premarket Notification.
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When loaded into the "gun", the plastic spacer clip is removed from the end of the Automatic Cutting Needle. The hinged cover of the "gun" is then closed. At this point, the device is cocked, thereby spring-loading the Automatic Cutting Needle within. The distal end of the protruding Automatic Cutting Needle is then inserted into the body towards the target tissue. Once in the proximity of the target, the "gun" is fired and within a fraction of a second, the stylet penetrates the target tissue, which drops into the notch and is subsequently severed by the cannula which moves to recover the entire stylet tip. The gun/needle assembly is then removed from the body and the specimen is removed from the stylet, thus completing the procedure.
5. INTENDED USE:
The Medical Biopsy Automatic Cutting Needle is intended for use in obtaining samples of tissues or lesions.
6. COMPARISON OF CHARACTERISTICS:
The Medical Biopsy Automatic Cutting Needle and the currently marketed Manan Pro-Mag Automatic Biopsy Device are very similar in design:
- Both devices consist of a two-piece design utilizing a cannula and a stylet. a.
- b. The devices have the same Intended Use.
- The devices are offered in the same sizes. C.
- d. The devices are manufactured from the same material (stainless steel).
- Both devices incorporate etched markings to guide depth of insertion. e.
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Image /page/2/Picture/2 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 & HU. N SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
JUN 1 0 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Biopsy, Incorporated ·c/o Mr. Stephen M. Page Regulatory Consultant 228 Hull Cove Farm Road Jamestown, Rhode Island 02835
K981477 Re : Medical Biopsy Automatic Cutting Needle Trade Name: Requlatory Class: II Product Code: KNW Dated: April 23, 1998 Received: April 24, 1998
Dear Mr. Page:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 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 (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. 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.
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Page 2 - Mr. Stephen M. Page
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) 594-4595. 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.
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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510(k) Number (if known):
- Sales Comments of Children Comments of Children
Device Name:
Medical Biopsy Automatic Cutting Needle
Indications For Use:
Medical Biopsy's Automatic Biopsy Needle is intended for use in Mediour Dropby of Issues or lesions from the Breast, Kidney, Prostate and Liver.
(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 LG 8 \ 4
510K) Number 510(k) Number .
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(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.