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 DUAL 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 DUAL can be used post-operatively for chest drainage. INSPIRE HVR DUAL is intended to be used for 6 hours or less.

Device Description

The INSPIRE 8F DUAL is a high efficiency microporous hollow fiber membrane oxygenator integrated with an arterial filter and a heat exchanger (INSPIRE 8F M) and connected to a hardshell venous/cardiotomy reservoir (INSPIRE HVR DUAL). 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 arterial filter provides additional protection against air and solid emboli and the integrated hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage.

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

AI/ML Overview

The provided document is a 510(k) summary for a medical device, the INSPIRE 8F DUAL hollow fiber oxygenator. It details the device description, indications for use, technological characteristics, and non-clinical test results conducted to demonstrate substantial equivalence to a predicate device.

Based on the nature of this document (a 510(k) for a physical medical device, specifically an oxygenator used in cardiopulmonary bypass), the "study" referred to is a series of in vitro performance and physical/mechanical integrity tests, not a clinical study involving human patients or analysis of imaging data with expert readers. Therefore, many of the typical elements associated with AI/imaging device studies (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable in this context.

The document explicitly states that the "study" involved "in vitro testing" and lists various performance and physical/mechanical integrity tests.

Here's how the provided information maps to your request:

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

The document provides a list of tests conducted and states that "The INSPIRE 8F DUAL successfully met all acceptance criteria for each test." However, the specific numerical acceptance criteria for each test and the explicit numerical reported performance values are not detailed within this 510(k) summary. The table below lists the tests performed, and the performance is reported as meeting "all acceptance criteria."

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

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

Sample Size for Test Set: The sample sizes for each specific in vitro test are not provided in this summary. These are typically detailed in the full test reports, which are part of the detailed 510(k) submission, but not summarized here.
Data Provenance: The tests were "in vitro," meaning they were conducted in a laboratory setting, not on patient data. The manufacturer is Sorin Group Italia S.r.I., located in Italy. The tests would have been performed in a controlled laboratory environment. The methods followed "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'."

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)

This is not applicable as the "ground truth" for in vitro physical/performance tests is established by adhering to widely accepted engineering, chemical, and biological testing standards and protocols (e.g., ISO standards, FDA guidance documents) and measurements obtained from calibrated equipment. There are no "experts" in the sense of clinical readers establishing ground truth for image interpretation.

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

This is not applicable for in vitro performance testing. Performance is measured against predefined engineering specifications and standards.

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 is not applicable. This device is a physical medical device (an oxygenator), not an AI/imaging diagnostic tool. No human reader studies (MRMC or otherwise) were conducted or are relevant for its approval.

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

This is not applicable. There is no AI algorithm involved with this device. The "standalone" performance here refers to the device's own physical and functional characteristics measured in a lab setting, which were indeed tested ("in vitro test results").

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

The "ground truth" for this device's performance tests is based on engineering specifications, industry standards (e.g., ISO 15674), and regulatory guidance documents (e.g., FDA guidance for defoamer submissions). The device's measured performance during in vitro testing must fall within pre-defined acceptable ranges specified by these standards.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable for the same reason as above.

Summary

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K122844

INSPIRE 8F DUAL Sorin Group Italia S.r.I.

Special 510(k) September 14, 2012

OCT 1 7 2012

510(k) SUMMARY

SUBMITTER:

CONTACT PERSON:

DATE PREPARED:

COMMON NAMES:

DEVICE TRADE NAME:

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

Luigi Vecchi Phone: 39 0535 29811 Fax: 39 0535 25229

September 14, 2012

INSPIRE 8F DUAL 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

UNMODIFIED DEVICES:

CLASSIFICATION NAME:

INSPIRE 8F hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir (K121536)

DEVICE DESCRIPTION:

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

The INSPIRE 8F DUAL is a modified version of the currently marketed INSPIRE 8F 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 8F M: Hollow Fiber Oxygenator

INSPIRE HVR DUAL: Hardshell Venous/Cardiotomy Reservoir

TECHNOLOGICAL CHARACTERISTICS:

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

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

No change to the oxygenating module has been made as a result of this modification. The INSPIRE 8F DUAL 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 8F DUAL and the INSPIRE 8F unmodified device share the same 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 DUAL is substantially equivalent to the INSPIRE 8F on the basis of operating principles and basic function.

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

The INSPIRE 8F DUAL 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 8F DUAL and unmodified INSPIRE 8F utilize identical oxygenating modules integrated with an arterial filter and a heat exchanger. This 510(k) cross references the following oxygenating module performance data previously submitted in the INSPIRE 8F (K121536): structural integrity, blood, water, gas pathway integrity, blood volume capacity, gas transfer performance/blood side pressure drop, heat exchange performance/water side pressure drop, air handling capability, filtration efficiency, 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 8F DUAL 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

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TEST	TEST CLASSIFICATION	TEST TITLE
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

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 8F DUAL is equivalent to the INSPIRE 8F 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

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

OCT 1 7 200

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

Re: K122844

Trade/Device Names: INSPIRE 8F DUAL Hollow Fiber Oxygenator with Integrated Arterial Filter and Dual Chamber Hardshell Venous/Cardiotomy Reservoir Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ, DTN Dated: September 14, 2012 Received: September 17, 2012

Dear Mr. Light:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

G.A. Kleiber

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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510(k) Number (if known):

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

K122844

Indication for Use:

INSPIRE 8F M: Hollow Fiber Oxygenator

INSPIRE HVR DUAL: 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)

177844

M.A. Killelea

on Signician 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.”