HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H

K013393 · A-Med Systems, Inc. · KFM · Nov 9, 2001 · Cardiovascular

Device Facts

• Record ID: K013393
• Device Name: HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H
• Applicant: A-Med Systems, Inc.
• Product Code: KFM · Cardiovascular
• Decision Date: Nov 9, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The A-Med Heparin Coated Miniature Centrifugal Blood Pump System is indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc). The A-Med Heparin Coated Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.

Device Story

Sterile, disposable, non-pulsatile, non-roller centrifugal blood pump; utilizes impeller to impart energy to blood via centrifugal forces. Flow is demand-responsive; automatically adjusts to resistance and fluid return. Features hermetically sealed drive cable and magnetic coupling. Surface modified with photoactivated hydrogel heparin coating. Used in clinical settings for extracorporeal circulatory support; operated by healthcare professionals. Requires separate motor, ultrasonic flow sensor, and microcomputer-based control console. Output provides mechanical circulatory support; assists clinical decision-making by maintaining hemodynamics during surgical procedures; benefits patients by providing temporary circulatory bypass without oxygenation.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and performance similarities to the predicate device.

Technological Characteristics

Centrifugal blood pump; photoactivated hydrogel heparin surface modification; magnetic coupling; hermetically sealed drive cable. System includes motor, ultrasonic flow sensor, and microcomputer-based control console. Sterile, disposable.

Indications for Use

Indicated for patients requiring extracorporeal circulatory support for up to six hours in procedures not requiring artificial oxygenation, such as valvuloplasty, vena cava or aorta surgery, and liver transplants. Must be used with A-Med Blood Pump Controller.

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

• A-Med Miniature Centrifugal Blood Pump System (K992592)

Submission Summary (Full Text)

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## NOV 0 9 2001

# 510(k) SUMMARY OF SAFET EFFECTIVENESS

This 510(k) Summary details sufficient information to provide an understanding of the basis for a determination of substantial equivalence. For convenience, the summary is formatted pursuant to 21 CFR §807.92. This section may be used, as presented, to provide a substantial equivalence summary to anyone requesting it from the Agency.

#### 21 CFR §807.92 a (1)

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| Submitter: |
|------------|
|------------|

A-Med Systems, Inc 2491 Boatman Avenue West Sacramento, CA 95691-3817 [phone] ext. 5316 Contact person: Cynthia G. Royster Date prepared: 11 October 2001

#### 21 CFR §807.92 a (2)

| Trade name: | A-Med Heparin Coated Miniature Centrifugal<br>Pump System |
|--------------|-----------------------------------------------------------|
| Common name: | Centrifugal Pump |

| Common name: | Centrifugal Pump |
|----------------------|-----------------------------------------------|
| Classification name: | "Non-roller type Cardiopulmonary Bypass Blood |
| Pumps"870.4360 | |

#### 21 CFR 8807.92 a (3)

Identification of predicate(s): Substantial equivalence for the A-Med Heparin Coated Miniature Centrifugal Pump is based on its similarities to the predicate devices, A-Med Miniature Centrifugal Blood Pump System (K992592). The modified A-Med Heparin Coated Centrifugal Blood Pump is substantially equivalent to the uncoated A-Med Miniature Centrifugal Blood Pump System in intended use, material, design, performance and physical characteristics. The modification adding heparin coating is the only change to the existing device.

#### 21 CFR \$807.92 a (4)

Device Description-parts and function/concept: The A-Med Heparin Coated Miniature Centrifugal Blood Pump is a sterile, disposable, non-pulsatile,

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non-roller pump that utilizes an impeller to impart energy to the blood through centrifugal forces. The flow of the pump is "demand responsive" by automatically responding to the resistance against which it is pumping and to the amount of fluid returned to the large pump with the appropriate changes in flow and pressure. A drive cable and magnetic coupling are hermetically sealed components of the pump.

The coating which A-Med propose to add to the pump will be a photoactivated hydrogel surface modification. The process uses light activated chemistry to coat the device.

A motor ultrasonic flow sensor and a microcomputer-based control console are available separately.

#### 21 CFR §807.92 a (5)

Intended use and relationship to predicate(s): The A-Med Heparin Coated Miniature Centrifugal Blood Pump is indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc). The A-Med Heparin Coated Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller. The addition of the heparin coating does not impact the currently cleared indication for the existing device.

#### CFR §807.92 a (6)

Technological characteristics and relationship to predicate(s): The A-Med Heparin Coated Miniature Centrifugal Pump is identical in design, material, intended use and technological characteristics to the uncoated predicate device. The difference between the two devices is the heparin coating only.

#### 21 CFR 8807.92 b

This substantial equivalence is based on similarities to the predicate device in terms of intended uses and technological characteristics.

#### 21 CFR 8807.92 c

In accordance with the specifications of this subsection, this summary (two pages) is its own section, and has been clearly identified as such.

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NOV 0 9 2001

Ms. Cynthia G. Royster Director, Regulatory Affairs A-Med Systems, Inc. 2491 Boatman Avenye West Sacramento, CA 95691-3817

Re: K013393

> Trade Name: A-Med Heparin Coated Minature Centrifugal Blood Pump Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-type cardiopulmonary bypass blood pump Regulatory Class: II Product Code: KFM Dated: October 11, 2001 Received: October 15, 2001

Dear Ms. Royster:

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. 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 (PMA), it may be subject to such 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.

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); good manufacturing practice requirements as set

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Page 2 - Ms. Cynthia G. Royster

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to begin mailering of substantial equivalence of your device to a legally prematication: The PDF misms of casion 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 IT you desire specific arrice for your avitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of Compliance at [phone]. The of Compliance at [phone]. Also, please note the your device, pitted, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entined, "Mischanges of esponsibilities under the Act may be obtained from the Outer general information on your respectional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

James E. Dillard III

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication Statement

K013393

NOV 0 9 2001

of Page

510(k) Number (if known): N/A

Device Name: A-Med Heparin Coated Miniature Centrifugal Blood Pump

#### Indications for Use

The A-Med Heparin Coated Miniature Centrifugal Blood Pump System is indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc). The A-Med Heparin Coated Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 CFR 801.109) OR

Over-The-Counter

Optional Format 1-

W. Jobe

Division for Cardiovascular & Respiratory Devices
510(k) Number K01393

CONFIDENTIAL