GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP by SENORX, INC.

The Gel Mark UltraCor Breast Biopsy Marker consists of a 17 Ga disposable beveled needle Applicator containing: 2 resorbable polylactic acid/polyglycolic acid pellets. 1 gold marker in the center position. 1 polyethylene glycol (PEG) plug in the needle bevel. The gold marker is intended for long-term radiographic marking of the tissue site. The pellets are visible via ultrasound for approximately 4 weeks and are essentially resorbed in approximately 12 weeks. The Applicator has a beveled 20 cm needle with 1 cm depth marks and a locking plunger. The pellets are deployed from the beveled needle tip into the tissue site.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Gel Mark UltraCor Biopsy Site Marker." This document focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a performance study with detailed acceptance criteria and reported device performance metrics in the way one would for a diagnostic AI algorithm.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable or extractable from the provided text, as it's a regulatory submission for a medical device (a physical marker) and not a software/AI device.

However, I can extract the relevant information regarding the device itself and its equivalence claim.

Device Description and Equivalence Summary

Device Name: Gel Mark UltraCor Biopsy Site Marker

Indications for Use: To radiographically mark breast tissue during a percutaneous breast biopsy procedure.

Summary of Substantial Equivalence (as presented in the document):

The Gel Mark UltraCor Biopsy Site Marker has the following similarities to the previously cleared predicate devices (Biopsy Site Marker; K011402; and Gel Mark IV Tissue Marker, K040706):

Same indications for use.
Same intended treatment site.
Same operating principle.
Same basic design.

Preclinical testing (mentioned as the "study" context):

"Preclinical testing had confirmed the radiographic visibility of the gold marker."
"Gold, as a long-term implant, has an extensive history of use and has been cleared for use in a similar application."
"The resorbable polyethylene glycol plug has been used previously in SenoRx biopsy site markers to contain pellets in the applicator."
"The change to a metallic (stainless steel) applicator shaft is similar to the metallic (titanium) of a previous cleared SenoRx device."
"The reduction in the applicator shaft diameter varies in a manner that has no impact on device safety."

Given the nature of the document (a 510(k) summary for a physical medical device), a "table of acceptance criteria and reported device performance" in the context of an AI/software device's accuracy or other performance metrics is not provided. The "acceptance criteria" here are implied by the FDA's substantial equivalence pathway, meaning the device must be as safe and effective as a legally marketed predicate device. The "study" referenced is preclinical testing and a comparison to known properties of materials.

Therefore, for the specific questions:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied by 510(k) pathway): Substantial equivalence to predicate devices in terms of indications for use, intended treatment site, operating principle, basic design, and safety/effectiveness. Specifically, radiographic visibility of the marker, biocompatibility of implanted materials, and no adverse impact from design changes.
- Reported Device Performance:
  - Radiographic visibility of the gold marker confirmed by preclinical testing.
  - Gold has an extensive history of safe use as a long-term implant.
  - Pellets are visible via ultrasound for approximately 4 weeks and resorbed in approximately 12 weeks.
  - Polyethylene glycol plug previously used in SenoRx biopsy site markers.
  - Metallic applicator shaft change (stainless steel vs. titanium) deemed to have no impact on device safety.
  - Reduction in applicator shaft diameter deemed to have no impact on device safety.
Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing an algorithm's performance on a dataset. The "test set" would refer to the characteristics and function of the physical device components.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be related to material properties, physical dimensions, and radiographic characteristics, which are standard engineering and material science evaluations, not expert image interpretation.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/software device requiring an MRMC study for reader improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a physical device, not an algorithm.
The type of ground truth used: For a physical device, "ground truth" refers to physical properties, material characteristics, and functionality. For example, the ground truth for "radiographic visibility" would be observable evidence on radiographic images. For biocompatibility, it would be established through material testing and historical evidence of use.
The sample size for the training set: Not applicable. There is no training set as this is not an AI/software device.
How the ground truth for the training set was established: Not applicable.

Summary

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080698

MAR 3 1 2008

510(K) SUMMARY 7.

Date prepared	March 10, 2008
Name	SenoRx, Inc.11 ColumbiaAliso Viejo, CA 92656T. 949.362.4800; F. 949.362.0300
Contact person	Eben GordonVice President, RA/QASenoRx, Inc.T. 949.362.4800; F. 949.362.0300
Device name	Gel Mark UltraCor Biopsy Site Marker
Common name	Biopsy site marker
Classification name	Implantable Clip
Classification regulation	878.4300 NEU
Predicate device	Biopsy Site Marker; K011402; clearance date 7/16/2001; FZPGel Mark IV Tissue Marker, K040706, clearance date 4/8/2004, NEU
Description	The Gel Mark UltraCor Breast Biopsy Marker consists of a 17 Ga disposable beveledneedle Applicator containing:2 resorbable polylactic acid/polyglycolic acid pellets. 1 gold marker in the center position. 1 polyethylene glycol (PEG) plug in the needle bevel. The gold marker is intended for long-term radiographic marking of the tissue site. Thepellets are visible via ultrasound for approximately 4 weeks and are essentially resorbedin approximately 12 weeks.The Applicator has a beveled 20 cm needle with 1 cm depth marks and a lockingplunger. The pellets are deployed from the beveled needle tip into the tissue site.
Indications for use	The Gel Mark UltraCor Biopsy Site Marker is indicated for use to radiographicallymark breast tissue during a percutaneous breast biopsy procedure.
Summary of substantialequivalence	The Gel Mark UltraCor Biopsy Site Marker as the following similarities to thepreviously cleared predicate devices:Same indications for use; Same intended treatment site; Same operating principle; and Same basic design. Preclinical testing had confirmed the radiographic visibility of the gold marker. Gold, asa long-term implant, has an extensive history of use and has been cleared for use in asimilar application. The resorbable polyethylene glycol plug has been used previouslyin SenoRx biopsy site markers to contain pellets in the applicator. The change to ametallic (stainless steel) applicator shaft is similar to the metallic (titanium) of aprevious cleared SenoRx device. The reduction in the applicator shaft diameter variesin a manner that has no impact on device safety.In summary, the Gel Mark UltraCor Biopsy Sire Marker as described in this submissionis substantially equivalent to the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is in a simple sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2008

SenoRx, Inc. % Eben Gordonese VP. Regulatory Affairs & Quality Assurance 11 Columbia Aliso Viejo, California 92656

Re: K080698

Trade/Device Name: Gel Mark UltraCor Biopsy Site Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: NEU Dated: March 10, 2008 Received: March 12, 2008

Dear Mr. Mazzarese:

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

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Page 2 - Eben Gordonese

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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6. INDICATIONS FOR USE

510(k) Number (if known): 长080698

Device Name: _______ Gel Mark UltraCor Biopsy Site Marker ____________________________________________________________________________________________________________________

Indications for Use:

The Gel Mark UltraCor Biopsy Site Marker is indicated for use to radiographically mark breast tissue during a percutaneous breast biopsy procedure.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over the Counter Use _______

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mule M. Mllkess Page 1 of 1

Division of General, Restorative, and Neurological Devices

510(k) Number K08069

Regulation Number and Section

§ 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.