The SAFE MAXI – hollow fiber oxygenator is intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.

Device Description

SAFE MAXI is a hollow fiber oxygenator with an integral venous heat exchanger. The SAFE MAXI oxygenator is a single-use, disposable, sterile and non-pyrogenic device. The overall blood flow path is from bottom to top in the heat exchanger module and top to bottom in the gas exchange section. The inverted "U" shaped blood flow path optimizes the device's bubble trapping capabilities. Gas exchange occurs by diffusion across the porous hollow fiber membrane.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and study details. It's important to note that the provided document is a 510(k) summary for a medical device (oxygenator), which primarily demonstrates substantial equivalence to a predicate device rather than establishing new acceptance criteria or conducting a traditional clinical study with human readers assisting AI. Therefore, many of the requested categories related to AI performance, human expert involvement in ground truth, and training sets are not applicable.

Acceptance Criteria and Device Performance for SAFE MAXI Oxygenator

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Characteristic	Acceptance Criteria (from predicate/guidance)	Reported Device Performance (SAFE MAXI)
Biocompatibility	In vitro Cytotoxicity Test	(Implied: Non-cytotoxic)	Determined to be biocompatible and safe
	Guinea Pig Maximization Test	(Implied: Non-sensitizing)	Determined to be biocompatible and safe
	Intracutaneous Test	(Implied: Non-irritating)	Determined to be biocompatible and safe
	Systemic Injection Test	(Implied: Non-toxic)	Determined to be biocompatible and safe
	Haemolysis Test	(Implied: Acceptable haemocompatibility)	Determined to be biocompatible and safe
Physical Characteristics	Blood Pathway Integrity	(Implied: No leaks/defects)	Tested (implicitly met based on conclusion)
	Heat Exchanger Fluid Pathway Integrity	(Implied: No leaks/defects)	Tested (implicitly met based on conclusion)
	Gas Pathway Integrity	(Implied: No leaks/defects)	Tested (implicitly met based on conclusion)
	Blood Volume Capacity	(Implied: Meets design specifications)	Tested (implicitly met based on conclusion)
	Connectors	(Implied: Secure, functional)	Tested (implicitly met based on conclusion)
Performance Characteristics	Oxygen Gas Transfer	(Implied: Equivalent to predicate/guidance)	Tested (implicitly met based on conclusion)
	Carbon Dioxide Gas Transfer	(Implied: Equivalent to predicate/guidance)	Tested (implicitly met based on conclusion)
	Blood Cell Damage	(Implied: Acceptable level of damage, equivalent to predicate/guidance)	Tested (implicitly met based on conclusion)
	Blood Side Pressure Drop	(Implied: Equivalent to predicate/guidance)	Tested (implicitly met based on conclusion)
	Heat Exchanger Performance	(Implied: Equivalent to predicate/guidance)	Tested (implicitly met based on conclusion)
	Water Side Pressure Drop	(Implied: Equivalent to predicate/guidance)	Tested (implicitly met based on conclusion)
In vivo Testing	Animal testing	(Implied: Safe and effective in animal model, equivalent to predicate)	Performed (implicitly met based on conclusion)

Note: The document states that "In vitro bench testing was performed according to the FDA's 'Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff' of November 13, 2000. Reference to the ISO 7199:1996 standard was made where appropriate." This implies that the acceptance criteria for each test were derived from these detailed guidelines and standards, but the specific numerical criteria are not explicitly stated in this high-level summary.

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

The document does not explicitly state the specific sample sizes for each in-vitro or in-vivo test. It only mentions that "in-vitro testing was performed" and "animal testing was performed."

Test Set Sample Size: Not explicitly stated in the document for individual tests.
Data Provenance:
- In-vitro Bench Testing: Performed in accordance with FDA guidance and ISO 7199:1996. The location of the testing facility or specific details are not provided, but it's presumed to be the manufacturer's or a contracted lab. This would be prospective testing for the SAFE MAXI device.
- Biocompatibility Testing: Similar to in-vitro bench testing, performed according to recognized standards.
- In-vivo Testing: Animal testing was performed. The type of animal, number of animals, and location are not specified. This would be prospective testing on the SAFE MAXI device.

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

This information is not applicable to this type of device submission. This submission does not involve an AI algorithm with a "ground truth" established by human experts in the way suggested by the question. The "ground truth" for the oxygenator's performance is objective measurement against engineering and biological standards, or comparison to a predicate device.

4. Adjudication Method for the Test Set

This is not applicable. There's no "adjudication method" in the context of human expert review for establishing ground truth, as there's no diagnostic output or interpretation involved that would require such a process. The results of the physical, performance, and biological tests are objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. The submission is for a medical device (oxygenator), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study to measure improvement with AI vs. without AI assistance was not performed.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-loop Performance)

This is not applicable. The device is an oxygenator, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here. The device's performance is inherently its "standalone" performance.

7. Type of Ground Truth Used

The "ground truth" for this device's performance and safety is established through:

Objective Measurements: Results of physical tests (e.g., integrity, flow rates, volume capacity), performance tests (e.g., gas transfer rates, pressure drops, heat exchange efficiency), and biocompatibility assays (e.g., cytotoxicity, hemolysis).
Adherence to Standards and Guidance: Compliance with FDA's "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions" and ISO 7199:1996 standards.
Comparative Performance to Predicate Device: Demonstration of substantial equivalence to the legally marketed Quadrox HMO 1010 HF Membrane Oxygenator. This means the SAFE MAXI's performance fell within an acceptable range relative to the predicate, as defined by the aforementioned standards and guidance.
In-vivo (Animal) Data: Safety and function demonstrated in an animal model.

8. Sample Size for the Training Set

This is not applicable. The SAFE MAXI oxygenator is a physical medical device, not an AI algorithm that undergoes "training" on a dataset.

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

This is not applicable for the same reasons as #8.

Summary

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AUG 1 4 2002

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for the SAFE MAXI OXYGENATOR as required by section 807.92(c).

Submitter's Information

Name: Address: Phone: Fax Contact person: Date of preparation:

Device name:

Trade Name: Common/Usual name: Classification name:

POLYSTAN A/S Walgerholm 8, 3500 Værløse, Denmark + 45 44 65 15 66 + 45 44 68 15 66 Dana Olsen, Regulatory Affairs May 27, 2002

SAFE MAXI hollow fiber oxygenator membrane oxygenator Cardiopulmonary bypass oxygenator (21 CFR - 870.4350)

Predicate Device Name(s):

Quadrox HMO 1010 HF Membrane Oxygenator - Jostra AG - 510(k) no. K992559.

Device Description

Intended Use

The SAFE MAXI hollow fiber oxygenator is intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.

Technological Characteristics Summary

When compared to the predicate device the SAFE MAXI oxygenator has some different technological characteristics, e.g. design.

In order to demonstrate that the SAFE MAXI oxygenator is substantially equivalent to the currently marketed Quadrox HMO 1010 HF Membrane Oxygenator (Jostra AG) biocompatibility and in-vitro testing was performed.

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Biocompatibility Testing .
- o In vitro Cytotoxicity Test (Elution Test)
- Test for Delayed Contact Hypersensitivity using the Guinea Pig O Maximization Test (Sensitization)
- Intracutaneous Test in the Rabbit o
- Systemic Injection Test in the Mouse o
- Haemolysis Test (Haemocompatibility)

Based on the biocompatibility testing performed, the SAFE MAXI oxygenator was determined to be biocompatible and safe for its intended use.

. In vitro Bench Testing
In vitro bench testing was performed according to the FDA's "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff" of November 13, 2000. Reference to the ISO 7199:1996 standard was made where appropriate.

Physical Characteristics

Blood Pathway Integrity o
Heat Exchanger Fluid Pathway Integrity o
Gas Pathway Integrity o
Blood Volume Capacity o
Connectors o

Performance Characteristics

Oxygen Gas Transfer o
Carbon Dioxide Gas Transfer o
Blood Cell Damage o
Blood Side Pressure Drop o
Heat Exchanger Performance O
Water Side Pressure Drop O
. In vivo Testing
- o Animal testing was performed

Conclusion:

The biocompatibility, performance, and function data demonstrated that the SAFE MAXI oxygenator is substantially equivalent to the predicate device Jostra Quadrox HMO 1010 HF Membrane Oxygenator.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes extending from its head, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2002

POLYSTAN A/S c/o Ms. Dana Olsen 8. Walgerholm DK-3500 Værløse - Denmark

Re: K013038

SAFE MAXI Hollow Fiber Oxygenator Regulation Number: 870.4350, 870.4240 Regulation Name: CPB Oxygenator, CPB Heat Exchanger Regulatory Class: Class II (two) Product Code: DTZ and DTR Dated: May 29, 2002 Received: May 31, 2002

Dear Ms. Olsen:

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.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Elisa D. Hayes Sr.

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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3 Indication for Use

Statement of Indication for Use

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular and Respiratory Devices
510(k) Number	K013038

Prescription Use	OR	Over-The-Counter Use
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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.”