The LimFlow V-Ceiver consists of an intravascular catheter which incorporates a nitinol basket (the "Snare") at its distal tip. The nitinol basket has an outer diameter of 6 mm. The catheter has a built-in coaxial sheathing system and incorporates radiopaque markers at the distal tip on either end of the basket for added visibility. The catheter if compatible with 4 Fr introducer sheaths and has a working length of 100 cm.

AI/ML Overview

The provided text describes the LimFlow V-Ceiver, an embolectomy catheter, and its non-clinical performance tests to establish substantial equivalence with a predicate device. It does not contain information about a study involving human readers, AI assistance, or related ground truth evaluations that would typically be associated with an AI/ML device.

However, I can extract the information related to the device's acceptance criteria and the studies performed to meet these criteria, as described in the context of a medical device submission.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines several performance tests conducted for the LimFlow V-Ceiver, each with a statement of meeting predetermined acceptance criteria. Specific quantitative acceptance criteria are not provided in detail, but the outcomes are stated as successful.

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance
Tensile Strength	Met predetermined acceptance criteria for joint strengths (in conformance with ISO 10555-1).
Leak Testing	Met predetermined acceptance criteria (in conformance with ISO 10555-1).
Simulated Use Testing	Demonstrated the device can grasp guidewires during simulated clinical use, meeting predetermined acceptance criteria.
Kink Testing	Demonstrated the catheter would not kink during clinical use, meeting predetermined acceptance criteria.
Opening and Closing Basket Width	Demonstrated the basket could be opened and closed, meeting predetermined acceptance criteria.
Retraction Force	Demonstrated the snare can be retracted with a clinically acceptable amount of force, meeting predetermined acceptance criteria.
Radiopacity	Confirmed acceptable radiopacity during clinical use.
Corrosion	Confirmed acceptable corrosion performance.
Biocompatibility
Cytotoxicity	Confirmed biocompatibility (in conformance with ISO 10993-5).
Sensitization	Confirmed biocompatibility (in conformance with ISO 10993-10).
Irritation	Confirmed biocompatibility (in conformance with ISO 10993-10).
Acute Systemic Toxicity	Confirmed biocompatibility (in conformance with ISO 10993-11).
Material Mediated Pyrogenicity	Confirmed biocompatibility (in conformance with ISO 10993-11).
Hemolysis	Confirmed biocompatibility (in conformance with ISO 10993-4).
PTT (Partial Thromboplastin Time)	Confirmed biocompatibility (in conformance with ISO 10993-4).
Complement Activation	Confirmed biocompatibility (in conformance with ISO 10993-4).
Thromboresistance	Confirmed biocompatibility (in conformance with ISO 10993-4).
Packaging
Packaging Validation	Demonstrated the packaging system can maintain package integrity and met predetermined acceptance criteria.
Pre-clinical Study
Guidewire Snaring Performance	Demonstrated the device is appropriate with the stated indications by snaring various guidewires.
Thrombogenicity	Evaluated and confirmed to be acceptable.

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

Test Set (Non-clinical Performance Tests): The document does not specify exact sample sizes for each mechanical or biocompatibility test. It mentions that "a series of testing was conducted" and that "the below were shown to meet the acceptance criteria." The tests are typically conducted on multiple units or samples to ensure reproducibility and statistical significance, but specific numbers are not provided.
Test Set (Pre-clinical Study): "An acute swine model" was used. The specific number of animals is not provided.
Data Provenance: Not explicitly stated, but these are laboratory and animal model studies, not human patient data from a specific country.

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

This information is not applicable to the provided context. The studies described are non-clinical performance and pre-clinical animal studies, which do not involve expert human readers establishing ground truth in the way described for AI/ML performance evaluation studies.

4. Adjudication Method for the Test Set:

Not applicable for the non-clinical and pre-clinical studies described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This document describes the testing of a physical medical device (embolectomy catheter), not an AI/ML diagnostic or assistive tool for human readers.

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

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by established engineering and biological standards (e.g., ISO 10555-1, ISO 10993 series) and predetermined acceptance criteria derived from these standards and clinical relevance.

For the pre-clinical swine model, the "ground truth" for performance would be the observable success of guidewire snaring and the observed thrombogenicity outcomes within the animal model, judged against pre-defined acceptable ranges.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a training set as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary

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August 9, 2022

LimFlow Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K222083

Trade/Device Name: LimFlow V-Ceiver Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: MMX Dated: July 14, 2022 Received: July 15, 2022

Dear Prithul Bom:

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. 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 located 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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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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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-regulatoryassistance/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.

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222083

Device Name LimFlow V-Ceiver™

Indications for Use (Describe)

The LimFlow V-Ceiver™ is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU.

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 K222083 Date Prepared: 15 June 2022 Company LimFlow Inc. 3031 Tisch Wav 110 Plaza West San Jose. CA 95127 Contact: Zachary Woodson VP of Regulatory Affairs & Quality Phone: +1 707-328-6522 Email: zwoodson@limflow.com Device Trade Name: LimFlow V-Ceiver Device Common Name: Embolectomy Catheter Device Classification: Device, Embolectomy Catheter Product Code: MMX 21 CFR 870.5150 Class II Review Panel: Cardiovascular Devices K112185, CloverSnare™1 Vascular Retrieval Snare, Predicate Device: originally manufactured by Cook Incorporated Description of the Device: The LimFlow V-Ceiver consists of an intravascular catheter which incorporates a nitinol basket (the "Snare") at its distal tip. The nitinol basket has an outer diameter of 6 mm. The catheter has a built-in coaxial sheathing system and incorporates radiopaque markers at the distal tip on either end of the basket for added visibility. The catheter if compatible with 4 Fr introducer sheaths and has a working length of 100 cm. Intended Use / The LimFlow V-Ceiver is intended for use in the Indication for Use: cardiovascular system to manipulate and retrieve guidewires specified in the IFU. Technological A comparison of the technological characteristics of Characteristics: the subject device and the predicate device shows the LimFlow V-Ceiver to be substantially equivalent to the current marketed predicate device.

1 CloverSnare™ is the commercial name of the device that was approved under the name "FourSnare™" per 510(K) reference K112185

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Equivalence is based on the product performance, design, and intended use. The LimFlow V-Ceiver and the predicate device have similar materials of construction, dimensional specifications, designs, and sterilization process.

Performance Tests (Non-Clinical):

No performance standards have been established under section 514, performance standards, of the Food, Drug and Cosmetic Act for these devices. A series of testing was conducted in accordance with protocols based on requirements outlined in guidance and industry standards and the below were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence.

The following tests were performed under the specified testing parameters to support the LimFlow V-Ceiver device substantial equivalence.

Performance Testing, including:

Tensile Strength In conformance with the . applicable sections of ISO 10555-1, joint strengths were evaluated and met the predetermined acceptance criteria.
Leak Testing In conformance with the applicable . sections of ISO 10555-1, leak testing was performed and met the predetermined acceptance criteria.
Simulated Use Testing demonstrated the device ● can grasp guidewires during simulated clinical use, meeting the predetermined acceptance criteria.
. Kink Testing – Testing demonstrated the catheter would not kink during clinical use, meeting the predetermined acceptance criteria.
. Opening and Closing Basket Width - Testing demonstrated the basket could be opened and closed, meeting the predetermined acceptance criteria.
Retraction Force Testing demonstrated that the ● snare can be retracted with a clinically acceptable amount of force, meeting the predetermined acceptance criteria.
Radiopacity Testing confirmed acceptable ● radiopacity during clinical use.
Corrosion Testing confirmed acceptable ● corrosion performance.

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Packaging Validation - Testing demonstrated the
packaging system can maintain package integrity
and met the predetermined acceptance criteria.

Biocompatibility In conformance with the . applicable sections of ISO 10993-1, the following testing was performed confirming biocompatibility of the device:
- Cytotoxicity (ISO 10993-5) o
- Sensitization (ISO 10993-10) O
- Irritation (ISO 10993-10) o
- Acute Systemic Toxicity (ISO 10993-11) O
- Material Mediated Pyrogenicity (ISO 10993-11) O
- O Hemolysis (ISO 10993-4)
- PTT (ISO 10993-4) o
- Complement Activation (ISO 10993-4) O
- Thromboresistance (ISO 10993-4) O

A pre-clinical study was performed in an acute swine model to evaluate the performance of the LimFlow V-Ceiver. Snaring of various guidewires was performed to demonstrate the device is appropriate with the stated indications. Furthermore, thrombogenicity was evaluated and confirmed to be acceptable.

Based on the Indication for Use, design, safety, and Substantial Equivalence: performance testing, the LimFlow V-Ceiver device met the requirements for its intended use and is substantially equivalent to the predicate device.

Conclusion: The result of all testing demonstrates that the LimFlow V-Ceiver device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).