(88 days)
Not Found
No
The device description and performance studies focus on the physical components and functional performance of a cardiopulmonary bypass oxygenator, with no mention of AI or ML.
Yes.
The device provides gas exchange support and blood temperature control during cardiopulmonary bypass, which are therapeutic functions to maintain physiological stability during surgical procedures.
No
Explanation: The device is an oxygenator used for cardiopulmonary bypass to provide gas exchange and blood temperature control, which are therapeutic functions. It does not perform any diagnostic measurements or analyses to identify diseases or conditions.
No
The device description clearly outlines multiple physical components including hollow fibers, a heat exchanger, a hardshell venous/cardiotomy reservoir, and an arterial filter. This indicates 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 "adult surgical procedures requiring cardiopulmonary bypass." It provides "gas exchange support and blood temperature control." This describes a device used directly on the patient during surgery to support physiological functions.
- Device Description: The description details components like a heat exchanger, oxygenating module, venous/cardiotomy reservoir, and arterial filter. These are all components of a system designed to manage blood flow and gas exchange outside the body but connected to the patient during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of the Inspire 7F does not mention any analysis of specimens or diagnostic purposes.
The device is a medical device used for therapeutic support during surgery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Inspire 7F M is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F M is intended to be used for 6 hours or less.
The Inspire 7F is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F is intended to be used for 6 hours or less.
The Inspire 7F Dual is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F Dual is intended to be used for 6 hours or less.
The three subject devices (i.e., the INSPIRE 7F Hollow Fiber Oxygenator with integrated hard shell venous/cardiotomy reservoir, the INSPIRE 7F M Hollow Fiber Oxygenator and the INSPIRE 7F Dual Hollow Fiber Oxygenator with integrated hard shell venous/cardiotomy reservoir), - are intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. They all provide gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. All the devices are intended to be used for 6 hours or less. Note: The intended use of the three subject devices is identical to the intended use of the three respective predicates devices
Product codes (comma separated list FDA assigned to the subject device)
DTZ, DTM, DTR, DTN, DTP
Device Description
The INSPIRE 7F M, INSPIRE 7F and INSPIRE 7F Dual oxygenators (hereinafter identified as INSPIRE 7F) are intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass (CPB). It provides gas exchange support and blood temperature control.
The INSPIRE 7F consist of the following main components:
- . a heat exchanger consisting of a bundle of polyurethane hollow fibers that are wound on a cylindrical core.
- an oxygenating module element made of a coiled bundle of . polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly.
- Hardshell venous/cardiotomy reservoir to collect, filter, . and send venous blood and suction blood to the oxygenator (only models INSPIRE 7F/ 7F DUAL)
- Arterial filter: the integrated arterial filter surrounds the . oxygenating module and has been designed with a specific geometry that provides protection against air and solid emboli.
The heat exchanger consists of a bundle of polyurethane hollow fibers rolled on a cylindrical core. The heat transfer is obtained through the flow of water inside the fibers and the flow of blood outside them. The heat exchanger is inserted in the gas exchanger and surrounded by the oxygenating module element, which is constructed of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The blood path is around the outside of the fibers, while the gas path is through the lumen of the fibers. For the versions 7F/ 7F DUAL the oxygenator module is integrated with a hardshell/venous reservoir via a molded fitting joint.
The hardshell/venous reservoir is comprised of rigid polycarbonate housing. Venous and cardiotomy filtering systems are physically distinct to allow a good filtration efficiency of venous and suction blood (one filters venous blood, the other filters suction blood).
The reservoir is provided with a vent/vacuum port together with an over- underll valve, that prevents excess of negative or positive pressure avoiding implosion and over pressurization of the reservoir itself. The blood enters the reservoir through the cardiotomy section through the rotating turret equipped with 3/8ll, 1/4ll and female luer inlet connectors and through the venous inlet 1/2ll connector provided with female luer connector. Both cardiotomy turret and venous inlet connectors can rotate 360°. The reservoir lid also has additional unfiltered luer ports
The integrated arterial filter has a toroidal shape and a 38 um linear filter screen. It is molded to the shell of the oxygenator. It has been designed with a specific geometry that provides protection against air and solid emboli. The arterial filter has a twocompartment design, including pre- and post- filter chambers. Each one of the two compartments is provided with a dedicated purge site that enhances air purging. The pre-filter chamber removes air bubbles trapped by the filter screen. The post-filter collection chamber is located at the top of the filter and allows air bubble collection of the air dragged through the filter screen. In case of massive air embolism, the air bubbles can be removed through the purge sites located both in the pre- and post- filter collection chamber
The oxygenating module of all the INSPIRE oxygenators include a dedicated outlet with a one-way valve that provides access to arterial blood throughout the procedure for cardioplegia, perfusion or blood concentration. The outlet is placed close to the arterial outlet of the oxygenator and opposite to the temperature probe port. Arterial and venous temperature probe sites are also provided: the former is located close to the arterial blood outlet, while the latter is placed on the venous inlet of the reservoir.
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 Performance Data: Applicable tests were carried out in accordance with the requirements of ISO 10993-1, the FDA May 1st, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of materials, and 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 Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final Guidance for Industry and FDA" issued on November 29, 2000; and ISO 7199 "Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)".
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 includes performance tests and physical/mechanical integrity tests that demonstrate compliance with performance specifications. The INSPIRE 7F met all acceptance criteria for each of the tests listed in the table provided. The results of in vitro studies demonstrate that the INSPIRE 7F performs in a manner substantially equivalent to the INSPIRE 8F predicate device with respect to the relevant functional parameters.
Clinical Performance Data: No clinical testing was conducted in support of the INSPIRE 7F Hollow Fiber Oxygenator with integrated hardshell venous/cardiotomy reservoir r, the INSPIRE 7F M Hollow Fiber Oxygenator and the INSPIRE 7F Dual Hollow Fiber Oxygenator with integrated hardshell venous/cardiotomy reservoir, as the indications for use are equivalent to those of their respective predicates, which have been on the market for many years. The non-clinical testing summarized in this submission supports the substantial equivalence of these devices with their respective predicates in relation to the changes subject of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Summary of Performance Characteristics for INSPIRE 7F:
Maximum recommended blood flow: 7.0 l/min
Minimum recommended blood flow: 2.0 l/min
Minimum blood flow (up to 2 hours max. duration time): 0.5 l/min
Maximum suggested gas/blood flow ratio: 2:1
Blood path pressure drop (Hb 12 g/dl and temperature 37°C) @Qb=6 LPM: 174 mmHg (23.2 KPa /0.23 bar/3,4 psi)
Heat exchange performance factor (at Qb = 6 I/min) (Qw = 11.5 = 0.2 l/min): 0.59
Integrated Arterial filter: Filtration Efficiency: 100%
Maximum operating pressure Blood path: 750 mm Hg (100 kPa/ 1 bar / 14.5 psi
Maximum operating pressure Water path: 1500 mm Hg (200 kPa/ 2 bar / 29 PSI
GAS MODULE + HEAT EXCHANGER Priming volume: 366 ml
GAS MODULE + HEAT EXCHANGER Residual volume: 169 ml
GAS EXCHANGE MEMBRANE Fiber surface: 1.78 m²
HEAT EXCHANGE MEMBRANE Fiber surface: 0.4 m²
INTEGRATED ARTERIAL FILTER Filtering surface: 0.0097 m²
INTEGRATED ARTERIAL FILTER Type: Polyester screen 38 um
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 12, 2020
Sorin Group Italia S.R.L. Luigi Vecchi Director, Regulatory Affairs Via Statale 12 Nord, 86 Mirandola, Modena 41037 Italy
Re: K200683
Trade/Device Name: INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir
Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ, DTM, DTR, DTN, DTP Dated: May 7, 2020 Received: May 8, 2020
Dear Luigi Vecchi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200683
Device Name
INSPIRE 7F M Hollow Fiber Oxygenator with Integrated Arterial Filter
Indications for Use (Describe)
The Inspire 7F M is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control.
The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F M is intended to be used for 6 hours or less.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
PSC Publishing Services (301) 443-6740 EF
3
Indications for Use
510(k) Number (if known)
information unless it displays a currently valid OMBnumber."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
4
Indications for Use
510(k) Number (if known) K200683
Device Name
INSPIRE 7F Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir and Interial Filter
Indications for Use (Describe)
The Inspire 7F is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control.
The integrated arterial filter provides additional protection against air and solid emboli.
The Inspire 7F is intended to be used for 6 hours or less.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
5
Indications for Use
510(k) Number (if known)
information unless it displays a currently valid OMBnumber."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
6
Indications for Use
510(k) Number (if known)
Device Name
INSPIRE 7F Dual Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir and Integrated Arterial Filter
Indications for Use (Describe)
The Inspire 7F Dual is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control.
The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F Dual is intended to be used for 6 hours or less.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
7
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMBnumber."
8
510(k) Summary
(in accordance with 21 CFR 807.92)
510(k) Number: K200683
l. Applicant Information
| Applicant: | SORIN GROUP ITALIA S.R.L.
Via Statale 12 Nord, 86
Mirandola (MO) 41037 Italy |
|----------------------------|-------------------------------------------------------------------------------------------|
| Contact Person: | Luigi Vecchi
RA Director
Tel: +39-346-391-0707
e-mail: luigi.vecchi@livanova.com |
| Application Correspondent: | SORIN GROUP ITALIA S.R.L.
Via Statale 12 Nord, 86
Mirandola (MO) 41037 Italy |
| Contact Person: | Luigi Vecchi
RA Director
Tel: +39-346-391-0707
e-mail: luigi.vecchi@livanova.com |
INSPIRE 7F
Date Prepared: March 13, 2020
Subject Devices Identification
Proprietary Name:
II.
Common/Usual Name: Classification Name: Requlation Number: Product Code: Classification: Classification Panel:
Proprietary Name:
Classification Name:
Regulation Number:
Classification Panel:
Proprietary Name:
Product Code:
Classification:
Cardiopulmonary Bypass Oxygenator 21 CFR 870.4350 DTZ, DTM, DTR, DTN, DTP Class II Cardiovascular INSPIRE 7F M Hollow Fiber Oxygenator INSPIRE 7F M Common/Usual Name:
INSPIRE 7F Hollow Fiber Oxygenator with hardshell/venous cardiotomy reservoir
Cardiopulmonary Bypass Oxygenator 21 CFR 870.4350 DTZ, DTM, DTR Class II Cardiovascular
INSPIRE 7F Dual Hollow Fiber Oxygenator with hardshell/venous cardiotomy reservoir
Special 510(k) – Hollow Fiber Oxygenators
9
| Common/Usual Name: | INSPIRE 7F Dual |
|---|---|
| Classification Name: | Cardiopulmonary Bypass Oxygenator |
| Regulation Number: | 21 CFR 870.4350 |
| Product Code: | DTZ, DTM, DTR, DTN, DTP |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
lll. Predicate Devices
The INSPIRE 7F Hollow Fiber Oxygenator with hardshell/venous cardiotomy reservoir is substantially equivalent to the following cleared predicate device. Both models have the same fundamental scientific technology and intended use:
| 510(k) Number: | K130433 |
|---|---|
| Proprietary Name: | INSPIRE 8F Hollow Fiber Oxygenator with |
| hardshell/venous cardiotomy reservoir | |
| Common/Usual Name: | INSPIRE 8F |
| Classification Name: | Cardiopulmonary Bypass Oxygenator |
| Regulation Number: | 21 CFR 870.4350 |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
The INSPIRE 7F M Hollow Fiber Oxygenator device is substantially equivalent to the following cleared predicate device. Both models have the same fundamental scientific technology and intended use:
| 510(k) Number: | K180448 |
|---|---|
| Proprietary Name: | INSPIRE 8F M Hollow Fiber Oxygenator |
| Common/Usual Name: | INSPIRE 8F M |
| Classification Name: | Cardiopulmonary Bypass Oxygenator |
| Regulation Number: | 21 CFR 870.4350 |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
The INSPIRE 7F Dual Hollow Fiber Oxygenator with hardshell/venous cardiotomy reservoir device is substantially equivalent to the following cleared predicate device. Both models have the same fundamental scientific technology and intended use:
| 510(k) Number: | K122844 |
|---|---|
| Proprietary Name: | INSPIRE 8F Dual Hollow Fiber Oxygenator with |
| hardshell/venous cardiotomy reservoir | |
| Common/Usual Name: | INSPIRE 8F Dual |
| Classification Name: | Cardiopulmonary Bypass Oxygenator |
| Regulation Number: | 21 CFR 870.4350 |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
10
IV. Devices Description
The INSPIRE 7F M, INSPIRE 7F and INSPIRE 7F Dual
oxygenators (hereinafter identified as INSPIRE 7F) are intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass (CPB). It provides gas exchange support and blood temperature control.
The INSPIRE 7F consist of the following main components:
- . a heat exchanger consisting of a bundle of polyurethane hollow fibers that are wound on a cylindrical core.
- an oxygenating module element made of a coiled bundle of . polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly.
- Hardshell venous/cardiotomy reservoir to collect, filter, . and send venous blood and suction blood to the oxygenator (only models INSPIRE 7F/ 7F DUAL)
- Arterial filter: the integrated arterial filter surrounds the . oxygenating module and has been designed with a specific geometry that provides protection against air and solid emboli.
The heat exchanger consists of a bundle of polyurethane hollow fibers rolled on a cylindrical core. The heat transfer is obtained through the flow of water inside the fibers and the flow of blood outside them. The heat exchanger is inserted in the gas exchanger and surrounded by the oxygenating module element, which is constructed of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The blood path is around the outside of the fibers, while the gas path is through the lumen of the fibers. For the versions 7F/ 7F DUAL the oxygenator module is integrated with a hardshell/venous reservoir via a molded fitting joint.
The hardshell/venous reservoir is comprised of rigid polycarbonate housing. Venous and cardiotomy filtering systems are physically distinct to allow a good filtration efficiency of venous and
11
suction blood (one filters venous blood, the other filters suction blood).
The reservoir is provided with a vent/vacuum port together with an over- underll valve, that prevents excess of negative or positive pressure avoiding implosion and over pressurization of the reservoir itself. The blood enters the reservoir through the cardiotomy section through the rotating turret equipped with 3/8ll, 1/4ll and female luer inlet connectors and through the venous inlet 1/2ll connector provided with female luer connector. Both cardiotomy turret and venous inlet connectors can rotate 360°. The reservoir lid also has additional unfiltered luer ports
The integrated arterial filter has a toroidal shape and a 38 um linear filter screen. It is molded to the shell of the oxygenator. It has been designed with a specific geometry that provides protection against air and solid emboli. The arterial filter has a twocompartment design, including pre- and post- filter chambers. Each one of the two compartments is provided with a dedicated purge site that enhances air purging. The pre-filter chamber removes air bubbles trapped by the filter screen. The post-filter collection chamber is located at the top of the filter and allows air bubble collection of the air dragged through the filter screen. In case of massive air embolism, the air bubbles can be removed through the purge sites located both in the pre- and post- filter collection chamber
The oxygenating module of all the INSPIRE oxygenators include a dedicated outlet with a one-way valve that provides access to arterial blood throughout the procedure for cardioplegia, perfusion or blood concentration. The outlet is placed close to the arterial outlet of the oxygenator and opposite to the temperature probe port. Arterial and venous temperature probe sites are also provided: the former is located close to the arterial blood outlet, while the latter is placed on the venous inlet of the reservoir. Figure 1 shows the oxygenating modules with the visible ports identified.
12
Image /page/12/Figure/0 description: The image shows two diagrams, labeled A and B, of a device with various ports and connectors. Both diagrams depict the same device but from slightly different angles, highlighting different features. The device includes ports for gas inlet and outlet, water ports, and connectors for arterial sampling and temperature probes, among other components like the oxygenator interface/joint.
Figure 1: Oxygenating module integrated with heat exchanger and Arterial filter
The respective predicates devices Inspire 8F M, Inspire 8F and Inspire 8F Dual have the same main components of the three subject devices. CPB circuits mimic and temporarily replace the function of the heart and lungs while the heart is arrested to provide a bloodless and stable surgical field, while maintaining physiological support to the rest of the body in which venous blood is drained to a reservoir, oxygenated and sent back to the body through a pump.
The clinical need for the devices under evaluation is to provide a safe and well- functioning alternative to the patient circulation for the entire duration of a cardiopulmonary bypass procedure. The devices can be used to temporarily support pulmonary function of a patient immediately after a Cardiac surgery Operation within the maximum time allowed of 6 hours.
An overview of functional and performance characteristics of Inspire 7F is summarized in Table 1 below.
Table 1. Inspire 7F Performance Characteristics
| CHARACTERISTICS | INSPIRE 7F |
|---|---|
| Maximum recommended blood flow | 7.0 l/min |
| Minimum recommended blood flow | 2.0 l/min |
13
| Minimum blood flow | 0.5 l/min | |
|---|---|---|
| (up to 2 hours max. duration time) | ||
| Maximum suggested gas/blood flow ratio | 2 :1 | |
| Blood path pressure drop | ||
| (Hb 12 g/dl and temperature 37°C) | @Qb=6 LPM | |
| 174 mmHg | ||
| (23.2 KPa /0.23 bar/3,4 psi) | ||
| Heat exchange performance factor | (at Qb = 6 I/min) | |
| (Qw = 11.5 = 0.2 l/min) | 0.59 | |
| Integrated Arterial filter: Filtration | ||
| Efficiency | 100% | |
| Maximum operating | Blood path | 750 mm Hg |
| (100 kPa/ 1 bar / 14.5 psi | ||
| pressure | Water path | 1500 mm Hg |
| (200 kPa/ 2 bar / 29 PSI | ||
| GAS MODULE + HEAT | ||
| EXCHANGER | Priming | |
| volume | ||
| Residual | ||
| volume | 366 ml | |
| 169 ml | ||
| GAS EXCHANGE | ||
| MEMBRANE | Fiber | |
| surface | 1.78 m² | |
| HEAT EXCHANGE | ||
| MEMBRANE | Fiber | |
| surface | 0.4 m² | |
| INTEGRATED ARTERIAL | ||
| FILTER | Filtering | |
| surface | ||
| Type | 0.0097 | |
| Polyester screen 38 um |
V. Indications for Use
The three subject devices (i.e., the INSPIRE 7F Hollow Fiber Oxygenator with integrated hard shell venous/cardiotomy reservoir, the INSPIRE 7F M Hollow Fiber Oxygenator and the INSPIRE 7F Dual Hollow Fiber Oxygenator with integrated hard shell venous/cardiotomy reservoir), - are intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. They all provide gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. All the devices
14
are intended to be used for 6 hours or less. Note: The intended use of the three subject devices is identical to the intended use of the three respective predicates devices
VI. Summary of Technical Characteristics
The INSPIRE 7F has the same principles of operation and control mechanisms as the INSPIRE 8F unmodified device. The INSPIRE 7F and the INSPIRE 8F unmodified device share the same fundamental technological characteristics except for some modifications that do not affect the basic device function. These differences are summarized below and do not raise any new issues of safety and effectiveness. The density of the hollow fiber in the oxygenating bundle has been decreased from 16.3 to 15.3
The diameter of the oxygenator bundle has been increased from 82.9 -85.6 mm to 85.1-86.4 mm. The diameter of the oxygenating body has been increased from 83.85 mm to 84.41 mm (max) No change to the intended use has been made as a result of these modifications.
No different materials were introduced / changed as a result of these modifications.
There are no differences in packaging type and material between INSPIRE 7F and INSPIRE 8F unmodified device. Both modified and unmodified device are for single use only, ethylene oxide sterilized and has a non-pyrogenic fluid path.
VII. Substantial Equivalence Discussion
Based on equivalent intended use and technological characteristics, as well as on equivalent performance testing, the INSPIRE 7F can be deemed to be substantially equivalent to its predicate device, the Unmodified INSPIRE 8F The INSPIRE 7F as designed and manufactured, does not raise new questions regarding safety and effectiveness as compared to its predicate device and is determined to be substantially equivalent to its predicate device, the Unmodified INSPIRE 8F.
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Non-Clinical Performance Data VIII.
The subject devices were tested to ensure that they can provide all the capabilities necessary to operate safely and effectively. Applicable tests were carried out in accordance with the requirements of ISO 10993-1, the FDA May 1st, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of materials, and 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 Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final Guidance for Industry and FDA" issued on November 29, 2000; and ISO 7199 "Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)".
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 includes performance tests and physical/mechanical integrity tests that demonstrate compliance with performance specifications.
The INSPIRE 7F met all acceptance criteria for each of the tests listed in the table below.
| TEST | TEST
CLASSIFICATION | TEST TITLE |
|------|------------------------|--------------------------------------------------------------------------|
| 1 | Physical/Mechanical | Oxygenating module structural integrity |
| 2 | Physical/Mechanical | Oxygenating module blood, water, gas
pathway integrity |
| 3 | Functional/Performance | Oxygenating module blood volume
capacity |
| 4 | Functional/Performance | Oxygenating module heat exchange
performance/water side pressure drop |
| 5 | Functional/Performance | Oxygenating module gas transfer
performance/blood side pressure drop |
| 6 | Functional/Performance | Oxygenating module air handling
capability |
| 7 | Functional/Performance | Oxygenating module filtration efficiency |
| 8 | Functional/Performance | Oxygenating module blood trauma
(hemolysis and blood compatibility) |
| 9 | Functional/Performance | Oxygenating module leaching of coating |
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| 10 | Functional/Performance | Integrated device flaking of coating |
|---|---|---|
| 11 | Functional/Performance | Oxygenating module uniformity of |
| coating | ||
| 12 | Functional/Performance | Flow rate capacity |
The results of in vitro studies demonstrate that the INSPIRE 7F performs in a manner substantially equivalent to the INSPIRE 8F predicate device with respect to the relevant functional parameters.
IX. Clinical Performance Data
No clinical testing was conducted in support of the INSPIRE 7F Hollow Fiber Oxygenator with integrated hardshell venous/cardiotomy reservoir r, the INSPIRE 7F M Hollow Fiber Oxygenator and the INSPIRE 7F Dual Hollow Fiber Oxygenator with integrated hardshell venous/cardiotomy reservoir, as the indications for use are equivalent to those of their respective predicates, which have been on the market for many years. The non-clinical testing summarized in this submission supports the substantial equivalence of these devices with their respective predicates in relation to the changes subject of this submission.
Statement of Substantial Equivalence X.
As designed and manufactured and based on the intended use, technological characteristics, and performance testing, the INSPIRE 7F Hollow Fiber Oxygenator with integrated hardshell venous/cardiotomy reservoir, the INSPIRE 7F M Hollow Fiber Oxygenator and the INSPIRE 7F Dual Hollow Fiber Oxygenator with integrated hardshell venous/cardiotomy reservoir do not raise new questions regarding their safety and effectiveness as compared to their predicates devices and are determined to be substantially equivalent to the predicate devices.