(74 days)
Not Found
Not Found
No
The summary describes a physical device (applicator and pellets) for marking tissue and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as being used to radiographically mark breast tissue during a biopsy, which is a diagnostic procedure, not a therapeutic one. The long-term marking is for identification, not treatment.
No
The device is described as a marker used during a biopsy procedure to mark breast tissue radiographically, specifically for long-term marking of the biopsy cavity. This indicates it is an interventional or procedural aid, not a device that diagnoses a condition.
No
The device description explicitly states it consists of a disposable applicator containing resorbable pellets and a wireform, indicating it is a physical medical device, not software-only.
No, 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 outside of the body (in vitro) to analyze these samples.
- Gel Mark III Function: The Gel Mark III is a device used during a medical procedure (percutaneous breast biopsy) to physically mark tissue within the body. It is implanted into the breast tissue to provide a radiographic marker.
The Gel Mark III is a medical device, but its function is to physically mark tissue in vivo (within the living body), not to analyze samples in vitro.
N/A
Intended Use / Indications for Use
The Gel Mark III is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.
Product codes (comma separated list FDA assigned to the subject device)
NEU
Device Description
The SenoRx Gel Mark III consists of a disposable applicator containing resorbable pellets. Some pellets contain a wireform, which is intended for long-term marking of the biopsy cavity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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.
Not Found
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
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
SenoRx Inc. Premarket Notification Gel Mark III Biopsy Site Marker
,。
K$\phi$31938 (P. 1 of 2)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92
SUBMITTER INFORMATION 1.
| a. Company Name: | SenoRx Inc. |
|---|---|
| b. Company Address: | 11 Columbia, Suite A |
| c. Telephone: | |
| Facsimile: | (949) 362-4800 |
| (949) 362-3519 | |
| d. Contact Person: | Amy Boucly |
| Director, Regulatory Affairs | |
| and Quality Assurance | |
| e. Date Summary Prepared: | June 12, 2003 |
| DEVICE IDENTIFICATION |
| a. Trade/Proprietary Name: | Gel Mark III
(Trade Name is to be determined.) |
| ---------------------------- | --------------------------------------------------- |
|---|
- Implantable Staple, 21 CFR 878.4750 b. Classification Name:
IDENTIFICATION OF PREDICATE DEVICES 3.
| Gel Mark™ Biopsy Site
| Marker | SenoRx Inc. |
|---|---|
| Gel Mark™ Ultra Biopsy | |
| Site Marker | SenoRx Inc. |
| MammoMark™ Biopsy | |
| Site Marker | Artemis Medical, Inc. |
1
$\phi$31938 (P. 2 of 2)
DESCRIPTION OF THE DEVICE 4.
The SenoRx Gel Mark III consists of a disposable applicator containing resorbable pellets. Some pellets contain a wireform, which is intended for long-term marking of the biopsy cavity.
STATEMENT OF INTENDED USE 5.
The Gel Mark III is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.
6. COMPARISON WITH PREDICATE DEVICES
The intended use, design, construction, marker material and nominal specifications are similar to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.
SEP = 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Amy Boucly Director, Regulatory Affairs and Quality Assurance SenoRx. Inc. 11 Columbia, Suite A. Aliso Viejo, California 92656
Re: K031938
Trade/Device Name: Gel Mark III Biopsy Site Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: NEU Dated: June 20, 2003 Received: June 23, 2003
Dear Ms. Boucly:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Amy Boucly
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
FDA Indications for Use Page 2
510(k) number (if known): K931938
Device Name: Gel Mark III (Trade/Model Name to be determined.)
Indications for Use: The Gel Mark III is indicated for use to radiographically mark breast tissue during a percutaneous breast 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 21 CFR 801.109)
OR
Over-The-Counter Use
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K031938