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.

Device Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medos Hilite 1000 & 800 LT Infant Oxygenator:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than defining specific acceptance criteria for a new, novel device's performance. Therefore, explicit, quantitative acceptance criteria and direct performance metrics against those criteria are not explicitly stated in a typical "acceptance criteria vs. reported performance" table format for a medical device that generates data (like an AI/diagnostic device).

Instead, the "acceptance criteria" for this oxygenator are implicitly met by demonstrating that the device is substantially equivalent to a legally marketed predicate device (K090449, Medos Hilite Infant Oxygenator, Model 1000 & 800 LT Oxygenator). The reported performance is primarily established through a series of tests to ensure safety and function, particularly due to a change in potting material.

Here's an interpretation of what could be considered "acceptance criteria" in this context, and how the "reported performance" addresses them:

Acceptance Criteria (Implied by Substantial Equivalence and Testing)	Reported Device Performance and Evidence
Functional Equivalence: Device performs its intended function (extracorporeal oxygenation and CO2 removal) effectively at specified blood flow rates and duration.	"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."
Physiological Compatibility: Safe interaction with blood (no significant hemolysis, cytotoxicity, etc.).	"Hemocompatibility" test performed. "Hemolysis (elution method)" test performed.
Biocompatibility: Materials used are safe for human contact.	"Evaluation of Biological Safety - toxicology" performed. "Cytotoxicity, L 929-Proliferation" test performed. "Cytotoxicity" (general) test performed. "Sensitization" test performed. "Intracutaneous Reactivity" test performed. "Acute Systemic Toxicity" test performed. "Pyrogen" test performed.
Structural Integrity: Blood and heat exchanger pathways remain intact.	"Blood Pathway Integrity" test performed. "Heat Exchanger Fluid Pathway Integrity" test performed.
Material Equivalence: New potting material does not negatively impact performance or safety compared to predicate.	"Chemical analysis" performed for new potting materials (Macroplast CR 3502 / CR 4100 combinations). Testing covers "due to the change in potting material."
Substantial Equivalence: Device characteristics are sufficiently similar to the predicate device such that no new questions of safety or effectiveness are raised.	"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." "Differences... are minor and raise no new issues of safety or effectiveness."

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

Sample Size: The document does not specify exact sample sizes for the performance and safety tests listed. These types of tests (e.g., integrity, chemical analysis, cytotoxicity, hemolysis) are typically performed on a statistically relevant number of device units or material samples.
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the manufacturer (Medos Medizintechnik AG, Germany) and the testing descriptions, it's highly likely the data originated from laboratory testing conducted in Germany or by contract labs supporting the manufacturer. These are in vitro or ex vivo laboratory tests on the device itself or its components, not clinical data from patients.

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

This section is not applicable to this device. The Medos Hilite 1000 & 800 LT Infant Oxygenator is a physical medical device (an oxygenator), not a diagnostic algorithm or an AI system that generates interpretations requiring human ground truth. The "ground truth" for its performance is established through direct physical, chemical, and biological testing against established standards and validated methods, not through expert consensus on interpretations.

4. Adjudication Method for the Test Set:

This section is not applicable to this device for the same reasons as point 3. There is no ambiguous output or interpretation that would require an adjudication method. Test results are typically objective measurements (e.g., leakage rate, chemical composition, cell viability count).

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms where human reader performance is being evaluated, especially in comparison to an AI-assisted workflow. This oxygenator is a treatment device, not a diagnostic one.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance relies on:

Validated Test Methods and Standards: The performance tests (e.g., blood pathway integrity, chemical analysis, cytotoxicity, hemocompatibility) are conducted using internationally recognized and validated laboratory methods and standards relevant to medical devices (e.g., ISO standards for biocompatibility).
Engineering Specifications: The device is tested against its own engineering design specifications for functional parameters (e.g., flow rates, heat exchange efficiency, oxygenation capacity - though specific values are not detailed in the summary).
Predicate Device Performance Profile: The overarching "ground truth" or benchmark is the performance and safety established by the legally marketed predicate device (K090449). The new device must perform comparably.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for this device would be its design, engineering, and manufacturing processes.

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

Not applicable. As per point 8, there is no "training set" in the AI/ML sense for this physical medical device.

Summary

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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: +49 7131 2706 150 Telefax: +49 7131 2706 250 Head of Regulatory Affairs: Heiko Frerichs Email: h.frerichs@medos-ag.com FDA Registration: 3010223691

CONTACT PERSON II.

Leann Christman Novalung, Inc. 3526 West Liberty Rd., Suite 100 Ann Arbor, MI 48103 Telephone: (734) 995-9089 ext. 232 Fax: (734) 995-0840 Email: leann.christman@Novalung.com

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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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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510(k) Number (if known) K 140181

Device Name: Medos Hilite 1000 & 800 LT Infant Oxygenator

indications for use:

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

Over-The-Counter Use: No

M.A. Lilleheman

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.”