K Number
K090449
Device Name
MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT
Date Cleared
2009-09-18

(210 days)

Product Code
Regulation Number
870.4350
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The description focuses on the physical components and function of the oxygenator and heat exchanger, with no mention of AI or ML.

Yes
The device is used for extracorporeal oxygenation and carbon dioxide removal from human blood, which is a therapeutic intervention.

No
The device is described as an oxygenator that provides extracorporeal oxygenation and carbon dioxide removal from human blood, and acts as a heat exchanger. Its function is to facilitate gas exchange and temperature regulation, not to diagnose medical conditions by analyzing data or images.

No

The device description clearly states it consists of physical components like a hollow fiber membrane oxygenator, extracorporeal heat exchanger, and polycarbonate housing, indicating it is a hardware device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "extracorporeal oxygenation of and carbon dioxide removal from human blood." This describes a process performed outside the body to treat the blood, not a test performed on a sample of blood or other biological material to diagnose a condition or provide information about a physiological state.
  • Device Description: The description details a device that facilitates gas exchange and heat exchange with blood flowing through it. This aligns with a therapeutic device used in procedures like cardiopulmonary bypass, not a diagnostic test.
  • Lack of IVD Characteristics: There is no mention of analyzing a biological sample, detecting analytes, or providing diagnostic information.

Therefore, the MEDOS HILITE 1000 & 800 LT Hollow Fiber Oxygenators are considered a therapeutic medical device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

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.

Product codes

DTZ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

neonate, infant

Intended User / Care Setting

physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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.

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

CAPIOX® RX05 Hollow Fiber Oxygenator, K022115

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.”

0

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 Vista
Rancho Santa Margarita, CA 92688-
2600 |
| Telephone: | 949-635-6200 voice
949-635-6299 fax
janetp@gishbiomedical.com |
| Contact: | Janet Peets
Regulatory & 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:

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.

Indications for use: 6.

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.

1

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.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal.

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.

3

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

Image /page/3/Picture/8 description: The image shows a handwritten signature or symbol on the left side, followed by the letters 'B' and 'D' on the right side. The signature appears to be a stylized or abstract design, possibly representing initials or a unique mark. The letters 'B' and 'D' are printed in a simple, sans-serif font and are vertically aligned. The overall image has a clean and straightforward appearance, suggesting it may be part of a document or form requiring identification or authorization.

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

Enclosure

4

MEDOS Medizintechnik AG

510(k) Number K090449

Device Name: MEDOS HILITE 800 LT & 1000 Oxygenator

Indications for use:

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.

Prescription Device:

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

Prescription Use : Yes

OR

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