The Novalung® surgical Lung Assist (sLA) Membrane Lung™ is intended to be used for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.

Device Description

The Novalung® surgical Lung Assist (sLA) Membrane Lung™ is a sterile device for single use only and it is not intended to be resterilized by the user. The Novalung® surgical Lung Assist (sLA) Membrane Lung™ is used to deliver oxygen into the blood and remove carbon dioxide from the blood. It is intended to be used as a component in an extracorporeal circuit for patients undergoing cardiopulmonary bypass. The Novalung® surgical Lung Assist (sLA) Membrane Lung™ incorporates a solid surface hollow polymethylpentene (PMP) fiber membrane and has a 1.3 m² surface area. The Novalung® surgical Lung Assist (sLA) Membrane Lung™ has a nominal flow range from 0.5 L/min. to 4.5 L/min and is suitable for patients weighing >20kg.

AI/ML Overview

The provided text describes a medical device submission (K072362) for the Novalung® surgical Lung Assist (sLA) Membrane Lung™. This is a 510(k) premarket notification for a new oxygenator device, aiming to demonstrate substantial equivalence to a predicate device.

Crucially, the provided text describes a submission for a physical medical device (an oxygenator), not a software or AI-driven diagnostic device. Therefore, many of the requested categories related to acceptance criteria for AI performance, sample sizes for AI test sets, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, and AI training sets are not applicable.

Below is an attempt to answer the relevant questions based on the provided text, with explanations for the questions that are not applicable to this type of device submission.

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

The document does not explicitly present a table of acceptance criteria with corresponding performance against those criteria in a quantitative manner as would be expected for an AI/software device. Instead, it describes general performance testing and a comparison to a predicate device.

Acceptance Criteria (Inferred from device function and comparison)	Reported Device Performance (from text)
Intended Use Equivalence:
- Used for extracorporeal circulation during cardiopulmonary bypass	Intended use matches predicate: "extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery."
- Oxygenation of blood	"blood is oxygenated"
- Carbon Dioxide removal from blood	"carbon dioxide is removed"
- Utilization period up to 6 hours	"utilization period of this device is restricted to six hours"
Functional Equivalence:
- Compatible with specified flow rates	Nominal flow range: 0.5 L/min to 4.5 L/min. Suitable for patients >20kg.
- Physical characteristics	Incorporates a solid surface hollow polymethylpentene (PMP) fiber membrane, 1.3 m² surface area.
Safety & Effectiveness Equivalence:
- No new issues of safety and effectiveness compared to predicate	"Comparative testing has demonstrated that these differences do not raise new issues of safety and effectiveness."
- Characterization by bench testing	"fully characterized by bench testing in accordance with FDA Guidance."
- Evaluation of potential failure modes	"A failure mode and effects analysis has been performed... Potential failure modes... have been evaluated in vitro and results are provided..."

2. Sample size used for the test set and the data provenance

Not Applicable for this type of physical medical device. This device undergoes bench testing and in-vitro evaluation, not a "test set" with human data provenance in the context of an AI/software submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This device does not rely on expert-established ground truth for a test set in the way an AI/software diagnostic device would. Its performance is evaluated through physical and chemical testing.

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

Not Applicable. There is no "test set" and no human or expert adjudication involved in the evaluation of this physical medical 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

Not Applicable. This is a physical medical device (oxygenator), not an AI diagnostic tool. MRMC studies are specific to evaluating human reader performance with and without AI assistance for tasks like medical image interpretation.

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

Not Applicable. This is a physical medical device, not an algorithm. Therefore, "standalone" algorithm performance is not a concept relevant to its evaluation.

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

The "ground truth" for this device's performance would be established through principles of physics, chemistry, and established clinical performance standards for oxygenators. This would involve:

Bench Test Results: Measurements of oxygen transfer, CO2 removal, pressure drops, blood compatibility, and other physical/chemical parameters.
Predicate Device Performance: The established performance characteristics of the "Jostra Quadrox D Safeline Diffusion Membrane Oxygenator" serve as a benchmark for substantial equivalence.
FDA Guidance: Adherence to recognized FDA guidance for oxygenator testing.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not Applicable. As there is no AI model or training set, this question is irrelevant.

Summary

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K072362

007 2 3 2007

510(k) Summary for the Novalung® GmbH Novalung® surgical Lung Assist (sLA) Membrane Lung™

1. SUBMITTER/510(K) HOLDER

Novalung® GmbH Lotzenäcker 3 D-72379 Hechingen, Germany

Contact Person: Heiko Frerichs Telephone: +49 7471 98488-30

Date Prepared: August 21, 2007

2. DEVICE NAME

Proprietary Name:	Novalung® surgical Lung Assist (sLA) Membrane Lung™
Common/Usual Name:	Cardiopulmonary bypass oxygenator
Classification Name:	Oxygenator, cardiopulmonary bypass

3. PREDICATE DEVICES

Jostra Quadrox D Safeline Diffusion Membrane Oxygenator . (Maquet Cardiovascular AG. K061628)

4. DEVICE DESCRIPTION

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5. INTENDED USE

The Novalung® surgical Lung Assist (sLA) Membrane Lung™ is intended to be used for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates, blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours:

The application and use of the oxygenator is the sole responsibility of the attending physician.

6. TECENOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Novalung® surgical Lung Assist (sLA) Membrane Lung™ has the same intended use, design, principals of operation, and performance as the Jostra Quadrox D Safeline Diffusion Membrane Oxygenator. The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator uses a tight diffusive membrane, where as the Novalung® surgical Lung Assist (sLA) Membrane Lung™ uses a solid surface membrane. The Quadrox D offers 1.8 m² surface area and a blood flow range of 0.5 L/min to 7 L/min. The Novalung® surgical Lung Assist (sLA) Membrane Lung™ provides the user with a smaller surface area of 1.3m² and a reduced flow range of 0 L/min to 4.5 L/min. Comparative testing has demonstrated that these differences do not raise new issues of safety and effectiveness.

7. PERFORMANCE TESTING

The Novalung® surgical Lung Assist (sLA) Membrane Lung™ has been fully characterized by bench testing in accordance with FDA Guidance. A failure mode and effects analysis has been performed to identify potential failure modes of the device. Potential failure modes directly related to the design and function of the Novalung® surgical Lung Assist (sLA) Membrane Lung™ have been evaluated in vitro and results are provided in the premarket notification.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 3 2007

Novalung® GmbH c/o Mr. Heiko Frerichs Lotzenäcker 3 D-72379 Hechingen, Germany

Re: K072362

Novalung® Surgical Lung Assist (sLA) Membrane Lung™ Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: August 21, 2007 Received: August 22, 2007

Dear Mr. Frerichs:

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, EDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Heiko Frerichs

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

uma R. bohner

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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Indications for Use

510(k) Number (if known): Jo 7 2 7 2 3 6 2

Device Name: Novalung® surgical Lung Assist (sLA) Membrane Lung™

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

una R. hlmey
(Division Chief)

ardiovascular Devices

510(k) Number_

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.”