The UltraClip II US Wing and Coil are intended 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 UltraClip II US Wing and Coil are sterile, single use devices comprised of a disposable introducer needle and an implantable metal tissue marker with a polymer insert composed of polyvinyl alcohol (PVA). The device is designed to attach the marker to soft breast tissue at the surgical site during an open surgical breast at biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.

AI/ML Overview

The provided text is a 510(k) summary for the UltraClip II US Wing and Coil. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information, acceptance criteria, or performance data that would be needed to fill out most of the requested table.

The submission is a declaration of substantial equivalence based on the technological characteristics being identical to the predicate device and the new device meeting "predetermined acceptance criteria of the design verification and validation testing performed under design controls." It does not provide the specifics of those criteria or the results of the performance testing.

Therefore, for aspects requiring specific study details, sample sizes, expert qualifications, and detailed performance metrics, the information is not available in the provided document.

Here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

Criterion Category	Acceptance Criteria	Reported Device Performance
Overall Performance	"All predetermined acceptance criteria of the design verification and validation testing performed under design controls."	"The UltraClip II US Wing and Coil met all predetermined acceptance criteria..."
Technological Characteristics	Identical to the predicate device (UltraClip II Wing and Coil, K063238) in terms of intended use, indications for use, target population, fundamental scientific technology, operating principle, method of sterilization, packaging configuration, sterility assurance level, and performance characteristics.	"The technological characteristics of the subject device are identical to those of the predicate device..."
Specific Performance Metrics	Not detailed in document	Not detailed in document
Clinical Performance Metrics	Not detailed in document	Not detailed in document

Study Details

Information Point	Response
1. Sample size for test set	Not specified. The document refers to "design verification and validation testing" but does not provide details on sample sizes for any specific test sets.
1. Data provenance (e.g., country, retrospective/prospective)	Not specified. The document does not describe the nature, origin, or type of data collected for the design verification and validation.
2. Number of experts for ground truth	Not applicable/Not specified. The document does not describe a study involving expert consensus for establishing ground truth, as it is a device for marking tissue, not for diagnosis that would require expert interpretation of images.
2. Qualifications of experts	Not applicable/Not specified.
3. Adjudication method	Not applicable/Not specified.
4. MRMC comparative effectiveness study	No. The document does not describe a multi-reader multi-case comparative effectiveness study. The device is a tissue marker, not an AI diagnostic tool.
4. Effect size of human readers with AI vs. without AI	Not applicable.
5. Standalone performance (algorithm only)	Not applicable. This is a physical medical device (implantable clip), not a software algorithm. The "performance" refers to its physical and functional characteristics (e.g., ability to attach, visibility on imaging, sterility, etc.), not algorithmic accuracy.
6. Type of ground truth used	Not applicable in the context of diagnostic AI. For a physical device, performance is typically validated against engineering specifications, material properties, biocompatibility standards, and functional tests (e.g., deployment, visibility under imaging). The document implies tests were performed against "predetermined acceptance criteria."
7. Sample size for training set	Not applicable. This is a physical medical device, not a machine learning model.
8. How ground truth for training set was established	Not applicable.

Summary

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UltraClip II US Wing and Coil 510(k) Summary 21 CFR 807.92.

K090547 page 1/2

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the information upon which substantial equivalence determination is based as follows:

1. Submitter Information:

Applicant:	Bard Peripheral Vascular, Inc1625 West 3rd StreetTempe, Arizona 85281
Phone:	480-379-2836

Fax: 480-449-2546

Contact: Cindy Moss

2. Subject Device Name:

Device Trade Name:	UltraClip II US Wing and Co
Common or Usual Name:	Implantable Clip
Classification:	Class II
Classification Panel:	General & Plastic Surgery

3. Predicate Device:

UltraClip II Wing and Coil, K063238, cleared January 30, 2007

4. Summary of Change:

A line extension to provide for the Wing and Clip markers with PVA,

5. Device Description:

Bard Peripheral Vascular, Inc.

TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.

Image /page/0/Picture/20 description: The image shows the word "BARD" in a stylized, outlined font. The letters are bold and blocky, with a slight three-dimensional effect created by the outlines. The overall impression is a strong, simple logo or wordmark.

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to soft breast tissue at the surgical site during an open surgical breast at biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.

6. Intended Use of Device:

The UltraClip II US Wing and Coil are intended for use to mark a breast biopsy site.

7. Technological Comparison to Predicate Device:

The technological characteristics of the subject device are identical to those of the predicate device in terms of intended use, indications for use, target population, fundamental scientific technology, operating principle, method of sterilization, packaging configuration, sterility assurance level, and performance characteristics,

8. Conclusions:

The UltraClip II US Wing and Coil met all predetermined acceptance criteria of the design verification and validation testing performed under design controls, and is substantially equivalent to the predicate UltraClip II Wing and Coil.

TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.

Image /page/1/Picture/11 description: The image shows the word "BARD" in a bold, outlined font. The letters are all capitalized and evenly spaced. The font style is geometric and modern.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

MAR 1 8 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C.R. Bard, Inc. % Ms. Cindy Moss Associate Project Manager Regulatory Affairs 1625 W. 3rd Street Tempe, Arizona 85281

Re: K090547

Trade/Device Name: UltraClip II US Wing and Coil Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: February 27, 2009 Received: March 2, 2009

Dear Ms. Moss:

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. Cindy Moss

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,

L.A. m.D. for.
Mark N. Mellekerson

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

KO90547 510(k) Number (if known):

Device Name: UltraClip II US Wing and Coil

Indications For Use:

Prescription Use . X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Eva

Daniel Knoan for MKM March 16, 2009

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

510(k) Number K090647

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.