(90 days)
D903 AVANT, D734
No
The summary describes a mechanical device for cardiopulmonary bypass and does not mention any AI or ML components or functions.
Yes
The device, an oxygenator with integrated components, provides gas exchange support, controls blood temperature, filters blood, and collects blood for procedures requiring cardiopulmonary bypass, which are all therapeutic functions.
No
The device is an oxygenator and reservoir system used for gas exchange, blood temperature control, and blood collection/filtering during cardiopulmonary bypass; it does not diagnose medical conditions.
No
The device description clearly outlines physical components like an oxygenator, arterial filter, heat exchanger, and reservoir, indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical procedures requiring cardiopulmonary bypass." It provides "gas exchange support and blood temperature control," collects, defoams, and filters blood. These are all functions performed on the patient's blood within an extracorporeal circuit during surgery.
- Device Description: The description details components like an oxygenator, heat exchanger, arterial filter, and reservoir, all designed to process blood outside the body during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. The device's function is to support the patient's physiological processes during surgery, not to analyze biological samples for diagnostic purposes.
Therefore, the INSPIRE 8F is a medical device used in surgical procedures, specifically for cardiopulmonary bypass, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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 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 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.
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
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 INSPIRE 8F successfully met all acceptance criteria for each test performed. Tests included: Oxygenating module structural integrity; Reservoir structural integrity; Oxygenating module blood, water, gas pathway integrity; Reservoir blood pathway integrity; Oxygenating module blood volume capacity; Reservoir blood rest volume; Oxygenating module gas transfer performance/blood side pressure drop; Oxygenating module heat exchange performance/water side pressure drop; Oxygenating module air handling capability; Reservoir air handling; Reservoir break-through time and volume; Reservoir defoaming efficiency; Reservoir dynamic priming volume / Hold-up; Oxygenating module filtration efficiency; Reservoir filtration efficiency - venous section; Reservoir filtration efficiency - cardiotomy section; Reservoir flow rate capacity; Reservoir pressure drop; Integrated device hemolysis; Integrated device blood compatibility; Oxygenating module leaching of coating; Reservoir leaching of coating; Integrated device flaking of coating; Oxygenating module uniformity of coating; Reservoir uniformity of coating.
Key Metrics
Not Found
Predicate Device(s)
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
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: 011 39 0535 29811 Fax: 011 39 0535 25229
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
1
| 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.
2
| 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 |
| 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 | 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 |
| section |
3
INSPIRE 8F Sorin Group Italia S.r.l.
Traditional 510(k) May 23, 2012
| TEST | TEST
CLASSIFICATION | TEST TITLE |
|------|------------------------|---------------------------------------------------------|
| 16 | Functional/Performance | Reservoir filtration efficiency - cardiotomy
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.
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 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.
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 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 vours,
CMA Willebe
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:
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