(189 days)
The MicroMark clip is intended to staple soft breast tissue at the surgical site during an open or percutaneous biopsy procedure and radiographically mark the location.
It is indicated for use to radiographically mark breast tissue following an open surgical breast biopsy or percutaneous breast biopsy.
The devices consist of a non absorbable material compatible with X-ray, i.e., clearly visible on a radiograph; the staple/markers are deployed with manual appliers.
This document is a 510(k) premarket notification for a medical device called the "MicroMark Clip." It seeks to establish substantial equivalence to a legally marketed predicate device, the "BMI Surgical Staple Marker." This type of submission generally focuses on comparisons to existing devices rather than extensive clinical studies with acceptance criteria and performance metrics in the way a PMA (Premarket Approval) submission would.
Based on the provided text, a formal study with acceptance criteria and reported device performance, as well as details about sample sizes, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies, was not performed or is not described in this document.
Instead, the submission primarily relies on:
- Technological Characteristics Comparison: The core argument for substantial equivalence is that the MicroMark Clip has technological characteristics "substantially equivalent" to the predicate device.
- Identical Design, Construction, and Materials: The document explicitly states: "The design, construction, materials, nominal specifications are identical to the marketed predicate device." Both devices are described as consisting of a non-absorbable, X-ray compatible material.
- Identical Intended Use: The intended use of both devices is to "be applied to soft breast tissue during open or percutaneous procedures and radiographically mark the surgical location."
Therefore, I cannot provide the requested table or detailed study information because it is not present in this 510(k) submission. The FDA's letter confirms substantial equivalence based on the provided information, which emphasizes the similarity to the predicate device rather than independent performance testing against defined acceptance criteria.
To elaborate on why this information is missing:
- 510(k) Process: A 510(k) premarket notification is a regulatory pathway for medical devices that are substantially equivalent to a legally marketed predicate device. The core of a 510(k) is to demonstrate this equivalence, often by comparing design, materials, technological characteristics, and intended use. It typically does not require new clinical studies demonstrating safety and effectiveness against specific performance criteria if equivalence can be established through other means (e.g., bench testing, material comparisons, and comparison to the predicate's known performance).
- "Acceptance Criteria" in 510(k): While a 510(k) doesn't typically define "acceptance criteria" for clinical performance in the same way a clinical trial would, the "acceptance criteria" here implicitly refer to meeting the requirements for demonstrating substantial equivalence to the predicate device, which the FDA concluded was met.
In summary, the document you provided does not contain the information requested in points 1-9 because this type of 510(k) submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with explicit acceptance criteria and corresponding performance data.
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K970817
SEP | | 1997
APPENDIX V
Summary of Safety and Effectiveness
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The MicroMark clip is substantially equivalent to the BMI Surgical Staple Marker. The MicroMark clip has technologic characteristics which are substantially equivalent to the predicate device.
COMPANY AND CONTACT PERSON
Biopsys Medical, Inc. (BMI) 3 Morgan Irvine, CA 92618
Mark A. Cole. Ph.D. 714-460-7800
DEVICE NAME
TM MicroMark Clip
NAME OF PREDICATE OR LEGALLY MARKETED DEVICE
BMI Surgical Staple Marker
STATEMENT OF INTENDED USE
The MicroMark intended use is to be applied to soft breast tissue during open or percutaneous procedures and radiographically mark the surgical location.
STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES
The BMI Surgical Staple Marker's intended use is to be applied to soft tissue during open or percutaneous procedures; the staple may be used to radiographically mark the surgical location.
STATEMENT OF COMPARISON OF TECHNOLOGIC CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE
The design, construction, materials, nominal specifications are identical to the marketed predicate device. The devices consist of a non absorbable material compatible with X-ray, i.e., clearly visible on a radiograph; the staple/markers are deployed with manual appliers.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. 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 11 1997
Ms. Irene Parker, R.N., M.B.A. Director, Medical Affairs Biopsys Medical, Inc. 3 Morgan Irvine, California 92618
Re: K970817 Trade Name: MicroMark™ Clip Regulatory Class: II Product Code: GDW Dated: June 18, 1997 Received: June 19, 1997
Dear Ms. Parker:
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 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 (QS) 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 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 - Ms. Irene Parker, R.N., M.B.A.
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 entitied, "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,
signature
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):
JM Device Name: MicroMark Clip
Indications For Use: The MicroMark clip is intended to staple soft breast tissue at the surgical site during an open or percutaneous biopsy procedure and radiographically mark the location.
It is indicated for use to radiographically mark breast tissue following an open surgical breast biopsy or percutaneous breast biopsy.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Per 21 CFR 801.109
X
OR
Over-The-Counter Use
(Division Sign-Off)
Division: Restorative Devices
510(k) Number. K970817
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.