(119 days)
D 905 EOS
D905 EOS
No
The summary describes a mechanical device for cardiopulmonary bypass and does not mention any AI or ML components or functionalities.
Yes.
The device provides gas exchange support and blood temperature control, and collects, defoams, and filters venous blood, which are therapeutic functions.
No.
The device functions to provide cardiopulmonary bypass support, including gas exchange, blood temperature control, and blood collection/filtration, rather than to diagnose medical conditions.
No
The device description clearly states it is a physical device consisting of an oxygenator and a reservoir, which are hardware components.
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 use in "adult and small adult surgical procedures requiring cardiopulmonary bypass." This involves direct interaction with the patient's blood during surgery for gas exchange and temperature control.
- Device Description: The description details a device that oxygenates blood, removes carbon dioxide, controls blood temperature, and collects/filters blood during cardiopulmonary bypass. These are all functions performed on blood within the body's circulatory system during a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples of blood or other bodily fluids outside the body to provide diagnostic information. IVDs are typically used in laboratories or point-of-care settings for diagnostic purposes.
Therefore, the INSPIRE 6 is a medical device used for therapeutic support during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
INSPIRE 6 hollow fiber oxygenator with integrated hardshell Device Name: venous/cardiotomy reservoir
Indications 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 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
DTZ
Device Description
The INSPIRE 6 is consisting of an oxygenator (INSPIRE 6M) and a hardshell veo us/cardiotomy reservoir (INSPIRE HVR). The reservoir is connected to the gas exchange module by means of a molded fitting joint.
The INSPIRE 6 is a high efficiency microporous hollow fiber membrane oxygenator integrated with an heat exchanger and connected to an hardshell venous/cardiotomy reservoir.
The device can be operated at flow rates up to 6 liters per minute.
The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous 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 6 is a modified version of the currently marketed D905 EOS.
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 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, 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 mechanical integrity tests that demonstrate compliance with performance specifications.
The tests that were performed are listed in a summarizing table, with the test outcome (pass or fail) provided for each. Tests included:
- Physical/Mechanical: Structural Integrity
- Physical/Mechanical: Blood, water, gas pathway integrity
- Physical/Mechanical: Blood pathway integrity
- Functional/Performance: Blood volume capacity
- Functional/Performance: Reservoir blood rest volume
- Functional/Performance: Gas transfer performance/blood side pressure drop
- Functional/Performance: Heat exchange performance/water side pressure drop
- Functional/Performance: Reservoir Air handling
- Functional/Performance: Reservoir Break-through time and volume
- Functional/Performance: Reservoir Defoaming efficiency
- Functional/Performance: Reservoir Dynamic priming volume / Hold-up
- Functional/Performance: Reservoir Filtration Efficiency - venous section
- Functional/Performance: Reservoir Filtration Efficiency - cardiotomy section
- Functional/Performance: Reservoir Flow rate capacity
- Functional/Performance: Reservoir Pressure drop
- Functional/Performance: Hemolysis
- Functional/Performance: Reservoir Hemolysis
- Functional/Performance: Blood compatibility
- Functional/Performance: Reservoir Blood compatibility
- Functional/Performance: Leaching of coating
- Functional/Performance: Reservoir Leaching of coating
- Functional/Performance: Flaking of coating
- Functional/Performance: Reservoir Flaking of coating
- Functional/Performance: Flaking of coating on integrated device
- Functional/Performance: Uniformity of coating
Key results: The in-vitro testing was successfully completed and INSPIRE 6 passed all the above listed tests. The results demonstrate that the INSPIRE 6 performs in a manner substantially equivalent to the predicate device with respect to the relevant functional parameters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
D 905 EOS
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K-113626
- 5 2012
510(k) SUMMARY
| 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: | March 14, 2012 |
| DEVICE TRADE NAME: | INSPIRE 6 hollow fiber oxygenator with
integrated hardshell venous/cardiotomy
reservoir |
| COMMON NAMES: | Hollow Fiber Oxygenator with 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: | D 905 EOS: hollow fiber oxygenator with
integrated hardshell venous/cardiotomy
reservoir |
DEVICE DESCRIPTION:
The INSPIRE 6 is consisting of an oxygenator (INSPIRE 6M) and a hardshell veo us/cardiotomy reservoir (INSPIRE HVR). The reservoir is connected to the gas exchange module by means of a molded fitting joint.
The INSPIRE 6 is a high efficiency microporous hollow fiber membrane oxygenator integrated with an heat exchanger and connected to an hardshell venous/cardiotomy reservoir.
The device can be operated at flow rates up to 6 liters per minute.
The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery.
nomiothermia daring cargory.
The integrated hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage.
The INSPIRE 6 is a modified version of the currently marketed D905 EOS.
1
INDICATION FOR USE:
The intended use for the two elements that constitute the integrated device 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 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 6 has the same fundamental technological characteristics, principles of operation and control mechanisms as the predicate device.
Sorin believes that the INSPIRE 6 is substantially equivalent to the D905 EOS on the basis of operating principles and basic function.
The INSPIRE 6 and the D905 EOS 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 6 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.
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, 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 mechanical integrity tests that demonstrate compliance with performance specifications.
Spoollied.lond.
The tests that were performed are listed in the following summarizing table. For each test mentioned in the table the test outcome in terms of pass or fail is also provided.
2
| TEST | TEST
CLASSIFICATION | TEST TITLE |
|------|------------------------|-------------------------------------------------------|
| 1 | Physical/Mechanical | Structural Integrity |
| 2 | Physical/Mechanical | Blood, water, gas pathway integrity |
| 3 | Physical/Mechanical | Blood pathway integrity |
| 4 | Functional/Performance | Blood volume capacity |
| 5 | Functional/Performance | Reservoir blood rest volume |
| 6 | Functional/Performance | Gas transfer performance/blood side
pressure drop |
| 7 | Functional/Performance | Heat exchange performance/water side
pressure drop |
| 8 | Functional/Performance | Reservoir Air handling |
| 9 | Functional/Performance | Reservoir Break-through time and volume |
| 10 | Functional/Performance | Reservoir Defoaming efficiency |
| 11 | Functional/Performance | Reservoir Dynamic priming volume / Hold-up |
| 12 | Functional/Performance | Reservoir Filtration Efficiency - venous section |
| 13 | Functional/Performance | Reservoir Filtration Efficiency - cardiotomy section |
| 14 | Functional/Performance | Reservoir Flow rate capacity |
| 15 | Functional/Performance | Reservoir Pressure drop |
| 16 | Functional/Performance | Hemolysis |
| 17 | Functional/Performance | Reservoir Hemolysis |
| 18 | Functional/Performance | Blood compatibility |
| 19 | Functional/Performance | Reservoir Blood compatibility |
| 20 | Functional/Performance | Leaching of coating |
| 21 | Functional/Performance | Reservoir Leaching of coating |
| 22 | Functional/Performance | Flaking of coating |
| 23 | Functional/Performance | Reservoir Flaking of coating |
| 24 | Functional/Performance | Flaking of coating on integrated device |
| 25 | Functional/Performance | Uniformity of coating |
The in-vitro testing was successfully completed and INSPIRE 6 passed all the above listed tests.
3
CONCLUSIONS:
- The results of in vitro studies demonstrate that the INSPIRE 6 performs in a manner substantially equivalent to the predicate device with respect to the relevant functional parameters. Test results of this study suggest the INSPIRE 6 is equivalent to the predicate device with respect 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract birds in flight, stacked vertically.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 5 2012
Sorin Group Italia s.r.1. c/o Mr. Barry Sall Principal Consultant Parexel International Consulting 195 West Street Waltham, WA 02451
Re: K113626
Trade/Device Name: Inspire 6 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: March 14, 2012 Received: March 15, 2012
Dear Mr. Sall:
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 r ou may, alers 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 classified (controls. Existing major regulations affecting your device an 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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M.A. Hillebenne
Jin Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K113626
INSPIRE 6 hollow fiber oxygenator with integrated hardshell Device Name: venous/cardiotomy reservoir
Indications 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 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 LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
- Ju Gencerregarge of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
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510(k) Number_KII 3626