ROTAFLOW CENTRIFUGAL PUMP SYSTEM

K991864 · Jostra Medizintechnik AG · KFM · Aug 31, 2000 · Cardiovascular

Device Facts

• Record ID: K991864
• Device Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Applicant: Jostra Medizintechnik AG
• Product Code: KFM · Cardiovascular
• Decision Date: Aug 31, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RotaFlow Centrifugal Pump System is intended for use in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

Device Story

RotaFlow Centrifugal Pump System consists of console, drive unit, emergency drive, centrifugal pump (RF-32/RF-32F), and flowprobe (FP-32E). System pumps blood in extracorporeal perfusion circuits during cardiopulmonary bypass. Operates via magnetic coupling between drive unit and pump rotor. Used in clinical settings by perfusionists/physicians. Provides continuous blood flow; monitored via console and external flowprobe. Benefits include short-term circulatory support during bypass. Components include polycarbonate pump housing/rotor, sapphire ball bearing, and neodymium magnet. System supports both Jostra and Bio-Medicus consoles (via magnet adapter).

Clinical Evidence

Clinical assessment performed alongside extensive bench testing. Bench testing included function/load testing (continuous/pulsatile), flow-pressure curve verification, heat generation analysis, stagnant blood zone evaluation, and flowprobe validation. Biocompatibility testing conducted per ISO 10993-1 and USP XXIII. Sterilization validated to SAL 10^-6 per ANSI/AAMI/ISO 11135. EtO residuals verified per ANSI/AAMI/ISO 10993-7. Pyrogen testing performed via LAL method.

Technological Characteristics

Centrifugal pump system; materials: polycarbonate (housing/rotor/connector), polyethylene (callote), sapphire (ball), neodymium (magnet), HDPE (caps). Power: 230V/50Hz mains, 24V NiCd battery. Dimensions: 179x385x243mm console. Connectivity: Standalone console with interface for heart-lung machine. Sterilization: EtO. Software: Validated for functional safety.

Indications for Use

Indicated for patients undergoing short duration cardiopulmonary bypass procedures (6 hours or less) requiring extracorporeal blood pumping.

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 Bio-Medicus Bio-Console Model 550
• Medtronic Bio-Medicus Bio-Pump Centrifugal Blood Pump BP 80
• St. Jude Medical Pulse 2100 Centrifugal Pump Interface
• Medtronic Bio-Probe DP-38

Submission Summary (Full Text)

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#### AUG 3 1 2000

K991864 510/WBromark Notification JOSTRA MEDIZINTECHNIK AG - RotaFlow Centrifugal Pump System

## SUMMARY OF SAFETY AND EFFECTIVENESS

#### 510(k) SUMMARY

#### COMPANY NAME AND CONTACT PERSON

May 21, 1999

Jostra Medizintechnik AG Hechinger Straße 38 72145 Hirrlingen Germany

Kathy Johnson, Product Manager tel. [phone] fax [phone]

#### DEVICE NAME

RotaFlow Centrifugal Pump System Magnet Adapter MA-32 RotaFlow Centrifugal Pump RF-32 / RF-32F Flowprobe FP-32E

#### COMMON NAME

Cardiopulmonary Bypass Pump Console, Magnet Adapter Centrifugal Blood Pump Cardiovascular Blood Flowprobe

## CLASSIFICATION NAME

Control, Pump Speed, Cardiopulmonary Bypass, Adapter, Stopcock, Manifold, Fitting, Pump, Blood, Non-roller-type, Cardiopulmonary Bypass, Flowprobe, Blood, Cardiovascular

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## PREDICATE DEVICE OR LEGALLY MARKETED DEVICE

Medtronic Bio-Medicus Bio-Console Model 550 Medtronic Bio-Medicus Bio-Pump Centrifugal Blood Pump BP 80 St. Jude Medical Pulse 2100 Centrifugal Pump Interface Medtronic Bio-Probe DP-38

## DEVICE DESCRIPTION

......

The RotaFlow Centrifugal Pump System includes both hardware and disposables. The RotaFlow Centrifugal Pump System includes the following components:

| RotaFlow Centrifugal Pump System (= RotaFlow System) | |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| 1. Components to be used in combination with the RotaFlow Console: | |
| 1.1 Hardware | RotaFlow Console RFC 20-970<br>RotaFlow Drive Unit RFD 20-973<br>RotaFlow Emergency Drive RFE 20-976 |
| 1.2 Disposable | RotaFlow Centrifugal Pump RF-32 |
| 2. Components to be used in combination with the Bio-Medicus Console: | |
| 2.1 Hardware | Magnet Adapter MA-32 |
| 2.2 Disposables | RotaFlow Centrifugal Pump RF-32F<br>External Flow Probe FP-32E |

## INTENDED USE

The RotaFlow Centrifugal Pump System is intended for use in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

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#### TECHNOLOGICAL CHARACTERISTICS

Table 1. Comparison between RotaFlow System (Hardware) and Medtronic Bio-Medicus Bio-Console Type 550

| Name of Product | RotaFlow System<br>(Hardware) | Medtronic Bio-Medicus<br>Bio-Console Model 550 |
|----------------------------|----------------------------------|-----------------------------------------------------------------|
| Power supply Mains | 230 V~/ 50 Hz Stand<br>Alone<br> | 220-240 Vac with 50-60<br>Hz |
| Batteries Console: | + 24 V, NiCd | Two, series connected,<br>12 Vdc lead-acid gel;<br>rechargeable |
| Weight | app. 14.400 kg Console | 23.000 kg (50 lbs.) |
| Measurements<br>LxWxH/Size | 179 x 385 x 243 mm<br>Console | 420 x 230 x 360 mm |

Table 2. Comparison between RotaFlow Centrifugal Pump RF-32 / RF-32F and Medtronic Bio-Medicus Bio-Pump Centrifugal Blood Pump BP 80

| Name of Product | RotaFlow Centrifugal<br>Pump RF-32 / RF-32F | Bio-Pump Centrifugal<br>Blood Pump BP-80 |
|-------------------------------|---------------------------------------------|------------------------------------------|
| Priming Volume | 32 ml | 80 ml |
| Inlet/Outlet I. D. | 9,5 mm (3/8 inches) | 9,5 mm (3/8 inches) |
| Maximum Operating<br>Pressure | 750 mmHg | 900 mmHg |
| Surface Area | 190 cm² | 590 cm² |
| Rotor Diameter | 50 mm | 79 mm |
| System | Flowchannel | Vortex rotors |
| Connectors | 3/8" | 3/8" |

SOOR

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| Name of Product | RotaFlow Centrifugal<br>Pump RF-32 / RF-32F | Bio-Pump Centrifugal<br>Blood Pump BP-80 |
|----------------------------|---------------------------------------------|------------------------------------------|
| materials: | | |
| Housing | polycarbonate | polyacryl |
| Rotor | polycarbonate | polyacryl |
| Connector | polycarbonate | polyacryl |
| Callote | polyethylene | unknown |
| Ball | sapphire | unknown |
| Magnet | neodymium | unknown |
| in. - and outlet caps 3/8" | HDPE | unknown |

## SUMMARY OF PERFORMANCE DATA

The following tests were performed to demonstrate substantial equivalence between the RotaFlow Centrifugal Pump System and predicate devices (Medtronic, St. Jude):

Disposables:

- Function and Load testing in continuous and pulsatile mode
- Verification of the flow-pressure curves
- Mean Transit Time
- Heat generation
- Stagnant blood zones
- Validation Flowprobe

Magnet Adapter:

- Endurance Test
- Heat Generation
- Magnetic Clutch

RotaFlow System (Hardware):

- Clinical Assessment
- Functional Safety
- EMC
- Construction Safety
- Mains and Battery Operation
- Interface Testing Console with Jostra Heart-Lung Machine
- Emergency Unit Accuracy Testing
- Software Validation

The above listed testings demonstrated that the RotaFlow Centrifugal Blood Pump System is substantial equivalent to the compared predicate devices from Medtronic and St. Jude.

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#### Biocompatibility and Blood Damage Testing:

Biocompatibility testing of the RotaFlow Centrifugal Pump was performed in accordance with the FDA Blue Book Memorandum - #G95-1 and Biological Evaluation of Medical Devices Guidance – International Standard ISO 10993-1, and in accordance with United States Pharmacopeia - XXIII.

Based on the results of the biocompatibility testing performed, the RotaFlow Centrifugal Pump was determined to be biocompatible and nontoxic and, therefore, safe for its intended use.

Blood Damage Testing has also been performed in comparison to the predicate device.

#### Sterility:

Sterilization of the RotaFlow Centrifugal Pump and Flowprobe have been validated to assure a sterility assurance level (SAL) of 106

EtO sterilized RotaFlow Pump is sterilized in accordance with the American National Standards Institute, Inc. (ANSI) standard ANSI/AAMI/ISO 11135-1994 (Medical Devices -Validation and Routine Control of Ethylene Oxide Sterilization).

#### EtO Residuals:

RotaFlow Centrifugal Pump meets the limits for residual concentrations of ethylene oxide (<25 ppm), ethylene chlorohydrin (<25 ppm), and ethylene glycol (< 250 ppm) as published in ANSI Standard Number ANSI/AAMI/ISO 10993-7 (Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals).

#### Pvrogens:

Routine pyrogen testing is performed using the Limulus Amebocyte Lysate (LAL) method. Product testing and release criteria (less than 20 EU/ml) is in accordance to the December 1987 Guideline issued by the Food and Drug Administration, office of Compliance ( Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices").

## Conclusion

Performance, functional, and biocompatibility testing demonstrated that the RotaFlow Centrifugal Pump System is substantially equivalent to the named predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 31 2000

Jostra Incorporated c/o Ms. Kathy Johnson Product Manager 2035 Sunset Lake Road Newark, DE 19702

Re: K991864 Rotaflow Centrifugal Pump System Regulatory Class: III (three) Product Code: KFM Dated: August 14, 2000 Received: August 15, 2000

Dear Ms. Johnson:

We have reviewed your Section 510 (k) notification of intent to market is We have reviewed your section Juvis hourseaving the device is the device referenced and we indications for use stated in the
substantially equivalent (for the indications for use stated in substantially equivalenc (tor the 1976, the enactment date enclosure) to legally marketed predicate actroso macment date of the interstate commerce prior to May 26, 1970, cho bare been reclassified
Medical Device Amendments, or to devices that have been reclassified Medical Device Amendments, or co creat food, Drug, and in accordance with the provisions of the readed be device, subject to
Cosmetic Act (Act). You may, therefore, market the device, subject to Cosmetic Act (Act). You ilay, chefore marmers on and controls the general controls provisions of the for annual registration,
provisions of the Act include requirements for annual mand provisions of the Act Incrude requiring practice, labeling, and
listing of devices, good manufacturing and adulteration, listing of devices, good manazation of adulteration.

If your device is classified (see above) into either class II (Special If your device is classified (see above) it may be subject to such Controls) or class III (Premarket Applovar) required on the may bevice
additional controls Existing major regulations Title 21, Parts 800 additional controls. Existing Mary regulations, Title 21, Parts 800
can be found in the Code of Federal Regulations, Title 21, Parts 800 ound in the Code of Federal Regardion assumes compliance
A substantially equivalent determination assumes as set to 895. A substantially equivarient actorization requirements, as set
with the Current Good Manufacturing VCS, for Medical Devices: to 895. with the Current Good Manufaccuring raddS) for Medical Devices:
forth in the Quality System Regulation (OS) for Medical periodic forth in the Quality System Regulation that, through periodic QS
General regulation (21 CFR Part 2010) will verify su General regulation (21 Cra rare edo) and time (FDA) will verify such inspections, the Food and Drug Administration may result in assumptions. Failure to compry with the ourcher announcements
regulatory action. In addition, FDA may publish further and regulatory action. In addition, from my pare. Please note: this concerning your device in the rederal submission does not affect any
response to your premarket not samission does of the Act response to your premarket notification 531 through 542 of the Act
obligation you might have under sections 531 through provision obligation you might have under sections of the may of the most on trol provisions,
for devices under the Electronic Product Radiation Control provisions, for devices arral laws or regulations.

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#### Page 2 - Ms. Kathy Johnson

This letter will allow you to begin marketing your device as described inis recei will arrow you co icention. The FDA finding of substantial in your Sront, promodevice to a legally marketed predicate device equivalence or 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 reguration (21 crr), please contact the Office of Compliance at GraynoStre actrees), promotions on the promotion and [phone]. haarermally, same contact the Office of Compliance at [phone]. Also, please note the regulation entitled, a (Misbranding by reference to premarket notification" (21CFR 807.97). MESDIanana by Formation on your responsibilities under the Act may other general inform Division of Small Manufacturers Assistance at its be obtained from 2000) 638-2041 or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

James E. Dillard

James E. Dillard III Director Division of Cardiovascurar and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page 1 of 1

510(k) Number (if known): not assigned

Device Name: RotaFlow Centrifugal Pump System

# Indications for Use "RotaFlow Centrifugal Pump System":

indications for boo jjitugal Pump System is intended for use in an extracorporeal The Kotal low Sonthluga Famp by during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Besse R. Kimberlin (Optional Format 3-10-98)

(Division Sign-Off)
Division of Cardiovascular, Respiratory.
and Neurological Devices
510(k) Number K991864