The MEDOS HILITE 1000 & 800 LT Hollow Fiber Oxygenators are indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. The 1000 & 800 LT are neonate, infant oxygenators intended for use at blood flow rates of 0.2 to 1.0 liters per minute for the HILITE 1000 and 0.2 to 0.8 liters per minute for the HILITE 800 LT for periods of up to six (6.0) hours.

Device Description

The MEDOS HILITE 1000 & 800 LT Hollow Fiber Oxygenators consist of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 1000 hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 800 LT hollow fiber membrane consists of a polymethylpentene plasma tight mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a polyester non-porous hollow fiber configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood around the outside of the fibers while water flows through the inner lumen of the fibers and therefore effects heat exchange while minimizing priming volume.

AI/ML Overview

The provided text describes a 510(k) submission for the MEDOS HILITE 1000 & 800 LT Oxygenators. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a comparative effectiveness study with human readers or a standalone AI algorithm.

Therefore, many of the requested information points (e.g., acceptance criteria, device performance table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in this document, as the submission follows a different regulatory pathway.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable / Not Provided. The document does not describe specific acceptance criteria (e.g., a certain percentage accuracy, sensitivity, or specificity) or present a table of device performance against such criteria. The submission is based on demonstrating equivalence to a predicate device through safety, performance, and validation testing.

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

Not Applicable / Not Provided. The document mentions "extensive safety, performance, and validation testing." However, it does not specify the sample size of devices used in these tests, nor does it detail a "test set" in the context of performance metrics that would be used for AI or diagnostic devices. Data provenance (country of origin, retrospective/prospective) is also not specified for these tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable / Not Provided. This information is relevant for studies involving human interpretation or AI performance evaluation where a "ground truth" needs to be established (e.g., by experts reviewing images). For an oxygenator, the "ground truth" during testing would be objective physical measurements of performance (e.g., gas exchange rates, pressure drops) rather than expert consensus on a diagnostic outcome.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided. Adjudication methods (like 2+1 or 3+1) are typically used when there's disagreement among experts in establishing ground truth for diagnostic studies. This is not relevant for the type of device and testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. MRMC studies assess the change in human reader performance (e.g., diagnosis accuracy) with and without AI assistance. This type of study is not relevant for an oxygenator device, which is a therapeutic rather than a diagnostic tool. The document focuses on the physical and functional performance of the oxygenator itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. Standalone algorithm performance is relevant for AI or software as a medical device. The MEDOS HILITE oxygenator is a physical medical device. The "performance" here refers to its mechanical and physiological function, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for the oxygenator's performance would be objective physiological and engineering measurements. This includes parameters like oxygen transfer rates, carbon dioxide removal rates, pressure drop across the device, heat exchange efficiency, and material compatibility. The document states "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." These specifications are typically derived from industry standards and clinical requirements for oxygenators.

8. The Sample Size for the Training Set

Not Applicable / Not Provided. The concept of a "training set" applies to machine learning algorithms. For a physical device like an oxygenator, there isn't a "training set" in this context. Device design and development involve engineering principles and testing, not AI training.

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

Not Applicable / Not Provided. As there is no training set for an AI algorithm, this question is not relevant.

Summary

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MEDOS Medizintechnik AG

090000 Traditional 510(k) Section 5, 510(k) Summary

Summary

SEP 1 8 2009

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

Company making the submission: 1.

Name:	GISH Biomedical, Inc.A member of the MEDOS group
Address:	22942 Arroyo VistaRancho Santa Margarita, CA 92688-2600
Telephone:	949-635-6200 voice949-635-6299 faxjanetp@gishbiomedical.com
Contact:	Janet PeetsRegulatory & Clinical Affairs

1. Device:
  MEDOS HILITE 1000 & 800 LT Oxygenator Proprietary Name: Common Name: Blood Oxygenator Oxygenator. Cardiopulmonary Bypass Classification Name:

3. Predicate Devices:

CAPIOX® RX05 Hollow Fiber Oxygenator, K022115, Manufactured by Terumo

Classifications Names & Citations: 4.

21 CFR 870.4350, Oxygenator, Cardiopulmonary Bypass, Class II, DTZ, Cardiovascular

5. Description:

Indications for use: 6.

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7. Contra-indications:

For oxygenators, no contra-indications have been noted.

8. Comparison:

The MEDOS HILITE 1000 & 800 LT Oxygenators have the same device characteristics as the predicate device.

9. Test Data:

In accordance with FDA Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions, the MEDOS HILITE 1000 and 800 LT Oxygenators have completed extensive safety, performance, and validation testing prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards.

10. Literature Review:

A review of literature pertaining to the safety and effectiveness has been conducted. Appropriate safeguards have been incorporated in the design of the MEDOS HILITE 1000 & 800 LT Oxygenator.

11. Conclusions:

Based upon the testing and comparison to the predicate device, the MEDOS HILITE 1000 & 800 LT Oxygenators have the same intended use, with similar technological characteristics. MEDOS Medizintechnik AG therefore posits that its device is equivalent in safety and effectiveness to predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Contról Room -WO66-G609 Silver Spring, MD 20993-0002

Gish Biomedical, Inc. c/o Ms. Janet Peets . Regulatory & Clinical Affairs Specialist 22942 Arroyo Vista Rancho Santa Margarita, CA 92688

K090449 Re:

Medos Hilite Infant Oxygenator, Model 1000, 800 LT Regulation Number: 21 CFR 870.4350 Regulation Name: Oxygenator, cardiopulmonary bypass (with heat exchanger) Regulatory Class: Class II Product Code: DTZ Dated: August 26, 2009 Received: August 27, 2009

SEP 1 8 2009

Dear Ms. Peets:

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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Page 2 - Ms. Janet Peets

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (240) 276-3150 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

R. Widner

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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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MEDOS Medizintechnik AG

510(k) Number K090449

Device Name: MEDOS HILITE 800 LT & 1000 Oxygenator

Indications for use:

Prescription Device:

Federal Law (US) restricts this device to sale by or on the order of a physician.

Prescription Use : Yes

Over-The-Counter Use: No

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma D. Johnson
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_K09044

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Confidential Indications forUse doc Section 4 510(k) Submission

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.”