INSPIRE 8M: Hollow Fiber Oxygenator
INSPIRE 8M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 8M is intended to be used for 6 hours or less.

INSPIRE HVR: Hardshell Venous/Cardiotomy Reservoir
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 8 is a high efficiency microporous hollow fiber membrane oxygenator integrated with heat exchanger (INSPIRE 8M) and connected to a hardshell venous/cardiotomy reservoir (INSPIRE HVR). A molded fitting joint connects the oxygenator to the reservoir.

The device can be operated at flow rates up to 8 liters per minute (I/min).

The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous blood or suction 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 8 is a modified version of the currently marketed INSPIRE 8 DUAL integrated oxygenator/hardshell venous cardiotomy reservoir system.

AI/ML Overview

The provided document describes a Special 510(k) submission for the INSPIRE 8 hollow fiber oxygenator with an integrated hardshell venous/cardiotomy reservoir. This submission is for a modified version of an already marketed device, the INSPIRE 8 DUAL. The core of the submission is to demonstrate substantial equivalence between the modified device and the predicate device through non-clinical testing.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria with corresponding performance values for each individual test. Instead, it states that "The INSPIRE 8 successfully met all acceptance criteria for each test." The tests conducted are primarily focused on demonstrating substantial equivalence to the predicate device and compliance with relevant ISO standards and FDA guidance.

Here's a table summarizing the types of tests conducted and the general performance statement:

Test (Classification)	Test Title	Acceptance Criteria (General)	Reported Device Performance
Physical/Mechanical	Structural integrity	Meet established safety and functionality standards	Successfully met all acceptance criteria.
Physical/Mechanical	Blood pathway integrity	Meet established safety and functionality standards	Successfully met all acceptance criteria.
Functional/Performance	Blood rest volume	Meet established safety and functionality standards	Successfully met all acceptance criteria.
Functional/Performance	Air handling	Meet established safety and functionality standards	Successfully met all acceptance criteria.
Functional/Performance	Break-through time and volume	Meet established safety and functionality standards	Successfully met all acceptance criteria.
Functional/Performance	Defoaming efficiency	Meet established safety and functionality standards	Successfully met all acceptance criteria.
Functional/Performance	Dynamic priming volume / Hold-up	Meet established safety and functionality standards	Successfully met all acceptance criteria.
Functional/Performance	Filtration efficiency - venous section	Meet established safety and functionality standards	Successfully met all acceptance criteria.
Functional/Performance	Filtration efficiency - cardiotomy section	Meet established safety and functionality standards	Successfully met all acceptance criteria.
Functional/Performance	Flow rate capacity	Meet established safety and functionality standards	Successfully met all acceptance criteria.
Functional/Performance	Pressure drop	Meet established safety and functionality standards	Successfully met all acceptance criteria.
Functional/Performance	Hemolysis	Meet established safety and functionality standards	Successfully met all acceptance criteria.
Functional/Performance	Blood compatibility	Meet established safety and functionality standards	Successfully met all acceptance criteria.
Functional/Performance	Leaching of coating	Meet established safety and functionality standards	Successfully met all acceptance criteria.
Functional/Performance	Flaking of coating	Meet established safety and functionality standards	Successfully met all acceptance criteria.
Functional/Performance	Uniformity of coating	Meet established safety and functionality standards	Successfully met all acceptance criteria.
Biocompatibility (Not listed in table but mentioned)	(Various per ISO 10993-1)	Meet ISO 10993-1 and FDA memorandum requirements	Conducted and met requirements.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria consists of in vitro non-clinical tests. These tests were conducted according to:

ISO 10993-1 ("Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process") and the FDA May 1st, 1995 Memorandum for biocompatibility.
"Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions: Final Guidance for Industry and FDA" issued on November 29, 2000 for relevant defoamer requirements.
ISO 15674, "Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags" for the hardshell venous/cardiotomy reservoir.

The primary goal of these tests was to demonstrate the substantial equivalence of the modified INSPIRE 8 to the predicate device, INSPIRE 8 DUAL, and compliance with general safety and effectiveness requirements.

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

Sample Size: The document does not specify the exact number of devices or replicates used for each in vitro test. It refers to "in vitro testing" without providing specific sample sizes.
Data Provenance: The tests were conducted by Sorin Group Italia S.r.I. (the submitter) in Italy (Mirandola, MO). The data is retrospective in the sense that it was generated for the purpose of the 510(k) submission, not as a prospective clinical trial.

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

This section is not applicable as this is a non-clinical, in vitro study of a physical medical device. There is no "ground truth" to be established by human experts in the context of diagnostic performance or clinical outcomes. The "ground truth" for these tests is defined by the technical specifications and performance characteristics outlined in the relevant ISO standards and FDA guidance documents.

4. Adjudication Method for the Test Set

This section is not applicable as this is a non-clinical, in vitro study. There are no human "readings" or interpretations that would require adjudication. The test results are objectively measured parameters.

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 section is not applicable. This submission is for a physical medical device (oxygenator and reservoir) and does not involve AI or human readers for diagnostic interpretation. Therefore, no MRMC study or AI-assisted improvement effect size is relevant.

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

This section is not applicable. This device is a physical medical component for cardiopulmonary bypass and does not involve any algorithms or standalone AI performance evaluation.

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

The "ground truth" for this engineering and performance study is the technical specifications and performance requirements established by international standards (ISO 10993-1, ISO 15674) and regulatory guidance documents (FDA guidance for Extracorporeal Blood Circuit Defoamer, FDA 1995 Biocompatibility Memorandum). The device's performance metrics were measured and compared against these predefined physical, chemical, and functional requirements.

8. The sample size for the training set

This section is not applicable. This is not an AI/machine learning device; therefore, there is no "training set." The testing involved physical samples of the modified device.

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

This section is not applicable for the same reason as point 8.

Summary

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K122254

INSPIRE 8 Sorin Group Italia S.r.I. Special 510(k) July 26, 2012

2012

510(k) SUMMARY

SUBMITTER:	Sorin Group Italia86, Via Statale 12 Nord41037 Mirandola (MO) Italy	AUG 24
CONTACT PERSON:	Luigi VecchiPhone: 39 0535 29811Fax: 39 0535 25229
DATE PREPARED:	July 26, 2012
DEVICE TRADE NAME:	INSPIRE 8 hollow fiber oxygenator with integratedhardshell venous/cardiotomy reservoir
COMMON NAMES:	Hollow Fiber Oxygenator with integrated hardshellvenous/cardiotomy reservoirHollow Fiber OxygenatorHardshell Venous/Cardiotomy Reservoir
CLASSIFICATION NAME:	Cardiopulmonary Bypass Oxygenator/Cardiopulmonary Bypass Heat Exchanger/Cardiopulmonary Bypass Blood Reservoir/Cardiopulmonary Bypass Defoamer
UNMODIFIED DEVICES:	INSPIRE 8 DUAL hollow fiber oxygenator withintegrated hardshell venous/cardiotomy reservoir(K121229)

DEVICE DESCRIPTION:

The device can be operated at flow rates up to 8 liters per minute (I/min).

The INSPIRE 8 is a modified version of the currently marketed INSPIRE 8 DUAL integrated oxygenator/hardshell venous cardiotomy reservoir system.

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INDICATION FOR USE:

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

INSPIRE 8M: Hollow Fiber Oxygenator

INSPIRE 8M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 8M is intended to be used for 6 hours or less.

INSPIRE HVR: Hardshell Venous/Cardiotomy Reservoir

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.

TECHNOLOGICAL CHARACTERISTICS:

The INSPIRE 8 has the same fundamental technological characteristics, principles of operation and control mechanisms as the unmodified device.

The INSPIRE 8 integrated device will be provided with a single chamber venous/cardiotomy reservoir (INSPIRE HVR) rather than a dual chamber venous/cardiotomy reservoir (INSPIRE HVR DUAL) as for the INSPIRE 8 DUAL unmodified device.

No change to the oxygenating module has been made as a result of this modification. The INSPIRE 8 modified device is provided with oxygenating module identical with respect to the unmodified device.

No change to the intended use has been made as a result of these modifications.

The INSPIRE 8 and the INSPIRE 8 DUAL unmodified device share fundamental technological characteristics except for some modifications that do not affect the basic device function. These differences do not raise any new issues of safety and effectiveness.

The INSPIRE 8 is substantially equivalent to the INSPIRE 8 DUAL on the basis of operating principles and basic function.

There are no differences in packaging type and material between unmodified and the modified device.

The INSPIRE 8 is ethylene oxide sterilized and has a non-pyrogenic fluid path. It is for single use only.

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NON CLINICAL TEST RESULTS:

Applicable tests were conducted 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 conducted in accordance with the relevant requirements of "Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions: Final Guidance for Industry and FDA" issued on November 29, 2000: 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 conducted on hardshell venous/cardiotomy reservoir to demonstrate unmodified device substantial equivalency and compliance to safety and effectiveness requirements.

The modified INSPIRE 8 and unmodified INSPIRE 8 DUAL utilize identical oxygenating modules integrated with heat exchanger. This 510(k) cross references the following oxygenating module performance data previously submitted in the INSPIRE 8 DUAL (K121229): structural integrity, blood, water, gas pathway integrity, blood volume capacity, gas transfer performance/blood side pressure drop, heat exchange performance/water side pressure drop, hemolysis, blood compatibility, leaching of coating, flaking of coating, uniformity of coating,

The following table lists the performance and physical/mechanical integrity tests conducted to demonstrate compliance to the product's performance specifications. The INSPIRE 8 successfully met all acceptance criteria for each test.

TEST	TEST CLASSIFICATION	TEST TITLE
1	Physical/Mechanical	Structural integrity
2	Physical/Mechanical	Blood pathway integrity
3	Functional/Performance	Blood rest volume
4	Functional/Performance	Air handling
5	Functional/Performance	Break-through time and volume
6	Functional/Performance	Defoaming efficiency
7	Functional/Performance	Dynamic priming volume / Hold-up
8	Functional/Performance	Filtration efficiency - venous section
9	Functional/Performance	Filtration efficiency - cardiotomy section
10	Functional/Performance	Flow rate capacity
11	Functional/Performance	Pressure drop
12	Functional/Performance	Hemolysis
13	Functional/Performance	Blood compatibility
14	Functional/Performance	Leaching of coating
15	Functional/Performance	Flaking of coating
16	Functional/Performance	Uniformity of coating

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INSPIRE 8	Special 510(k)
Sorin Group Italia S.r.I.	July 26, 2012

CONCLUSIONS:

The results of in vitro studies demonstrate that the modified device performs in a manner substantially equivalent to the unmodified device with respect to the relevant functional parameters. Test results of this study demonstrate the INSPIRE 8 is equivalent to the INSPIRE 8 DUAL unmodified device with respect to 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

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

AUG 2 4 2012

Sorin Group USA, Inc. c/o Mr. Scott Light Regulatory Affairs Manager 14401 W. 65th Way Arvada, CO 80004

Re: K122254

Trade/Device Name: Inspire 8 Hollow Fiber Oxygenator with integrated Single-Chamber Hardshell Venous/Cardiotomy Reservoir Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator . Regulatory Class: Class II Product Code: DTZ Dated: July 26, 2012 Received: July 27, 2012

Dear Mr. Light:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved for 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 for use stated in the entribution of the enactment date of the Medical Device Amendments, or to conninered prior to Frid 2011-07-11 accordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). and Costile 110 (110) that as nevice, subject to the general controls provisions of the Act. The r ou may, merelore, maines 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 clausified (boo are 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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Page 2 - Mr. Scott Light

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 I ou may 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,

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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INSPIRE 8 Sorin Group Italia S.r.I. Special 510(k) July 26, 2012

510(k) Number (if known):

Device Name: INSPIRE 8 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir

K122254

Indication for Use:

INSPIRE 8M: Hollow Fiber Oxygenator

INSPIRE HVR: Hardshell Venous/Cardiotomy Reservoir

Prescription Use (Part 21CFR 801 Subpart D) Over-the- Counter Use AND/OR (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)

vision/Sign-Off
vision of Cardiovascular Devices

510(k) Num

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.”