QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030

K030264 · Jostra AG · DTZ · Feb 26, 2003 · Cardiovascular

Device Facts

• Record ID: K030264
• Device Name: QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030
• Applicant: Jostra AG
• Product Code: DTZ · Cardiovascular
• Decision Date: Feb 26, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hollow Fiber Membrane Oxygenator Quadrox Safeline is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide and to temper blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

Device Story

The Quadrox Safeline HMO 2030 is a hollow fiber membrane oxygenator used in extracorporeal perfusion circuits during cardiopulmonary bypass. It functions by oxygenating blood and removing carbon dioxide while tempering blood temperature. The device is intended for short-term use (≤ 6 hours). It is operated by perfusionists or clinicians in a clinical setting. The device is a modification of the HMO 1030, featuring a heat exchanger fiber constructed from polyurethane instead of polyethylene to reduce the risk of electrostatic discharge. The device provides essential life support during cardiac surgery by managing gas exchange and thermal regulation of the patient's blood.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Hollow fiber membrane oxygenator with integrated heat exchanger. Heat exchanger fiber material: polyurethane. Energy source: passive (extracorporeal circuit). Sterilization: not specified. Connectivity: none.

Indications for Use

Indicated for patients undergoing short duration cardiopulmonary bypass procedures (6 hours or less) requiring extracorporeal blood oxygenation, carbon dioxide removal, and blood tempering.

Regulatory Classification

Identification

A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”

Predicate Devices

• Jostra Hollow Fiber Membrane Oxygenator Quadrox Safeline HMO 1030 (K992559)

Submission Summary (Full Text)

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K030264

FEB 2 6 200

## Special 510(k): Device Modification: Quadrox Safeline HMO 2030

# 510(k) SUMMARY

### SUBMITTER:

Katrin Schwenkalenks Phone: [phone]

Fax: + 49 (7478) 921-400

Hechinger Strasse 38 72145 Hirrlingen, Germany

January 24, 2003

Quadrox Safeline

Integral Heat Exchanger

Jostra AG.

DATE PREPARED:

CONTACT PERSON:

DEVICE TRADE NAME:

COMMON/USAUAL NAME

CLASSIFICATION NAME

PREDICATE DEVICE OR LEGALLY MARKETED DEVICE:

Jostra Hollow Fiber Membrane Oxygenator Quadrox Safeline HMO 1030

Cardiopulmonary Bypass Oxygenator

Cardiopulmonary Bypass Heat Exchanger

Jostra Hollow Fiber Membrane Oxygenator

Hollow Fiber Membrane Blood Oxygenator with

### DEVICE DESCRIPTION/INDICATONS FOR USE

The Hollow Fiber Membrane Oxygenator Quadrox Safeline is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide and to temper blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

#### STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The Jostra Hollow Fiber Oxyqenator Quadrox Safeline HMO 2030 is identical to the Jostra Hollow Fiber Oxygenator Safeline Quadrox HMO 1030 in design, intended use, method of operation, components, packaging, and fundamental scientific technology. The primary difference between the two devices is that the Jostra Hollow Fiber Oxygenator Quadrox Safeline HMO 2030 contains a heat exchanger fiber made of polyurethane (instead of polyethylene) which reduces the risk of electrostatic discharge for the patient significantly.

### TESTING TO DETERMINE SUBSTANTIAL EQUIVALENCE

In-vitro tests were performed to demonstrate that the Jostra Hollow Fiber Oxygenator Quadrox Safeline HMO 2030 described in this submission is substantially equivalent to the Jostra Hollow Fiber Oxygenator Safeline Quadrox HMO 1030 (K992559).

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2003

Jostra AG Ms. Katrin Schwenkglenks Regulatory Affairs Hechinger Strasse 38 72145 Hirrlingen, Germany

Re: K030264

> Trade/Device Name: Quadrox Safeline Hollow Fiber Membrane Oxygenator HMO 2030 Regulation Number: 21 CFR 870.4350 Regulation Name: CARDIOPULMONARY BYPASS OXYGENATOR Regulatory Class: Class II Product Code: DTZ Dated: January 24, 2003 Received: January 27, 2003

Dear Ms. Schwenkglenks:

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. Katrin Schwenkglenks

forth in the quality systems (OS) 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], 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/dsma/dsmamain.html

Sincerely yours,

Kirt Miller

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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Special 510(K): Device Modification Jostra AG – Safeline Quadrox Hollow Fiber Membrane Oxygenator

Page 1 of 1

510(k) Number (if known): K050864

Device Name: Jostra Safeline Quadrox Hollow Fiber Membrane Oxygenator

#### Indications for Use

The Hollow Fiber Membrane Oxygenator Quadrox Safeline is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbondioxide 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)

(Optional Format 3-10-98)

Prescription Use Only

A. Catter

**510(k) Number** K02004