(28 days)
Not Found
No
The document describes a mechanical device for cardiopulmonary bypass and makes no mention of AI or ML technology.
Yes
The device is described as an oxygenator and heat exchanger used in cardiopulmonary bypass, which directly provides gas exchange and temperature control for the patient's blood, thus treating a medical condition.
No
The device is described as an oxygenator and reservoir system intended for use in cardiopulmonary bypass procedures, providing gas exchange support, blood temperature control, and blood collection/filtration. Its function is to support or replace physiological functions, not to diagnose a condition.
No
The device description clearly outlines a physical medical device consisting of an oxygenator, heat exchanger, and reservoir, all of which are hardware components used in cardiopulmonary bypass. There is no mention of software as the primary or sole component.
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 in vitro (in a test tube or lab setting).
- Device Description: The description details the components and their functions, which are related to managing blood flow and gas exchange during surgery. There is no mention of analyzing blood or other samples for diagnostic purposes.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (biomarkers, pathogens, etc.)
- Providing diagnostic information
- Use in a laboratory setting
The device is an extracorporeal blood circuit component used during surgery.
N/A
Intended Use / Indications for Use
INSPIRE 8M: Hollow Fiber Oxygenator
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: 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.
Product codes (comma separated list FDA assigned to the subject device)
DTZ
Device Description
The INSPIRE 8 is a high efficiency microporous hollow fiber membrane oxygenator integrated with heat exchanger (INSPIRE 8M) and connected to a hardshell venous/cardiotomy reservoir (INSPIRE HVR). A molded fitting joint connects the oxygenator to the 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 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 hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage.
The INSPIRE 8 is a modified version of the currently marketed INSPIRE 8 DUAL integrated oxygenator/hardshell venous cardiotomy reservoir system.
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:
Applicable tests were conducted 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 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 hardshell venous/cardiotomy reservoir to demonstrate unmodified device substantial equivalency and compliance to safety and effectiveness requirements.
The modified INSPIRE 8 and unmodified INSPIRE 8 DUAL utilize identical oxygenating modules integrated with heat exchanger. This 510(k) cross references the following oxygenating module performance data previously submitted in the INSPIRE 8 DUAL (K121229): structural integrity, blood, water, gas pathway integrity, blood volume capacity, gas transfer performance/blood side pressure drop, heat exchange performance/water side pressure drop, hemolysis, blood compatibility, leaching of coating, flaking of coating, uniformity of coating,
The following table lists the performance and physical/mechanical integrity tests conducted to demonstrate compliance to the product's performance specifications. The INSPIRE 8 successfully met all acceptance criteria for each test.
| TEST | TEST CLASSIFICATION | TEST TITLE |
|---|---|---|
| 1 | Physical/Mechanical | Structural integrity |
| 2 | Physical/Mechanical | Blood pathway integrity |
| 3 | Functional/Performance | Blood rest volume |
| 4 | Functional/Performance | Air handling |
| 5 | Functional/Performance | Break-through time and volume |
| 6 | Functional/Performance | Defoaming efficiency |
| 7 | Functional/Performance | Dynamic priming volume / Hold-up |
| 8 | Functional/Performance | Filtration efficiency - venous section |
| 9 | Functional/Performance | Filtration efficiency - cardiotomy section |
| 10 | Functional/Performance | Flow rate capacity |
| 11 | Functional/Performance | Pressure drop |
| 12 | Functional/Performance | Hemolysis |
| 13 | Functional/Performance | Blood compatibility |
| 14 | Functional/Performance | Leaching of coating |
| 15 | Functional/Performance | Flaking of coating |
| 16 | Functional/Performance | Uniformity of coating |
CONCLUSIONS:
The results of in vitro studies demonstrate that the modified device performs in a manner substantially equivalent to the unmodified device with respect to the relevant functional parameters. Test results of this study demonstrate the INSPIRE 8 is equivalent to the INSPIRE 8 DUAL unmodified 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.
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
INSPIRE 8 Sorin Group Italia S.r.I. Special 510(k) July 26, 2012
2012
510(k) SUMMARY
| SUBMITTER: | Sorin Group Italia
86, Via Statale 12 Nord
41037 Mirandola (MO) Italy | AUG 24 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| CONTACT PERSON: | Luigi Vecchi
Phone: 39 0535 29811
Fax: 39 0535 25229 | |
| DATE PREPARED: | July 26, 2012 | |
| DEVICE TRADE NAME: | INSPIRE 8 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 NAME: | Cardiopulmonary Bypass Oxygenator/
Cardiopulmonary Bypass Heat Exchanger/
Cardiopulmonary Bypass Blood Reservoir/
Cardiopulmonary Bypass Defoamer | |
| UNMODIFIED DEVICES: | INSPIRE 8 DUAL hollow fiber oxygenator with
integrated hardshell venous/cardiotomy reservoir
(K121229) | |
DEVICE DESCRIPTION:
The INSPIRE 8 is a high efficiency microporous hollow fiber membrane oxygenator integrated with heat exchanger (INSPIRE 8M) and connected to a hardshell venous/cardiotomy reservoir (INSPIRE HVR). A molded fitting joint connects the oxygenator to the 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 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 hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage.
The INSPIRE 8 is a modified version of the currently marketed INSPIRE 8 DUAL integrated oxygenator/hardshell venous cardiotomy reservoir system.
1
INDICATION FOR USE:
The intended uses for the two elements that constitute the integrated device are:
INSPIRE 8M: Hollow Fiber Oxygenator
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: 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 8 has the same fundamental technological characteristics, principles of operation and control mechanisms as the unmodified device.
The INSPIRE 8 integrated device will be provided with a single chamber venous/cardiotomy reservoir (INSPIRE HVR) rather than a dual chamber venous/cardiotomy reservoir (INSPIRE HVR DUAL) as for the INSPIRE 8 DUAL unmodified device.
No change to the oxygenating module has been made as a result of this modification. The INSPIRE 8 modified device is provided with oxygenating module identical with respect to the unmodified device.
No change to the intended use has been made as a result of these modifications.
The INSPIRE 8 and the INSPIRE 8 DUAL unmodified device 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 8 is substantially equivalent to the INSPIRE 8 DUAL on the basis of operating principles and basic function.
There are no differences in packaging type and material between unmodified and the modified device.
The INSPIRE 8 is ethylene oxide sterilized and has a non-pyrogenic fluid path. It is for single use only.
2
NON CLINICAL TEST RESULTS:
Applicable tests were conducted 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 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 hardshell venous/cardiotomy reservoir to demonstrate unmodified device substantial equivalency and compliance to safety and effectiveness requirements.
The modified INSPIRE 8 and unmodified INSPIRE 8 DUAL utilize identical oxygenating modules integrated with heat exchanger. This 510(k) cross references the following oxygenating module performance data previously submitted in the INSPIRE 8 DUAL (K121229): structural integrity, blood, water, gas pathway integrity, blood volume capacity, gas transfer performance/blood side pressure drop, heat exchange performance/water side pressure drop, hemolysis, blood compatibility, leaching of coating, flaking of coating, uniformity of coating,
The following table lists the performance and physical/mechanical integrity tests conducted to demonstrate compliance to the product's performance specifications. The INSPIRE 8 successfully met all acceptance criteria for each test.
| TEST | TEST CLASSIFICATION | TEST TITLE |
|---|---|---|
| 1 | Physical/Mechanical | Structural integrity |
| 2 | Physical/Mechanical | Blood pathway integrity |
| 3 | Functional/Performance | Blood rest volume |
| 4 | Functional/Performance | Air handling |
| 5 | Functional/Performance | Break-through time and volume |
| 6 | Functional/Performance | Defoaming efficiency |
| 7 | Functional/Performance | Dynamic priming volume / Hold-up |
| 8 | Functional/Performance | Filtration efficiency - venous section |
| 9 | Functional/Performance | Filtration efficiency - cardiotomy section |
| 10 | Functional/Performance | Flow rate capacity |
| 11 | Functional/Performance | Pressure drop |
| 12 | Functional/Performance | Hemolysis |
| 13 | Functional/Performance | Blood compatibility |
| 14 | Functional/Performance | Leaching of coating |
| 15 | Functional/Performance | Flaking of coating |
| 16 | Functional/Performance | Uniformity of coating |
3
| INSPIRE 8 | Special 510(k) |
|---|---|
| Sorin Group Italia S.r.I. | July 26, 2012 |
CONCLUSIONS:
The results of in vitro studies demonstrate that the modified device performs in a manner substantially equivalent to the unmodified device with respect to the relevant functional parameters. Test results of this study demonstrate the INSPIRE 8 is equivalent to the INSPIRE 8 DUAL unmodified 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 2 4 2012
Sorin Group USA, Inc. c/o Mr. Scott Light Regulatory Affairs Manager 14401 W. 65th Way Arvada, CO 80004
Re: K122254
Trade/Device Name: Inspire 8 Hollow Fiber Oxygenator with integrated Single-Chamber Hardshell Venous/Cardiotomy Reservoir Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator . Regulatory Class: Class II Product Code: DTZ Dated: July 26, 2012 Received: July 27, 2012
Dear Mr. Light:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved for 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 for use stated in the entribution of the enactment date of the Medical Device Amendments, or to conninered prior to Frid 2011-07-11 accordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). and Costile 110 (110) that as nevice, subject to the general controls provisions of the Act. The r ou may, merelore, maines 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 If your device is clausified (boo are 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. 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 I ou may of Small 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 Sorin Group Italia S.r.I. Special 510(k) July 26, 2012
510(k) Number (if known):
Device Name: INSPIRE 8 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir
Indication for Use:
INSPIRE 8M: Hollow Fiber Oxygenator
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: 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 (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
vision/Sign-Off
vision of Cardiovascular Devices
510(k) Num