The UltraCor Twirl Breast Tissue Marker is 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 biopsy procedure.

Device Description

The UltraCor® Twirl™ Breast Tissue Marker consists of a disposable beveled needle applicator containing a Nitinol radiographic ring marker is intended for long-term radiographic marking of the tissue site. The applicator has a beveled 17q x 10cm needle with 1 cm depth marks and a locking plunger. The ring is deployed from the beveled needle tip into the tissue site.

AI/ML Overview

The provided document describes the UltraCor® Twirl™ Breast Tissue Marker and its substantial equivalence to a predicate device, UltraClip® II US Wing and Coil. It outlines performance testing that was conducted, but it does not present acceptance criteria in a table format nor does it describe a study proving the device met specific performance metrics in a way that allows for a direct comparison table as requested.

The document focuses on design verification and validation testing, confirming that modifications from the predicate device do not impact safety or effectiveness. The conclusion states that the subject device "met all predetermined acceptance criteria of design verification and validation," but it does not list these criteria or the specific results against them.

Therefore, based on the provided text, I cannot complete parts 1, 2, 3, 4, 5, 6, 7, 8, and 9 of your request as these specific details are not present. The document summarizes the types of tests performed, rather than the quantitative results or the methodology for establishing ground truth, sample sizes, or expert involvement in those tests.

Here's a breakdown of what can be extracted and what is missing:

Information that can be extracted from the document:

Device Name: UltraCor® Twirl™ Breast Tissue Marker
Predicate Device: UltraClip® II US Wing and Coil (K090547)
Types of Testing Performed (as listed in "Performance Testing Summary"):
- Marker shape distinguishability
- Ultrasound visibility
- Marker deployment accuracy
- Marker deployment force
- Marker deployment
- Marker retention
- Marker dimensional testing
- Applicator dimensional testing
- Applicator tensile testing
- Visual inspection of the product
- Visual integrity of the packaging
- Pouch seal strength of the packaging
- MRI testing (magnetic field interactions, MRI-related heating, artifact testing)
- Biocompatibility testing on the applicator and the marker implant
Ground Truth for performance testing: The document implies that the ground truth for these tests was based on "applicable standards, guidance, test protocols and/or customer inputs," but the specifics of how this ground truth was established are not detailed.

Information that is NOT available in the document and therefore cannot be provided in response to your request:

A table of acceptance criteria and the reported device performance: The document states that the device "met all predetermined acceptance criteria," but does not list these criteria or report the specific performance metrics achieved against them.
Sample size used for the test set and the data provenance: Not specified for any of the performance tests. The nature of these tests (e.g., bench testing) suggests lab-based experiments, but details are missing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
Adjudication method for the test set: Not applicable and not mentioned, as this device's testing relates to physical properties, not diagnostic interpretation.
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: Not applicable. This device is a breast tissue marker, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While the document mentions "applicable standards, guidance, test protocols and/or customer inputs," the specific type of ground truth (e.g., whether "ultrasound visibility" was assessed by expert consensus on images, or by quantitative metrics) is not detailed.
The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the document confirms that various design verification tests were conducted, and the device met its acceptance criteria, contributing to its substantial equivalence determination. However, it does not provide the granular detail requested concerning the specific acceptance criteria, test results, sample sizes, or expert involvement.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 13, 2016

Bard Peripheral Vascular, Inc. Ms. Kristen Dejeu Regulatory Affairs Associate 1625 West 3rd Street Tempe, Arizona 85281

Re: K152510

Trade/Device Name: Ultracore Twirl Breast Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: April 12, 2016 Received: April 13, 2016

Dear Ms. Dejeu:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K152510

Device Name UltraCor Twirl Breast Tissue Marker

Indications for Use (Describe)

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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510(k) Summary [As required by 21 CFR 807.92(c)]

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 is as follows:

Submitter Information:

Applicant:	Bard Peripheral Vascular, Inc.1625 West 3rd StreetTempe, Arizona 85281
Phone:	480-350-6067
Fax:	480-449-2546
Contact:	Kristen DeJeu, Regulatory Affairs Associate
Date:	May 11, 2016

Subject Device:

Device Trade Name:	UltraCor® Twirl™ Breast Tissue Marker
Common or Usual Name:	Breast Tissue Marker
Classification:	Class 2
Classification Name:	Marker, Radiographic, Implantable ( Product Code NEU)
Review Panel:	General & Plastic Surgery
Regulation Number:	21 CFR 878.4300 (Implantable Clip)

Predicate Device:

UltraClip® II US Wing and Coil (K090547, Cleared March 18, 2009)

Summary of Change:

The modifications from the predicate device, the UltraClip® II US Wing and Coil Breast Tissue Marker, to the subject device, the UltraCor® Twirl™ Breast Tissue Marker, include differences in marker design and material, applicator design and material, packaging material, and labeling.

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Device Description:

Indications for Use of Device:

The UltraCor® Twirl™ Breast Tissue Marker is 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.

Technological Characteristics:

The UltraCor® Twirl™ has the following similarities to the predicate device:

. Same intended use / indications for use
. Similar technological characteristics
. Same fundamental scientific technology
. Same target population
. Same operating principle
. Same sterility assurance level
. Same method of sterilization
. Same packaging configuration

Performance Testing Summary:

Bench testing was performed to verify that the modifications to the subject device do not impact safety or effectiveness of the device. Design verification testing included: marker shape distinguishability, ultrasound visibility, marker deployment accuracy, marker deployment force, marker deployment, marker retention, marker dimensional testing, applicator dimensional testing, applicator tensile testing, visual inspection of the product, visual integrity of the packaging, pouch seal strength of the packaging, MRI testing (magnetic field interactions, MRIrelated heating, artifact testing), as well as biocompatibility testing on the applicator and the marker implant.

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Conclusion:

The subject device, the UltraCor® Twirl™ Breast Tissue Marker, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. Therefore, the UltraCor® Twirl™ Breast Tissue Marker is substantially equivalent to the legally marketed predicate device, the UltraClip II US Wing and Coil Breast Tissue Marker (K090547).

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.