The LimFlow ARC is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The LimFlow ARC is not intended for use in the coronary or cerebral vasculature.

Device Description

The LimFlow ARC is a single-use device designed to facilitate placement and positioning of quide wires within the peripheral vasculature. The device consists of three primary elements: 1) Cannula, 2) Catheter shaft, and 3) Deployment handle with deployment control slide. The LimFlow ARC is used in a healthcare facility, such as a cardiac catheter lab or hospital. It is in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible. The LimFlow ARC is supplied sterile.

AI/ML Overview

The provided text is a 510(k) summary for the LimFlow ARC device. It details a comparison to a predicate device and lists performance data presented to the FDA. However, it does not explicitly state acceptance criteria or provide a study with detailed performance results against those criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a predicate device (OUTBACK® Elite Re-Entry Catheter, K150836) rather than independently proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance, is not present in the provided text.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

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

Not provided. The document states that "performance data were provided to establish that the LimFlow ARC does not raise new questions of safety or effectiveness compared to the predicated OUTBACK Elite." It lists types of tests (Biocompatibility, Dimensional and Functional, Packaging, Sterilization) but does not give specific acceptance criteria for these tests nor the quantitative performance results of the LimFlow ARC against such criteria. For example, it doesn't say "Tensile Strength acceptance criterion: > X N; LimFlow ARC result: Y N."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document mentions "Biocompatibility testing was performed on finished and sterilized LimFlow ARC" and "Device Dimensional and Functional Testing" but does not specify the sample sizes used for these tests. Data provenance (country, retrospective/prospective) is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. This type of information is typically relevant for studies involving human interpretation or performance, such as diagnostic accuracy studies. The tests described (biocompatibility, mechanical properties) are engineering and biological tests that do not involve expert interpretation or ground truth establishment in the diagnostic sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. As with point 3, adjudication methods are typically for studies involving human interpretation of data, which is not the nature of the tests described.

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

No. An MRMC study was not done. The device (LimFlow ARC) is a mechanical percutaneous catheter aimed at facilitating guidewire placement, not an AI-powered diagnostic tool. Therefore, human readers or AI assistance in interpretation are not relevant to its stated function or the tests conducted.

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

Not applicable. The device is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance data provided relate to the physical and biological characteristics of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly stated in the context of ground truth validation. For the engineering tests, the "ground truth" would be established mechanical and material science principles, and for biocompatibility, it would be established biological safety standards (e.g., ISO 10993).

8. The sample size for the training set

Not applicable/Not provided. This device does not involve machine learning or AI, so there is no concept of a "training set."

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

Not applicable/Not provided. (See point 8)

Summary of available information related to performance:

The provided document describes the types of tests conducted to demonstrate substantial equivalence, but not detailed acceptance criteria or quantitative performance results for the LimFlow ARC.

Performance Data Categories:

Biocompatibility Testing (in compliance with 21 CFR Part 58 (GLP) and ISO 10993-1):
- Cytotoxicity
- Hemolysis
- Complement Activation
- Intracutaneous Irritation
- Maximum Sensitization
- Acute Systemic Toxicity
- Pyrogenicity
- Partial Thromboplastin Time
- Thrombogenicity
Device Dimensional and Functional Testing:
- Dimensional Verification
- Device Joint Tensile Strength
- Catheter Torqueability
- Device Joint Torque to Failure
- Flex / Kink Testing
- Simulated Use
Packaging and Sterilization Testing:
- Packaging Validation
- Sterilization Validation

The conclusion states that these tests "confirm the LimFlow ARC raises no new questions of safety and effectiveness and meets the requirements that are considered essential for its intended use and that the LimFlow ARC is substantially equivalent to the predicate device, OUTBACK Elite." This indicates that the device met the implicit acceptance criteria for substantial equivalence based on these tests.

Summary

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August 31, 2022

Image /page/0/Picture/1 description: The image shows 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

LimFlow, Inc. Zachary Woodson VP of Regulatory Affairs & Quality 3031 Tisch Way - 110 Plaza West San Jose. California 95128

Re: K221541

Trade/Device Name: LimFlow ARC Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: May 26, 2022 Received: May 27, 2022

Dear Zachary Woodson:

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.

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

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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 (OS) 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 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/cdrl-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.

for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular 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) K221541

Device Name LimFlow ARC

Indications for Use (Describe)

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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LimFlow ARC™

510(k) Summary 21 CFR807.92

Submitter Information

Applicant: Address

E-mail:

Contact:

Phone Number:

Contact e-mail:

Date Prepared:

Contact Phone Number:

LimFlow Inc. 3031 Tisch Way 110 Plaza West San Jose, CA 95127 +1 (888) 478-7705 info@limflow.com Zachary Woodson zwoodson@limflow.com +1 (707) 328-6522 26 May 2022

Proposed Device

Trade Name:	LimFlow ARC
Common name:	Percutaneous catheter
Classification name:	Catheter for Crossing Total Occlusions
Classification:	Class II
Regulation:	21 CFR 870.1250
Product Code:	PDU

Predicate Device

Trade Name:	OUTBACK® Elite Re-Entry Catheter
Common name:	Percutaneous catheter
Classification name:	Catheter for Crossing Total Occlusions
Classification:	Class II
Regulation:	21 CFR 870.1250
Product Code:	PDU
Premarket Notification:	K150836Note: This predicate device has not been subject to a recall.

Device Description

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Intended Use/Indications For Use

The LimFlow ARC is intended to facilitate placement and positioning of guide wires and catheters within the peripheral vasculature. The LimFlow ARC is not intended for use in the coronary or cerebral vasculature.

Comparison of Technological Characteristics with the Predicate Device

The LimFlow ARC is substantially equivalent to the predicate device based upon the following similarities:

. Both devices are intended to be used to cross chronic total occlusions (CTOs) in peripheral vessels
Both devices are used in cardiac catheter labs in either a hospital or an ● office-based lab
Both devices are advanced to the target occlusion through an ● indwelling vascular sheath
Advancement of both devices is monitored by external fluoroscopy ●
. Both devices have equivalent sizes in terms of outer diameter and working length of the cannula
. Both devices share the same basic design, mechanism of action, and principles of operation
Both devices share the same sterilization method (EO) ●

The table below compares the LimFlow ARC (this submission) to the predicate device, the Outback Elite (K150836).

Device Feature	OUTBACK Elite (Predicate)	LimFlow ARC (This Submission)
Device Classification	Class II	Same
Classification Name	Catheter for Crossing Total Occlusions (21 CFR870.1250)	Same
Device Category	Percutaneous catheter	Same
Indications for Use	The OUTBACK Elite is intended to facilitateplacement and positioning of guide wires andcatheters within the peripheral vasculature. TheOUTBACK Elite is not intended for use in thecoronary or cerebral vasculature.	Same
Device Description: Design& Operating Principle	The OUTBACK Elite is a single-use device designedto facilitate placement and positioning of guide wireswithin the peripheral vasculature. The deviceconsists of three primary elements: 1) Cannula, 2)Catheter shaft, and 3) Deployment handle withdeployment control slide. The OUTBACK Elite Re-Entry Catheter is supplied sterile and is available intwo usable lengths (80 cm and 120 cm).	Same, except the is available in one usablelength (100 cm).
Packaging Contents	One (1) OUTBACK Elite	Same
Device Feature	OUTBACK Elite (Predicate)	LimFlow ARC (This Submission)
Contraindications	The OUTBACK Elite is not intended for use in thecoronary or cerebral vasculature.	Same
Where used	Hospital or office-based lab	Same
TechnologicalCharacteristics	The OUTBACK Elite consists of three primaryelements:1) 22-gauge nitinol re-entry cannula2) Catheter shaft3) Deployment handle with deployment control slideKey features of the OUTBACK Elite Re-EntryCatheter include:- 6F sheath compatibility- 0.014" guide wire compatibility- Hydrophilic coating along the entire length of thecatheter- Ergonomic Handle- Radiopaque markers at the distal end thatenables lumen orientation under fluoroscopy	Same, except the LimFlow ARC does notcontain a hydrophilic coating.
Guide wire compatibility	The OUTBACK Elite is recommended for use withthe following guide wires:Cordis ATW 0.014"Cordis STABILIZER® Plus 0.014"Cordis STABILIZER® XS 0.014"Boston Scientific Platinum Plus 0.014"Boston Scientific Choice Extra Support 0.014"Boston Scientific Mailman 0.014"Boston Scientific Luge 0.014"	The LimFlow ARC is recommended for use withthe following crossing guide wires:Boston Scientific Thruway 0.014"Medtronic Nitrex 0.014"Terumo Runthrough 0.014"
Duration of use perISO 10993-1	Externally communicating medical device in contactwith circulating blood for ≤ 24 hrs.	Same
Target Population	Patients requiring placement and positioning of guidewires and catheters in the peripheral vasculature.	Same
Anatomical Sites	Cardiovascular system	Cardiovascular system
Key Dimensions	Catheter OD6 French	Catheter ODSame
	Catheter Length80 cm or 120 cm	Catheter Length100 cm
	Cannula Throw8 mm	Cannula Throw10 mm
	Cannula Opening22-gauge	Cannula OpeningSame
Materials	Medical grade metals and polymers	Same
Sterilization Method	Ethylene Oxide	Same
Performance & Test data	Biocompatibility per 21 CFR Part 58 and perISO 10993-1, including:- Dimensional and Functional Testing, including:o Device Joint Tensile Strengtho Catheter Torqueabilityo Device Joint Torque to Failure- Packaging Validation- Sterilization Validation	Same

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Performance Data

The following performance data were provided to establish that the LimFlow ARC does not raise new questions of safety or effectiveness compared o the predicated OUTBACK Elite cleared under K150836:

Biocompatibility Testing

Biocompatibility testing was performed on finished and sterilized LimFlow ARC in compliance with the U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFR Part 58 and ISO 10993-1 Biological evaluation of medical devices - Part 1. Biocompatibility testing included the following:

Cytotoxicity ●
Hemolysis ●
Complement Activation ●
Intracutaneous Irritation ●
Maximum Sensitization ●
Acute Systemic Toxicity ●
Pyrogenicity ●
Partial Thromboplastin Time ●
Thrombogenicity ●

Device Dimensional and Functional Testing

Dimensional Verification ●
Device Joint Tensile Strength ●
Catheter Torqueability ●
Device Joint Torque to Failure
Flex / Kink Testing ●
Simulated Use

Packaging and Sterilization Testing

Packaging Validation
. Sterilization Validation

Conclusions

The information submitted in this premarket notification confirms the LimFlow ARC raises no new questions of safety and effectiveness and meets the requirements that are considered essential for its intended use and that the LimFlow AR is substantially equivalent to the predicate device, OUTBACK Elite.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).