INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR

K121536 · Sorin Group Italia S.R.L. · DTZ · Aug 22, 2012 · Cardiovascular

Device Facts

• Record ID: K121536
• Device Name: INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
• Applicant: Sorin Group Italia S.R.L.
• Product Code: DTZ · Cardiovascular
• Decision Date: Aug 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

INSPIRE 8F M: Hollow Fiber Oxygenator 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 Story

Integrated cardiopulmonary bypass system combining hollow fiber oxygenator, heat exchanger, arterial filter, and hardshell venous/cardiotomy reservoir. Device receives venous and suctioned blood; performs gas exchange (oxygenation/CO2 removal), temperature regulation, and filtration of air/solid emboli. Used in surgical settings by perfusionists/surgeons during cardiopulmonary bypass. Output is oxygenated, filtered, temperature-controlled blood returned to patient. Reservoir also supports post-operative chest drainage. Benefits include integrated support for bypass procedures, reduced circuit complexity by combining previously separate units (oxygenator/reservoir and arterial filter), and protection against emboli.

Clinical Evidence

Bench testing only. No clinical data presented. In vitro testing performed per ISO 7199, ISO 15674, ISO 15675, and relevant FDA guidance documents. Testing confirmed structural integrity, gas transfer performance, heat exchange efficiency, air handling, filtration efficiency, and blood compatibility. All acceptance criteria met.

Technological Characteristics

Microporous hollow fiber membrane oxygenator with integrated heat exchanger, arterial filter, and hardshell venous/cardiotomy reservoir. Ethylene oxide sterilized; non-pyrogenic fluid path; single-use. Flow rates up to 8 L/min. Materials and design consistent with predicate devices. Complies with ISO 10993-1 for biocompatibility.

Indications for Use

Indicated for adult and small adult patients undergoing surgical procedures requiring cardiopulmonary bypass for up to 6 hours. Provides gas exchange, blood temperature control, filtration of air/solid emboli, and collection/defoaming of venous and suctioned blood.

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

• 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)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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 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

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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

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.

# 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, gas<br>pathway 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 transfer<br>performance/blood side pressure drop |
| 8 | Functional/Performance | Oxygenating module heat exchange<br>performance/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 - venous<br>section |

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

Traditional 510(k) May 23, 2012

| TEST | TEST<br>CLASSIFICATION | TEST TITLE |
|------|------------------------|---------------------------------------------------------|
| 16 | Functional/Performance | Reservoir filtration efficiency - cardiotomy<br>section |
| 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 [phone] or [phone] 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

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.

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