The INSPIRE 8F M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 8F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 8F M 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 8F consists of an oxygenator, integrated with an arterial filter and a heat exchanger (INSPIRE 8F M), and a hardshell venous/cardiotomy reservoir (INSPIRE HVR). The reservoir is connected to the gas exchange module by means of a molded fitting joint.

The INSPIRE 8F is a high efficiency microporous hollow fiber membrane oxygenator, integrated with an arterial filter and a heat exchanger, connected to a hardshell venous/cardiotomy reservoir.

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

The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous blood or suctioned 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 arterial filter provides additional protection against air and solid emboli and the integrated hardshell reservoir collects, defoams, filters venous and suctioned blood, and can be used post-operatively for chest drainage. The INSPIRE 8F is a modified version of the currently marketed integrated oxvgenator/hardshell venous cardiotomy reservoir system (D903 AVANT 2 Ph.I.S.I.O., hereinafter referred to as D903 AVANT) combined with the arterial filter (Micro 40 Ph.I.S.I.O. Adult Arterial Filter, hereinafter referred to as D734). Currently, these products are offered as separate units.

AI/ML Overview

Here's an analysis of the provided information regarding the INSPIRE 8F device, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list specific quantitative acceptance criteria or numerical performance metrics for each test. Instead, it states that "The INSPIRE 8F successfully met all acceptance criteria for each test." The study's conclusion is that the device "performs in a manner substantially equivalent to the D903 AVANT predicate device" and "substantially equivalent to the D734 predicate device."

Therefore, the "acceptance criteria" are implied to be the performance levels demonstrated by the predicate devices, and the "reported device performance" is that INSPIRE 8F achieved these equivalent levels.

TEST	Test Classification	Acceptance Criterion (Implied)	Reported Device Performance
Oxygenating module structural integrity	Physical/Mechanical	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Reservoir structural integrity	Physical/Mechanical	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Oxygenating module blood, water, gas pathway integrity	Physical/Mechanical	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Reservoir blood pathway integrity	Physical/Mechanical	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Oxygenating module blood volume capacity	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Reservoir blood rest volume	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Oxygenating module gas transfer performance/blood side pressure drop	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Oxygenating module heat exchange performance/water side pressure drop	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Oxygenating module air handling capability	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Reservoir air handling	Functional/Performance	Equivalent to predicate device (D734)	Met acceptance criteria / Substantially equivalent
Reservoir break-through time and volume	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Reservoir defoaming efficiency	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Reservoir dynamic priming volume / Hold-up	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Oxygenating module filtration efficiency	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Reservoir filtration efficiency - venous section	Functional/Performance	Equivalent to predicate device (D734)	Met acceptance criteria / Substantially equivalent
Reservoir filtration efficiency - cardiotomy section	Functional/Performance	Equivalent to predicate device (D734)	Met acceptance criteria / Substantially equivalent
Reservoir flow rate capacity	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Reservoir pressure drop	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Integrated device hemolysis	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Integrated device blood compatibility	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Oxygenating module leaching of coating	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Reservoir leaching of coating	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Integrated device flaking of coating	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Oxygenating module uniformity of coating	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent
Reservoir uniformity of coating	Functional/Performance	Equivalent to predicate device (D903 AVANT)	Met acceptance criteria / Substantially equivalent

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

The document describes "in vitro testing" conducted in accordance with various ISO standards and FDA guidance documents. These are laboratory-based tests.

Sample Size for Test Set: Not explicitly stated. For in vitro device testing, this typically refers to the number of individual units tested for each specific test. The document does not provide these numbers.
Data Provenance: The tests were conducted by Sorin Group Italia S.r.l. in their labs (implied), following international and FDA standards. This is likely laboratory-controlled, experimental data rather than clinical patient data. The country of origin for the testing would be Italy, where Sorin Group Italia S.r.l. is based. The data is prospective in nature, as it involves testing a newly developed or modified device against established standards and predicate devices.

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

This type of device approval (Traditional 510(k)) relies on performance testing against established engineering and biological standards, and comparison to predicate devices, rather than human expert interpretation of clinical images or data for ground truth.

Number of Experts: Not applicable in the context of expert ground truth for interpretation. The "ground truth" here is objective physical and functional performance measurements and compliance with engineering specifications.
Qualifications of Experts: The experts involved would be engineers, scientists, and technicians conducting the specified in vitro tests, adhering to the protocols of ISO standards and FDA guidance. Their expertise would be in biomaterials, mechanical engineering, fluid dynamics, and quality assurance for medical devices.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation where adjudication for discrepancies would be needed. The tests are objective measurements (e.g., structural integrity, gas transfer, filtration efficiency). The "adjudication" would be achieved by comparing the measured performance against the pre-defined acceptance criteria (performance of predicate devices and standard requirements).

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

No. This document describes the premarket notification for a physical medical device (oxygenator/reservoir system), not an AI or software device that interprets data for human readers. Therefore, an MRMC comparative effectiveness study is not relevant or included.

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

No. This is not an algorithm-based device. The "standalone performance" is essentially what is described in the "IN VITRO TEST RESULTS" section, where the device's physical and functional capabilities are tested in a controlled laboratory environment.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on:

Established engineering specifications and performance benchmarks: Derived from relevant ISO standards (e.g., ISO 15675, ISO 15674, ISO 7199) and FDA guidance documents.
Performance of predicate devices: The D903 AVANT 2 Ph.I.S.I.O. Adult Hollow Fiber Oxygenator and the Micro 40 Ph.I.S.I.O. Adult Arterial Filter serve as the primary references for substantial equivalence. The INSPIRE 8F is considered to meet acceptance criteria if its performance is "substantially equivalent" to these predicates.

8. Sample Size for the Training Set

Not applicable. This is a conventional medical device, not an AI or machine learning model that requires a training set. The device itself is designed and engineered based on established principles and tested as described.

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

Not applicable. As there's no training set for an AI model, there's no ground truth needing to be established for it. The "ground truth" in the context of this traditional device development is the established scientific and engineering principles of cardiopulmonary bypass, and the performance characteristics of previously approved similar devices.

Summary

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K121536

INSPIRE 8F Sorin Group Italia S.r.I. Traditional 510(k) May 23, 2012

510(k) SUMMARY

Luigi Vecchi

May 23, 2012

SUBMITTER:

Sorin Group Italia S.r.l. 86. Via Statale 12 Nord 41037 Mirandola (MO) Italy

Phone: 011 39 0535 29811 Fax: 011 39 0535 25229

AUG 222 2012

CONTACT PERSON:

· DATE PREPARED:

DEVICE TRADE NAME:

COMMON NAMES:

CLASSIFICATION NAMES:

PREDICATE DEVICE:

INSPIRE 8F hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir

Hollow Fiber Oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir Hollow Fiber Oxygenator with integrated arterial filter

Hardshell Venous/Cardiotomy Reservoir

Cardiopulmonary Bypass Oxygenator/ Cardiopulmonary Bypass Heat Exchanger/ Cardiopulmonary Bypass Blood Reservoir/ Cardiopulmonary Bypass Defoamer/ Cardiopulmonary Bypass Arterial Line Blood Filter

D903 AVANT 2 Ph.I.S.I.O. Adult Hollow Fiber Oxygenator with Ph.I.S.I.O. coating (K033323)

Micro 40 Ph.I.S.I.O. Adult Arterial Filter (K040184)

DEVICE DESCRIPTION:

The INSPIRE 8F is a high efficiency microporous hollow fiber membrane oxygenator, integrated with an arterial filter and a heat exchanger, connected to a hardshell venous/cardiotomy reservoir.

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

The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous blood or suctioned blood. The integrated heat exchanger controls

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INSPIRE 8F	Traditional 510(k)
Sorin Group Italia S.r.I.	May 23, 2012

blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The integrated arterial filter provides additional protection against air and solid emboli and the integrated hardshell reservoir collects, defoams, filters venous and suctioned blood, and can be used post-operatively for chest drainage. The INSPIRE 8F is a modified version of the currently marketed integrated oxvgenator/hardshell venous cardiotomy reservoir system (D903 AVANT 2 Ph.I.S.I.O., hereinafter referred to as D903 AVANT) combined with the arterial filter (Micro 40 Ph.I.S.I.O. Adult Arterial Filter, hereinafter referred to as D734). Currently, these products are offered as separate units.

INDICATION FOR USE:

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

INSPIRE 8F M: Hollow Fiber Oxygenator

INSPIRE HVR: Hardshell Venous/Cardiotomy Reservoir

TECHNOLOGICAL CHARACTERISTICS:

The INSPIRE 8F has the same fundamental technological characteristics, principles of operation and control mechanisms as the predicate devices.

Sorin believes that the INSPIRE 8F is substantially equivalent to the D903 AVANT on the basis of operating principles and basic function. The integrated arterial filter of INSPIRE 8F is also substantially equivalent to the D734 predicate device with respect to the primary function of an arterial filter.

The INSPIRE 8F and the predicate devices 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 8F 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.

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INSPIRE 8F	Traditional 510(k)
Sorin Group Italia S.r.l.	May 23, 2012

IN VITRO TEST RESULTS:

In vitro testing was conducted 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; "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final Guidance for Industry and FDA" issued on November 29, 2000; ISO 15675 "Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters"; ISO 15674, "Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags"; and ISO 7199 "Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)".In vitro testing was conducted to demonstrate predicate devices substantial equivalency and compliance to safety and effectiveness requirements.

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

TEST	TEST CLASSIFICATION	TEST TITLE
1	Physical/Mechanical	Oxygenating module structural integrity
2	Physical/Mechanical	Reservoir structural integrity
3	Physical/Mechanical	Oxygenating module blood, water, gaspathway integrity
4	Physical/Mechanical	Reservoir blood pathway integrity
5	Functional/Performance	Oxygenating module blood volume capacity
6	Functional/Performance	Reservoir blood rest volume
7	Functional/Performance	Oxygenating module gas transferperformance/blood side pressure drop
8	Functional/Performance	Oxygenating module heat exchangeperformance/water side pressure drop
9	Functional/Performance	Oxygenating module air handling capability
10	Functional/Performance	Reservoir air handling
11	Functional/Performance	Reservoir break-through time and volume
12	Functional/Performance	Reservoir defoaming efficiency
13	Functional/Performance	Reservoir dynamic priming volume / Hold-up
14	Functional/Performance	Oxygenating module filtration efficiency
15	Functional/Performance	Reservoir filtration efficiency - venoussection

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INSPIRE 8F Sorin Group Italia S.r.l.

Traditional 510(k) May 23, 2012

TEST	TESTCLASSIFICATION	TEST TITLE
16	Functional/Performance	Reservoir filtration efficiency - cardiotomysection
17	Functional/Performance	Reservoir flow rate capacity
18	Functional/Performance	Reservoir pressure drop
19	Functional/Performance	Integrated device hemolysis
20	Functional/Performance	Integrated device blood compatibility
21	Functional/Performance	Oxygenating module leaching of coating
22	Functional/Performance	Reservoir leaching of coating
23	Functional/Performance	Integrated device flaking of coating
24	Functional/Performance	Oxygenating module uniformity of coating
25	Functional/Performance	Reservoir uniformity of coating

CONCLUSIONS:

The results of in vitro studies demonstrate that the INSPIRE 8F performs in a manner substantially equivalent to the D903 AVANT predicate device with respect to the relevant functional parameters. Also, the INSPIRE 8F performs in a manner substantially equivalent to the D734 predicate device, with respect to the filtering and air handling performances. Test results of this study demonstrate the INSPIRE 8F is equivalent to the predicate devices 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 222 2012

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

Re: K121536

Trade/Device Name: Inspire 8F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: May 23, 2012 Received: May 24, 2012

Dear Mr. Light:

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 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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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 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 vours,

CMA Willebe

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:

INSPIRE 8F M: 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 THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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MZ. Hilleben

ision of Cardiovascular Devices

510(k) Number_

Confidential

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.”