(96 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical components for guidewire placement.
No
The device is intended to facilitate the placement and positioning of guidewires and catheters, which are diagnostic or interventional tools, rather than directly providing a therapeutic effect itself.
No
The device's intended use is to facilitate the placement and positioning of guidewires and catheters, which is a procedural/interventional function, not a diagnostic one. It does not mention identifying, analyzing, or monitoring medical conditions.
No
The device description explicitly details physical components (Cannula, Catheter shaft, Deployment handle) and mentions biocompatibility, sterilization, and physical testing, indicating it is a hardware device.
Based on the provided information, the LimFlow ARC is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature." This describes a device used in vivo (within the body) for a procedural purpose, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical device used for manipulating guidewires and catheters within the patient's vasculature. This aligns with an interventional or procedural device, not a diagnostic test performed on a sample.
- Anatomical Site: The device is used in the "peripheral vasculature; Cardiovascular system," which is an anatomical location within the body.
- Input Imaging Modality: The use of "external fluoroscopy" further indicates a procedure performed on a patient, not an in vitro test.
IVD devices are typically used to examine samples like blood, urine, or tissue to detect diseases, conditions, or infections. The LimFlow ARC's function is entirely different, focusing on facilitating procedures within the patient's circulatory system.
N/A
Intended Use / Indications for Use
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.
Product codes
PDU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Advancement of both devices is monitored by external fluoroscopy
Anatomical Site
Cardiovascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital or office-based lab
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
Indications for Use
510(k) Number (if known) K221541
Device Name LimFlow ARC
Indications for Use (Describe)
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.
| 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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3
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: | K150836 |
| Note: This predicate device has not been subject to a recall. |
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.
4
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 CFR | |
| 870.1250) | Same | |
| Device Category | Percutaneous catheter | Same |
| Indications for Use | The OUTBACK Elite is intended to facilitate | |
| placement and positioning of guide wires and | ||
| catheters within the peripheral vasculature. The | ||
| OUTBACK Elite is not intended for use in the | ||
| coronary or cerebral vasculature. | Same | |
| Device Description: Design | ||
| & Operating Principle | The OUTBACK Elite is a single-use device designed | |
| to facilitate placement and positioning of guide 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 OUTBACK Elite Re- | ||
| Entry Catheter is supplied sterile and is available in | ||
| two usable lengths (80 cm and 120 cm). | Same, except the is available in one usable | |
| length (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 the | |
| coronary or cerebral vasculature. | Same | |
| Where used | Hospital or office-based lab | Same |
| Technological | ||
| Characteristics | The OUTBACK Elite consists of three primary | |
| elements: |
- 22-gauge nitinol re-entry cannula
- Catheter shaft
- Deployment handle with deployment control slide
Key features of the OUTBACK Elite Re-Entry
Catheter include:
- 6F sheath compatibility
- 0.014" guide wire compatibility
- Hydrophilic coating along the entire length of the
catheter - Ergonomic Handle
- Radiopaque markers at the distal end that
enables lumen orientation under fluoroscopy | Same, except the LimFlow ARC does not
contain a hydrophilic coating. |
| Guide wire compatibility | The OUTBACK Elite is recommended for use with
the 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 with
the following crossing guide wires:
Boston Scientific Thruway 0.014"
Medtronic Nitrex 0.014"
Terumo Runthrough 0.014" |
| Duration of use per
ISO 10993-1 | Externally communicating medical device in contact
with circulating blood for ≤ 24 hrs. | Same |
| Target Population | Patients requiring placement and positioning of guide
wires and catheters in the peripheral vasculature. | Same |
| Anatomical Sites | Cardiovascular system | Cardiovascular system |
| Key Dimensions | Catheter OD
6 French | Catheter OD
Same |
| | Catheter Length
80 cm or 120 cm | Catheter Length
100 cm |
| | Cannula Throw
8 mm | Cannula Throw
10 mm |
| | Cannula Opening
22-gauge | Cannula Opening
Same |
| Materials | Medical grade metals and polymers | Same |
| Sterilization Method | Ethylene Oxide | Same |
| Performance & Test data | Biocompatibility per 21 CFR Part 58 and per
ISO 10993-1, including: - Dimensional and Functional Testing, including:
o Device Joint Tensile Strength
o Catheter Torqueability
o Device Joint Torque to Failure - Packaging Validation
- Sterilization Validation | Same |
5
6
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.