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

The INSPIRE 7M is intended for use in adult surgical procedures requiring cardiopulmonary bypass (CPB). It provides gas exchange support and blood temperature control. The INSPIRE 7M is intended to be used for 6 hours or less.

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

Device Description

The INSPIRE 6M, INSPIRE 7M and INSPIRE 8M oxygenators (hereinafter identified as INSPIRE) consist of an oxygenator with an integrated heat exchanger.

The INSPIRE devices are intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass (CPB). It provides gas exchange support and blood temperature control.

The INSPIRE consist of the following main components

a heat exchanger consisting of a bundle of polyurethane hollow fibers that are wound on a cylindrical core. it controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery.
an oxygenating module element made of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The hollow fiber membrane provides oxygenation and carbon dioxide removal from venous blood or suction blood.

The modified devices are modified versions of the currently marketed INSPIRE 6M, INSPIRE 7M and INSPIRE 8M products.

AI/ML Overview

The provided documents describe the Inspire 6M, 7M, and 8M Hollow Fiber Oxygenators, which are modifications of previously cleared devices. The submission focuses on demonstrating substantial equivalence to the predicate devices, rather than proving that the device meets acceptance criteria as would typically be done for a novel device. The primary change is the replacement of a purge line unidirectional valve.

Therefore, the study focuses on showing that the modified device performs equivalently to the unmodified predicate device, rather than establishing absolute performance metrics against a defined set of acceptance criteria for a new device.

Here's the information extracted from the document, tailored to your request, with an emphasis on the equivalence study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for this specific submission. Instead, it relies on demonstrating that the modified device performs equivalently to the predicate devices, which are already presumed to meet established safety and effectiveness criteria. The acceptance is based on the modified device successfully meeting performance expectations in comparison to the unmodified (predicate) device.

Performance Metric Demonstrated	Acceptance Criteria (Implied by equivalence to predicate)	Reported Device Performance (Modified device vs. Unmodified predicate)
Recirculation Line Handling (specifically related to the purge line unidirectional valve)	System successfully handles recirculation line operation, including gas exchange support and blood temperature control, as per predicate performance.	The oxygenating module with the modified purge line unidirectional valve successfully met all acceptance criteria for the recirculation line handling. (This implies it performed equivalently to the unmodified device).
All other relevant functional parameters (e.g., gas exchange, blood temperature control)	Equivalent to predicate device.	The results of in vitro studies demonstrate that the subject INSPIRE performs in a manner substantially equivalent to the Unmodified INSPIRE predicate device with respect to the relevant functional parameters.

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

Sample Size: The document implies that "devices" were tested, but it does not specify the exact number of modified and unmodified devices used in the in vitro testing.
Data Provenance: The study was retrospective in the sense that it compared a modified device to an existing predicate. The testing itself was in-vitro. The country of origin of the data is not specified, but the applicant is Sorin Group Italia S.r.l. in Italy, suggesting the testing likely occurred there or at a contract lab.

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

Not applicable. This was an in-vitro performance study comparing a modified medical device component to its predecessor, not a diagnostic or AI-driven study requiring expert interpretation or ground truth establishment in the traditional sense.

4. Adjudication Method for the Test Set

Not applicable. This was an in-vitro performance study. "Adjudication" typically refers to resolving disagreements among experts in establishing ground truth for diagnostic studies, which is not relevant here.

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/diagnostic device.

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

Not applicable. This is not an AI/diagnostic device.

7. The Type of Ground Truth Used

The "ground truth" for this study was the established performance of the predicate (unmodified) devices as assessed through their own previous regulatory clearances and real-world usage. The study aimed to demonstrate that the modified device's performance was equivalent to this established "ground truth." The specific tests (e.g., for recirculation line handling, gas exchange, temperature control) are based on performance standards for cardiopulmonary bypass oxygenators (ISO 7199, FDA guidances).

8. The Sample Size for the Training Set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

August 13, 2020

Sorin Group Italia S.r.l Luigi Vecchi Director, Regulatory Affairs Via Statale 12 Nord, 86 Mirandola, Modena 41037 Italy

Re: K201916

Trade/Device Name: Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ, DTR Dated: July 9, 2020 Received: July 10, 2020

Dear Luigi Vecchi:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K201916

Device Name INSPIRE 6M Hollow fiber Oxygenator INSPIRE 7M Hollow fiber Oxygenator INSPIRE 8M Hollow fiber Oxygenator

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

(in accordance with 21 CFR 807.92)

510(k) Number: K201916

l. Applicant Information

APPLICANT:	Sorin Group Italia S.r.l.86, Via Statale 12 Nord41037 Mirandola (MO) ITALY
CONTACT PERSON:	Luigi VecchiPhone: +39 0535 29957e-mail: luigi.vecchi@livanova.com
APPLICATION CORRESPONDANT:	Sorin Group Italia S.r.l.86, Via Statale 12 Nord41037 Mirandola (MO) ITALY
CONTACT PERSON:	Luigi VecchiPhone: +39 0535 29957e-mail: luigi.vecchi@livanova.com
DATE PREPARED:	July 6, 2020

II. Subject Devices Identification

PROPRIETARY NAME:	INSPIRE 6M Hollow Fiber OxygenatorINSPIRE 7M Hollow Fiber OxygenatorINSPIRE 8M Hollow Fiber Oxygenator
COMMON/ USUAL NAME:	INSPIRE 6M; INSPIRE 7M; INSPIRE 8M.
CLASSIFICATION NAME:	Cardiopulmonary Bypass Oxygenator,Cardiopulmonary Bypass Heat Exchanger.
REGULATION NUMBER:	21 CFR 870.4350
PRODUCT CODE:	DTZ, DTR
CLASSIFICATION:	Class II
CLASSIFICATION PANEL:	Cardiovascular

III. Predicate Devices

The INSPIRE 6M Hollow Fiber Oxygenator, INSPIRE 7M Hollow Fiber Oxygenator and INSPIRE 8M Hollow Fiber Oxygenator are substantially equivalent to the following cleared predicate devices. All models have the same

{4}------------------------------------------------

fundamental scientific technology and intended use

510(k) NUMBER:	K180448
PROPRIETARY NAME:	INSPIRE 6M Hollow Fiber Oxygenator,INSPIRE 8M Hollow Fiber Oxygenator.
COMMON/ USUAL NAME:	INSPIRE 6M; INSPIRE 8 M.
CLASSIFICATION NAME:	Cardiopulmonary Bypass Oxygenator
REGULATION NUMBER:	21 CFR 870.4350
CLASSIFICATION:	Class II
CLASSIFICATION PANEL:	Cardiovascular

510(k) NUMBER:	K190690
PROPRIETARY NAME:	INSPIRE 7M Hollow Fiber Oxygenator
COMMON/ USUAL NAME:	INSPIRE 7M
CLASSIFICATION NAME:	Cardiopulmonary Bypass Oxygenator
REGULATION NUMBER:	21 CFR 870.4350
CLASSIFICATION:	Class II
CLASSIFICATION PANEL:	Cardiovascular

Device Description IV.

The INSPIRE 6M, INSPIRE 7M and INSPIRE 8M oxygenators (hereinafter identified as INSPIRE) consist of an oxygenator with an integrated heat exchanger.

The INSPIRE devices are intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass (CPB). It provides gas exchange support and blood temperature control.

The INSPIRE consist of the following main components

a heat exchanger consisting of a bundle of polyurethane hollow fibers ● that are wound on a cylindrical core. it controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery.
an oxygenating module element made of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The hollow fiber membrane provides oxygenation and carbon dioxide removal from venous blood or suction blood.

The modified devices are modified versions of the currently marketed INSPIRE 6M, INSPIRE 7M and INSPIRE 8M products.

{5}------------------------------------------------

V. Indications for use

The subject devices (i.e., the INSPIRE 6M, INSPIRE 7M and INSPIRE 8M) are intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. They all provide gas exchange support and blood temperature control. All the devices are intended to be used for 6 hours or less. Note: The intended use of the subject devices is identical to the intended use of the respective predicates

VI. Summary of technical characteristics

The INSPIRE subject devices have the same principles of operation and control mechanisms as the INSPIRE unmodified device. The INSPIRE subject devices and the INSPIRE unmodified device share the same fundamental technological characteristics except for some modifications that do not affect the basic device function. These differences are summarized below and do not raise any new issues of safety and effectiveness.

1. The purge line unidirectional valve present in the recirculation line of the INSPIRE devices was changed with another valve from a different supplier. made with different materials and having different performances;
1. A warning in the Instructions for Use was revised to reflect the evidence found during V&V testing.

No change to the intended use has been made as a result of these modifications. Also, there are no differences in packaging type and material between INSPIRE and INSPIRE unmodified device. Both modified and unmodified device are for single use only, ethylene oxide sterilized and has a non-pyrogenic fluid path

VII. Substantial equivalence discussion

Based on equivalent intended use and technological characteristics, as well as on equivalent performance testing, the INSPIRE can be deemed to be substantially equivalent to its predicate device, the Unmodified INSPIRE The INSPIRE as designed and manufactured, does not raise new questions reqarding safety and effectiveness as compared to its predicate device and is determined to be substantially equivalent to its predicate device, the Unmodified INSPIRE

VIII. Non clinical performance data

The subject devices were tested to ensure that they can provide all the capabilities necessary to operate safely and effectively. Applicable tests were carried out in accordance with the requirements of ISO 10993-1, the FDA May 1st, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility

{6}------------------------------------------------

testing of materials, and 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 Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final Guidance for Industry and FDA" issued on November 29, 2000; and ISO 7199 "Cardiovascular implants and artificial organs - Blood-gas exchangers (oxyqenators)".

In vitro testing was performed to compare devices with the modified and unmodified purqe line unidirectional valve.

This performance testing was conducted on sterile aged devices; accelerated aging for a period of time equivalent to at least 3 years as per device labeling The oxygenating module with the modified purge line unidirectional valve.

successfully met all acceptance criteria for the recirculation line handling.

The results of in vitro studies demonstrate that the subject INSPIRE performs in a manner substantially equivalent to the Unmodified INSPIRE predicate device with respect to the relevant functional parameters.

IX. Clinical performance data

No clinical testing was conducted in support of the INSPIRE, as the indications for use are equivalent to those of their respective predicates, which have been on the market for many years. The non-clinical testing summarized in this submission supports the substantial equivalence of these devices with their respective predicates in relation to the changes subject of this submission.

X. Statement of Substantial Equivalence

As designed and manufactured and based on the intended use, technological characteristics, and performance testing, the modified INSPIRE do not raise new questions reqarding their safety and effectiveness as compared to their predicates devices and are determined to be substantially equivalent to the predicate devices.

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.”