The Inspire 7F M is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F M is intended to be used for 6 hours or less.

The Inspire 7F is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F is intended to be used for 6 hours or less.

The Inspire 7F Dual is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F Dual is intended to be used for 6 hours or less.

Device Description

The INSPIRE 7F M, INSPIRE 7F and INSPIRE 7F Dual oxygenators (hereinafter identified as INSPIRE 7F) 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 7F consist of the following main components:

. a heat exchanger consisting of a bundle of polyurethane hollow fibers that are wound on a cylindrical core.
an oxygenating module element made of a coiled bundle of . polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly.
Hardshell venous/cardiotomy reservoir to collect, filter, . and send venous blood and suction blood to the oxygenator (only models INSPIRE 7F/ 7F DUAL)
Arterial filter: the integrated arterial filter surrounds the . oxygenating module and has been designed with a specific geometry that provides protection against air and solid emboli.

The heat exchanger consists of a bundle of polyurethane hollow fibers rolled on a cylindrical core. The heat transfer is obtained through the flow of water inside the fibers and the flow of blood outside them. The heat exchanger is inserted in the gas exchanger and surrounded by the oxygenating module element, which is constructed of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The blood path is around the outside of the fibers, while the gas path is through the lumen of the fibers. For the versions 7F/ 7F DUAL the oxygenator module is integrated with a hardshell/venous reservoir via a molded fitting joint.

The hardshell/venous reservoir is comprised of rigid polycarbonate housing. Venous and cardiotomy filtering systems are physically distinct to allow a good filtration efficiency of venous and suction blood (one filters venous blood, the other filters suction blood).

The reservoir is provided with a vent/vacuum port together with an over- underll valve, that prevents excess of negative or positive pressure avoiding implosion and over pressurization of the reservoir itself. The blood enters the reservoir through the cardiotomy section through the rotating turret equipped with 3/8ll, 1/4ll and female luer inlet connectors and through the venous inlet 1/2ll connector provided with female luer connector. Both cardiotomy turret and venous inlet connectors can rotate 360°. The reservoir lid also has additional unfiltered luer ports

The integrated arterial filter has a toroidal shape and a 38 um linear filter screen. It is molded to the shell of the oxygenator. It has been designed with a specific geometry that provides protection against air and solid emboli. The arterial filter has a twocompartment design, including pre- and post- filter chambers. Each one of the two compartments is provided with a dedicated purge site that enhances air purging. The pre-filter chamber removes air bubbles trapped by the filter screen. The post-filter collection chamber is located at the top of the filter and allows air bubble collection of the air dragged through the filter screen. In case of massive air embolism, the air bubbles can be removed through the purge sites located both in the pre- and post- filter collection chamber

The oxygenating module of all the INSPIRE oxygenators include a dedicated outlet with a one-way valve that provides access to arterial blood throughout the procedure for cardioplegia, perfusion or blood concentration. The outlet is placed close to the arterial outlet of the oxygenator and opposite to the temperature probe port. Arterial and venous temperature probe sites are also provided: the former is located close to the arterial blood outlet, while the latter is placed on the venous inlet of the reservoir.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the INSPIRE 7F series of hollow fiber oxygenators. This submission aims to demonstrate substantial equivalence to previously cleared predicate devices. The document explicitly states that no clinical performance data was conducted in support of the INSPIRE 7F Oxygenator series. The evaluation of the device relied solely on non-clinical performance data to ensure it meets safety and effectiveness requirements.

Therefore, the following information regarding the acceptance criteria and study that proves the device meets the acceptance criteria is based on in vitro testing and not on a clinical study involving human subjects or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The INSPIRE 7F met all acceptance criteria for each of the tests listed in the table below." However, the exact acceptance criteria values for each test are not explicitly provided in the given text. It only lists the tests performed. The table below represents the tests conducted with a general statement of compliance.

Test Title	Test Classification	Reported Device Performance
Oxygenating module structural integrity	Physical/Mechanical	Met acceptance criteria
Oxygenating module blood, water, gas pathway integrity	Physical/Mechanical	Met acceptance criteria
Oxygenating module blood volume capacity	Functional/Performance	Met acceptance criteria
Oxygenating module heat exchange performance/water side pressure drop	Functional/Performance	Met acceptance criteria
Oxygenating module gas transfer performance/blood side pressure drop	Functional/Performance	Met acceptance criteria
Oxygenating module air handling capability	Functional/Performance	Met acceptance criteria
Oxygenating module filtration efficiency	Functional/Performance	Met acceptance criteria
Oxygenating module blood trauma (hemolysis and blood compatibility)	Functional/Performance	Met acceptance criteria
Oxygenating module leaching of coating	Functional/Performance	Met acceptance criteria
Integrated device flaking of coating	Functional/Performance	Met acceptance criteria
Oxygenating module uniformity of coating	Functional/Performance	Met acceptance criteria
Flow rate capacity	Functional/Performance	Met acceptance criteria

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

The document does not specify the exact sample size for each in vitro test. The data provenance is stated as non-clinical performance data (bench testing), conducted in accordance with relevant ISO standards and FDA guidance documents. The country of origin of the data is not explicitly stated, but the applicant is Sorin Group Italia S.R.L., Mirandola, Italy, suggesting the testing likely occurred in Italy or a certified lab. The testing is considered prospective as it was conducted to demonstrate the safety and effectiveness of the new device formulation.

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

Not applicable. This was an in vitro, non-clinical study for a medical device (oxygenator) and not an AI/imaging device requiring expert interpretation for ground truth establishment. The "ground truth" for these tests would be established by physical measurements and adherence to engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. This was an in vitro, non-clinical study for a medical device (oxygenator) and not an AI/imaging device requiring expert adjudication.

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. No MRMC study was conducted as this is not an AI/imaging device. The study focused on the physical and functional performance of a medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm; it is a physical medical device. The "standalone" performance refers to the device's functional characteristics as measured in vitro.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the non-clinical performance data was based on:

Established engineering specifications and design requirements for oxygenators.
Compliance with international standards such as ISO 10993-1 (biocompatibility), ISO 7199 (Blood-gas exchangers), and relevant FDA guidance documents.
Physical measurements and laboratory analyses to quantify performance characteristics (e.g., blood flow, pressure drop, heat exchange, filtration efficiency, material properties).

8. The Sample Size for the Training Set

Not applicable. This is not an AI model requiring a training set.

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

Not applicable. This is not an AI model requiring a training set.

Summary

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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.

June 12, 2020

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

Re: K200683

Trade/Device Name: INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir

Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ, DTM, DTR, DTN, DTP Dated: May 7, 2020 Received: May 8, 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.

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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 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 (OS) 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

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Indications for Use

510(k) Number (if known) K200683

Device Name

INSPIRE 7F M Hollow Fiber Oxygenator with Integrated Arterial Filter

Indications for Use (Describe)

The Inspire 7F M is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control.

The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F M is intended to be used for 6 hours or less.

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

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

PSC Publishing Services (301) 443-6740 EF

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

Indications for Use

510(k) Number (if known)

information unless it displays a currently valid OMBnumber."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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Indications for Use

510(k) Number (if known) K200683

Device Name

INSPIRE 7F Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir and Interial Filter

Indications for Use (Describe)

The Inspire 7F is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control.

The integrated arterial filter provides additional protection against air and solid emboli.

The Inspire 7F is intended to be used for 6 hours or less.

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

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.

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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

Indications for Use

510(k) Number (if known)

information unless it displays a currently valid OMBnumber."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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

Indications for Use

510(k) Number (if known)

K200683

Device Name

INSPIRE 7F Dual Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir and Integrated Arterial Filter

Indications for Use (Describe)

The Inspire 7F Dual is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control.

The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F Dual is intended to be used for 6 hours or less.

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

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.

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

{7}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

"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 OMBnumber."

{8}------------------------------------------------

510(k) Summary

(in accordance with 21 CFR 807.92)

510(k) Number: K200683

l. Applicant Information

Applicant:	SORIN GROUP ITALIA S.R.L.Via Statale 12 Nord, 86Mirandola (MO) 41037 Italy
Contact Person:	Luigi VecchiRA DirectorTel: +39-346-391-0707e-mail: luigi.vecchi@livanova.com
Application Correspondent:	SORIN GROUP ITALIA S.R.L.Via Statale 12 Nord, 86Mirandola (MO) 41037 Italy
Contact Person:	Luigi VecchiRA DirectorTel: +39-346-391-0707e-mail: luigi.vecchi@livanova.com

INSPIRE 7F

Date Prepared: March 13, 2020

Subject Devices Identification

Proprietary Name:

II.

Common/Usual Name: Classification Name: Requlation Number: Product Code: Classification: Classification Panel:

Proprietary Name:

Classification Name:

Regulation Number:

Classification Panel:

Proprietary Name:

Product Code:

Classification:

Cardiopulmonary Bypass Oxygenator 21 CFR 870.4350 DTZ, DTM, DTR, DTN, DTP Class II Cardiovascular INSPIRE 7F M Hollow Fiber Oxygenator INSPIRE 7F M Common/Usual Name:

INSPIRE 7F Hollow Fiber Oxygenator with hardshell/venous cardiotomy reservoir

Cardiopulmonary Bypass Oxygenator 21 CFR 870.4350 DTZ, DTM, DTR Class II Cardiovascular

INSPIRE 7F Dual Hollow Fiber Oxygenator with hardshell/venous cardiotomy reservoir

Special 510(k) – Hollow Fiber Oxygenators

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Common/Usual Name:	INSPIRE 7F Dual
Classification Name:	Cardiopulmonary Bypass Oxygenator
Regulation Number:	21 CFR 870.4350
Product Code:	DTZ, DTM, DTR, DTN, DTP
Classification:	Class II
Classification Panel:	Cardiovascular

lll. Predicate Devices

The INSPIRE 7F Hollow Fiber Oxygenator with hardshell/venous cardiotomy reservoir is substantially equivalent to the following cleared predicate device. Both models have the same fundamental scientific technology and intended use:

510(k) Number:	K130433
Proprietary Name:	INSPIRE 8F Hollow Fiber Oxygenator withhardshell/venous cardiotomy reservoir
Common/Usual Name:	INSPIRE 8F
Classification Name:	Cardiopulmonary Bypass Oxygenator
Regulation Number:	21 CFR 870.4350
Classification:	Class II
Classification Panel:	Cardiovascular

The INSPIRE 7F M Hollow Fiber Oxygenator device is substantially equivalent to the following cleared predicate device. Both models have the same fundamental scientific technology and intended use:

510(k) Number:	K180448
Proprietary Name:	INSPIRE 8F M Hollow Fiber Oxygenator
Common/Usual Name:	INSPIRE 8F M
Classification Name:	Cardiopulmonary Bypass Oxygenator
Regulation Number:	21 CFR 870.4350
Classification:	Class II
Classification Panel:	Cardiovascular

The INSPIRE 7F Dual Hollow Fiber Oxygenator with hardshell/venous cardiotomy reservoir device is substantially equivalent to the following cleared predicate device. Both models have the same fundamental scientific technology and intended use:

510(k) Number:	K122844
Proprietary Name:	INSPIRE 8F Dual Hollow Fiber Oxygenator with
	hardshell/venous cardiotomy reservoir
Common/Usual Name:	INSPIRE 8F Dual
Classification Name:	Cardiopulmonary Bypass Oxygenator
Regulation Number:	21 CFR 870.4350
Classification:	Class II
Classification Panel:	Cardiovascular

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IV. Devices Description

The INSPIRE 7F M, INSPIRE 7F and INSPIRE 7F Dual

oxygenators (hereinafter identified as INSPIRE 7F) 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 7F consist of the following main components:

. a heat exchanger consisting of a bundle of polyurethane hollow fibers that are wound on a cylindrical core.
an oxygenating module element made of a coiled bundle of . polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly.
Hardshell venous/cardiotomy reservoir to collect, filter, . and send venous blood and suction blood to the oxygenator (only models INSPIRE 7F/ 7F DUAL)
Arterial filter: the integrated arterial filter surrounds the . oxygenating module and has been designed with a specific geometry that provides protection against air and solid emboli.

The hardshell/venous reservoir is comprised of rigid polycarbonate housing. Venous and cardiotomy filtering systems are physically distinct to allow a good filtration efficiency of venous and

{11}------------------------------------------------

suction blood (one filters venous blood, the other filters suction blood).

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Image /page/12/Figure/0 description: The image shows two diagrams, labeled A and B, of a device with various ports and connectors. Both diagrams depict the same device but from slightly different angles, highlighting different features. The device includes ports for gas inlet and outlet, water ports, and connectors for arterial sampling and temperature probes, among other components like the oxygenator interface/joint.

Figure 1: Oxygenating module integrated with heat exchanger and Arterial filter

The respective predicates devices Inspire 8F M, Inspire 8F and Inspire 8F Dual have the same main components of the three subject devices. CPB circuits mimic and temporarily replace the function of the heart and lungs while the heart is arrested to provide a bloodless and stable surgical field, while maintaining physiological support to the rest of the body in which venous blood is drained to a reservoir, oxygenated and sent back to the body through a pump.

The clinical need for the devices under evaluation is to provide a safe and well- functioning alternative to the patient circulation for the entire duration of a cardiopulmonary bypass procedure. The devices can be used to temporarily support pulmonary function of a patient immediately after a Cardiac surgery Operation within the maximum time allowed of 6 hours.

An overview of functional and performance characteristics of Inspire 7F is summarized in Table 1 below.

Table 1. Inspire 7F Performance Characteristics

CHARACTERISTICS	INSPIRE 7F
Maximum recommended blood flow	7.0 l/min
Minimum recommended blood flow	2.0 l/min

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Minimum blood flow		0.5 l/min
(up to 2 hours max. duration time)
Maximum suggested gas/blood flow ratio		2 :1
Blood path pressure drop(Hb 12 g/dl and temperature 37°C)		@Qb=6 LPM174 mmHg(23.2 KPa /0.23 bar/3,4 psi)
Heat exchange performance factor	(at Qb = 6 I/min)
(Qw = 11.5 = 0.2 l/min)	0.59
Integrated Arterial filter: FiltrationEfficiency		100%
Maximum operating	Blood path	750 mm Hg(100 kPa/ 1 bar / 14.5 psi
pressure	Water path	1500 mm Hg(200 kPa/ 2 bar / 29 PSI
GAS MODULE + HEATEXCHANGER	PrimingvolumeResidualvolume	366 ml169 ml
GAS EXCHANGEMEMBRANE	Fibersurface	1.78 m²
HEAT EXCHANGEMEMBRANE	Fibersurface	0.4 m²
INTEGRATED ARTERIALFILTER	FilteringsurfaceType	0.0097Polyester screen 38 um

V. Indications for Use

The three subject devices (i.e., the INSPIRE 7F Hollow Fiber Oxygenator with integrated hard shell venous/cardiotomy reservoir, the INSPIRE 7F M Hollow Fiber Oxygenator and the INSPIRE 7F Dual Hollow Fiber Oxygenator with integrated hard shell venous/cardiotomy reservoir), - are intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. They all provide gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. All the devices

{14}------------------------------------------------

are intended to be used for 6 hours or less. Note: The intended use of the three subject devices is identical to the intended use of the three respective predicates devices

VI. Summary of Technical Characteristics

The INSPIRE 7F has the same principles of operation and control mechanisms as the INSPIRE 8F unmodified device. The INSPIRE 7F 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 are summarized below and do not raise any new issues of safety and effectiveness. The density of the hollow fiber in the oxygenating bundle has been decreased from 16.3 to 15.3

The diameter of the oxygenator bundle has been increased from 82.9 -85.6 mm to 85.1-86.4 mm. The diameter of the oxygenating body has been increased from 83.85 mm to 84.41 mm (max) No change to the intended use has been made as a result of these modifications.

No different materials were introduced / changed as a result of these modifications.

There are no differences in packaging type and material between INSPIRE 7F and INSPIRE 8F 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 7F can be deemed to be substantially equivalent to its predicate device, the Unmodified INSPIRE 8F The INSPIRE 7F as designed and manufactured, does not raise new questions regarding safety and effectiveness as compared to its predicate device and is determined to be substantially equivalent to its predicate device, the Unmodified INSPIRE 8F.

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Non-Clinical Performance Data VIII.

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 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 (oxygenators)".

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 includes performance tests and physical/mechanical integrity tests that demonstrate compliance with performance specifications.

The INSPIRE 7F met all acceptance criteria for each of the tests listed in the table below.

TEST	TESTCLASSIFICATION	TEST TITLE
1	Physical/Mechanical	Oxygenating module structural integrity
2	Physical/Mechanical	Oxygenating module blood, water, gaspathway integrity
3	Functional/Performance	Oxygenating module blood volumecapacity
4	Functional/Performance	Oxygenating module heat exchangeperformance/water side pressure drop
5	Functional/Performance	Oxygenating module gas transferperformance/blood side pressure drop
6	Functional/Performance	Oxygenating module air handlingcapability
7	Functional/Performance	Oxygenating module filtration efficiency
8	Functional/Performance	Oxygenating module blood trauma(hemolysis and blood compatibility)
9	Functional/Performance	Oxygenating module leaching of coating

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10	Functional/Performance	Integrated device flaking of coating
11	Functional/Performance	Oxygenating module uniformity ofcoating
12	Functional/Performance	Flow rate capacity

The results of in vitro studies demonstrate that the INSPIRE 7F performs in a manner substantially equivalent to the INSPIRE 8F predicate device with respect to the relevant functional parameters.

IX. Clinical Performance Data

No clinical testing was conducted in support of the INSPIRE 7F Hollow Fiber Oxygenator with integrated hardshell venous/cardiotomy reservoir r, the INSPIRE 7F M Hollow Fiber Oxygenator and the INSPIRE 7F Dual Hollow Fiber Oxygenator with integrated hardshell venous/cardiotomy reservoir, 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.

Statement of Substantial Equivalence X.

As designed and manufactured and based on the intended use, technological characteristics, and performance testing, the INSPIRE 7F Hollow Fiber Oxygenator with integrated hardshell venous/cardiotomy reservoir, the INSPIRE 7F M Hollow Fiber Oxygenator and the INSPIRE 7F Dual Hollow Fiber Oxygenator with integrated hardshell venous/cardiotomy reservoir do not raise new questions regarding 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.”