INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED

K130209 · Sorin Group Italia S.R.L. · DTZ · Feb 12, 2013 · Cardiovascular

Device Facts

• Record ID: K130209
• Device Name: INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED
• Applicant: Sorin Group Italia S.R.L.
• Product Code: DTZ · Cardiovascular
• Decision Date: Feb 12, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Extracorporeal cardiopulmonary bypass system; integrates hollow fiber membrane oxygenator, heat exchanger, and hardshell venous/cardiotomy reservoir (HVR). INSPIRE 6F variant includes integrated arterial filter. Device receives venous and suction blood; performs gas exchange (O2/CO2), temperature regulation, defoaming, and filtration. Used in OR by perfusionists/surgeons during cardiac surgery. Modified version features conical venous filter frame, two-part polyester screen (120µm/41µm), and modified lid o-ring. Output provides oxygenated, filtered, temperature-controlled blood to patient. Benefits include hemodynamic support and emboli protection during bypass.

Clinical Evidence

Bench testing only. In vitro performance testing conducted per ISO 15674 and FDA guidance. Tests included blood pathway integrity, air handling, break-through time, priming volume, filtration efficiency, flow rate capacity, pressure drop, hemolysis, and blood compatibility. All acceptance criteria met.

Technological Characteristics

Microporous hollow fiber membrane oxygenator; integrated heat exchanger; hardshell venous/cardiotomy reservoir. Materials: polyester screens (120µm/41µm), plastic frame. Sterilization: Ethylene oxide. Single-use. Flow rate: up to 6 L/min. Non-pyrogenic fluid path. Conical venous filter frame design.

Indications for Use

Indicated for adult and small adult patients undergoing surgical procedures requiring cardiopulmonary bypass for up to 6 hours. Used for gas exchange, blood temperature control, venous/suction blood collection, defoaming, and filtration. INSPIRE 6F M includes arterial filtration for air/solid emboli protection. Can be used post-operatively for chest drainage.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• INSPIRE 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir (K113626)
• INSPIRE 6F hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir (K120185)

Submission Summary (Full Text)

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K130209

## 510(k) SUMMARY

## FEB 1 2 2013

SUBMITTER:

CONTACT PERSON:

DATE PREPARED:

DEVICE TRADE NAME:

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

Luigi Vecchi Phone: [phone] Fax: [phone]

January 25, 2013

INSPIRE 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir

INSPIRE 6F hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir

INSPIRE 6: Hollow Fiber Oxygenator with integrated hardshell

venous/cardiotomy reservoir Hollow Fiber Oxygenator Hardshell Venous/Cardiotomy Reservoir

INSPIRE 6F: Hollow Fiber Oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir Hollow Fiber Oxygenator with integrated arterial filter Hardshell Venous/Cardiotomy Reservoir

INSPIRE 6: Cardiopulmonary Bypass Oxygenator/ Cardiopulmonary Bypass Heat Exchanger/ Cardiopulmonary Bypass Blood Reservoir/ Cardiopulmonary Bypass Defoamer

INSPIRE 6F: Cardiopulmonary Bypass Oxygenator/ Cardiopulmonary Bypass Heat Exchanger/ Cardiopulmonary Bypass Blood Reservoir/ Cardiopulmonary Bypass Defoamer/ Cardiopulmonary Bypass Arterial Line Blood Filter

UNMODIFIED DEVICES: INSPIRE 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir (K113626)

> INSPIRE 6F hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir (K120185)

COMMON NAMES:

#### CLASSIFICATION NAME:

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## DEVICE DESCRIPTION:

The INSPIRE 6 and INSPIRE 6F are high efficiency microporous hollow fiber membrane oxygenators integrated with heat exchanger (INSPIRE 6M and INSPIRE 6F M, respectively) and connected to a hardshell venous/cardiotomy reservoir (INSPIRE HVR). A molded fitting joint connects the oxygenator to the reservoir. As compared to the INSPIRE 6, the INSPIRE 6F oxygenating module is also integrated with an arterial filter.

The devices can be operated at flow rates up to 6 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 modified devices, hereafter referred to as INSPIRE 6/6F with modified HVR (Hardshell Venous Reservoir), are a modified version of the currently marketed INSPIRE 6 and INSPIRE 6F integrated systems.

## INDICATION FOR USE:

The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are:

## INSPIRE 6M: Hollow Fiber Oxygenator

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

## INSPIRE 6F M: Hollow Fiber Oxygenator

The INSPIRE 6F 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 6F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 6F 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.

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## TECHNOLOGICAL CHARACTERISTICS:

The INSPIRE 6/6F with modified HVR have the same fundamental technological characteristics, principles of operation and control mechanisms as the unmodified devices.

As compared to the unmodified devices, the INSPIRE 6/6F with modified HVR will be provided with a different shape of the plastic frame that supports the filtering system and with a different venous filter.

The shape of the plastic frame that supports the venous filter has been changed from a cvlindrical to a conical profile.

The venous filter has been modified from a one-part design, consisting of a continuous double polyester screen on the whole filtering system (105um internal and 41 um external), to a two-part design consisting of a single polyester screen for the upper part (120µm) and a double polyester screen for the lower part (120um internal and 41 um external).

The modified hardshell venous/cardiotomy reservoir will be also provided with a different o-ring at the interface between the top of the reservoir housing and the lid. The modified o-ring has a reduced hardness to assure a seal.

No modification described in the present 510(k) applies to the oxygenating module, heat exchanger or arterial filter.

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

The INSPIRE 6/6F with modified HVR and the unmodified devices 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 6/6F with modified HVR are substantially equivalent to the unmodified devices 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 6/6F with modified HVR are ethylene oxide sterilized and have a non-pyrogenic fluid path. The devices are for single use only.

## NON CLINICAL TEST RESULTS:

Applicable tests were conducted in accordance with the requirements of ISO 10993-1, USP class VI requirements, and the FDA May 1st, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of materials.

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## 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 the modified reservoir to demonstrate unmodified reservoir substantial equivalency and compliance to safety and effectiveness requirements.

The present application includes no changes that apply to the oxygenating module or the oxygenating module integrated with the arterial filter.

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

| TEST | TEST CLASSIFICATION | TEST TITLE |
|------|------------------------|----------------------------------------|
| 1 | Physical/Mechanical | Blood pathway integrity |
| 2 | Functional/Performance | Air handling |
| 3 | Functional/Performance | Break-through time and volume |
| 4 | Functional/Performance | Dynamic priming volume / Hold-up |
| 5 | Functional/Performance | Filtration efficiency - venous section |
| 6 | Functional/Performance | Flow rate capacity |
| 7 | Functional/Performance | Pressure drop |
| 8 | Functional/Performance | Hemolysis |
| 9 | Functional/Performance | Blood compatibility |

## CONCLUSIONS:

The results of in vitro studies demonstrate that the modified reservoir performs in a manner substantially equivalent to the unmodified reservoir with respect to the relevant functional parameters. Test results of this study demonstrate the INSPIRE 6/6F with modified HVR are equivalent to unmodified 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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.

#### Public Health Service

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

FEB 1 2 2013

Sorin Group Italia S.R.I. c/o Sorin Group USA, Inc. 14401 West 65th Way Arvada, Colorado, 80004 Attn: Mr. Scott Light

Re: K130209

INSPIRE 6 and 6F Hollow Fiber Oxygenator with Integrated Hardshell Reservoir (INSPIRE HVR)

Regulation Number: 21 CFR 870.4350

Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: January 25, 2013 Received: January 29, 2013

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. 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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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 (OS) 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

# Matthew G. Hillebrenner

for

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 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir

Indication for Use:

#### INSPIRE 6M: Hollow Fiber Oxygenator

INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 6M 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 cardiopylmonary 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 Name: INSPIRE 6F hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir

Indication for Use:

#### INSPIRE 6F M: Hollow Fiber Oxygenator

The INSPIRE 6F 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 6F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 6F 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.

Prescription Use_ X (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)

. A. Zillahn

iovascular Devices

510(k) Number