AB-180 XC SYSTEM, MODEL AB-180XC

K991783 · Cardiacassist, Inc. · KFM · Nov 1, 2000 · Cardiovascular

Device Facts

• Record ID: K991783
• Device Name: AB-180 XC SYSTEM, MODEL AB-180XC
• Applicant: Cardiacassist, Inc.
• Product Code: KFM · Cardiovascular
• Decision Date: Nov 1, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AB-180 XC System consists of the AB-180 XC Blood Pump, a single use, disposable device; the AB-180 XD Blood Pump Controller; a reusable control system for the AB-180 XC Blood Pump; and disposable accessory items used in conjunction with the AB-180 XC Blood Pump. The extracorporeal circuit is not supplied with the AB-180 XC System. The AB-180 XC Blood Pump is a single use, disposable centrifugal blood pump designed to circulate blood through an extracorporeal circuit. The AB-180 XC Blood Pump is intended for extracorporeal circulatory support using an extracorporeal bypass circuit. Intended duration of use is for periods appropriate to cardiopulmonary bypass, up to six hours. It is also intended to be used as an extracorporeal circulatory support system (for periods up to six hours) for procedures not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, mitral valve reoperation, surgery of the vena cava and/or aorta, liver transplant, etc.)

Device Story

Centrifugal blood pump for extracorporeal circulatory support; provides local anticoagulant delivery via infusate system. System comprises single-use disposable AB-180 XC pump and reusable AB-180 XD controller. Pump features upper housing with impeller and lower housing with rotor; infusate acts as fluid bearing and anticoagulant delivery mechanism. Operated by clinical staff in surgical settings; controller provides manual speed variability and flow monitoring. Benefits include circulatory support during bypass or complex surgeries; disposable design reduces cross-contamination risk compared to reusable pumps.

Clinical Evidence

No clinical data. Evidence consists of in-vitro bench testing comparing hydraulic performance, safety (IEC 60601-1/1-2), and hemolysis against predicate devices. Biocompatibility verified per ISO 10993-1. Sterilization validated to SAL 10^-6 with EtO residuals meeting ISO 10993-7 limits. Pyrogen testing performed via LAL method.

Technological Characteristics

Centrifugal blood pump; polysulfone impeller; DC brushless motor with integral stator winding. Single-use disposable design. Lubricated by sterile biocompatible infusate. Sterilized via EtO. Complies with IEC 60601-1, IEC 60601-1-2, IEC 68, and ISO 10993 standards.

Indications for Use

Indicated for patients requiring extracorporeal circulatory support via bypass circuit for up to 6 hours, including cardiopulmonary bypass and procedures such as valvuloplasty, mitral valve reoperation, vena cava/aorta surgery, and liver transplant.

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

• Medtronic BP-80 Bio-Pump (K973011, K852698)
• Hemadyne Minnimed Model 1861 Extracorporeal Blood Pump (K780953)

Submission Summary (Full Text)

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

## NOV = 1 2000

# (D) Cardiac Assist Technologies, Inc.

510(k) Summary

February 25, 2000

#### Company Name and Address

Sponsor/Manufacturer Cardiac Assist Technologies, Inc. 240 Alpha Drive Pittsburgh, PA 15238 Contact Individual: Richard G. Confer Telephone: [phone] Fax: [phone]

#### Device Name

Proprietary Name: AB-180 XC System Common/Usual Name: Centrifugal Blood Pump Classification Name: Pump, Blood, Cardiopulmonary Bypass, Non-roller type

#### Establishment Registration Number

Manufacturing Site 2531527 Registration Number Owner Operator Number 9028561 Cardiac Assist Technologies, Inc. 240 Alpha Drive Pittsburgh, PA 15238

#### Device Classification

Non-roller type blood pumps have been classified as Class III devices by the

Cardiovascular Devices Panel Product Code 74KFM

Note: A petition for reclassification of this type of device from Class III to Class II has been approved by the panel, but the final rule has not been promulgated yet.

## 000041

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

Cardiac Assist Technologies, Inc. AB-180 XC System

## Predicate Device or Legally Marketed Device

Medtronic BP-80 Bio-Pump®, K973011, K852698 Hemadyne Minnimed™ Model 1861 Extracorporeal Blood Pump, K780953

#### Device Description

The AB-180 XC Blood Pump provides extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusate system. The Pump is electrically driven and can only be used with the AB-180 XD Blood Pump Controller. The AB-180 XD Blood Pump Controller provides pump monitoring, manual pump speed variability and a constant flow of infusate to the Pump.

The AB-180 XC Blood Pump consists of an upper and lower housing. The upper housing encloses the blood contact area of the Pump and holds the impeller, which propels the blood through the Pump. This chamber has a low priming volume. Two tubes connect to this chamber allowing easy connection to extracorporeal circulatory support circuits. The lower housing contains the main rotating component (the rotor) and has an inlet port for the infusion fluid. This infusate acts as a fluid bearing and a local anticoagulation delivery system.

### Statement of Intended Use

The AB-180 XC System consists of the AB-180 XC Blood Pump, a single use, disposable device; the AB-180 XD Blood Pump Controller; a reusable control system for the AB-180 XC Blood Pump; and disposable accessory items used in conjunction with the AB-180 XC Blood Pump. The extracorporeal circuit is not supplied with the AB-180 XC System.

The AB-180 XC Blood Pump is a single use, disposable centrifugal blood pump designed to circulate blood through an extracorporeal circuit. The AB-180 XC Blood Pump is intended for extracorporeal circulatory support using an extracorporeal bypass circuit. Intended duration of use is for periods appropriate to cardiopulmonary bypass, up to six hours. It is also intended to be used as an extracorporeal circulatory support system (for periods up to six hours) for procedures not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, mitral valve reoperation, surgery of the vena cava and/or aorta, liver transplant, etc.).

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

Cardiac Assist Technologies, Inc. AB-180 XC System

#### Technological Characteristics

The technological characteristics of the AB-180 XC Blood Pump are identical to the Hemadyne Minnimed™ Model 1861 Extracorporeal Blood Pump with the exception of the following modifications:

- The impeller material has been changed from pyrolytic carbon to polysulfone .
- The AB-180 XC Blood Pump contains an integral stator winding for the DC brushless motor, whereas the Minnimed 1861 was magnetically coupled to the drive unit.
- The Minnimed 1861 was reusable whereas the AB-180 XC Blood Pump is for single . patient use and is disposable.

#### Summary of Performance Data

In-vitro Bench Testing:

The AB-180 XC Blood Pump was compared to the predicate device, the Medtronic BP-80 Bio-Pump®, via a battery of in-vitro bench tests. These tests demonstrated that the AB-180 XC Blood Pump is substantially equivalent to commercially distributed centrifugal blood pumps. The in-vitro bench testing included analysis of the following:

- Hydraulic Performance Tests .
- Safety and Environmental Tests to IEC 60601-1, IEC 60601-1-2 and IEC 68 ●
- Hemolysis Testing .

#### Biocompatibility:

Biocompatibility testing of the AB-180 XC Blood Pump was performed in accordance with the FDA Blue Book Memorandum - G95-1 and appropriate sections of Biological Evaluation of Medical Devices Guidance - International Standard ISO 10993-1.

Biocompatibility testing in accordance with these standards demonstrated that the AB-180 XC Blood Pump is bicompatible and non-toxic and, thus, safe for its intended use. The AB-180 XC Blood Pump is lubricated by the infusion of a sterile biocompatible solution; and, thus, there are no biocompatibility issues associated with the infusate.

#### Sterilization:

Sterilization of the AB-180 XC Blood Pump has been validated to assure a sterility assurance level (SAL) of 10°.

EtO dissipation curves are used to assure that the EtO sterilized AB-180 XC Blood Pump meets the limits for residual concentrations of ethylene oxide and ethylene chlorohydrin as published in ANSI Standard Number ANSVAAMI/ISO 10993-7:1995 (Biological Evaluation of Medical Devices - Part 7: Ehtylene Oxide Sterilization Residuals).

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

Cardiac Assist Technologies, Inc. AB-180 XC System

#### Pyrogens:

The Limlus Amebocyte Lysate (LAL) method is used for pyrogen testing. LAL testing is The Limitus Amooooyie Dycax (ump and release criteria is in accordance to the December performed on the FD 100 the FDA, Office of Compliance (Guideline of Validation of the 1907 Guildomio Institute Test as an End-Product Endotoxin Test for Human and Linnal Parenteral Drugs, Biological Products, and Medical Devices).

#### Conclusion

The Cardiac Assist Technologies, Inc. AB-180 XC System is substantially equivalent to the Hemadyne Minnimed Model 1861 Blood Pump and control system, K780953, and the Bio-Medicus BP-80 Bio-Pump and Bio-Console, K852698 and K973011. The intended use, indications for use, and technological characteristics, safety information mence abo, mance data support the substantial equivalence of the AB-180 XC System.

4

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

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a bird or eagle with three wavy lines extending from its head, resembling feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 1 2000

Cardiac Assist Technologies, Inc C/O Joe Schwoebel, RAC Vice President of Regulatory Affairs 240 Alpha Drive 15238 Pittsburgh, PA.

K991783 Re: AB180 XC System, Model AB-180XC Regulatory Class: III (three) Product Code: KFM Dated: June 22, 2000 Received: June 23, 2000

Dear Mr. Schwoebel:

We have reviewed your Section 510(k) notification of intent to market we nave revrenced above and we have determined the device is che device forcemed at (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encrosure, co regarificant to May 28, 1976, the enactment date of the Incercate ocaments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and In accordance with the pamy, therefore, market the device, subject to the general controls provisions of the Act. The general controls ene gollora of the Act include requirements for annual registration, provisions of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your device is cli (Premarket Approval), it may be subject to such odditional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 our be 19 million in the equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set with the Quality System Regulation (QS) for Medical Devices: General regulation (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 assumptions. 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.

{5}------------------------------------------------

## Page 2 - Mr. Joe Schwoebel, RAC

This letter will allow you to begin marketing your device as described inis recei will as on formarket notification. The FDA finding of substantial In your Sroth, promainoice to a legally marketed predicate device equivalence or your device and thus, permits your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling II you desire Specific and additionally 809.10 for in vitro regulation (Er or: , please contact the Office of Compliance at (301) diagnobers actions on the promotions on the promotion and 594 4040. Thatelonaderice, please contact the Office of Compliance at Also, please note the regulation entitled, [phone]. "Misbranding by reference to premarket notification" (21CFR 807.97). MSDranding by rerorchoo on your responsibilities under the Act may Ocher general information of Small Manufacturers Assistance at its be obtained from the more [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Center for Devices and Radiological Health

Brim E. Atarr

James E. Dillard III
Director
Division of Cardiovascular and
Respiratory Devices
Office of Device Evaluation

Enclosure

{6}------------------------------------------------

## Cardiac Assist Technologies, Inc.

Indications For Use Statement

510(k) number: K991783

Device Name: AB-180 XC System

Indications For Use:

The AB-180 XC System consists of the AB-180 XC Blood Pump, a single use, disposable device; the AB-180 XD Blood Pump Controller, a reusable control system for the AB-180 XC Blood Pump; and disposable accessory items used in conjunction with the AB-180 XC Blood Pump. The extracorporeal circuit is not supplied with the AB-180 XC System.

The AB-180 XC Blood Pump is a single use, disposable centrifugal blood pump designed to circulate blood through an extracorporeal circuit. The AB-180 XC Blood Pump is intended for extracorporeal circulatory support using an extracorporeal bypass circuit. Intended duration of use is for periods appropriate to cardiopulmonary bypass, up to six hours. It is also intended to be used as an extracorporeal circulatory support system (for periods up to six hours) for procedures not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, mitral valve reoperation, surgery of the vena cava and/or aorta, liver transplant, etc.)

DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

or

Prescription Use: X (Per 21 CFR 801.109) Over the Counter Use

### 000082