(25 days)
K112185, CloverSnare™
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML, image processing, or data-driven algorithms.
No.
The device's intended use is to "manipulate and retrieve guidewires," which describes an instrumental function rather than a direct therapeutic effect on a disease or condition. While it operates within the cardiovascular system, its role is to assist in procedures, not to treat.
No
The device description and intended use indicate it is an intravascular catheter designed to manipulate and retrieve guidewires, which is a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines a physical intravascular catheter with a nitinol basket, radiopaque markers, and a coaxial sheathing system. The performance studies also detail physical testing like tensile strength, leak testing, and biocompatibility, all indicative of a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "use in the cardiovascular system to manipulate and retrieve guidewires". This describes a procedure performed within the body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The description details an "intravascular catheter" with a "nitinol basket" for use within the cardiovascular system. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and procedural within the cardiovascular system.
N/A
Intended Use / Indications for Use
The LimFlow V-Ceiver™ is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU.
Product codes (comma separated list FDA assigned to the subject device)
MMX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Performance Tests (Non-Clinical):
- 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.
- 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), Sensitization (ISO 10993-10), Irritation (ISO 10993-10), 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), Thromboresistance (ISO 10993-4).
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K112185, CloverSnare™
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/0 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 the FDA logo, which 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.
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.
1
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.