. an implantable component, composed of a bioabsorbable and permanent component, and
a deployment device utilized for placement of the implantable component at the site of . interest.
This family of devices is intended for use with the manual method of deployment under the following imaging modalities: ultrasound, x-ray, magnetic resonance, and direct visualization. The device is intended for single patient use only.

AI/ML Overview

The provided text is a 510(k) summary for the SeCurMark Biopsy Site Identification System. This document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than detailing a specific study with acceptance criteria and performance metrics typically seen for diagnostic or AI-driven devices.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment cannot be found in this document. This filing is about a physical medical device (an implantable clip and its deployment system), not a software or AI-based diagnostic tool.

However, I can extract what is available:

1. Table of acceptance criteria and the reported device performance:

This document does not provide a table of acceptance criteria or specific quantitative performance metrics for the device’s efficacy (e.g., accuracy, sensitivity, specificity, or resolution of the marker). The submission focuses on substantial equivalence based on design control processes for safety and effectiveness.

2. Sample size used for the test set and the data provenance:

This information is not provided in the document. The filing refers generally to "Verification and validation testing" as part of the design control process, but does not specify sample sizes or data provenance for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as there is no mention of a ground truth established by experts in the context of this device's performance given its nature as a physical marker.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided.

5. 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:

This information is not applicable as the SeCurMark Biopsy Site Identification System is a physical implantable marker and not an AI or diagnostic imaging device that would involve human readers interpreting AI output.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable as the SeCurMark Biopsy Site Identification System is a physical implantable marker and not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The document does not specify a formal "ground truth" in the context of diagnostic accuracy, as it pertains to a physical marker rather than a diagnostic interpretation. The "truth" in this context would likely be related to the physical presence, stability, and visibility of the marker through imaging, which would be assessed through standard engineering and biocompatibility testing, not expert consensus on diagnostic images.

8. The sample size for the training set:

This information is not provided as this is not an AI or machine learning device requiring a training set.

9. How the ground truth for the training set was established:

This information is not provided as this is not an AI or machine learning device requiring a training set with established ground truth.

Summary of the Study Mentioned (Verification and Validation Testing for Substantial Equivalence):

The document states: "Verification and validation testing has been conducted as part of the Suros divisions design control process and has proven that the SeCurMark family of devices is substantially equivalent to the predicates devices and is safe and effective for use."

Nature of the "Study": This refers to the overall design control process, which includes various tests (e.g., biocompatibility, sterilization, mechanical testing, visibility under imaging modalities, deployment mechanism functionality). It is not a single, defined clinical study with specific performance metrics and acceptance criteria as one would expect for a diagnostic device.
Purpose: To demonstrate substantial equivalence to the predicate devices (K062528 in-house and K042296 BiomarC) for regulatory clearance, thereby confirming the device is "safe and effective for use."
Key Outcome: The FDA reviewed the submission and concurred that the device is substantially equivalent, allowing it to proceed to market. The letter explicitly states there are "No new safety or efficacy questions or risks are raised with the SeCurMark Biopsy System."

In essence, the "study" is the entirety of the design control, verification, and validation activities required for medical devices, geared towards proving equivalence to existing legally marketed devices, rather than establishing de novo performance against a defined clinical endpoint with specific statistical acceptance criteria.

Summary

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K072913 Page 1/2

Hologic, Inc.

6100 Technology Center Drive, Indianapolis, IN 46278 USA Main: +1.800.650.2169 Fax: +1.317.344.7600

510(k) Summary

Senior Quality & Regulatory Consultant

Hologic, Inc. – Suros Division 6100 Technology Center Drive

Indianapolis, IN 46278 Phone: 317-344-7687

OWNER/OPERATOR:

Firm:	Hologic, Inc. - Suros Division
Address:	6100 Technology Center DriveIndianapolis, IN 46278
Phone #:	317-344-7500
Fax #:	317-344-7697
Registration #:	3003862400
CONTACT:	Paula A. Gray

JAN - 4 2008

DATE: 12/06/2007

DEVICE NAME:

Classification Name:	Marker, Implantable Radiographic
Common/Usual Name:	Tissue Site Marking System
Proprietary Name:	SeCurMark Biopsy Site Identification System
Device Class:	Class II
Description	Implantable Clip
Number	NEU
21 CFR Ref.	878.4300
Performance Standards	No applicable performance standards established

PREDICATE DEVICES:

510(k)-Number	Device Name	Device Manufacturer	Location
K062528IN	Tissue Site MarkingSystem	Hologic, Inc. – Suros Division	Indianapolis,
K042296	BiomarC	Carbon MedicalTechnologies, Inc.	St. Paul, MN

Page 1 of 2

Image /page/0/Picture/13 description: The image shows the word "HOLOGIC" in all caps. The letters are bold and black. The background is white.

Image /page/0/Picture/14 description: The image shows the text "Clarity of Vision" in a simple, sans-serif font. The text is black and appears to be printed on a white background. To the left of the text, there is a partial, abstract graphic, also in black, that adds a visual element to the composition.

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K072913 Page 2/2

6100 Technology Center Drive, Indianapolis, IN 46278 U Main: +1.800.650.2169 Fax: +1.317.344.7600

DEVICE DESCRIPTION AND CHARACTERISTICS:

The SeCurMark family of Tissue Site Marking Systems is composed of two components:

. an implantable component, composed of a bioabsorbable and permanent component, and
a deployment device utilized for placement of the implantable component at the site of . interest.

Hologic, Inc.

This family of devices is intended for use with the manual method of deployment under the following imaging modalities: ultrasound, x-ray, magnetic resonance, and direct visualization. The device is intended for single patient use only.

INTENDED USE:

The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.

SUBSTANTIAL EQUIVALENCE:

Verification and validation testing has been conducted as part of the Suros divisions design control process and has proven that the SeCurMark family of devices is substantially equivalent to the predicates devices and is safe and effective for use.

CONCLUSION:

Based on the information presented in this 510(k) submission, the SeCurMark Biopsy Site Identification System is substantially equivalent to the presently marketed predicate devices. No new safety or efficacy questions or risks are raised with the SeCurMark Biopsy System.

Image /page/1/Picture/13 description: The image shows the word "HOLOGIC" in bold, black letters. The letters are evenly spaced and appear to be a sans-serif font. The word is horizontally oriented and fills most of the frame.

Image /page/1/Picture/14 description: The image contains the text "Clarity of Vision" in a bold, sans-serif font. The text is arranged horizontally, with "Clarity of" appearing above "Vision". The overall impression is clean and straightforward, suggesting a focus on clear and distinct visual perception.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

JAN - 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Suros Surgical Systems, Inc. % Ms. Paula A. Gray Senior Quality & Regulatory Consultant 6100 Technology Center Drive Indianapolis, Indiana 46278

Re: K072913

Trade/Device Name: SeCurMark Biopsy Site Identification System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: December 6, 2007 Received: December 7, 2007

Dear Ms. Gray:

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 - Ms. Paula A. Gray

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 Protmarket, 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 vours.

Mark N Milhusan

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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Indications for Use

510(k) Number (if known): K072913

Device Name: SeCurMark Biopsy Site Identification System

Indications for Use:

The SeCurMark Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.

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)

Page 1 of 1

Kimbay H. Bley FOR M.MEIERSON

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

K072913 510(k) Number

(Posted November 13, 2003)

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.