The 8 Gauge MicroMark II Tissue Marker is indicated 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.

Device Description

The 8 Gauge MicroMark II Tissue Marker is a sterile, single patient use device comprised of a small stainless steel marker (clip) and a disposable Introducer and Applier. The Introducer consists of a flexible tube, a distal ramp, and a lateral port. The applier consists of a flexible shaft, a deployment mechanism and a handle. The marker is located at the distal end of the applier.

The 8 Gauge MicroMark II Tissue Marker is used with the currently marketed Ethicon Endo-Surgery, Inc. Mammotome® Hand-Held 8 Gauge Probe, which functions as a standard rigid coaxial Introducer.

The Tissue Marker is used with imaging guidance (stereotactic and ultrasound).

AI/ML Overview

The provided text is a 510(k) summary for the 8 Gauge MicroMark™ II Tissue Marker. It describes the device, its indications for use, and technological characteristics. However, it does not contain detailed information about acceptance criteria or specific studies proving the device meets these criteria.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Study for the 8 Gauge MicroMark™ II Tissue Marker

The provided 510(k) summary does not explicitly state acceptance criteria or provide a detailed study report demonstrating how the device meets them. It generally refers to "bench testing" to show the device performs as intended, which is common for predicate device submissions focused on substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The document focuses on demonstrating substantial equivalence to a predicate device, the MicroMark Clip, and mentions design changes (increase in introducer diameter) but not specific quantitative or qualitative acceptance criteria.	"Bench testing was performed to demonstrate that the device will perform as intended." The document does not provide details of the "bench testing" or its results. It states that the implantable stainless steel marker (clip) is identical to the marketed predicate device.

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

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The document only mentions "bench testing," implying laboratory-based testing, but does not provide details on data origin or whether it's retrospective or prospective.

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

This information is not applicable and not provided. The review is for a medical device (a tissue marker), not an AI or diagnostic imaging device that typically requires expert-established ground truth for performance evaluation. The "ground truth" for a device like this would relate to its physical properties, safe deployment, and ability to mark tissue effectively, which are evaluated through engineering tests, not expert interpretation of outputs.

4. Adjudication method for the test set

Not applicable and not provided. See explanation for point 3.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done

No, a MRMC comparative effectiveness study was not done. Such studies are typically for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. This device is a physical marker.

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

This question is not applicable as the device is a physical tissue marker, not an algorithm.

7. The type of ground truth used

For a device like this, the "ground truth" would be established by engineering specifications, material properties, and functional performance tests (e.g., successful deployment, retention in tissue, visibility under imaging). The document broadly states "Bench testing was performed to demonstrate that the device will perform as intended," implying these types of evaluations were conducted, but specific details of the ground truth (e.g., a measured dimension, a successful deployment rate) are not provided.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

Not applicable. This device is a physical medical device, not an AI or machine learning algorithm.

Summary of Missing Information in the 510(k) Summary:

The provided 510(k) summary is very high-level and, by its nature as a summary, omits many details that would be found in a full submission. Specifically, it lacks:

Quantitative or qualitative acceptance criteria.
Detailed descriptions of the "bench testing" study, including methods, protocols, sample sizes, and specific results.
Any information related to human readers, experts, or ground truth establishment in a diagnostic context, as the device is a physical marker.

The regulatory approval (K020276) for this device was based on a finding of substantial equivalence to a predicate device (MicroMark Clip), which often relies on demonstrating that the new device's design and performance are comparable to the previously cleared device, rather than extensive de novo clinical trials or detailed performance metrics against novel acceptance criteria. The claim of "bench testing was performed to demonstrate that the device will perform as intended" is the extent of the performance data provided in this public summary.

Summary

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510(k) Summary of Safety and Effectiveness Information

1020276

Company	Ethicon Endo-Surgery, Inc.4545 Creek RoadCincinnati, OH 45242
Contact	Georgia C. Abernathy, MBA, RACSenior Regulatory Affairs Associate
	Telephone:	(513) 337-3179
	Fax:	(513) 337-1444
	Email:	gabernat@eesus.jnj.com
Date Prepared	January 25, 2002
Device Name	Trade Name: 8 Gauge MicroMark™ II Tissue MarkerClassification Name: Implantable Staple
Predicate Device	MicroMark Clip

Device Description

The 8 Gauge MicroMark II Tissue Marker is used with the currently marketed Ethicon Endo-Surgery, Inc. Mammotome® Hand-Held 8 Gauge Probe, which functions as a standard rigid coaxial Introducer.

The Tissue Marker is used with imaging guidance (stereotactic and ultrasound).

Indications for Use

Technological Characteristics

Design changes made to the 8 Gauge MicroMark II Tissue Marker are an increase in the diameter of the Introducer. There are no changes to the implantable stainless steel marker (clip); it is identical to the marketed device.

Performance Data

Bench testing was performed to demonstrate that the device will perform as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

APR 1 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD -20850

Ms. Georgia C. Abernathy, MBA, RAC Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839

Re: K020276

Trade/Device Name: 8 Gauge MicroMark™II Tissue Marker Regulation Number: 878.4750 Regulation Name: Implantable Staple Regulatory Class: II Product Code: NEU Dated: January 25, 2002 Received: January 28, 2002

Dear Ms. Abernathy:

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 mav 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 (OS) 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. Georgia C. Abernathy, MBA, RAC

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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

for 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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Indications for Use Statement

K020276 510 (k) Number (if known):

Device Name:

8 Gauge MicroMark™ II Tissue Marker

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost
Division of OM

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

(Optional Format 3-10-98)

510(k) Number K020276

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.