JOSTRA HLM TUBING SETS WITH SAFELINE COATING

K061832 · Maquet Cardiopulmonary, AG · DWF · Aug 11, 2006 · Cardiovascular

Device Facts

• Record ID: K061832
• Device Name: JOSTRA HLM TUBING SETS WITH SAFELINE COATING
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: DWF · Cardiovascular
• Decision Date: Aug 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jostra HLM Tubing Set with Safeline Coating is indicated for use in surgical procedures requiring extracorporeal support for up to six hours. The Safeline coating is used to reduce the surface tension on blood contact surfaces.

Device Story

Jostra HLM Tubing Sets are single-use components for extracorporeal perfusion circulation systems; used during open heart surgery to connect patient to heart-lung machine for blood oxygenation and carbon dioxide removal. Device consists of tubing and connectors treated with Safeline coating to reduce surface tension on blood-contacting surfaces. Operated by perfusionists or surgical staff in clinical settings; duration of use restricted to six hours. Safeline coating modification intended to improve hemocompatibility; device performance remains comparable to uncoated versions. Benefits include reduced surface tension during extracorporeal support.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility, pyrogenicity, ETO-degassing, and functional integrity testing, alongside FMEA-based risk analysis.

Technological Characteristics

Single-use extracorporeal tubing and connectors; Safeline coating applied to blood-contacting surfaces. Materials and design identical to predicate Jostra HLM Tubing Set (K053025). No electronic components or software.

Indications for Use

Indicated for patients undergoing surgical procedures requiring extracorporeal support for up to six hours; Safeline coating reduces surface tension on blood contact surfaces.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

• Jostra HLM Tubing Set (K053025)
• RotaFlow Centrifugal Pump with Safeline Coating (K061072)

Submission Summary (Full Text)

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Maquet Cardiopulmonary AG

Hechinger Strasse 38 72145 Hirrlingen

# 510(K) Summary

Submitter:

| K0618 | ( (<br>24 |
|-----------|-----------|
| age<br>11 | 1-<br>Of |

AUG 1 1 2006

- Contact Person: James Collie Phone: [phone] Or Katrin Schwenkglenks Phone: [phone]
Germany

- Date Prepared: June 30, 2006
- Device Trade Name: Jostra HLM Tubing Sets with Safeline Coating
- Common/Usual name: Custom Tubing Pack
- Classification names: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing

Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting

Cardiopulmonary Bypass Pump Tubing

Jostra HLM Tubing Sets - 510(k) number Predicate Devices: K053025

> RotaFlow Centrifugal Pump with Safeline Coating. K061072, (with regards to the Safeline Coating only)

Device Description:

The Jostra HLM Tubing Sets with Safeline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Tubing sets that are sold sterile are not to be re-sterilized by the user.

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In open heart surgery the Jostra HLM Tubing Sets with Safeline Coating are used in combination with the heartlung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the Jostra HLM Tubing Sets with Safeline Coating is to connect the patient to the heartlung machine and it's components. The Jostra HLM Tubing Sets with Safeline Coating are therefore a component in the extracorporeal perfusion circulation system, for the oxygenation of blood and the removal of carbon dioxide. The utilization period of the use of the tubing sets is restricted to six hours.

The performance data of the Jostra HLM Tubing Sets with Safeline Coating are comparable with the performance data of the Jostra HLM Tubing Sets without the Safeline Coating.

Indications for Use:

#### Jostra HLM Tubing Set - Safeline coated

The Jostra HLM Tubing Set with Safeline Coating is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

### Indications for use Jostra Safeline Coating

To reduce the surface tension on blood contact surfaces.

The above tubing set indications for use has been cleared with the Jostra HLM Tubing Set 510(k) number K0503025. The intended use of the modified devices, as described in its labeling, has not changed as a result of the modification.

#### Statement of Technical Comparison:

The Jostra HLM Tubing Set - Safeline Coated has the same intended use, design, principals of operation, and performance as the Jostra HLM Tubing Set without the Safeline Coating, The only difference is the application of the Safeline Coating to the tubing and connectors.

#### Non-clinical Testing:

All of the Jostra HLM Tubing Set tests in 510(k) number K0503025 are applicable to the Jostra HLM Tubing Set - Safeline Coated product.

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K061832
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## Risk analysis

The risk analysis method used to assess the impact of the modification was done according to the logic of a Failure Modes and Effects Analysis (FMEA). Design verification tests were performed as a result of this risk analysis assessment.

All possible risks for the user and the patient related to the design change (combination of the existing Jostra HLM Tubing Set with the existing Safeline Coating) have been assessed by evaluation or testing acc. to the risk analysis for the Jostra HLM Tubing Set with Safeline Coating. As a result of this analysis the following hazards were addressed:

Biological Hazards related to

- pyrogenicity .
- ETO-degassing �
- Biocompatibility ●

Functional Hazards related to

- . device integrity
Hazards due to wrong application

- interaction between Safeline and other coatings .
The evaluation and test results do not show any kind of risk potential for the user and/or the patient. The modification does not alter the fundamental scientific technologies of the Jostra HLM Tubing Set.Based on the test results and the evaluation the Jostra HLM Tubing Set with Safeline Coating are safe and effective for their intended use and are substantially equivalent to the named predicate devices, the uncoated Jostra HLM Tubing Set and the RotaFlow Centrifugal Pump with Safeline Coating (regarding the Safeline Coating).

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's seal, which includes an abstract caduceus symbol. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2006

Maquet Cardiopulmonary AG c/o Mr. James Collie President 414 Maryjoe Way Warrington, PA 18976

Re: K061832

Jostra HLM Tubing Sets with Safeline Coating Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular Regulatory Class: Class II (two) Product Code: DWF Dated: June 30, 2006 Received: June 29, 2006

Dear Mr. Collie:

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.

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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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) premarket notification. The FDA finding of substantial equivalence 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 regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna R. Vicines

Image /page/4/Picture/4 description: The image shows a black and white drawing of a squiggly line. The line is thick and appears to be drawn with a marker or pen. The line is not straight and has several curves and bends. The drawing is simple and abstract.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K06 1832

Device Name: Jostra HLM Tubing Set with Safeline Coating

Indications For Use:

The Jostra HLM Tubing Set with Safeline Coating is indicated for use in surgical procedures requiring extracorporeal support for up to six hours

The Safeline coating is used to reduce the surface tension on blood contact surfaces.

Prescription Use _ x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Diana R. V. Innes

(Division Sign-Off) Division of Cardiovascular Devices

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510(k) Number *k06183d*