HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010

K992559 · Jostra Bentley · DTZ · Sep 20, 1999 · Cardiovascular

Device Facts

• Record ID: K992559
• Device Name: HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010
• Applicant: Jostra Bentley
• Product Code: DTZ · Cardiovascular
• Decision Date: Sep 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hollow Fibre Membrane Oxygenator HMO 1010 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

Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 is a blood gas exchanger with an integrated heat exchanger used in open-heart surgery. It functions within an extracorporeal perfusion circuit to oxygenate blood, remove carbon dioxide, and regulate blood temperature. The device consists of two membrane compartments: the first contains crosswise-arranged heat exchanger fibers and microporous polypropylene oxygenation fibers; the second contains only oxygenation fibers. Blood enters via an inlet, flows through the membrane package for gas exchange and tempering, and exits. An integrated hydrophobic de-airing membrane at the top facilitates priming and air elimination. The device is a single-use, sterile component operated by perfusionists or surgical staff during cardiopulmonary bypass. By providing gas exchange and thermal control, it supports patient physiological stability during surgery.

Clinical Evidence

Evidence includes in-vitro bench testing (performance, heat exchanger efficiency, integrity), biocompatibility testing per ISO 10993-1 and USP XXIII, blood cell damage testing, and animal testing. Sterility and pyrogenicity (LAL method) were validated. No human clinical trial data was required for this 510(k) determination.

Technological Characteristics

Materials: Microporous polypropylene hollow fiber membranes, polyethylene heat exchanger fibers. Dimensions: 1.8 m² membrane surface area, 0.60 m² heat exchanger surface area. Flow: 0.5-7 L/min blood flow, 15 L/min max gas flow. Connectivity: 3/8" arterial/venous ports, 1/2" Hansen quick-connect water ports. Sterilization: Ethylene Oxide (EtO). Single-use device.

Indications for Use

Indicated for use in extracorporeal perfusion circuits to oxygenate blood, remove carbon dioxide, and regulate blood temperature during short-duration cardiopulmonary bypass procedures (≤ 6 hours).

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

• Affinity Hollow Fiber Oxygenator (K932252)

Submission Summary (Full Text)

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#### SEP 2 0 1999 SUMMARY OF SAFETY AND EFFECTIVENESS

### 510(k) SUMMARY

#### COMPANY NAME AND CONTACT PERSON

June 28, 1999

Jostra Medizintechnik AG Hechinger Straße 38 72145 Hirrlingen Germany

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

### DEVICE NAME

Hollow Fibre Membrane Oxygenator Quadrox HMO 1010

#### COMMON NAME

Oxygenator

#### CLASSIFICATION NAME

Cardiopulmonary bypass oxygenator (21 CFR - 870.4350)

# PREDICATE DEVICE OR LEGALLY MARKETED DEVICE

Avecor Cardiovascular, Inc. - Affinity Hollow Fiber Oxygenator (K 932252)

## DEVICE DESCRIPTION

The Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 is a blood gas exchanger with integrated heat exchanger. In open heart surgery it is used in an extracorporeal perfusion circuit first to oxygenate blood and remove carbondioxide second to regulate the blood temperature during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

The oxygenation system is principally based on microporous polypropylene hollow fiber membranes. The heat exchanger is made of thight polyethylene fibers. The QUADROX consists of two membrane compartments. In the first chamber of the oxygenator, sheets of heat exchanger fibers and sheets of microporous oxygenation fibers are arranged crosswise. In the second chamber only sheets of the oxygenation fibers are arranged.

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Blood enters the housing via the inlet connector and is distributed into a pre-chamber. Then the blood streams through the membrane package. In the first section it is tempered and oxygenated. In the second part only oxygenation and removal of carbondioxide takes place.

Positioned and integrated at the top of the oxygenator is a de-airing membrane. This membrane is a hydrophobic membrane allowing only gaseous substances to pass through the membrane but fluids are held back. The de-airing membrane allows easier priming, deairing and elimination of air throughout the whole procedure. To prime the oxygenator the Luer cap has to be removed. It should be kept open during perfusion to eliminate air continuously.

### INTENDED USE

The Hollow Fibre Membrane Oxygenator HMO 1010 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.

| Name of the Product | Hollow Fibre Membrane<br>Oxygenator HMO 1010 (Jostra) | Affinity Hollow Fiber<br>Oxygenator (Avecor) |
|---------------------------------------|-------------------------------------------------------|----------------------------------------------|
| Parameter | | |
| 510(k) number | not assigned | K932252 |
| Specifications: | | |
| Membrane Type | Microporous Polypropylene Hollow<br>Fibre | Microporous Polypropylene<br>Hollow Fibers |
| Membrane Structure | Hollow fibre woven mats | unknown |
| Membrane surface area | $1.8 m^2$ | $2.5 m^2$ |
| Static priming volume | 250 ml | 270 ml |
| Blood flow path | Around the fibres | Around the fibres |
| Recommended blood flow rate | 0.5-7 liters/minute | 1-7 liters/minute |
| Maximal recommended gas<br>flow rate | 15 liters/minute | unknown |
| Maximum water side pressure | 14 psi | 30 psi |
| Material of heatexchanger | Polyethylene | Stainless steel |
| Surface area of the heat<br>exchanger | $0.60 m^2$ | unknown |
| Arterial outlet port | 3/8" | 3/8" |
| Venous inlet port | 3/8" | 3/8" |
| Arterial sample port | Luer-Port | Female Luer Port |
| Recirculation port | 1/4" | 1/4" |
| Gas inlet port | 1/4" | 1/4" |
| Gas outlet port | 1/4" | 3/8" non-barbed |
| Water ports | ½" Quick-Connect Fittings (Hansen) | ½" quick disconnects |
| Method of sterilization | Ethylene Oxide | unknown |
| Storage temperature | +15°C - +30°C (+59° -+86°F) | unknown |
| Use | Single-use device | Single-use device |
| Weight | 0.7 kg | unknown |

# TECHNOLOGICAL CHARACTERISTICS

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# SUMMARY OF PERFORMANCE DATA

# In-vitro Bench Testing:

In-vitro bench testing demonstrated that when compared to the predicate device (Affinity Hollow Fiber Oxygenator), the Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 does not significantly affect safety and effectiveness and is substantially equivalent to the Affinity Hollow Fiber Oxygenator. The in-vitro bench testing included analysis of

- . Performance Tests
- Heat Exchanger Performance Factor .
- Intearity testing of the product .

### In-vivo Testing:

- Animal Testing has been performed .
### Clinical Studies:

- . Clinical comparative studies
# Biocompatibility and Blood Cell Damage:

Biocompatibility testing of the Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 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 Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 was determined to be biocompatible and nontoxic and, therefore, safe for its intended use.

Blood cell damage testing of the Quadrox HMO 1010 was performed.

# Sterility:

Sterilization of the Hollow Fibre Membrane Oxygenator HMO 1010 has been validated to assure a sterility assurance level (SAL) of 10-6

EtO sterilized Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 are according to Federal Register , Vol. 43, No. 122 - Friday, June 23, 1978.

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# EtO Residuals:

Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 meets the limits for residual concentrations of ethylene oxide (<25 ppm), ethylene chlorohydrin (<25 ppm), and ethylene glycol (< 250 ppm) as published in Federal Register , Vol. 43, No. 122 – Friday, June 23, 1978.

# Pyrogens:

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, function, and biocompatibility testing demonstrated that the Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 is substantially equivalent to the Affinity Hollow Fiber Membrane Oxygenator.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 1999

Ms. Kathy Johnson Product Manager Jostra Inc. 2035 Sunset Lake Road Newark, DE 19702

K992559 Re: Hollow Fiber Membrane Oygenator Quadrox HMO 1010 Regulatory Class: III (three) Product Code: DTZ Dated: July 29, 1999 Received: July 30, 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 leqally 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with 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 requlation may result in regulatory action. 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.

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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 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 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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

Enclosure

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Page 1 of 1

K992559
510(k) Number: ~~not yet known~~

Device Name: Hollow Fibre Membrane Oxygenator HMO 1010

# Indications for Use Hollow Fibre Membrane Oxygenator HMO 1010

inte Hollow Fibre Membrane Oxygenator HMO 1010 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)

Bate B. Bempere

. (Optional Format 3-10-98)

(Division Sign-Off) Division of Cardiovascular, Respira veurological Device KK | Number _

x Prescription Use