VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE

K974259 · Edwards Lifesciences Research Medical · DWF · Dec 1, 1998 · Cardiovascular

Device Facts

• Record ID: K974259
• Device Name: VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE
• Applicant: Edwards Lifesciences Research Medical
• Product Code: DWF · Cardiovascular
• Decision Date: Dec 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae, PIFlex-II-xxx-V, are intended for use in situations in which short term cardiopulmonary bypass peripheral access venous return procedures, i.e., internal jugular vein, right innominate vein, and femoral vein access, as well as the standard intra-operative access venous return procedures, i.e., right atrial appendage and right atriotomy access is desired. Venous access is left to the discretion of the physician.

Device Story

Sterile, single-use, disposable venous return cannula; wire-reinforced polyurethane thin-wall tube with unreinforced proximal section and barbed connector; supplied with polyethylene dilator. Used intra-operatively by surgeons for short-term cardiopulmonary bypass. Device provides venous access via jugular, femoral, innominate, or atrial sites. Physician inserts cannula to facilitate venous return during bypass procedures. Benefits include versatile access options for cardiopulmonary support. Device is EtO sterilized.

Clinical Evidence

Bench testing only. Biocompatibility testing performed on whole product extract/tubesheet slices per ISO 10993: Cytotoxicity (MEM Elution), Guinea Pig Maximization (sensitization), CFR Primary Skin Irritation, USP Systemic Toxicity, and Hemolysis (0.0% hemolysis).

Technological Characteristics

Materials: Polyurethane body, PVC vent cap/connector, polyethylene dilator. Design: Wire-reinforced thin-wall cannula, 16-24 Fr, 12-20.5" length. Sterilization: EtO. Single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring short-term cardiopulmonary bypass venous return via peripheral (internal jugular, right innominate, femoral) or intra-operative (right atrial appendage, right atriotomy) access. Physician discretion determines specific venous access site.

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

• Baxter Research Medical, Inc. Various Cardiovascular Surgical Devices [Dual Stage and Single Stage Venous Return Catheters] (K831769)
• Baxter Research Medical, Inc. FEM-Flex Femoral Access Cannulation Set (K891576)

Submission Summary (Full Text)

{0}------------------------------------------------

K974259

1 1998 DEC

### Subsection II.A.

SMDA Summary of Safety and Effectiveness Information

In compliance with requirements of the Safe Medical Device Act (SMDA) of 1990, the following information is submitted as a summary of safety and effectiveness information for this 510(k) premarket notification:

#### 1. Predicate Device Identification

A claim of substantial equivalence of the BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae is made to the following Baxter Research Medical, Inc. product family 510(k)s:

- K831769, Various Cardiovascular Surgical Devices [Dual Stage and Single Stage . Venous Return Catheters
- K891576, FEM-Flex Femoral Access Cannulation Set .

These devices were marketed prior to May 28, 1976 or have received FDA clearance to market since that date.

#### 2. Biocompatibilitv Assessment

Biocompatibility testing was performed on whole product extract and/or tubesheet slices of the ethylene oxide (EtO) sterilized test article in accordance with testing which is based on ISO 10993 Standard. Biological Evaluation of Medical Devices.

The BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae, PIFlex-II-xxx-V, are substantially equivalent in design and materials to BRMI FEM-FLEX™ II Femoral Cannulae, FEM II-xxx-A, marketed under K891576. The FEM II-xxx-A was used as the test article for this testing. The reports are summarized as follows:

- Cytotoxicity Test (MEM Elution Test) Under conditions of the test . article is not cytotoxic.
- Guinea Pig Maximization Study (Magnuson/Kligman) The test group and . negative control animals showed no signs of sensitization and therefore Passes Test as a grade I sensitizer (weak).
- CFR Primary Skin Irritation Test Under conditions of the test, the test article . Passes Test in accordance with requirements of CFR Title 16 Part 1500.41.
- USP Systemic Toxicity Test Under conditions of the test, the test article Passes . Test in accordance with requirements of the USP Systemic Injection Test.
- Hemolysis Test The test article had 0.0% Hemolysis.

{1}------------------------------------------------

#### Comparative Information 3.

## Table 1. Comparison of Specifications

## Proposed Venous PIFlex II Cannulae vs. Predicate FEM-II Cannulae

### BRMI PIFlex-II-xxx-V

Description: A sterile, single use, disposable cannula. Polyurethane, wire reinforced thin-wall cannula with unreinforced proximal section terminating in a barbed connector. Supplied with a polyethylene dilator.

Design: BRMI will offer the cannula in the following ranges: Size: 16 - 24 Fr. Length: 12" - 20.5'

Material: Body: Polyurethane Vent Cap Body: PVC Connector: PVC Dilator: Polyethylene

Manufacturing/Inspection: SOP: Comparable to 70225 IPQA: Comparable to 80160

Labeling: Comparable to p/n 61227 Exception: additional statement "care should be taken to avoid vessel perforation". This statement will be added to IFU p/n 61227. VF-IIxxx products will be used intraoperatively and in situations which peripheral cannulation (i.e. jugular, femoral, innominate) is desired for short term cardiopulmonary bypass.

Packaging: Individually packaged in a sealed Kwik Breathe pouch.

Sterilization: EtO. Product is intended for single use only.

# BRMI FEM-II-xxx-A

Description: A sterile, single use, disposable cannula. Polyurethane, wire reinforced thin-wall cannula with unreinforced proximal section terminating in a barbed connector. Supplied with a polyethylene dilator.

Design: BRMI offers the femoral access cannula in the following: Size: 8 - 28 Fr. Length: 6" - 20.5"

Material: Body: Polyurethane Vent Cap Body: PVC Connector: PVC Suture Ring: Silicone Dilator: Polyethylene Cap, Non Vent ML (T-models): ABS

Manufacturing/Inspection: SOP: BRMI p/n 70225 IPQA: BRMI p/n 80160

Labeling: BRMI p/n 61227 . FEM-II-xxx-x are for femoral access only access.

Packaging: Individually packaged in a sealed K wik Breathe pouch.

Sterilization: EtO. Product is intended for single use only.

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1

Mr. John W. Smith Baxter Healthcare Corporation 6864 South 300 West Midvale, UT 84047-1051

Re: K974259 Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae Regulatory Class: II (two) 74 DWF Product Code: Dated: September 4, 1998 Received: September 24, 1998

Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

### Page 2 - Mr. John W. Smith

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J.V Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page_______ of _______________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): 长 97-4259 __________________________________________________________________________________________________________________________________________

BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Device Name: Return Cannulae, PIFlex-II-xxx-V

Indications For Use:

The BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae, PIFlex-II-xxx-V, are intended for use in situations in which short term cardiopulmonary bypass peripheral access venous return procedures, i.e., internal jugular vein, right innominate vein, and femoral vein access, as well as the standard intra-operative access venous return procedures, i.e., right atrial appendage and right atriotomy access is desired. Venous access is left to the discretion of the physician.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div align="center">(Division Sign-Off)</div> |
|--|-----------------------------------------------|
|--|-----------------------------------------------|

Division of Cardiovascular, Respiratory, and Neurological Devices

| 510(k) Number | K974259 |
|---------------|---------|
|---------------|---------|

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---------------------------------------|----|-----------------------------------------------|
|---------------------------------------|----|-----------------------------------------------|