(74 days)
The Gel Mark III is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.
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.
The provided document is a 510(k) summary for the SenoRx Gel Mark III Biopsy Site Marker. It focuses on establishing substantial equivalence to predicate devices for market clearance, rather than presenting a study to prove the device meets specific acceptance criteria in terms of performance metrics like sensitivity or specificity.
Therefore, the document does not provide the information requested regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the following information is not present in the provided text:
- A table of acceptance criteria and the reported device performance: This document does not establish performance criteria (e.g., in terms of imaging visibility, artifact generation, or long-term visibility) nor does it present a study to measure and report such performance against those criteria.
- Sample size used for the test set and the data provenance: No performance study is described; therefore, no test set, sample size, or data provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no performance study is described.
- Adjudication method for the test set: Not applicable as no performance study is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical marker for biopsy sites, not an AI diagnostic tool, so an MRMC study related to AI assistance is irrelevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no performance study is described.
- The sample size for the training set: Not applicable as no algorithm training is described.
- How the ground truth for the training set was established: Not applicable as no algorithm training is described.
The document is a regulatory submission demonstrating that the device is "substantially equivalent" to previously cleared devices based on its intended use, design, construction, marker material, and nominal specifications. It does not detail new performance studies against specific acceptance criteria for diagnostic accuracy or efficacy.
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SenoRx Inc. Premarket Notification Gel Mark III Biopsy Site Marker
,。
K$\phi$31938 (P. 1 of 2)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92
SUBMITTER INFORMATION 1.
| a. Company Name: | SenoRx Inc. |
|---|---|
| b. Company Address: | 11 Columbia, Suite A |
| c. Telephone:Facsimile: | (949) 362-4800(949) 362-3519 |
| d. Contact Person: | Amy BouclyDirector, Regulatory Affairsand Quality Assurance |
| e. Date Summary Prepared: | June 12, 2003 |
| DEVICE IDENTIFICATION |
| a. Trade/Proprietary Name: | Gel Mark III(Trade Name is to be determined.) |
|---|---|
| ---------------------------- | --------------------------------------------------- |
- Implantable Staple, 21 CFR 878.4750 b. Classification Name:
IDENTIFICATION OF PREDICATE DEVICES 3.
| Gel Mark™ Biopsy SiteMarker | SenoRx Inc. |
|---|---|
| Gel Mark™ Ultra BiopsySite Marker | SenoRx Inc. |
| MammoMark™ BiopsySite Marker | Artemis Medical, Inc. |
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$\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.
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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.
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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
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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
§ 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.