The UltraCor® Twirl® Breast Tissue Marker is intended for use to attach to soft breast tissue, including axillary lymph nodes, to radiographically mark the location of the biopsy procedure.

Device Description

The ULTRACOR® Twirl® Breast Tissue Marker consists of a disposable beveled needle applicator containing a nitinol radiographic ring wireform. The wireform is intended for longterm radiographic marking of the tissue site. The applicator has a beveled 17G x 10cm needle with 1cm depth marks and a locking plunger. The ring is deployed from the beveled needle tip into the tissue site.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the UltraCor Twirl Breast Tissue Marker. However, it explicitly states that no performance data (bench testing or clinical analysis) was warranted due to the nature of the change.

The key information regarding acceptance criteria and study details is as follows:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not applicable.	No new or increased risks identified from the updated Indications for Use.

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

Sample Size: Not applicable. No test set was used for a performance study.
Data Provenance: Not applicable.

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

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

Adjudication Method: Not applicable.

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:

MRMC Study: No. This device is not an AI-assisted diagnostic tool, but rather an implanted marker.

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

Standalone Performance: No. This device is an implanted marker, not a diagnostic algorithm.

7. The type of ground truth used:

Ground Truth Type: Not applicable. The submission is based on an update to the Indications for Use, supported by a literature review and physician statements on existing clinical practice, rather than a direct performance study to establish a ground truth.

8. The sample size for the training set:

Sample Size: Not applicable. No training set was used.

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

Ground Truth Establishment: Not applicable.

Explanation from the document:

The 510(k) submission (K180061) for the UltraCor Twirl Breast Tissue Marker focused on an update to its Indications for Use to include axillary lymph nodes. The manufacturer explicitly states:

"The change to the Indications for Use described in this submission does not affect the design of the device and no new or increased risks have been identified, therefore additional bench performance testing was not warranted." (Page 5, Section 8. Performance Data)
"The change to the Indications for Use is clinically supported by both a comprehensive literature review and physician statements." (Page 5, Section 9. Clinical Analysis)

Therefore, this submission did not involve a study to prove performance against specific acceptance criteria in the traditional sense of a diagnostic or therapeutic device. Instead, it leveraged existing knowledge and clinical practice to justify the expanded indication of an already cleared device.

Summary

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March 9, 2018

Bard Peripheral Vascular, Inc. Meghan McKelvey Regulatory Affairs Associate 1625 W. 3rd Street Tempe, Arizona 85281

Re: K180061

Trade/Device Name: UltraCor Twirl Breast Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: January 5, 2018 Received: January 8, 2018

Dear Ms. McKelvey:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180061

Device Name UltraCor® Twirl® Breast Tissue Marker

Indications for Use (Describe)

The UltraCor® Twirl® Breast Tissue Marker is intended for use to attach to soft breast tissue, including axillary lymph nodes, to radiographically mark the location of the biopsy procedure.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)

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ULTRACOR®Twirl® Breast Tissue Marker 510(k) Summary 21 CFR 807.92

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 510(k) summary upon which substantial equivalence determination is based is as follows:

1. Submitter Information:

Applicant:	Bard Peripheral Vascular, Inc1625 West 3rd StreetTempe, Arizona 85281
Phone:	(480) 350-6153
Fax:	(480) 966-7062
Contact:	Meghan McKelvey, Regulatory Affairs Associate
Date:	January 5, 2018

2. Subject Device Names:

Device Trade Name:	ULTRACOR® TWIRL® Breast Tissue Marker
Common or Usual Name:	Breast Tissue Marker
Classification:	Class II
Review Panel:	General & Plastic Surgery
Regulation Number:	21 CFR 878.4300 (FDA Product Code NEU)

3. Predicate Devices:

Predicate 510(k) Number	Subject Device
K152510; cleared May 13, 2016	ULTRACOR® TWIRL®

Summary of Change 4.

The Indications for Use statement is being updated to include the axillary lymph nodes. Subject device labeling updates including updates to the Instructions for Use and Potential Complications, are being implemented through this submission.

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5. Device Description:

6. Indications for Use of Device:

The ULTRACOR® Twirl® Breast Tissue Marker is intended for use to attach to soft breast tissue, including axillary lymph nodes, to radiographically mark the location of the biopsy procedure.

7. Technological Comparison to Predicate Devices:

The ULTRACOR® Twirl® Breast Tissue Marker has the following similarities to the predicate device:

. Same Intended Use
Same Target Population .
. Same Technological Characteristics
Same Fundamental Scientific Technology .
Same Operating Principal .
. Same Implant Design and Materials
. Same Applicator Design and Materials
. Same Performance Specifications
. Same Packaging Materials and Configurations
. Same Sterility Assurance Level and Method of Sterilization

The subject device and the predicate device are different in the following manner:

Modifications to Indications for Use .
There are no changes to the implants or delivery systems. The subject device labeling has been updated to include the updated Indications for Use language.

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8. Performance Data:

The change to the Indications for Use described in this submission does not affect the design of the device and no new or increased risks have been identified, therefore additional bench performance testing was not warranted.

9. Clinical Analysis:

The change to the Indications for Use is clinically supported by both a comprehensive literature review and physician statements. A comprehensive literature review was conducted to collect and assess relevant clinical literature related to the use of clips (breast tissue markers) in axillary lymph nodes in metastatic breast cancer patients. To further reinforce the clinical use of a breast tissue marker in the axillary lymph node region, Bard consulted with physicians to gain further insight on current practices.

10. Conclusions:

The subject device, ULTRACOR® Twirl® Breast Tissue Marker, is substantially equivalent to the legally marketed predicate device.

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.