MEDOS HILITE INFANT OXYGENATOR

K140181 · Medos Medizintechnik AG · DTZ · Feb 19, 2014 · Cardiovascular

Device Facts

• Record ID: K140181
• Device Name: MEDOS HILITE INFANT OXYGENATOR
• Applicant: Medos Medizintechnik AG
• Product Code: DTZ · Cardiovascular
• Decision Date: Feb 19, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The MEDOS HILITE 1000 & 800 LT Infant Hollow Fiber Oxygenators are indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of 200 ml/min (0.2 liters/minute) to 1000ml/min (1.0 liters per minute) for the Hilite 1000 and 200 ml/min (0.2 liters/minute) to 800 ml/min (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.

Device Story

Hollow fiber membrane oxygenator with integrated heat exchanger; used for extracorporeal blood oxygenation and CO2 removal in neonates/infants. Hilite 1000 uses polypropylene gas-permeable mat; Hilite 800 LT uses polymethylpentene plasma-tight mat. Heat exchanger utilizes polyester non-porous hollow fibers within polycarbonate housing; blood flows outside fibers, water flows through inner lumen. Operated by clinicians in clinical settings. Device facilitates gas exchange and temperature control during short-term (up to 6 hours) extracorporeal circulation. Output is oxygenated blood returned to patient; assists in maintaining physiological gas levels during procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included blood pathway integrity, heat exchanger fluid pathway integrity, chemical analysis of potting materials, and biological safety evaluations (cytotoxicity, hemolysis, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, and hemocompatibility).

Technological Characteristics

Hollow fiber membrane oxygenator with integrated heat exchanger. Materials: Polypropylene (Hilite 1000) or polymethylpentene (Hilite 800 LT) gas-permeable mats; polyester non-porous hollow fibers for heat exchange; polycarbonate housing. Potting material: Macroplast CR 3502 / CR 4100. Sterilization: Ethylene Oxide (EO). Standalone device.

Indications for Use

Indicated for neonates and infants requiring extracorporeal oxygenation and CO2 removal during procedures. Flow rates: 0.2-1.0 L/min (Hilite 1000) or 0.2-0.8 L/min (Hilite 800 LT). Duration: up to 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

• Medos Hilite Infant Oxygenator, Model 1000 & 800 LT Oxygenator (K090449)

Submission Summary (Full Text)

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# FEB 1 9 2014

## SPECIAL 510(K) 510(k) Summary For the Medos Medizintechnik AG Medos Hilite 1000 & 800 LT Infant Oxygenator

#### l. SUBMITTER/510(k) HOLDER:

Medos Medizintechnik AG Obere Steinfurt 8-10 5222 Stolberg, Germany Telephone: [phone] Telefax: [phone] Head of Regulatory Affairs: Heiko Frerichs Email: [e-mail] FDA Registration: 3010223691

#### CONTACT PERSON II.

Leann Christman Novalung, Inc. 3526 West Liberty Rd., Suite 100 Ann Arbor, MI 48103 Telephone: [phone] ext. 232 Fax: [phone] Email: [e-mail]

#### III. DEVICE NAME

Proprietary Trade Name: Medos Hilite 1000 & 800 LT Infant Oxygenator Common/Usual Name: Blood Oxygenator

#### IV. DEVICE CLASS:

Class II

#### V. CLASSIFICATION NAME AND CITATION:

Classification Name: Oxygenator, Cardiopulmonary Bypass Classification regulation: Sec. 870.4350

#### PRODUCT CODES: VI.

DTZ

#### VII. PREDICATE DEVICES

K090449, Medos Hilite Infant Oxygenator, Model 1000 & 800 LT Oxygenator

#### PRODUCT DESCRIPTION VIII.

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The MEDOS HILITE 1000 & 800 LT Infant Hollow Fiber Oxygenators consist of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 1000 infant hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 800 LT infant hollow fiber membrane consists of a polymetbylpentene plasma tight mat. The unique mat design increases tbe interaction between blood and gas, creating a highly efficient blood oxygenator. Tue 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 tbe inner lumen of the fibers and tberefore effects heat exchange while minimizing priming volume.

#### INDICATIONS OF USE IX.

The MEDOS HILITE 1000 & 800 LT Infant 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 tbe HILITE 800 LT for periods of up to six (6.0) hours.

#### TECHNOLOGICAL CHARACTERISITICS AND SUBSTANTIAL EQUIVALENCE X.

The Medos Hilite 1000 & 800 LT Infant Oxygenator are identical to the predicate device in terms of intended use, indications for use, levels of attachment, fundamental scientific technology, materials and surgical technique. Based on the information provided herein, the subject Medos Hilite 1000 & 800 LT Infant Oxygenator have been demonstrated to be substantially equivalent to the previously cleared Medos Hilite 1000 & 800 LT Infant Oxygenator (K090449). Please refer to the Table 9-1 for a comparison of the predicate and subject Medos Hilite 1000 & 800 LT Infant Oxygenator regarding substantial equivalence.

#### XI. PERFORMANCE TESTING

The 1000 & 800 LT Infant Oxygenator have been subjected to extensive safety, performance, and validations 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. The following tests were performed due to the change in potting material:

)

- Blood Pathway Integrity .
- Heat Exchanger Fluid Pathway Integrity .
- . Chemical analysis
- Macroplast CR 3502 / CR 4100, EO sterilized o
- O Hilite 7000, PUR Macroplast CR3505/CR4605
- Hilite 7000 LT, PUR Macroplast CR3505/CR4605 0
- Hilite 7000, PUR Macroplast CR3505/CR4100 0
- . Evaluation of Biological Safety - toxicology

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- Macroplast CR 3502 / CR 4100, PUR posting material for hollow fibers of o oxygenators
- . Cytotoxicity, L 929-Proliferation
- Macroplast CR 3502 / CR 4100, EO sterilized o
- Hemolysis (elution method) .
- · Macroplast CR 3502 / CR 4100, EO sterilized
- Cytotoxicity .
- Sensitization .
- Intracutaneous Reactivity .
- Acute Systemic Toxicity .
- . Pyrogen
- . Hemocompatibility

#### XII. SUMMARY AND CONCLUSIONS

Medos Medizintechnik AG makes the claim that the Medos Hilite 1000 & 800 LT Infant Oxygenator is substantially equivalent to the cited predicate in terms of intended use, indications for use, fundamental technology, design characteristics, generic materials of construction, and operational characteristics. As shown in Table 9-1 and the discussion above, the differences between the Medos Hilite 1000 & 800 LT Infant Oxygenator and cited predicate are minor and raise no new issues of safety or effectiveness. The Medos Hilite 1000 & 800 LT Infant Oxygenator meets design specifications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

February 19, 2014

Medos Medizintechnik AG c/o Leann Christman Novalung, Inc. 3526 West Liberty, Suite 100 Ann Arbor, Mich. 48103

Re: K140181

Trade/Device Name: Medos hilite 1000 & 800 LT Infant Oxygenators Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ, DTR Dated: January 22, 2014 Received: January 24, 2014

Dear Ms. Christman:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misicading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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Page 2 - Ms. Leann Christman

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/default.htm. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M. A. Hillerman

for 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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1

510(k) Number (if known) K 140181

## Device Name: Medos Hilite 1000 & 800 LT Infant Oxygenator

### indications for use:

The MEDOS HILITE 1000 & 800 LT Infant Hollow Fiber Oxygenators are indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of 200 ml/min (0.2 liters/minute) to 1000ml/min (1.0 liters per minute) for the Hilite 1000 and 200 ml/min (0.2 liters/minute) to 800 ml/min (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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: Yes

OR

Over-The-Counter Use: No

M.A. Lilleheman