K Number
K121229
Device Name
INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
Date Cleared
2012-07-23

(90 days)

Product Code
Regulation Number
870.4350
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INSPIRE 8M: Hollow Fiber Oxygenator: The INSPIRE 8M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 8M is intended to be used for 6 hours or less. INSPIRE HVR DUAL: Hardshell Venous/Cardiotomy Reservoir: The 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 8 DUAL is consisting of an oxygenator, integrated with a heat exchanger (INSPIRE 8M), and a hardshell venous/cardiotomy reservoir (INSPIRE HVR DUAL). The reservoir is connected to the gas exchange module by means of a molded fitting joint. The INSPIRE 8 DUAL is a high efficiency microporous hollow fiber membrane oxygenator, integrated with a heat exchanger, connected to a hardshell venous/cardiotomy 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 or suctioned 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 hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage. The INSPIRE 8 DUAL is a modified version of the currently marketed integrated oxygenator/hardshell venous cardiotomy reservoir system D903 AVANT 2 Ph.I.S.I.O (hereinafter referred to as D903 AVANT).
More Information

Not Found

No
The device description and performance studies focus on the physical components and in vitro performance of a cardiopulmonary bypass system, with no mention of AI or ML technologies.

Yes
The device is described as an oxygenator that provides gas exchange support and blood temperature control, which are therapeutic functions in cardiopulmonary bypass.

No

Explanation: The INSPIRE 8 DUAL is described as a device that provides gas exchange support, blood temperature control, and collects/filters blood during cardiopulmonary bypass. Its function is to support or replace physiological functions, not to diagnose medical conditions or provide diagnostic information.

No

The device description clearly details physical components like a hollow fiber oxygenator, heat exchanger, and hardshell venous/cardiotomy reservoir, indicating it is a hardware device, not software-only.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "surgical procedures requiring cardiopulmonary bypass" and provides "gas exchange support and blood temperature control" and "collects, defoams and filters venous blood and suction blood." These are all functions performed on the patient's blood outside the body during a surgical procedure, not for the purpose of diagnosing a condition.
  • Device Description: The description details the physical components and their functions (oxygenation, CO2 removal, temperature control, blood collection, defoaming, filtering). These are all related to supporting the patient's physiological functions during surgery.
  • Lack of Diagnostic Purpose: There is no mention of the device being used to analyze blood or other samples to provide information for diagnosis, monitoring, or screening.

IVD devices are specifically designed to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnostic purposes. This device's function is therapeutic and supportive during surgery, not diagnostic.

N/A

Intended Use / Indications for Use

INSPIRE 8M: Hollow Fiber Oxygenator

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

INSPIRE HVR DUAL: Hardshell Venous/Cardiotomy Reservoir

The 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.

Product codes (comma separated list FDA assigned to the subject device)

DTZ

Device Description

The INSPIRE 8 DUAL is consisting of an oxygenator, integrated with a heat exchanger (INSPIRE 8M), and a hardshell venous/cardiotomy reservoir (INSPIRE HVR DUAL). The reservoir is connected to the gas exchange module by means of a molded fitting joint.

The INSPIRE 8 DUAL is a high efficiency microporous hollow fiber membrane oxygenator, integrated with a heat exchanger, connected to a hardshell venous/cardiotomy 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 or suctioned 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 hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage. The INSPIRE 8 DUAL is a modified version of the currently marketed integrated oxygenator/hardshell venous cardiotomy reservoir system D903 AVANT 2 Ph.I.S.I.O (hereinafter referred to as D903 AVANT).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult and small adult

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non clinical test results and in vitro test results were performed.
In vitro testing was carried out 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 ISO 7199 "Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)"; ISO 15675 "Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters" and 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 carried out to demonstrate both the substantial equivalence with the predicate device and also to comply with safety and effectiveness requirements.
Testing supplied in the 510(k) premarket notification includes performance tests and physical/mechanical integrity tests that demonstrate compliance with performance specifications.
The INSPIRE 8 DUAL passed each test mentioned in the table provided in the summary.
The results of in vitro studies demonstrate that the INSPIRE 8 DUAL performs in a manner substantially equivalent to the D903 AVANT predicate device with respect to the relevant functional parameters. Test results of this study demonstrate the INSPIRE 8 DUAL is equivalent to the predicate 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

D903 AVANT 2 Ph.I.S.I.O. Adult Hollow Fiber Oxygenator with Ph.I.S.I.O. coating (K033323)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.”

0

K12/229

INSPIRE 8 DUAL Sorin Group Italia S.r.I. Traditional 510(k) April 24, 2012

510(k) SUMMARY
JUL 2 3 2012
SUBMITTER:Sorin Group Italia S.r.l.
86, Via Statale 12 Nord
41037 Mirandola (MO) Italy
CONTACT PERSON:Luigi Vecchi
Phone: 011 39 0535 29811
Fax: 011 39 0535 25229
DATE PREPARED:April 24, 2012
DEVICE TRADE NAME:INSPIRE 8 DUAL hollow fiber oxygenator with
integrated hardshell venous/cardiotomy
reservoir
COMMON NAMES:Hollow Fiber Oxygenator with integrated
hardshell venous/cardiotomy reservoir
Hollow Fiber Oxygenator
Hardshell Venous/Cardiotomy Reservoir
CLASSIFICATION NAMES:Cardiopulmonary Bypass Oxygenator/
Cardiopulmonary Bypass Heat Exchanger/
Cardiopulmonary Bypass Blood Reservoir/
Cardiopulmonary Bypass Defoamer/
PREDICATE DEVICE:D903 AVANT 2 Ph.I.S.I.O. Adult Hollow Fiber
Oxygenator with Ph.I.S.I.O. coating (K033323)

DEVICE DESCRIPTION:

The INSPIRE 8 DUAL is consisting of an oxygenator, integrated with a heat exchanger (INSPIRE 8M), and a hardshell venous/cardiotomy reservoir (INSPIRE HVR DUAL). The reservoir is connected to the gas exchange module by means of a molded fitting joint.

The INSPIRE 8 DUAL is a high efficiency microporous hollow fiber membrane oxygenator, integrated with a heat exchanger, connected to a hardshell venous/cardiotomy 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 or suctioned blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia or aids in the maintenance of

1

INSPIRE 8 DUALTraditional 510(k)
Sorin Group Italia S.r.I.April 24, 2012

normothermia during surgery. The integrated hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage. The INSPIRE 8 DUAL is a modified version of the currently marketed integrated oxygenator/hardshell venous cardiotomy reservoir system D903 AVANT 2 Ph.I.S.I.O (hereinafter referred to as D903 AVANT).

INDICATION FOR USE: ·

The intended use for the two elements that constitute the integrated device are:

INSPIRE 8M: Hollow Fiber Oxygenator

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

INSPIRE HVR DUAL: Hardshell Venous/Cardiotomy Reservoir

The 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.

TECHNOLOGICAL CHARACTERISTICS:

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

Sorin believes that the INSPIRE 8 DUAL is substantially equivalent to the D903 AVANT on the basis of operating principles and basic function.

The INSPIRE 8 DUAL and the D903 AVANT share the same fundamental technological characteristics except for some modifications that do not affect the basic device function. Any differences do not raise any new issues of safety and effectiveness.

The INSPIRE 8 DUAL is ethylene oxide sterilized and has a non-pyrogenic fluid path. It is for sinale 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.

IN VITRO TEST RESULTS:

In vitro testing was carried out 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 ISO 7199 "Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)"; ISO 15675 "Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line

2

INSPIRE 8 DUALTraditional 510(k)
Sorin Group Italia S.r.I.April 24, 2012

filters" and 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 carried out to demonstrate both the substantial equivalence with the predicate device and also to comply with safety and effectiveness requirements.

Testing supplied in the 510(k) premarket notification includes performance tests and physical/mechanical integrity tests that demonstrate compliance with performance specifications.

The tests that were performed are listed in the following summary table. The INSPIRE 8 DUAL passed each test mentioned in the table below.

| 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
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
performance/blood side pressure drop |
| 8 | Functional/Performance | Oxygenating module heat exchange
performance/water side pressure drop |
| 9 | Functional/Performance | Reservoir air handling |
| 10 | Functional/Performance | Reservoir break-through time and volume |
| 11 | Functional/Performance | Reservoir defoaming efficiency |
| 12 | Functional/Performance | Reservoir dynamic priming volume / Hold-up |
| 13 | Functional/Performance | Reservoir filtration efficiency - venous
section |
| 14 | Functional/Performance | Reservoir filtration efficiency - cardiotomy
section |
| 15 | Functional/Performance | Reservoir flow rate capacity |
| 16 | Functional/Performance | Reservoir pressure drop |
| 17 | Functional/Performance | Integrated device hemolysis |
| 18 | Functional/Performance | Integrated device blood compatibility |
| 19 | Functional/Performance | Oxygenating module leaching of coating |
| 20 | Functional/Performance | Reservoir leaching of coating |

3

| TEST | THEST
CLASSIFICATION | TEST TITLE | |
|------|-------------------------|------------------------------------------|--|
| 21 | Functional/Performance | Integrated device flaking of coating | |
| 22 | Functional/Performance | Oxygenating module uniformity of coating | |
| 73 | Functional/Performance | Reservoir uniformity of coating | |

CONCLUSIONS:

The results of in vitro studies demonstrate that the INSPIRE 8 DUAL performs in a manner substantially equivalent to the D903 AVANT predicate device with respect to the relevant functional parameters. Test results of this study demonstrate the INSPIRE 8 DUAL is equivalent to the predicate 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.

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.

Public Health Service

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

JUL 2 3 2012

Sorin Group Italia s.r.1. c/o Mr. Barry Sall Principal Consultant Parexel International Consulting 195 West Street Waltham, WA 02451

Re: K121229

Trade/Device Name: Inspire 8 DUAL Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: April 24, 2012 Received: April 24, 2012

Dear Mr. Sall:

We have reviewed your Section 510(k) premarket notification of intent to market the device we neve rollowed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 ass stated in the Med 28, 1976, the enactment date of the Medical Device Amendments, or to conninered print to trial 2011-17, 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). and Cosmetic (110.) that the novice, subject to the general controls provisions of the Act. The r ou may, merelore, manot of the Act include requirements for annual registration, listing of general controls provisions of 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 If your device is elabilited been of . 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.

5

Page 2 - Mr. Barry Sall

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be har nou a determination that your device complies with other requirements of the Act that I Drinas intact and regulations administered by other Federal agencies. You must or uny I eath 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 Or K F at 607), hoo!ing (21 CFR 803); good manufacturing practice requirements as set do rece related daty systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualify of oversions (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 11 you desire speethe ad 100 ros JVA /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 note the regulations 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 Tou may of amall 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

6

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

Indications for Use:

INSPIRE 8M: Hollow Fiber Oxygenator

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

INSPIRE HVR DUAL: Hardshell Venous/Cardiotomy Reservoir

The 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.

× Prescription Use _ (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)

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_ 220

68