(154 days)
No
The summary describes a mechanical snaring device and does not mention any AI/ML components or capabilities.
No
The device is described as a percutaneous snaring device used to manipulate and retrieve guidewires, which is an interventional tool rather than a device intended for treating or curing a disease or condition. Its function is procedural assistance.
No
The device description indicates it is a "percutaneous snaring device" used to "manipulate and retrieve guidewires," which describes an interventional tool, not a diagnostic one. Its intended use is to physically interact with guidewires within the cardiovascular system, rather than to gather information for diagnosis.
No
The device description clearly states it is a percutaneous snaring device with physical components (luer, snaring basket made of nitinol, coaxial sheathing system) and the performance studies include biocompatibility, sterilization, packaging, and non-clinical testing of these physical components.
Based on the provided information, the LimFlow V-Ceiver is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "manipulate and retrieve guidewires specified in the IFU" within the "cardiovascular system." This describes a device used within the body for a procedural purpose, not a device used to examine specimens outside the body to diagnose or monitor a condition.
- Device Description: The description details a percutaneous snaring device with a basket and sheathing system, designed for physical interaction within the cardiovascular system. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or performing diagnostic tests in vitro.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The LimFlow V-Ceiver's function is purely mechanical and procedural within the body.
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
MMX
Device Description
The LimFlow V-Ceiver is a percutaneous snaring device with a luer on the proximal end and a snaring basket at the distal end. The basket is composed of nitinol for shape memory and visibility with radiopaque markers on either end of the basket for added visibility. The coaxial sheathing system is used to re-constrain the basket once a guide wire is captured.
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
Not Found
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
The following performance tests were conducted on the subject device to demonstrate substantial equivalence:
Biocompatibility
The biocompatibility tests listed below were completed to meet the requirements of ISO 10993-1.
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material-Mediated Hemocompatibility (Hemolysis, PTT, Complement Activation)
- Pyrogenicity
- Platelet and Leukocyte Count
- Comparative Surface Assessment
Sterilization
Sterilization validation was conducted in accordance ISO 11135:2014/A1:2018.
Packaging Validation
Packaging validation was conducted in accordance with ASTM F1886/F1886M-16, ASTM F2096-11(2019) and ASTM F88/F88M-21 and ASTM D4169-22.
Non-Clinical Testing
The non-clinical tests listed below were conducted on the subject device.
- Dimensional Verification and Visual Inspection
- Simulated Use
- Catheter Bond Strength Test
- Flexibility & Kink Test
- Torque Test
- Leak Test
- Corrosion Test
- Radiopacity and luer fitting tests were leveraged from K222083.
Animal Testing
Animal testing was not required for the determination of substantial equivalence.
Conclusion
The results of all testing conducted on the subject device demonstrates that the subject device is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
LimFlow V-Ceiver (K222083)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below that.
February 14, 2025
LimFlow Inc. Tosan Eweka Principal Regulatory Affairs Specialist 6001 Oak Canyon Suite 100 Irvine, California 92618
Re: K242776
Trade/Device Name: LimFlow V-Ceiver Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: MMX Dated: January 21, 2025 Received: January 21, 2025
Dear Tosan Eweka:
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.
1
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 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-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 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-device-advicecomprehensive-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-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-regulatory
2
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,
ARIEL G. ASH- Digitally signed by ARIEL
G. ASH- G. ASH- G. ASH-SHAKOOR -S SHAKOOR -S Date: 2025.02.14 12:31:28 -05'00'
For
Gregory O'Connell 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
3
Indications for Use
510(k) Number (if known) K242776
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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4
510(k) Summary
| Date prepared | February 13, 2025 |
|---|---|
| Company | LimFlow Inc. |
| 6001 Oak Canyon, Suite | |
| 100 Irvine, CA 92618 | |
| Contact person | Tosan Eweka |
| Principal Regulatory Affairs Specialist | |
| Phone: +1 (949) 227-3148 Email: tosan.eweka@inarimedical.com | |
| Name of Device | LimFlow V-Ceiver |
| Regulation name | Embolectomy catheter |
| Classification number | 21 CFR 870.5150 |
| Product code | MMX |
| Regulatory class | II |
| Predicate device | LimFlow V-Ceiver (K222083) |
| Description | The LimFlow V-Ceiver is a percutaneous snaring device with a luer on the |
| proximal end and a snaring basket at the distal end. The basket is composed of | |
| nitinol for shape memory and visibility with radiopaque markers on either end of | |
| the basket for added visibility. The coaxial sheathing system is used to re-constrain | |
| the basket once a guide wire is captured. | |
| Indications for Use | The LimFlow V-Ceiver is intended for use in the cardiovascular system to |
| manipulate and retrieve guidewires specified in the IFU. | |
| Device Modifications | Incremental, non-significant modifications made to the LimFlow V-Ceiver since |
| clearance was granted under K222083. | |
| Comparison of | |
| Technological | |
| Characteristics with | |
| the Predicate Device | The subject device and the predicate device have the same key dimensions: 4 Fr |
| catheter OD, 1000 mm catheter length and 6 mm basket OD. The subject device | |
| and predicate device also have identical design features. They both include a nitinol | |
| snare basket with radiopaque markers on either end, encased in a polyimide sheath | |
| with inner nitinol and stainless-steel tubing for pushability and flexibility. The only | |
| difference between the subject device and predicate device is in the materials used | |
| in the distal tip component, materials used in the packaging and adhesives used for | |
| both devices. | |
| Summary of | |
| substantial equivalence | There is no change to the intended use, indications for use, principles of operation, |
| or fundamental technological characteristics between the subject device and the | |
| predicate device. The subject device and predicate device have similar materials of | |
| construction and packaging. The following performance tests were conducted on | |
| the subject device to demonstrate substantial equivalence: | |
| Biocompatibility | |
| The biocompatibility tests listed below were completed to meet the requirements of | |
| ISO 10993-1. |
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Page 2 of 2
- Cytotoxicity . Sensitization . Intracutaneous Reactivity . Acute Systemic Toxicity Material-Mediated . . Hemocompatibility Pyrogenicity (Hemolysis, PTT, Complement Activation) ● Platelet and Leukocyte Count . Comparative Surface Assessment Sterilization Sterilization validation was conducted in accordance ISO 11135:2014/A1:2018. Packaging Validation Packaging validation was conducted in accordance with ASTM F1886/F1886M-16, ASTM F2096-11(2019) and ASTM F88/F88M-21 and ASTM D4169-22. Non-Clinical Testing The non-clinical tests listed below were conducted on the subject device. . Dimensional Verification and Visual Inspection Simulated Use ● Catheter Bond Strength Test ● Flexibility & Kink Test ● ● Torque Test Leak Test ● Corrosion Test ● Radiopacity and luer fitting tests were leveraged from K222083. Animal Testing Animal testing was not required for the determination of substantial equivalence. Conclusion The results of all testing conducted on the subject device demonstrates that the subject device is substantially equivalent to the predicate device.