(109 days)
INSPIRE 6F M: Hollow Fiber Oxygenator
INSPIRE 6F 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 6F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 6F 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.
The INSPIRE 6F is consisting of an oxygenator, integrated with an arterial filter and a heat exchanger (INSPIRE 6F 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 6F 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 6 liters per minute (I/min).
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 arterial filter provides additional protection against air and solid emboli and the integrated hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage.
Here's a breakdown of the acceptance criteria and study information for the INSPIRE 6F device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| TEST # | TEST CLASSIFICATION | TEST TITLE | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| 1 | Physical/Mechanical | Structural Integrity | Not explicitly stated in the provided text. Implied to meet specifications for safe operation. | Passed |
| 2 | Physical/Mechanical | Blood, water, gas pathway integrity | Not explicitly stated in the provided text. Implied to meet specifications for preventing leaks and cross-contamination. | Passed |
| 3 | Physical/Mechanical | Blood pathway integrity | Not explicitly stated in the provided text. Implied to meet specifications for preventing leaks and maintaining blood circuit integrity. | Passed |
| 4 | Functional/Performance | Blood volume capacity | Not explicitly stated in the provided text. Implied to be comparable to predicate devices and acceptable for intended use. | Passed |
| 5 | Functional/Performance | Blood rest volume | Not explicitly stated in the provided text. Implied to be comparable to predicate devices and acceptable for intended use. | Passed |
| 6 | Functional/Performance | Gas transfer performance/blood side pressure drop | Not explicitly stated in the provided text. Implied to be comparable to predicate devices (D905 EOS) and meet requirements for oxygenation and CO2 removal with acceptable blood side pressure drop. | Passed |
| 7 | Functional/Performance | Heat exchange performance/water side pressure drop | Not explicitly stated in the provided text. Implied to be comparable to predicate devices (D905 EOS) and meet requirements for temperature control with acceptable water side pressure drop. | Passed |
| 8 | Functional/Performance | Air handling capability | Not explicitly stated in the provided text. Implied to be comparable to predicate devices (D733) and meet requirements for air removal. | Passed |
| 9 | Functional/Performance | Air handling | Not explicitly stated in the provided text. Implied to be comparable to predicate devices (D733) and meet requirements for air removal. | Passed |
| 10 | Functional/Performance | Break-through time and volume | Not explicitly stated in the provided text. Implied to be comparable to predicate devices and acceptable for preventing breakthrough of air or foam. | Passed |
| 11 | Functional/Performance | Defoaming efficiency | Not explicitly stated in the provided text. Implied to be comparable to predicate devices (D905 EOS) and meet requirements for effective defoaming of blood. | Passed |
| 12 | Functional/Performance | Dynamic priming volume / Hold-up | Not explicitly stated in the provided text. Implied to be comparable to predicate devices and acceptable for intended use. | Passed |
| 13 | Functional/Performance | Filtration Efficiency | Not explicitly stated in the provided text. Implied to be comparable to predicate devices (D733) and meet requirements for filtering emboli. | Passed |
| 14 | Functional/Performance | Filtration Efficiency - venous section | Not explicitly stated in the provided text. Implied to be comparable to predicate devices and meet requirements for filtering emboli in the venous section. | Passed |
| 15 | Functional/Performance | Filtration Efficiency - cardiotomy section | Not explicitly stated in the provided text. Implied to be comparable to predicate devices and meet requirements for filtering emboli in the cardiotomy section. | Passed |
| 16 | Functional/Performance | Flow rate capacity | Not explicitly stated in the provided text. The device can be operated at flow rates up to 6 liters per minute (l/min). This is a performance specification rather than a formal AC, but it's a key operating parameter. | Passed (The device is stated to operate at flow rates up to 6 liters per minute, which is consistent with the general requirement for this type of device.) |
| 17 | Functional/Performance | Pressure drop | Not explicitly stated in the provided text. Implied to be comparable to predicate devices and within acceptable limits for clinical use. | Passed |
| 18 | Functional/Performance | Hemolysis | Not explicitly stated in the provided text. Implied to be within acceptable limits as defined by relevant standards (e.g., ISO 10993) and comparable to predicate devices. | Passed |
| 19 | Functional/Performance | Reservoir Hemolysis | Not explicitly stated in the provided text. Implied to be within acceptable limits as defined by relevant standards (e.g., ISO 10993) and comparable to predicate devices. | Passed |
| 20 | Functional/Performance | Blood compatibility | Not explicitly stated in the provided text. Implied to meet biocompatibility requirements as defined by relevant standards (ISO 10993-1) and comparable to predicate devices. | Passed |
| 21 | Functional/Performance | Reservoir Blood compatibility | Not explicitly stated in the provided text. Implied to meet biocompatibility requirements as defined by relevant standards (ISO 10993-1) and comparable to predicate devices. | Passed |
| 22 | Functional/Performance | Leaching of coating | Not explicitly stated in the provided text. Implied to be within acceptable limits as defined by relevant standards and comparable to predicate devices. | Passed |
| 23 | Functional/Performance | Reservoir Leaching of coating | Not explicitly stated in the provided text. Implied to be within acceptable limits as defined by relevant standards and comparable to predicate devices. | Passed |
| 24 | Functional/Performance | Flaking of coating | Not explicitly stated in the provided text. Implied to be within acceptable limits as defined by relevant standards and comparable to predicate devices. | Passed |
| 25 | Functional/Performance | Reservoir Flaking of coating | Not explicitly stated in the provided text. Implied to be within acceptable limits as defined by relevant standards and comparable to predicate devices. | Passed |
| 26 | Functional/Performance | Uniformity of coating | Not explicitly stated in the provided text. Implied to be within acceptable limits as defined by relevant standards and comparable to predicate devices. | Passed |
Study Proving Device Meets Acceptance Criteria:
The study described is a non-clinical in vitro testing program designed to demonstrate substantial equivalence to predicate devices and compliance with safety and effectiveness requirements.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the exact number of units or replicates used for each in vitro test. It generally states that "In vitro testing was carried out" and "The INSPIRE 6F passed each test mentioned in the table below."
- Data Provenance: The study was conducted as in vitro testing. The country of origin of the data is implied to be within the company's testing facilities (Sorin Group Italia S.r.I. is located in Italy), but this is not explicitly stated for the testing location itself. The nature of the testing is non-clinical (laboratory-based), making "retrospective or prospective" labels less applicable in the typical sense; it's a prospective testing program for device validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable to this type of study. The ground truth for in vitro performance tests is established by objective measurements against predefined specifications and recognized standards (e.g., ISO standards, FDA Guidance documents) rather than expert consensus on diagnostic imaging or clinical outcomes.
4. Adjudication Method for the Test Set:
- This information is not applicable to this type of study. Adjudication methods like "2+1" are typically used in clinical or diagnostic studies involving human interpretation. Here, tests yield objective quantitative or qualitative results (e.g., pressure drop values, filtration efficiency percentages, pass/fail for integrity).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance, often in diagnostic imaging, and is not relevant for an in vitro performance evaluation of a cardiopulmonary bypass device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This concept is not applicable here. The INSPIRE 6F is a medical device (oxygenator with integrated filter and reservoir), not an algorithm or AI system. Its performance is inherent to its physical design and function tests, not algorithmic output.
7. The Type of Ground Truth Used:
- The ground truth for the in vitro tests was established by:
- Reference Standards: International and national standards (e.g., ISO 10993-1, ISO 15675, ISO 15674)
- Regulatory Guidance Documents: FDA guidances ("Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions," "Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions," "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions")
- Predicate Device Performance: Performance data from the D905 EOS and D733 devices served as a benchmark for demonstrating substantial equivalence.
- Internal Specifications: Implied by the statement "demonstrate compliance with performance specifications."
8. The Sample Size for the Training Set:
- Not applicable. This study does not involve a training set as it is not a machine learning or AI algorithm development study.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set, there is no ground truth established for one.
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K120185
510(k) SUMMARY
May 08, 2012
arterial filter
MAY 1 1 2012
Sorin Group Italia S.r.I. SUBMITTER: 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:
DEVICE TRADE NAME:
COMMON NAMES:
CLASSIFICATION NAMES:
Cardiopulmonary Bypass Oxygenator/ Cardiopulmonary Bypass Heat Exchanger/ Cardiopulmonary Bypass Blood Reservoir/ Cardiopulmonary Bypass Defoamer/ Cardiopulmonary Bypass Arterial Line Blood Filter
INSPIRE 6F hollow fiber oxygenator with
Hollow Fiber Oxygenator with integrated
Hollow Fiber Oxygenator with integrated
Hardshell Venous/Cardiotomy Reservoir
integrated arterial filter and hardshell
venous/cardiotomy reservoir
arterial filter and hardshell venous/cardiotomy reservoir
D905 EOS: hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir (K043323)
D733 MICRO 40 Ph.I.S.I.O. Arterial Filter: Sorin D733 MICRO 40 Arterial Filter with 40 micron screen with phosphoryIcholine coating (K112525)
DEVICE DESCRIPTION:
PREDICATE DEVICE:
The INSPIRE 6F is consisting of an oxygenator, integrated with an arterial filter and a heat exchanger (INSPIRE 6F 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 6F 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.
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The device can be operated at flow rates up to 6 liters per minute (I/min).
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 arterial filter provides additional protection against air and solid emboli and the integrated hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage.
The INSPIRE 6F is a modified version of the currently marketed integrated oxygenator/hardshell venous cardiotomy reservoir system (D905 EOS) and of the arterial filter (D733 MICRO 40 Ph.I.S.I.O., hereinafter referred to as D733) respectively in commercial distribution as separate units.
INDICATION FOR USE:
The intended use for the two elements that constitute the integrated device are:
INSPIRE 6F M: Hollow Fiber Oxygenator
INSPIRE 6F 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 6F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 6F 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 6F has the same fundamental technological characteristics, principles of operation and control mechanisms as the predicate devices.
Sorin believes that the INSPIRE 6F is substantially equivalent to the D905 EOS on the basis of operating principles and basic function. The integrated arterial filter of INSPIRE 6F is also substantially equivalent to the D733 predicate device with respect to the expected main function of an arterial filter.
The INSPIRE 6F and the predicate devices 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 6F 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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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; "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" 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 the following summary table. The · INSPIRE 6F passed each test mentioned in the table below.
| TEST | TESTCLASSIFICATION | 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 | Blood rest volume |
| 6 | Functional/Performance | Gas transfer performance/blood sidepressure drop |
| 7 | Functional/Performance | Heat exchange performance/water sidepressure drop |
| 8 | Functional/Performance | Air handling capability |
| 9 | Functional/Performance | Air handling |
| 10 | Functional/Performance | Break-through time and volume |
| 11 | Functional/Performance | Defoaming efficiency |
| 12 | Functional/Performance | Dynamic priming volume / Hold-up |
| 13 | Functional/Performance | Filtration Efficiency |
| 14 | Functional/Performance | Filtration Efficiency - venous section |
| 15 | Functional/Performance | Filtration Efficiency - cardiotomy section |
| 16 | Functional/Performance | Flow rate capacity |
| 17 | Functional/Performance | Pressure drop |
| 18 | Functional/Performance | Hemolysis |
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| TEST | TESTCLASSIFICATION | TEST TITLE |
|---|---|---|
| 19 | Functional/Performance | Reservoir Hemolysis |
| 20 | Functional/Performance | Blood compatibility |
| 21 | Functional/Performance | Reservoir Blood compatibility |
| 22 | Functional/Performance | Leaching of coating |
| 23 | Functional/Performance | Reservoir Leaching of coating |
| 24 | Functional/Performance | Flaking of coating |
| 25 | Functional/Performance | Reservoir Flaking of coating |
| 26 | Functional/Performance | Uniformity of coating |
CONCLUSIONS:
The results of in vitro studies demonstrate that the INSPIRE 6F performs in a manner substantially equivalent to the D905 EOS predicate device with respect to the relevant functional parameters. Also, the INSPIRE 6F performs in a manner substantially equivalent to the D733 predicate device, with respect to the filtering and air handling performances. Test results of this study suggest the INSPIRE 6F 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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 1 2012
Sorin Group Italia s.r.l. c/o Mr. Barry Sall Principal Consultant Parexel International Consulting 195 West Street Waltham, WA 02451
Re: K120185
Trade/Device Name: Inspire 6F 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 8, 2012 Received: May 9, 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). Tournete Frev (100) 2007 the device, subject to the general controls provisions of the Act. The I va may, allers, which 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. 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 of any I outlar state and the equirements, 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 11 you desire specific advisor your your your contrices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Comer Devices and National by reference to premarket notification" (21CFR Part note the regulation onlined, 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 rou 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
(000) 050 x 6da.gov/MedicalDevices/ResourcesforYou/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
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Indications for Use
510(k) Number (if known): K120185
INSPIRE 6F Hollow Fiber Oxygenator with integrated Arterial Filter Device Name: and Hardshell Venous/Cardiotomy Reservoir:
Indications for Use:
INSPIRE 6F M: Hollow Fiber Oxygenator
INSPIRE 6F 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 6F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 6F 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 requiring 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 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
§ 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.”