(88 days)
Not Found
No
The device description and intended use focus on a physical tissue marker and its delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device's intended use is to mark the location of a biopsy procedure, not to treat a disease or condition.
No
The device is a tissue marker used to mark the location of a biopsy procedure, not to diagnose a condition.
No
The device description clearly outlines physical components such as a disposable introducer, applier, needle, rod, and marker, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "attach to soft breast tissue at the surgical site...to radiographically mark the location of the biopsy procedure." This describes a device used in vivo (within the body) to mark a location for imaging.
- Device Description: The description details a physical device (introducer, applier, marker) designed for insertion into tissue.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, tissue, urine) to provide information about a patient's health. This device does not perform any analysis of biological samples.
Therefore, the UltraClip Tissue Marker is a medical device used in vivo for marking purposes, not an IVD.
N/A
Intended Use / Indications for Use
The UltraClip Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
Product codes (comma separated list FDA assigned to the subject device)
GDW, FZP
Device Description
A sterile, single patient use device comprised of a disposable introducer and applier in addition to the marker itself. The set includes an introducer needle comprised of a plastic molded hub, a needle with 1 cm depth marks, and an ultrasound enhancement on the distal end to aid in needle placement. The applier consists of a stainless steel rod with plastic hub, and the marker, located at the distal end of the introducer needle, is made of stainless steel or . titanium. A plastic safety connector holds the applier and introducer needle in the appropriate position and helps prevent premature deployment of the marker.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft 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): 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
§ 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
FEB 4 2000
Image /page/0/Picture/2 description: The image shows the logo for INRAD Optics. The logo consists of a black square with a white diagonal line in the upper left corner, followed by the word "INRAD" in bold, black letters. There is a registered trademark symbol to the right of the "D" in "INRAD".
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (per 21 CFR 807.92(c))
1. SUBMITTER:
Joseph M. Mazurek Director of Regulatory Affairs and Quality Assurance Inrad, Inc. 3956 44th Street S.E. Kentwood, Michigan 49512 Telephone: (616) 554-7750 Fax: (616) 554-7751 Date Prepared: November 5, 1999
2. PRODUCT NAME:
| Proprietary Name: | UltraClip Tissue Marker |
|---|---|
| Common/Usual Name: | UltraClip Tissue Marker |
| Classification Name: | Staple, Implantable |
3. PREDICATE DEVICE:
Micromark Clip (K970817) Biopsys Medical, Inc. 3 Morgan Irving, CA 92718
4. DESCRIPTION OF THE DEVICE:
A sterile, single patient use device comprised of a disposable introducer and applier in addition to the marker itself. The set includes an introducer needle comprised of a plastic molded hub, a needle with 1 cm depth marks, and an ultrasound enhancement on the distal end to aid in needle placement. The applier consists of a stainless steel rod with plastic hub, and the marker, located at the distal end of the introducer needle, is made of stainless steel or . titanium. A plastic safety connector holds the applier and introducer needle in the appropriate position and helps prevent premature deployment of the marker.
1
Image /page/1/Picture/1 description: The image shows the logo for INRAD Optics. The logo consists of a black square with a white diagonal line in the upper left corner, followed by the word "INRAD" in bold, black letters. The "D" in "INRAD" has a small circle with a dot inside it in the upper right corner, indicating that it is a registered trademark.
5. INTENDED USE OF THE DEVICE:
The UltraClip Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
6. TECHNICAL CHARACTERISTICS COMPARISON TO PREDICATE DEVICE:
A comparison of features between the Inrad UltraClip Tissue Marker and the Biopsys Medical Micromark Clip is provided in Tab 7. Both devices place a radiographically visible marker in breast tissue to identify the location of biopsy procedure and are technically equivalent.
7. NON-CLINICAL PERFORMANCE DATA ASSESSMENT:
Comparison of non-clinical performance data between the Inrad UltraClip Tissue Marker and the Biopsys Medical Micromark Clip indicates the devices are substantially equivalent.
8. CONCLUSIONS:
There are no substantial differences between the Inrad UltraClip Tissue Marker and the predicate device. The UltraClip Tissue Marker will utilize a small gauge needle which will result in less trauma to the patient. Other performance characteristics are substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 4 2000
Joseph M. Mazurek, M.S., J.D., RAC Directory of Regulatory Affairs and Quality Assurance Inrad. Inc. 3956 44th Street, S.E. Kentwood, Michigan 49512
Re: K993785 Trade Name: UltraClip Tissue Marker Regulatory Class: II Product Code: GDW, FZP Dated: November 5, 1999 Received: November 8, 1999
Dear Mr. Mazurek:
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 requirement, 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.
3
Page 2 - Joseph M. Mazurek, M.S., J.D., RAC
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.
Niaj.R.P.Ogden
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows a handwritten alphanumeric string. The string is "K993785". The characters are written in a cursive style with thick, dark lines.
510(k) Number (if known):
UltraClip Tissue Marker DEVICE NAME: INDICATIONS FOR USE: The UltraClip Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | |
| (per 21CFR 801.109) | OR Over-The-Counter-Use |
| (Optional Format 1-2-96) |
NPAOFW JzD
(Division Sign-Off)
Division of General Restorative Devices K993785
510(k) Number.