(189 days)
Not Found
Not Found
No
The summary describes a physical staple/marker and manual applier, with no mention of AI/ML or image processing.
No
The device is used to mark breast tissue after a biopsy procedure. It does not treat any disease or condition.
No
Explanation: The device is used to mark the location of a biopsy and is not used for diagnosis.
No
The device description explicitly states it consists of a non-absorbable material (staple/marker) and manual appliers, which are hardware components.
Based on the provided information, this device 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 provide information for diagnosis, monitoring, or screening.
- Device Function: The MicroMark clip is a physical device intended to be implanted into breast tissue during a biopsy procedure. Its purpose is to physically mark the location for future radiographic identification. It does not analyze a sample from the body to provide diagnostic information.
- Intended Use: The intended use clearly states it's for "stapling soft breast tissue at the surgical site... and radiographically mark the location." This is a procedural and marking function, not a diagnostic test.
Therefore, the MicroMark clip falls under the category of a surgical implant or marker, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
GDW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft breast tissue, breast tissue
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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.
2
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
3
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