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 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.

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.

AI/ML Overview

Acceptance Criteria and Device Performance for Jostra Medizintechnik AG Hollow Fibre Membrane Oxygenator Quadrox HMO 1010

This document outlines the acceptance criteria and performance data for the Hollow Fibre Membrane Oxygenator Quadrox HMO 1010, based on the provided 510(k) summary. The device was found to be substantially equivalent to the Affinity Hollow Fiber Oxygenator by Avecor Cardiovascular, Inc.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the substantial equivalence determination to the predicate device. The performance data for the Quadrox HMO 1010 are compared to the predicate device's specifications.

Parameter	Acceptance Criteria (Predicate Device: Affinity Hollow Fiber Oxygenator)	Reported Device Performance (Quadrox HMO 1010)
Membrane Type	Microporous Polypropylene Hollow Fibers	Microporous Polypropylene Hollow Fibre
Membrane Surface Area	$2.5 m^2$	$1.8 m^2$
Static Priming Volume	270 ml	250 ml
Recommended Blood Flow Rate	1-7 liters/minute	0.5-7 liters/minute
Maximum Water Side Pressure	30 psi	14 psi
Material of Heat Exchanger	Stainless steel	Polyethylene
Arterial Outlet Port	3/8"	3/8"
Venous Inlet Port	3/8"	3/8"
Arterial Sample Port	Female Luer Port	Luer-Port
Recirculation Port	1/4"	1/4"
Gas Inlet Port	1/4"	1/4"
Gas Outlet Port	3/8" non-barbed	1/4"
Water Ports	½" quick disconnects	½" Quick-Connect Fittings (Hansen)
Method of Sterilization	unknown	Ethylene Oxide
Use	Single-use device	Single-use device
Biocompatibility	Biocompatible and non-toxic	Biocompatible and non-toxic
Sterility Assurance Level (SAL)	10-6	10-6
EtO Residuals (Ethylene Oxide)	<25 ppm	<25 ppm
EtO Residuals (Ethylene Chlorohydrin)	<25 ppm	<25 ppm
EtO Residuals (Ethylene Glycol)	<250 ppm	<250 ppm
Pyrogens (EU/ml)	<20 EU/ml	<20 EU/ml

Note: For parameters listed as "unknown" for the predicate device, the performance of the Quadrox HMO 1010 was assessed against general safety and effectiveness standards, and determined to be acceptable. The critical factor for substantial equivalence is that these differences do not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for specific "test sets" in the traditional sense of a clinical study. The evaluation primarily relies on in-vitro bench testing and in-vivo animal testing. The provenance of this data is Germany, where Jostra Medizintechnik AG is located. The nature of the data is likely retrospective as it compares the new device to an existing predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the summary. For device testing of this nature (bench and animal), the ground truth is established through standardized testing protocols and measurements, rather than expert consensus on diagnostic interpretation.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes. For this type of device submission, which focuses on in-vitro and animal testing, an explicit adjudication method is not applicable or described. Performance is evaluated against objective measurements and established scientific criteria.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not conducted as described in the provided summary. This type of study is more relevant for diagnostic AI devices where human reader performance is a key metric. The current submission focuses on the safety and effectiveness of a medical device (oxygenator) through physical/chemical performance and biocompatibility.

6. Standalone Performance Study

A standalone (algorithm only without human-in-the loop performance) study was not explicitly conducted. However, the in-vitro bench testing and animal testing can be considered a form of standalone performance evaluation for the device itself, independent of human interaction beyond standard operational procedures. This evaluated the device's technical specifications and functionality directly.

7. Type of Ground Truth Used

The ground truth for the device's performance was established through:

Objective Measurements: For in-vitro bench testing (e.g., membrane surface area, priming volume, flow rates, pressure, heat exchanger performance factor, integrity testing).
Standardized Biological Evaluation: For biocompatibility (in accordance with FDA Blue Book Memorandum - #G95-1, ISO 10993-1, and United States Pharmacopeia - XXIII), blood cell damage, sterility assurance level (SAL), EtO residuals, and pyrogen testing (Limulus Amebocyte Lysate (LAL) method).
Physiological Outcomes: For in-vivo animal testing, though specific outcome measures are not detailed in this summary.

There is no mention of pathology or human patient outcomes data being used as ground truth for this specific application.

8. Sample Size for the Training Set

This information is not applicable or provided. The development of this medical device (oxygenator) does not involve a "training set" in the context of machine learning. The device design and manufacturing rely on engineering principles, materials science, and established medical device standards.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the machine learning sense for this device, this question is not applicable. The underlying principles and data used for design and manufacturing are based on scientific understanding of cardiopulmonary bypass, material properties, and regulatory standards.

Summary

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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. (610)932-7365 fax (610)932-7366

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

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INTENDED USE

Name of the Product	Hollow Fibre MembraneOxygenator HMO 1010 (Jostra)	Affinity Hollow FiberOxygenator (Avecor)
Parameter
510(k) number	not assigned	K932252
Specifications:
Membrane Type	Microporous Polypropylene HollowFibre	Microporous PolypropyleneHollow 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 gasflow rate	15 liters/minute	unknown
Maximum water side pressure	14 psi	30 psi
Material of heatexchanger	Polyethylene	Stainless steel
Surface area of the heatexchanger	$0.60 m^2$	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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 870.4350 Cardiopulmonary bypass oxygenator.

(a)
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.(b)
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.”