The MEDOS HILITE 7000 & 7000 LT Hollow Fiber Oxygenator is 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 one (1 .0) to seven (7.0) liters per minute for periods of up to six (6.0) hours.

Device Description

The MEDOS HI LITE 7000 & 7000 L T Oxygenator consists of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 7000 hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 7000 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. All materials of the heat exchanger are biocompatible. The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifyigal pump connected through the tubing. The MEDOS HILITE 7000 Oxygenator may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit,

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Medos Hilite 7000 & 7000 LT Oxygenator), not an AI/ML product. Therefore, many of the requested criteria related to AI/ML device studies (such as MRMC studies, standalone performance, training set details, ground truth for AI, etc.) are not applicable and cannot be found in this document.

However, I can extract information related to the device's performance testing and the criteria it meets based on the provided text.

Here's a summary of the requested information, adapted for a medical device rather than an AI/ML product:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present quantitative acceptance criteria in a table alongside reported performance values for each criterion. Instead, it states that "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." It then lists the types of tests performed. The overall conclusion is that "The Medos Hilite 7000 & 7000 LT Oxygenator meets design specifications," implying that all tested parameters fell within acceptable ranges.

Acceptance Criteria Category	Reported Device Performance
Blood Pathway Integrity	Device passed testing to ensure integrity. (Implied: No leaks or functional issues in blood flow path)
Heat Exchanger Fluid Pathway Integrity	Device passed testing to ensure integrity. (Implied: No leaks or functional issues in heat exchanger fluid path)
Chemical Analysis (Potting Materials)	Device components (Macroplast CR 3502 / CR 4100, Macroplast CR3505/CR4605, Macroplast CR3505/CR4100) were analyzed for chemical composition and suitability. (Implied: Met purity/specification requirements)
Biocompatibility/Biological Safety Toxicology	Device components (Macroplast CR 3502 / CR 4100) and the final device underwent: Cytotoxicity (L 929-Proliferation)Hemolysis (elution method)SensitizationIntracutaneous ReactivityAcute Systemic ToxicityPyrogenicityHemocompatibility (Implied: Device components and the final device were found to be biologically safe and hemocompatible as per testing.)
Overall Functional Requirements	"Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." (Implied: All functional requirements and specifications were met.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the quantitative sample sizes for the performance and safety tests. It mentions "extensive safety, performance, and validations prior to release" and "Final testing" as well as specific types of tests. There is no information regarding the data provenance (country of origin, retrospective/prospective). The testing appears to be internal validation by the manufacturer, Medos Medizintechnik AG, located in Germany, suggesting in-house prospective testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This concept is not applicable to the evaluation of this type of medical device. The "ground truth" for device performance typically refers to established engineering specifications, safety standards, and biological compatibility requirements, assessed through laboratory testing by qualified technicians and scientists, rather than expert clinical review of data for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This concept (adjudication for ground truth in diagnostic tests) is not applicable to the engineering and biocompatibility testing of this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the device is a blood oxygenator, not an AI/ML diagnostic or assistive tool.

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

This is not applicable as the device is a blood oxygenator, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance and safety is derived from:

Established mechanical and material engineering specifications.
Biocompatibility standards and test protocols (e.g., ISO 10993 series used for cytotoxicity, hemolysis, sensitization, etc.).
Functional performance specifications (e.g., blood flow rate capabilities, oxygenation efficiency, CO2 removal efficiency, heat exchange capacity – although explicit values are not detailed in this summary, they are implied to be met).

8. The sample size for the training set

This is not applicable as the device is a blood oxygenator, not an AI/ML product that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as the device is a blood oxygenator, and no training set or ground truth in that context is relevant.

Summary

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K133261 page 1 of 3 Special 510(k) Submission Section 2, 510(k) Summary

SPECIAL 510(K) : 510(k) Summary For the Medos Medizintechnik AG Medos Hilite 7000 & 7000 LT Oxygenator

JAN - 9 2014

SUBMITTER/510(k) HOLDER: l.

Medos Medizintechnik AG Obere Steinfurt 8-10 5222 Stolberg, Germany Telephone: +49 7131 2706 150 Telefax: +49 7131 2706 250 Head of Requlatory Affairs: Heiko Frerichs Email: h.frerichs@medos-ag.com

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 7000 & 7000 LT 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

VI. PRODUCT CODES:

DTZ

VII. PREDICATE DEVICES

K088403, Medos Hilite 7000 & 7000 LT Oxygenator

VIII. PRODUCT DESCRIPTION

The MEDOS HI LITE 7000 & 7000 L T Oxygenator consists of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 7000 hollow fiber

Medos Medizintechnik AG, Special 510(k) Medos Hilite 7000 & 7000 LT Oxygenator

Confidential Page 2-1

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membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 7000 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. All materials of the heat exchanger are biocompatible. The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifyigal pump connected through the tubing. The MEDOS HILITE 7000 Oxygenator may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit,

IX. INDICATIONS OF USE

The Medos Hilite 7000 & 7000 LT Oxygenator is 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 one (1.0) to eight (7.0) liters per minute for periods of up to six (6.0) hours.

X. TECHNOLOGICAL CHARACTERISITICS AND SUBSTANTIAL EQUIVALENCE

The Medos Hilite 7000 & 7000 LT 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 7000 & 7000 LT Oxygenator have been demonstrated to be substantially equivalent to the previously cleared Medos Hilite 7000 & 7000 LT Oxygenator (K088403). Please refer to the Table 9-1 for a comparison of the predicate and subject Medos Hilite 7000 & 7000 LT Oxygenator regarding substantial equivalence.

XI. PERFORMANCE TESTING -

The Medos Hilite 7000 & 7000 LT Oxygenator has 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 0
- Hilite 7000, PUR Macroplast CR3505/CR4605
- Hilite 7000 LT, PUR Macroplast CR3505/CR4605 O
- Hilite 7000, PUR Macroplast CR3505/CR4100 o
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 �
- o Macroplast CR 3502 / CR 4100, EO sterilized
Hemolysis (elution method) .
- · Macroplast CR 3502 / CR 4100, EO sterilized
. Cytotoxicity
. Sensitization
Intracutaneous Reactivity ●
. Acute Systemic Toxicity
Pyrogen .
Hemocompatibility .

SUMMARY AND CONCLUSIONS XII.

Medos Medizintechnik AG makes the claim that the Medos Hilite 7000 & 7000 LT 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 7000 & 7000 LT Oxygenator and cited predicate are minor and raise no new issues of safety or effectiveness. The Medos Hilite 7000 & 7000 LT Oxygenator meets design specifications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 9, 2014

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

Re: K133261

Trade/Device Name: Medos hilite 7000 & 7000LT Hollow Fiber Oxygenators Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: December 9, 2013 Received: December 11, 2013

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. Ilsting 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 misleading.

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/ResourcesforYou/Industry/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 vours.

MDA

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 133261

Device Name: Medos Hilite 7000 & 7000 LT 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: Yes

Over-The-Counter Use: No

MDA

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.”