The Boomerang™ Valvulotome is a sterile, single-use, non-coated intravascular catheter designed to disrupt or cut venous valves. Both models of the Boomerang™ Valvulotome consist of a flexible 4F catheter shaft, with a working length of either 80cm (BMGVT080) or 125cm (BMGPVT125). Both models utilize a self-expanding nitinol basket with shielded blades that is mounted at the distal end of the catheter which self-centers in the vessel to prevent the blades from damaging the vessel wall. When deployed, the size of the basket adjusts to the internal diameter of the vein as the device is tracked through the vessel. The Boomerang™ Valvulotome is compatible with standard 0.018" vascular guidewires. The device is used by a physician in a healthcare facility such as a hospital or catheterization lab. The device is in contact with the patient for a short duration (< 24hrs.)

AI/ML Overview

The FDA 510(k) Clearance Letter for the Boomerang™ Valvulotome does not detail specific acceptance criteria or study results in a format that would allow for a direct numerical comparison of performance, as is typical for AI/Software as a Medical Device (SaMD) clearances. This is primarily a Class II mechanical device (External Vein Stripper) rather than a software-based diagnostic or AI-driven system.

The "Performance Data" section lists various types of tests conducted (e.g., Dimensional Measurements, Tensile Strength, Simulated Use, Biocompatibility, Cadaveric studies), but it does not provide the quantitative acceptance criteria for each test or the reported device performance against those criteria. It also does not discuss an AI component, MRMC study, or expert ground truth adjudication in the context of diagnostic accuracy, which would be relevant for an AI/SaMD.

Therefore, many of the requested points below cannot be fulfilled from the provided document as they relate to AI/SaMD performance evaluation rather than a traditional medical device's physical and functional performance.

Based on the provided document, here's an attempt to address your request, noting where the information is absent:

Description of Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the Boomerang™ Valvulotome

The provided FDA 510(k) clearance letter for the Boomerang™ Valvulotome indicates that a substantial equivalence determination was made based on various performance testing. However, the document does not explicitly state quantitative acceptance criteria or the specific numerical results of these tests. Instead, it lists categories of tests performed to demonstrate the device's safety and effectiveness compared to the predicate device.

The "Conclusion" states that "The information supplied in this premarket notification confirms that the Boomerang™ Valvulotome has the same intended use as the legally marketed predicate device. The performance testing data demonstrates that the Boomerang™ Valvulotome is substantially equivalent to the legally marketed predicate device." This implies that the device met internal design specifications and performance standards aligned with the predicate device, although these specific values are not disclosed in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

As per the provided 510(k) summary, specific quantitative acceptance criteria and their corresponding reported device performance values are not detailed. The document lists the types of performance tests conducted. For a traditional medical device like this, acceptance criteria would typically involved:

Dimensional Accuracy: Device dimensions falling within specified tolerances.
Tensile Strength & Torque Strength: Ability to withstand forces without breaking or deforming.
Flexibility: Ability to navigate venous anatomy without kinking or fracturing.
Radiopacity: Visibility under fluoroscopy.
Simulated Use: Functionality in a simulated environment (e.g., successful valve disruption without vessel damage).
Corrosion Resistance: No degradation when exposed to physiological fluids.
Biocompatibility: Absence of adverse biological reactions (cytotoxicity, sensitization, irritation, etc.).
Sterilization Validation: Assurance of sterility after processing.
Packaging Validation: Integrity of packaging to maintain sterility and device function.

The document states that these tests were "completed under specified test conditions to support a determination of substantial equivalence," implying that the device met the pre-defined acceptance criteria for each, but the specific numerical targets and results are proprietary and not included in this public summary.

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

The document does not specify the sample sizes used for each of the performance tests (e.g., number of devices tested for tensile strength, number of simulated uses, or number of cadaveric studies).

Data Provenance: The studies are described as "performance testing," which typically occurs in a lab environment. The "Cadaveric studies" imply the use of human cadaveric tissue, but the geographical origin of these cadavers or whether the studies were retrospective or prospective observational studies is not stated. These are likely prospective studies conducted specifically for regulatory submission.

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

Given this is a mechanical device, the concept of "ground truth" established by experts (like radiologists for imaging) is not directly applicable in the sense of diagnostic accuracy. However, for "Simulated Use" and "Cadaveric studies," the "experts" would likely be the engineers conducting the tests, potentially with oversight or input from medical professionals (e.g., surgeons performing the cadaveric procedures) to validate the device's functional performance and intended use. The number of such professionals and their specific qualifications are not stated.

4. Adjudication Method for the Test Set

As this is not an AI/SaMD diagnostic study, an adjudication method (like 2+1, 3+1 for consensus reads) is not applicable or described in the context of device performance testing. Performance tests typically have objective pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done or mentioned. This type of study is relevant for AI/SaMD products that assist in interpretation of medical data (e.g., radiology images). The Boomerang™ Valvulotome is a physical medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a "standalone" algorithm performance study was not done or mentioned. This device does not have an AI algorithm component in the described functionality.

7. The Type of Ground Truth Used

For a mechanical device:

Objective Measurements: E.g., dimensional measurements against blueprints, force measurements against specifications.
Functional Success: E.g., successful disruption of valves in simulated or cadaveric models, successful tracking through simulated vessels.
Material Properties: E.g., verification of material composition and properties against established standards.
Biocompatibility Standards: Compliance with ISO 10993 series for biological safety.

The "cadaveric studies" would involve an anatomical "ground truth" to assess the device's physical interaction, such as successful valve disruption without vessel wall damage. However, the specific methodology for defining and assessing this "ground truth" within the cadaveric study is not detailed.

8. The Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI. Therefore, this question is not applicable.

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

As there is no "training set" in the AI/ML context, this question is not applicable.

Summary

FDA 510(k) Clearance Letter - Boomerang Valvulotome

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 3, 2025

Aveera Medical, Inc.
Christopher Chapek
Director of Regulatory and Quality
929 Calle Negocio, Suite A
San Clemente, California 92673

Re: K250105
Trade/Device Name: Boomerang Valvulotome
Regulation Number: 21 CFR 870.4885
Regulation Name: External vein stripper
Regulatory Class: Class II
Product Code: MGZ
Dated: January 8, 2025
Received: January 15, 2025

Dear Christopher Chapek:

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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K250105 - Christopher Chapek
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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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250105 - Christopher Chapek
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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,

Rohini Retarekar -S

for Carmen Gacchina Johnson, Ph.D.
Assistant Director
DHT2B: Division of Circulatory Support,
Structural, and Vascular Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known): K250105

Device Name: Boomerang™ Valvulotome

Indications for Use (Describe):
The Boomerang™ Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Aveera Medical, Inc. K250105 - Boomerang™ Valvulotome
Page 1 of 3

Boomerang™ Valvulotome 510(k) Summary

K250105

1.1 Submitter Information

Applicant: Aveera Medical, Inc.
Address: 929 Calle Negocio, Suite A
San Clemente, CA 92673
Contact: Chris Chapek
Director of Regulatory and Quality
Contact email: cchapek@aveeramedical.com
Contact Phone: (440) 567-1793
Date Prepared: 08 January 2025

1.2 Proposed Device

Trade Name: Boomerang™ Valvulotome
Common Name: Valvulotome
Classification Name: Device, External Vein Stripper
Classification: Class II
Regulation: 21 CFR Part 870.4885
Product Code: MGZ

1.3 Predicate Device

Trade Name: Expandable Lemaitre Valvulotome (ELV)
Common Name: Valvulotome
Classification Name: Device, External Vein Stripper
Classification: Class II
Regulation: 21 CFR Part 870.4885
Product Code: MGZ
Premarket Notification: K132190

1.4 Device Description

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Aveera Medical, Inc.
K250105 - Boomerang™ Valvulotome

1.5 Intended Use / Indications for Use

The Boomerang™ Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.

1.6 Comparison of the Technological Characteristics with the Predicate Device

A comparison between the technological characteristics of the proposed device and the predicate device, including materials of construction, design, and mechanism of action, show that the Boomerang™ Valvulotome is substantially equivalent to the currently marketed predicate device, the Expandable Lemaitre Valvulotome. Both devices are deployed using a luer hub at the proximal end of the catheter. Both devices use self-centering, self-sizing expandable nitinol baskets with blades that are intended to engage and disrupt competent venous valves. The Boomerang™ Valvulotome is offered in two lengths, 80cm and 125cm, compared to the predicate device which is offered in two lengths, 40cm and 98cm. The Boomerang™ Valvulotome shaft is 4 French outer diameter and the basket is 5mm outer diameter, compared to the 4 French shaft outer diameter and 9.5mm basket outer diameter of the predicate device. Both devices are sterilized using Ethylene Oxide (EO).

1.7 Performance Data

The following performance testing was completed under specified test conditions to support a determination of substantial equivalence for the Boomerang™ Valvulotome:

Dimensional Measurements and Verification
Tensile Strength Testing of all Bonds
Flexibility
Torque Strength
Radiopacity
Simulated Use
Corrosion Resistance
Luer Flush Testing
Distribution Testing
Sterilization Validation
Packaging Validation
Biocompatibility Evaluation
- Including: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-23), Acute Systemic Toxicity (ISO 10993-11), Material Mediated Pyrogenicity (ISO 10993-11), Hemolysis (ISO 10993-4), PTT (ISO 10993-4), Complement Activation (ISO 10993-4), Platelet and Leukocyte Count Assay (ISO 10993-4)
Cadaveric studies

1.8 Conclusion

The information supplied in this premarket notification confirms that the Boomerang™ Valvulotome has the same intended use as the legally marketed predicate device. The

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Aveera Medical, Inc.
K250105 - Boomerang™ Valvulotome
Page 3 of 3

performance testing data demonstrates that the Boomerang™ Valvulotome is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 870.4885 External vein stripper.

(a)
Identification. An external vein stripper is an extravascular device used to remove a section of a vein.(b)
Classification. Class II (performance standards).