JOSTRA HL-20 TWIN PUMP

K984338 · Jostra Bentley · DPW · Aug 19, 1999 · Cardiovascular

Device Facts

• Record ID: K984338
• Device Name: JOSTRA HL-20 TWIN PUMP
• Applicant: Jostra Bentley
• Product Code: DPW · Cardiovascular
• Decision Date: Aug 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2100
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Jostra HL-20 Twin Pump is intended for use as an extra corporeal circulation device for perfusion appropriate to cardiopulmonary bypass procedures of six hours or less. It is only intended for use with the Jostra HL-20 Heart Lung Machine.

Device Story

Jostra HL-20 Twin Pump functions as extracorporeal circulation device for cardiopulmonary bypass procedures (≤6 hours). Device consists of two half-scale roller pump heads integrated into single module, designed for use with Jostra HL-20 Heart Lung Machine. Operates by providing controlled blood flow; enables lower flow rates suitable for pediatric perfusion, cardioplegia delivery, suction, or venting. Used in clinical settings (e.g., OR) by perfusionists. Modification from predicate includes occlusion locking mechanism without open-position stop due to size constraints. Output provides mechanical circulatory support; assists clinical decision-making by enabling precise flow control during bypass. Benefits patient through specialized flow capabilities for diverse surgical needs.

Clinical Evidence

Bench testing only. Performance data provided in submission demonstrates device operates within specifications and meets international standards including IEC 601-1 (Safety of Medical Electrical Equipment) and EU 89/336 (Electromagnetic Compatibility).

Technological Characteristics

Extracorporeal roller pump; two half-scale pump heads in single module. Materials identical to predicate. Complies with IEC 601-1 (2nd Ed) and EMC Directive 89/336/EEC. Mechanical occlusion locking mechanism.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures of six hours or less requiring extracorporeal circulation.

Regulatory Classification

Identification

A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.

Predicate Devices

• Jostra HL-20 Single Head Roller Pump (K943803)

Submission Summary (Full Text)

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

# SUBSTANTIAL EQUIVALENCE SUMMARY

This summary follows the format of the FDA 510(k) Substantial Equivalence Decision-Making Process document.

## EQUIVALENT (PREDICATE) DEVICE: K943803 Jostra HL-20 Single Head Roller Pump

MANUFACTURED BY:

Jostra, AB Lund, Sweden

#### A. Does the Jostra HL-20 Twin Pump have the same indications statements?

Yes, the Jostra HL-20 Twin Pump and the Jostra HL-20 Single Head Roller Pump have the same intended use which is for use as an extra corporeal circulation device for perfusion appropriate to cardiopulmonary bypass procedures of six hours or less.

### B. Does the Jostra HL-20 Twin Pump have the same technological characteristics, e.g., design, materials, etc.?

Yes, both products have the same technological characteristics. The materials are the same and essentially, the HL-20 Twin Pump is two half-scale predicate pumps in the same size module as the predicate device.

### C. Could the new characteristics affect safety and effectiveness?

The safety and effectiveness are not affected due to the modification to the predicate device. If anything, the new product is more effective, due to its capacity of lower flow rates which are necessary during procedures such as pediatric perfusion, cardioplegia delivery, suction or venting.

The occlusion locking mechanism on the Twin Pump model does not have a stop to hold it in the open position (for adjusting occlusion) as on the predicate device. This is due to size limitations on the smaller pump head, but this change is not deemed to have an adverse effect on safety and efficacy.

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

### Do the new characteristics raise new types of safety or effectiveness D. questions?

No, none of the changes to the predicate device are deemed to have an adverse effect on safety or efficacy.

## E. Do acceptable scientific methods exist for assessing effects of the new characteristics?

N/A

#### Are performance data available to assess the effects of new characteristics? F.

Yes, performance data is included in Attachment # 5.

#### G. Do performance data demonstrate equivalence?

Yes, it is evident from the data provided that the Twin Pump performs within its specifications and also within acceptable limits for performance standards such as

| General: | EN93/42: | EU Council Directive 93/42/EEC concerning<br>Medical Devices |
|-----------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Constructional<br>Safety: | IEC 601-1: | IEC 601-1, 2nd Edition: 1988<br>Safety of Medical Electircal Equipment,<br>Part 1: General Requirement (Identical with<br>DIN VDE 0750 Part 1) |
| Electromagnetic<br>Compatibility: | EU 89/336:<br>IEC 601-1-2: | EMC Directive 89/336/EEC<br>1993 Electromagnetic Compatibility<br>(Identical with DIN VDE 0750, Part 1-2) |

## CONCLUSION:

Jostra AB has provided data in this pre-market notification submission, which demonstrate that the HL-20 Twin Pump model is similar in materials, design and function to that of the predicate device.

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three birds in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 1999

Mathy Johnson Product Manager Jostra USA 478 Media Road Oxford, PA 19363

Re: K984338 Jostra HL-20 Twin Pump II (TWO) Requlatory Class: Product Code: DPW Dated: August 4, 1999 Received: August 6, 1999

Dear Ms. Johnson:

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 Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 - Ms. Kathy Johnson

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial emivalence 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 requlation (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" (21CFR 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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Sincerely yours,

Thomas J. Callahan

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

Enclosure

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

Page 1 of 1

# 510(k) Number (if known): K984338

Device Name:

Jostra HL-20 Twin Pump

Indications for Use:

The Jostra HL-20 Twin Pump is intended for use as an extra corporeal circulation device for perfusion appropriate to cardiopulmonary bypass procedures of six hours or less. It is only intended for use with the Jostra HL-20 Heart Lung Machine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurie L. Barker, PA

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_

K984338

(Optional Format 3-10-98)