SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT

K952879 · Baxter Healthcare Corp · KFM · Apr 22, 1996 · Cardiovascular

Device Facts

• Record ID: K952879
• Device Name: SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT
• Applicant: Baxter Healthcare Corp
• Product Code: KFM · Cardiovascular
• Decision Date: Apr 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 3M™ Sarns™ Centrifugal Pumps with Duraflo® II Treatment are indicated as extracorporeal pumps for use in cardiopulmonary bypass procedures only and for use exclusively with Sarns™ centrifugal control systems.

Device Story

Centrifugal pump imparts velocity to blood via rotating impeller; two-chamber design; pump chamber contains impeller with vanes, seals, inlet/outlet ports; rear chamber contains bearings for magnet rotor alignment; rear chamber hermetically sealed from pump chamber and atmosphere. Duraflo® II treatment provides heparin-based blood path (up to 400 USP units) to improve blood compatibility of non-biological surfaces. Used in cardiopulmonary bypass procedures; operated by perfusionists/clinicians in clinical settings. Output is mechanical blood flow; healthcare provider monitors flow via Sarns™ centrifugal control systems to maintain systemic circulation during bypass.

Clinical Evidence

Bench testing only. In vitro studies included hemolysis, platelet depletion, white blood cell depletion, heparin leaching, and heparin quantitation. Functional testing included 12-hour life test (n=16) and burst test (n=16). Results showed no statistical difference in platelet or WBC depletion between coated and uncoated units; hemolysis changes were within acceptable limits compared to predicate device historical data.

Technological Characteristics

Centrifugal pump with rotating impeller; heparin-based Duraflo® II surface treatment; hermetically sealed rear chamber; mechanical bearings; magnet rotor drive. Designed for use with Sarns™ centrifugal control systems.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures requiring extracorporeal circulation.

Regulatory Classification

Identification

A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Special Controls

*Classification* —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability; (ii) The patient-contacting components of the device must be demonstrated to be biocompatible; (iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and (iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device. (b) *Nonroller-type temporary ventricular support blood pump* —(1)*Identification.* A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2) *Classification.* Class III (premarket approval).(c) *Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required.* A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• 3M™ Sarns™ Centrifugal Pump (K915363)

Submission Summary (Full Text)

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510 K Submission for Sarns™ Centrifugal Pump with Duraflo® II Treatment

510(k) Summary

K952879

1. Name and Address of Contact Person

Scott Beggins
Baxter Healthcare Corporation
CardioVascular Group
Bentley Division
P.O. Box 19522
Irvine, California 92713-9522

APR 22 1996

2. Name of Device: 3M™ Sarns™ Centrifugal Pump with Duraflo® II Treatment

3. Predicate Device: 3M™ Sarns™ Centrifugal Pump

4. Device Description

The Sarns™ Centrifugal Pump is a centrifugal pump which imparts velocity to blood through action of a rotating impeller. The pump is comprised of two chambers. The pump chamber contains the impeller with vanes, seals components, inlet port and outlet port for connection to tubing. The rear chamber contains bearings used to support and align the magnet rotor. The rear chamber is sealed off from the pump chamber. The rear chamber is isolated from atmosphere via a hermetic seal of the housing components forming this chamber. The Duraflo® II Treatment provides a heparin-based blood path containing up to 400 USP units of heparin. This treatment improves the blood compatibility of non-biological surfaces in the extracorporeal circuit.

5. Intended Use

The 3M™ Sarns™ Centrifugal Pumps with Duraflo® II Treatment are indicated as extracorporeal pumps for use in cardiopulmonary bypass procedures only and for use exclusively with Sarns™ centrifugal control systems.

6. a. Technology Comparison

The proposed device and predicate device are essentially identical with the exception of the addition of the Duraflo® II treatment. Components remain the same.

b. Testing Summary

The following invitro studies were conducted to qualify the 3M™ Sarns™ Centrifugal Pumps with Duraflo®II Treatment:

- Hemolysis
- Platelet Depletion

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510 K Submission for Sarns™ Centrifugal Pump with Duraflo® II Treatment

- White Blood Cells
- Heparin Leaching
- Heparin Quantitation

Test methods were based on the proposed “Special Control Protocol for Evaluation of Blood Trauma Caused by Extracorporeal Centrifugal Pumps”. The test results indicated that there was no statistical difference in %PLT depletion or in average % WBC depletion between the coated and uncoated units. While there was a some change noted in hemolysis between the two groups, these results are in line with results from previous centrifugal pump testing at worst case conditions. The test results were also compared to a study that was conducted in early 1995 on the predicate device (K915363).

Functional testing included a 12 hour Life Test (n=16), and a Burst Test (n=16) to test the pump housing, housing welds and mechanical seal under conditions of over pressurization. All Duraflo® II treated pumps passed these tests.

## c. Rational for Substantial Equivalence Determination

The coated and uncoated versions of the 3M™ Sarns™ Centrifugal Pumps are essentially identical, basic materials remain the same with the exception being the addition of the Duraflo® II Treatment with the substantially equivalent. Testing has demonstrated that units with the proposed addition of the Duraflo® II Treatment are substantially equivalent to the predicate (uncoated) device, and that there were no adverse effects on overall pump performance.

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