INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 6M is intended to be used for 6 hours or less.

INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, defoams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. INSPIRE HVR is intended to be used for 6 hours or less.

Device Description

The INSPIRE 6 is consisting of an oxygenator (INSPIRE 6M) and a hardshell veo us/cardiotomy reservoir (INSPIRE HVR). The reservoir is connected to the gas exchange module by means of a molded fitting joint.

The INSPIRE 6 is a high efficiency microporous hollow fiber membrane oxygenator integrated with an heat exchanger and connected to an hardshell venous/cardiotomy reservoir.

The device can be operated at flow rates up to 6 liters per minute.

The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery.

The integrated hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage.

The INSPIRE 6 is a modified version of the currently marketed D905 EOS.

AI/ML Overview

The provided document is a 510(k) summary for the INSPIRE 6 hollow fiber oxygenator with an integrated hardshell venous/cardiotomy reservoir. This document details the device's technical characteristics, intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device.

It's important to note that this document describes a medical device (an oxygenator and reservoir system) and not an AI/ML-enabled medical device. Therefore, many of the typical acceptance criteria and study aspects requested for AI/ML devices (like sample size for test sets, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable to this type of submission.

The "acceptance criteria" for this device are its performance in various in vitro tests to ensure its safety and effectiveness, and its substantial equivalence to a legally marketed predicate device.

Here's a breakdown of the available information, tailored to what is provided in the document:

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

For a medical device like an oxygenator, "acceptance criteria" are typically defined by recognized standards and guidance documents, which specify performance benchmarks. The document states that testing was performed in accordance with relevant FDA guidance and ISO standards (ISO 10993-1, "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions," "Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions," and ISO 15674). The device's "performance" is reported as having successfully passed all these tests.

Test Category	Test Title	Acceptance Criteria (Implied by Standards/Guidance)	Reported Device Performance
Physical/Mechanical	Structural Integrity	Meets specified mechanical strength and design requirements for safe operation.	Passed
Physical/Mechanical	Blood, water, gas pathway integrity	No leaks or breaches in the system's pathways under operational conditions.	Passed
Physical/Mechanical	Blood pathway integrity	No leaks or breaches in the blood pathway under operational conditions.	Passed
Functional/Performance	Blood volume capacity	Meets specified volume capacity for intended use.	Passed
Functional/Performance	Reservoir blood rest volume	Meets specified residual blood volume after operation.	Passed
Functional/Performance	Gas transfer performance/blood side pressure drop	Achieves adequate oxygenation and CO2 removal, and acceptable pressure drop.	Passed
Functional/Performance	Heat exchange performance/water side pressure drop	Effectively controls blood temperature with an acceptable pressure drop.	Passed
Functional/Performance	Reservoir Air handling	Effectively removes air from the blood path.	Passed
Functional/Performance	Reservoir Break-through time and volume	Maintains integrity and prevents air breakthrough for specified duration/volume.	Passed
Functional/Performance	Reservoir Defoaming efficiency	Effectively defoams blood.	Passed
Functional/Performance	Reservoir Dynamic priming volume / Hold-up	Meets specified priming and hold-up volume requirements.	Passed
Functional/Performance	Reservoir Filtration Efficiency - venous section	Effectively filters particulates from venous blood.	Passed
Functional/Performance	Reservoir Filtration Efficiency - cardiotomy section	Effectively filters particulates from cardiotomy blood.	Passed
Functional/Performance	Reservoir Flow rate capacity	Operates effectively at intended flow rates (up to 6 L/min).	Passed
Functional/Performance	Reservoir Pressure drop	Maintains an acceptable pressure drop across the reservoir.	Passed
Functional/Performance	Hemolysis	Causes acceptable levels of blood cell damage (hemolysis).	Passed
Functional/Performance	Reservoir Hemolysis	Causes acceptable levels of blood cell damage within the reservoir.	Passed
Functional/Performance	Blood compatibility	Biocompatible with blood, causing no adverse reactions.	Passed
Functional/Performance	Reservoir Blood compatibility	Biocompatible with blood within the reservoir.	Passed
Functional/Performance	Leaching of coating	No unacceptable leaching of coating materials into the blood path.	Passed
Functional/Performance	Reservoir Leaching of coating	No unacceptable leaching of coating materials within the reservoir.	Passed
Functional/Performance	Flaking of coating	No unacceptable flaking of coating materials into the blood path.	Passed
Functional/Performance	Reservoir Flaking of coating	No unacceptable flaking of coating materials within the reservoir.	Passed
Functional/Performance	Flaking of coating on integrated device	No unacceptable flaking of coating materials on the entire integrated device.	Passed
Functional/Performance	Uniformity of coating	Coating is uniformly applied as specified.	Passed
Other	Sterility	Demonstrated to be sterile.	Passed (mentioned in conclusion)
Other	Non-pyrogenic	Demonstrated to be non-pyrogenic.	Passed (mentioned in conclusion)

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

Sample Size: The document does not specify the exact number of devices or test samples used for each in vitro test. For medical device testing, sample sizes are typically determined by statistical methods to ensure robustness and acceptable confidence levels, often referencing ISO or ASTM standards, but these details are not present in this 510(k) summary.
Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are in vitro (laboratory-based) performance and mechanical integrity tests conducted by the manufacturer, Sorin Group Italia S.r.l., located in Mirandola (MO) Italy. The data is prospective as it was generated specifically for this submission.

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)

Not applicable. This device is not an AI/ML system that requires expert-established ground truth from clinical cases. The "ground truth" for these tests is the objective measurement of the device's physical and functional properties against predefined engineering and performance specifications.

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

Not applicable, as this is not an AI/ML system requiring human adjudication of clinical data.

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 not an AI/ML-enabled device. MRMC studies are used to evaluate the impact of AI on human reader performance, which is not relevant here.

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.

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

Not applicable. The "ground truth" for the in vitro tests are the objective, measurable performance characteristics and physical properties of the device as defined by engineering specifications and recognized industry standards (e.g., specific thresholds for gas transfer rates, pressure drops, blood compatibility metrics, structural integrity limits, etc.).

8. The sample size for the training set

Not applicable. This is not an AI/ML-enabled device that requires a training set.

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

Not applicable. This is not an AI/ML-enabled device.

Summary

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K-113626

5 2012

510(k) SUMMARY

SUBMITTER:	Sorin Group Italia S.r.l.86, Via Statale 12 Nord41037 Mirandola (MO) Italy
CONTACT PERSON:	Luigi VecchiPhone: 011 39 0535 29811Fax: 011 39 0535 25229
DATE PREPARED:	March 14, 2012
DEVICE TRADE NAME:	INSPIRE 6 hollow fiber oxygenator withintegrated hardshell venous/cardiotomyreservoir
COMMON NAMES:	Hollow Fiber Oxygenator with HardshellVenous/Cardiotomy ReservoirHollow Fiber OxygenatorHardshell Venous/Cardiotomy Reservoir
CLASSIFICATION NAMES:	Cardiopulmonary Bypass Oxygenator/Cardiopulmonary Bypass Heat Exchanger/Cardiopulmonary Bypass Blood Reservoir/Cardiopulmonary Bypass Defoamer
PREDICATE DEVICE:	D 905 EOS: hollow fiber oxygenator withintegrated hardshell venous/cardiotomyreservoir

DEVICE DESCRIPTION:

The INSPIRE 6 is a high efficiency microporous hollow fiber membrane oxygenator integrated with an heat exchanger and connected to an hardshell venous/cardiotomy reservoir.

The device can be operated at flow rates up to 6 liters per minute.

nomiothermia daring cargory.
The integrated hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage.

The INSPIRE 6 is a modified version of the currently marketed D905 EOS.

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INDICATION FOR USE:

The intended use for the two elements that constitute the integrated device are:

INSPIRE 6M: Hollow Fiber Oxygenator

INSPIRE HVR: Hardshell Venous/Cardiotomy Reservoir

TECHNOLOGICAL CHARACTERISTICS:

The INSPIRE 6 has the same fundamental technological characteristics, principles of operation and control mechanisms as the predicate device.

Sorin believes that the INSPIRE 6 is substantially equivalent to the D905 EOS on the basis of operating principles and basic function.

The INSPIRE 6 and the D905 EOS share the same fundamental technological characteristics except for some modifications that do not affect the basic device function. Any differences do not raise any new issues of safety and effectiveness.

The INSPIRE 6 is ethylene oxide sterilized and has a non-pyrogenic fluid path. It is for single use only.

NON CLINICAL TEST RESULTS:

Applicable tests were carried out in accordance with the requirements of ISO 10993-1 and the FDA May 1st, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of materials.

IN VITRO TEST RESULTS:

In vitro testing was carried out in accordance with the relevant requirements of "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff" issued on November 13, 2000, "Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final Guidance for Industry and FDA" issued on November 29, 2000, and ISO 15674, "Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags".

In vitro testing was carried out to demonstrate both the substantial equivalence with the predicate device and also to comply with safety and effectiveness requirements. Testing supplied in the 510(k) premarket notification includes performance tests and mechanical integrity tests that demonstrate compliance with performance specifications.

Spoollied.lond.
The tests that were performed are listed in the following summarizing table. For each test mentioned in the table the test outcome in terms of pass or fail is also provided.

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TEST	TESTCLASSIFICATION	TEST TITLE
1	Physical/Mechanical	Structural Integrity
2	Physical/Mechanical	Blood, water, gas pathway integrity
3	Physical/Mechanical	Blood pathway integrity
4	Functional/Performance	Blood volume capacity
5	Functional/Performance	Reservoir blood rest volume
6	Functional/Performance	Gas transfer performance/blood sidepressure drop
7	Functional/Performance	Heat exchange performance/water sidepressure drop
8	Functional/Performance	Reservoir Air handling
9	Functional/Performance	Reservoir Break-through time and volume
10	Functional/Performance	Reservoir Defoaming efficiency
11	Functional/Performance	Reservoir Dynamic priming volume / Hold-up
12	Functional/Performance	Reservoir Filtration Efficiency - venous section
13	Functional/Performance	Reservoir Filtration Efficiency - cardiotomy section
14	Functional/Performance	Reservoir Flow rate capacity
15	Functional/Performance	Reservoir Pressure drop
16	Functional/Performance	Hemolysis
17	Functional/Performance	Reservoir Hemolysis
18	Functional/Performance	Blood compatibility
19	Functional/Performance	Reservoir Blood compatibility
20	Functional/Performance	Leaching of coating
21	Functional/Performance	Reservoir Leaching of coating
22	Functional/Performance	Flaking of coating
23	Functional/Performance	Reservoir Flaking of coating
24	Functional/Performance	Flaking of coating on integrated device
25	Functional/Performance	Uniformity of coating

The in-vitro testing was successfully completed and INSPIRE 6 passed all the above listed tests.

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CONCLUSIONS:

The results of in vitro studies demonstrate that the INSPIRE 6 performs in a manner substantially equivalent to the predicate device with respect to the relevant functional parameters. Test results of this study suggest the INSPIRE 6 is equivalent to the predicate device with respect device function.
Additional testing has also demonstrated the effectiveness of production techniques to assure that the device is sterile and non-pyrogenic.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract birds in flight, stacked vertically.

Public Health Service

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

APR - 5 2012

Sorin Group Italia s.r.1. c/o Mr. Barry Sall Principal Consultant Parexel International Consulting 195 West Street Waltham, WA 02451

Re: K113626

Trade/Device Name: Inspire 6 Hollow Fiber Oxygenator with Integrated Hardshell Venous Cardiotomy/Reservoir Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: March 14, 2012 Received: March 15, 2012

Dear Mr. Sall:

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 r ou may, alers 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 If your device is classified (controls. Existing major regulations affecting your device an 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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Page 2 - Mr. Barry Sall

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M.A. Hillebenne

Jin 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): K113626

INSPIRE 6 hollow fiber oxygenator with integrated hardshell Device Name: venous/cardiotomy reservoir

Indications for Use:

INSPIRE 6M: Hollow Fiber Oxygenator

INSPIRE HVR: Hardshell Venous/Cardiotomy Reservoir

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 LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Ju Gencerregarge of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices

Page 1 of 1

510(k) Number_KII 3626

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.”