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 (Curls and Clover) consists of a disposable beveled needle applicator containing a Nitinol radiographic marker is intended for long-term radiographic marking of the tissue site. The applicator has a beveled 17g x 10cm needle with 1 cm depth marks and a locking plunger. Each marker shape is deployed from the beveled needle tip into the tissue site.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and performance studies, based on the requested categories.

Important Note: The provided document is an FDA 510(k) summary for a breast tissue marker. This type of device is a physical implant, not a software-driven AI solution. Therefore, many of the typical questions related to AI/ML device performance (like MRMC studies, training/test set ground truth establishment for an algorithm, expert adjudication for image interpretation, etc.) are not applicable to this document. The "tests" performed here are physical and chemical property tests, not clinical performance studies involving patient images and expert readers.

I will populate the table and address the questions as best as possible given the nature of the device and the provided document.

Acceptance Criteria and Device Performance Study for UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover)

As per the FDA 510(k) Summary (K243642), the device is a physical breast tissue marker. The "performance testing" summarized here pertains to the physical and chemical properties of the marker and its applicator, assessing its safety and effectiveness for its intended use as an implantable marker. It is designed to be substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative "acceptance criteria" with numerical thresholds for these tests, but rather reports "Pass" or lists the type of analysis performed. This is common for biocompatibility and material safety testing where the goal is to demonstrate compliance with standards rather than specific performance metrics against a clinical endpoint.

Test Category	Specific Test / Parameter	Reported Device Performance (Implied Acceptance)
Material Properties & Safety	Chemical characterization (Wireform/Marker)	Pass (SVOC by GC/MS, VOC by GC/MS by Headspace, ICP/MS, NVOC by UPLC/MS performed after exhaustive extraction at 50°C for 72 hours)
	Cytotoxicity (MEM Cell)	Pass
	Sensitization (Kligman Maximization)	Pass
	Irritation / Intracutaneous Reactivity	Pass
	Acute Systemic Toxicity	Pass
	Material Mediated Pyrogenicity	Pass
	Subchronic Toxicity Study in Rats (13 weeks)	Pass
	Genotoxicity (AMES Assay, Mouse Lymphoma Assay)	Pass
	Implantation (1, 4, 12 weeks)	Pass
	Toxicology (Toxicological Risk Assessment)	Pass
	Nickel Ion Release Testing	Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence)
	Transformation Temperature Testing	Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence)
	Corrosion Testing of Wireform (Marker)	Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence)
Applicator Properties	Aqueous Physicochemical Testing	Pass (Extract - Purified Water)
	Non-Aqueous Physicochemical Testing	Pass (Extract - Isopropyl Alcohol)
	Exaggerated Extraction	Pass (Extract - Purified Water, Isopropyl Alcohol, Cyclohexane)
	Cytotoxicity (MEM Elution)	Pass
	Sensitization (Kligman Guinea Pig Maximization)	Pass (Extract - 0.9% Sodium Chloride, Cottonseed oil)
	Irritation or Intracutaneous Reactivity	Pass (Extract - 0.9% Sodium Chloride, Cottonseed oil)
	Acute Systemic Toxicity	Pass (Extract - 0.9% Sodium Chloride, Sesame oil)
	Material-Mediated Pyrogenicity	Pass (Extract - 0.9% Sodium Chloride)
	Chemical Characterization (Applicator)	SVOC by GC/MS, VOC by GC/MS by Headspace, ICP/MS, NVOC by UPLC/MS performed (Implied pass by overall conclusion of substantial equivalence)
Functional Performance	Marker Differentiation (Stereotactic or X-Ray/Mammography)	Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence)
	Marker Visibility (Ultrasound, Stereotactic, X-Ray/Mammography, MRI)	Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence)
	Marker Retention Testing	Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence)
	Marker Deployment Accuracy	Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence)
	Marker Deployment Force	Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence)
	Marker Deployment	Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence)
	MRI Testing	Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence)

2. Sample Size Used for the Test Set and Data Provenance

Due to the nature of the device (implantable clip, not an AI diagnostic algorithm), the concept of a "test set" in the context of clinical data/images doesn't apply directly.

Sample Size: The document does not specify the sample sizes (number of markers or material samples) for each individual non-clinical test (e.g., how many markers were tested for deployment force, or how many rats were used for the subchronic toxicity study). However, the tests performed (biocompatibility, mechanical, radiographic visibility) inherently involve testing a sufficient sample size of the device or its components to ensure statistical reliability and demonstrate compliance with relevant standards.
Data Provenance: Not applicable in the sense of patient data. The tests are laboratory-based, performed on the device itself or its materials. The document does not state the country of origin for the testing.
Retrospective or Prospective: Not applicable; these are laboratory and animal studies, not human clinical studies involving observational data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This is not applicable as the device is a physical marker and its performance evaluation involves laboratory testing and animal studies (e.g., biocompatibility) rather than human expert interpretation of images for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation of data requiring adjudication for this type of device and performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC study was not done. This type of study is specifically designed for evaluating diagnostic algorithms or imaging techniques where human readers interpret medical images. The UltraCor™ Twirl™ Breast Tissue Marker is a physical implantable device, and its safety and performance are assessed through physical, chemical, and, in some cases, animal biocompatibility testing. It is not an AI-based diagnostic tool.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests outlined here is established through:

Standardized Physical and Chemical Measurements: For tests like marker differentiation, visibility, retention, deployment accuracy, force, and corrosion, the ground truth is determined by objective, measurable physical and chemical properties and engineering specifications.
Biocompatibility Standards: For the extensive biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation), the "ground truth" is compliance with international standards (e.g., ISO 10993 series) and observed biological responses in in vitro and in vivo models. "Pass" indicates that the material did not induce unacceptable biological reactions.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 24, 2025

Bard Peripheral Vascular, Inc. Meghan Mckelvey Regulatory Affairs Manager 1625 West 3rd Street Tempe, Arizona 85281

Re: K243642

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: November 25, 2024 Received: November 26, 2024

Dear Meghan 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

TEK N. LAMICHHANE -S

Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K243642

Device Name

The UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover)

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary 21 CFR 878.4300

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:

1. Submitter Information:

Applicant:	Bard Peripheral Vascular, Inc.1625 West 3rd StreetTempe, Arizona 85281
Phone:	602-830-5063
Contact:	Meghan McKelvey, Regulatory Affairs Manager
Date:	November 26, 2024

2. Subject Device-K243642:

Device Trade Name:	UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover)
Classification Name:	Marker, Radiographic, Implantable (Product Code: NEU)
Review Panel:	General & Plastic Surgery
Regulation Number:	21 CFR 878.4300

3. Predicate Device:

UltraCor™ Twirl™ Breast Tissue Marker (Ring shape; K180061)

4. Device Description:

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5. 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.

6. Technological Comparison to Predicate Devices:

The technological characteristics of the subject device are substantially equivalent to those of the predicate device, in terms of following:

. Intended Use
. Indications for Use
. Performance Characteristics
. Target Population
. Fundamental Scientific Technology
. Operating Principle (Mechanism of Action)
Wireform (Marker) Material ●
. Sterility Assurance Level and Method of Sterilization
. Shelf-Life
. Packaging Configuration

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

. Marker Shapes
. Applicator Handle Overmold Colorants

7. Performance Testing Summary:

To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated. Using the FDA Guidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997, and internal risk assessments procedures, the following non-clinical tests were performed:

. Marker Differentiation (Stereotactic or X-Ray/Mammography)
. Marker Visibility (Ultrasound, Stereotactic, X-Ray/Mammography, MRI)
. Marker Retention Testing
. Marker Deployment Accuracy
Marker Deployment Force ●
Marker Deployment .
. Corrosion Testing of Wireform (Marker)

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Nickel Ion Release Testing .
Transformation Temperature Testing ●
MRI Testing, and ●
. Biocompatibility Testing was conducted on both the wireform (marker) and the applicator as presented in Table 1.

Table 1: Biocompatibility Testing of UltraCor Twirl Breast Tissue Marker (Curls and Clover shapes)

Implantable Wireform (Marker)
Test Method	Results
Chemical characterization	Pass
Exhaustive Extraction at 50°C for 72 hours(in triplicate)	SVOC by GC/MSVOC by GC/MS by HeadspaceICP/MSNVOC by UPLC/MS
Cytotoxicity
MEM Cell Cytotoxicity	Pass
Sensitization (Kligman Maximization)	Pass
Irritation / Intracutaneous Reactivity(Intracutaneous Injection)	Pass
Acute Systemic Toxicity	Pass
Material Mediated Pyrogenicity	Pass
Subchronic Toxicity Study in Rats(13 weeks)	Pass
Genotoxicity
• AMES Assay	• Pass
• Mouse Lymphoma Assay	• Pass
Implantation
• 1 week	• Pass
• 4 weeks	• Pass
• 12 weeks	• Pass
Toxicology(Toxicological Risk Assessment)	Pass
Applicator
Aqueous Physicochemical Testing	PassExtract - Purifed Water
Non-Aqueous Physicochemical Testing	PassExtract - Isopropyl Alcohol
Exaggerated Extraction	PassExtract - Purified WaterExtract - Isopropyl AlcoholExtract - Cyclohexane

	Extract - MEM Elution
	Pass
Sensitization-Kligman Guinea PigMaximization	Extract - 0.9% Sodium Chloride
	Extract - Cottonseed oil
	Pass
Irritation or Intracutaneous Reactivity	Extract - 0.9% Sodium Chloride
	Extract - Cottonseed oil
	Pass
Acute Systemic Toxicity	Extract - 0.9% Sodium Chloride
	Extract - Sesame oil
	Pass
Material-Mediated Pyrogenicity	Extract - 0.9% Sodium Chloride
	Pass
Chemical Characterization	SVOC by GC/MS
	VOC by GC/MS by Headspace
	ICP/MS
	NVOC by UPLC/MS

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The biologic and chemical characterization test results demonstrate that the subject device is biocompatible for its intended use. The technological characteristics and performance criteria of the UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover) are comparable to the predicate device and that they perform as safely and as effectively as the legally marketed predicate device.

8. Conclusion:

The UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover) are substantially equivalent to the legally marketed predicate device, the UltraCor™ Twirl™ Breast Tissue Marker (Ring shape; K180061).

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.