RAP Femoral Venous Cannulae

K250283 · LivaNova USA, Inc. · DWF · Jul 10, 2025 · Cardiovascular

Device Facts

• Record ID: K250283
• Device Name: RAP Femoral Venous Cannulae
• Applicant: LivaNova USA, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Jul 10, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Remote Access Perfusion (RAP) femoral venous cannula is intended for use as a venous drainage cannula during cardiopulmonary bypass up to six hours

Device Story

The RAP Femoral venous cannula is a single-use, sterile, non-pyrogenic device designed for venous drainage during cardiopulmonary bypass. It consists of an open-lumen PVC polymer tube with wire reinforcement in distal sections and multiple drainage holes. A malleable obturator is included to facilitate placement along the femoral vein to the vena cava. The proximal end features a barbed connector for integration with standard bypass tubing. The device is operated by clinical staff in a surgical setting. The primary modification from the predicate is the removal of DEHP plasticizer from the PVC material. The device functions as a passive conduit for blood flow; it does not involve active sensing, processing, or electronic output. Its use supports extracorporeal circulation, benefiting patients requiring temporary cardiopulmonary support.

Clinical Evidence

No clinical testing was conducted. Substantial equivalence is supported by non-clinical performance data, including mechanical verification (pull tests, kink tests, flow/pressure drop, collapse resistance) and comprehensive biocompatibility testing (cytotoxicity, sensitization, systemic toxicity, pyrogenicity, hemocompatibility, and genotoxicity).

Technological Characteristics

Single-use, sterile, PVC polymer cannula with wire reinforcement. Features a malleable obturator for placement. Fluid path is non-pyrogenic. Sterilized via ethylene oxide. No electronic components, software, or active sensing. Material modified to be DEHP-free.

Indications for Use

Indicated for use as a venous drainage cannula during cardiopulmonary bypass for up to six hours.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

• Remote Access Perfusion (RAP) Femoral Venous cannula (K052081)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 10, 2025

LivaNova USA inc
% Martina Carlini
RA Specialist
Sorin Group Italia S.r.l.
86, Via statale 12 Nord
Mirandola, 41037
Italy

Re: K250283
Trade/Device Name: RAP Femoral Arterial Cannulae
Regulation Number: 21 CFR 870.4210
Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing
Regulatory Class: Class II
Product Code: DWF
Dated: June 11, 2025
Received: June 11, 2025

Dear Martina Carlini:

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.

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).

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K250283 - Martina Carlini
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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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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K250283 - Martina Carlini
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Sincerely,

Nicole M. Gillette -S

Nicole Gillette
Assistant Director
DHT2B: Division of Circulatory Support, Structural, and Vascular Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K250283

Device Name
RAP Femoral Arterial cannulae (200-100; 200-150)

Indications for Use (Describe)
The Remote Access Perfusion (RAP) femoral venous cannula is intended for use as a venous drainage cannula during cardiopulmonary bypass up to six hours

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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LivaNova
Health innovation that matters

# 510(k) Summary

(in accordance with 21 CFR 807.92)

510(k) Number: K250283

## I. Applicant Information

Applicant:
LIVANOVA USA INC
14401 West 65th Way
Arvada, CO 80004

Contact Person:
Martina Carlini
Regulatory Affairs Specialist
Tel: [phone]
e-mail: [e-mail]

Application Correspondent:
SORIN GROUP ITALIA S.R.L.
Via Statale 12 Nord, 86
Mirandola, MO 41047 Italy

Contact Person:
Martina Carlini
Regulatory Affairs Specialist
Tel: [phone]
e-mail: [e-mail]

Date Prepared: July 10th 2025

## II. Subject Device Identification

Device Trade Name: RAP Femoral Arterial cannulae

Classification Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing

Regulation Number: 21 CFR 870.4210

Product Code: DWF

Classification: Class II

Classification Panel: Cardiovascular

Special 510(k) – RAP femoral arterial cannula

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LivaNova
Health innovation that matters

## III. Predicate Device

The RAP Femoral Arterial cannulae are substantially equivalent to the following cleared predicate device. Both modified and unmodified models have the same fundamental scientific technology and intended use:

| | 510(k) Number: | K052081 |
| --- | --- | --- |
| | Device Trade Name: | Remote Access Perfusion (RAP) Femoral Venous cannula |
| | Classification Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing |
| | Regulation Number: | 21 CFR 870.4210 |
| | Product Code: | DWF |
| | Classification: | Class II |
| | Classification Panel: | Cardiovascular |

## IV. Device Description

RAP Femoral venous cannulae are single-use, non-toxic, non-pyrogenic fluid path devices and supplied sterile and individually packaged.

The device is composed of a cannula and a malleable obturator inserted into the cannula to allow the placement of the cannula along the femoral vein till the vena cava. The cannula and the obturator are packaged within the same pouch and sold together.

The cannula is an open lumen PVC polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple holes at multiple stages to allow fluid flow. The clear proximal section is not reinforced to allow clamping; the proximal end terminates in a 3/8" to ½" barbed connector for standard cardiopulmonary bypass tubing.

The RAP femoral arterial cannulae are the modified version of the disposables currently marketed as the RAP Femoral Venous cannula (K052081).

Both modified and unmodified cannulae models are recommended for use as a venous drainage cannula during cardiopulmonary bypass up to six hours

## V. Indications for Use

The Remote Access Perfusion (RAP) femoral venous cannula is intended for use as a venous drainage cannula during cardiopulmonary bypass up to six hours

## VI. Summary of Technical Characteristics

The RAP Femoral arterial cannulae have the same fundamental technological characteristics, principles of operation and control mechanisms as the unmodified devices.

The PVC material of the basket, body and tip of the RAP Femoral venous cannulae were changed within the modified RAP femoral venous cannula in order to remove the diethylhexyl phthalate (DEHP) used as plasticizer currently present in the device.

No other design changes have been made to the devices.

Special 510(k) – RAP femoral arterial cannula

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LivaNova
Health innovation that matters

The devices are ethylene oxide sterilized and have a non-pyrogenic fluid path. They are for single use only.

## VII. Non-Clinical Performance Data

Livanova USA Inc. has conducted extensive verification and validation testing of the RAP femoral venous cannula.

The devices passed all the testing in accordance with national and international standards.

In particular, the performed tests are the following:

| TEST CLASSIFICATION | TEST DESCRIPTION |
| --- | --- |
| Verification/Validation | Visual inspection |
| Verification/Validation | Connector testing 180° pull test |
| Verification/Validation | Cannula clamp test |
| Verification/Validation | Blood pathway integrity |
| Verification/Validation | Flow rate and pressure drop through cannulae |
| Verification/Validation | Cannula kink test |
| Verification/Validation | Label legibility |
| Verification/Validation | Drainage cannula collapse resistance |
| Verification/Validation | Cannula integrity |
| Verification/Validation | Pull strength |
| Verification/Validation | Blood trauma characterization test |
| Biocompatibility | Cytotoxicity |
| Biocompatibility | Intracutaneous reactivity |
| Biocompatibility | Sensitization |
| Biocompatibility | Systemic Toxicity |
| Biocompatibility | Pyrogenicity (material mediated) |
| Biocompatibility | Hemocompatibility (Hemolysis, Coagulation, Complement activation, Platelet and Leukocyte count assay) |
| Biocompatibility | Genotoxicity (Mutation Assay, Mouse lymphoma) |

## VIII. Clinical Performance Data

No clinical testing was conducted in support of the RAP Femoral venous cannulae, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use. The non-clinical testing summarized in this submission supports the substantial equivalence of the subject devices with the predicate devices when used according to their intended use.

Special 510(k) – RAP femoral arterial cannula

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LivaNova
Health innovation that matters

## IX. Statement of Substantial Equivalence

Based on equivalent intended use and technological characteristics, as well as on equivalent performance testing, the RAP femoral venous cannulae can be deemed to be substantially equivalent to their predicate devices:

- the unmodified RAP femoral venous cannulae, cleared under K052081;

The RAP femoral venous cannulae, as designed and manufactured, do not raise new questions regarding safety and effectiveness as compared to their predicate devices and are determined to be substantially equivalent to their predicate devices listed above.

Special 510(k) – RAP femoral arterial cannula
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