(34 days)
Not Found
No
The document describes a mechanical oxygenator and heat exchanger 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 during cardiopulmonary bypass, directly intervening to restore or maintain physiological function.
No
Explanation: The device, INSPIRE, is described as an oxygenator with an integrated heat exchanger that provides gas exchange support and blood temperature control during cardiopulmonary bypass. Its function is to provide life support and maintain physiological parameters, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines physical components like a heat exchanger and oxygenating module made of hollow fibers, indicating 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 use in adult surgical procedures requiring cardiopulmonary bypass (CPB) to provide gas exchange support and blood temperature control. This is a direct intervention on the patient's blood flow and temperature, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details components like a heat exchanger and an oxygenating module that directly interact with the patient's blood during surgery.
- Lack of Diagnostic Language: The text does not mention any diagnostic purpose, analysis of biological samples, or providing information for diagnosis.
- Performance Studies: The performance studies described are in vitro tests comparing the device's functional parameters (like recirculation line handling) to a predicate device, not studies evaluating diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The INSPIRE devices are therapeutic devices used during surgery to support physiological functions.
N/A
Intended Use / Indications for Use
The INSPIRE 6M is intended for use in adult surgical procedures requiring cardiopulmonary bypass (CPB). It provides gas exchange support and blood temperature control. The INSPIRE 6M is intended to be used for 6 hours or less.
The INSPIRE 7M is intended for use in adult surgical procedures requiring cardiopulmonary bypass (CPB). It provides gas exchange support and blood temperature control. The INSPIRE 7M is intended to be used for 6 hours or less.
The INSPIRE 8M is intended for use in adult surgical procedures requiring cardiopulmonary bypass (CPB). It provides gas exchange support and blood temperature control. The INSPIRE 8M is intended to be used for 6 hours or less.
Product codes (comma separated list FDA assigned to the subject device)
DTZ, DTR
Device Description
The INSPIRE 6M, INSPIRE 7M and INSPIRE 8M oxygenators (hereinafter identified as INSPIRE) consist of an oxygenator with an integrated heat exchanger.
The INSPIRE devices 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 consist of the following main components
- a heat exchanger consisting of a bundle of polyurethane hollow fibers • that are wound on a cylindrical core. it controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery.
- an oxygenating module element made of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The hollow fiber membrane provides oxygenation and carbon dioxide removal from venous blood or suction blood.
The modified devices are modified versions of the currently marketed INSPIRE 6M, INSPIRE 7M and INSPIRE 8M products.
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
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro testing: Performance testing was conducted on sterile aged devices, with accelerated aging for at least 3 years. The oxygenating module with the modified purge line unidirectional valve successfully met all acceptance criteria for recirculation line handling. The results demonstrate that the subject INSPIRE performs in a manner substantially equivalent to the Unmodified INSPIRE predicate device with respect to relevant functional parameters.
Clinical Performance Data: No clinical testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.”
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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.
August 13, 2020
Sorin Group Italia S.r.l Luigi Vecchi Director, Regulatory Affairs Via Statale 12 Nord, 86 Mirandola, Modena 41037 Italy
Re: K201916
Trade/Device Name: Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ, DTR Dated: July 9, 2020 Received: July 10, 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.
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
1
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 (QS) 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
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Indications for Use
510(k) Number (if known) K201916
Device Name INSPIRE 6M Hollow fiber Oxygenator INSPIRE 7M Hollow fiber Oxygenator INSPIRE 8M Hollow fiber Oxygenator
Indications for Use (Describe)
The INSPIRE 6M is intended for use in adult surgical procedures requiring cardiopulmonary bypass (CPB). It provides gas exchange support and blood temperature control. The INSPIRE 6M is intended to be used for 6 hours or less.
The INSPIRE 7M is intended for use in adult surgical procedures requiring cardiopulmonary bypass (CPB). It provides gas exchange support and blood temperature control. The INSPIRE 7M is intended to be used for 6 hours or less.
The INSPIRE 8M is intended for use in adult surgical procedures requiring cardiopulmonary bypass (CPB). It provides gas exchange support and blood temperature control. The INSPIRE 8M is intended to be used for 6 hours or less.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
(in accordance with 21 CFR 807.92)
510(k) Number: K201916
l. Applicant Information
| APPLICANT: | Sorin Group Italia S.r.l.
86, Via Statale 12 Nord
41037 Mirandola (MO) ITALY |
|----------------------------|------------------------------------------------------------------------------------|
| CONTACT PERSON: | Luigi Vecchi
Phone: +39 0535 29957
e-mail: luigi.vecchi@livanova.com |
| APPLICATION CORRESPONDANT: | Sorin Group Italia S.r.l.
86, Via Statale 12 Nord
41037 Mirandola (MO) ITALY |
| CONTACT PERSON: | Luigi Vecchi
Phone: +39 0535 29957
e-mail: luigi.vecchi@livanova.com |
| DATE PREPARED: | July 6, 2020 |
II. Subject Devices Identification
| PROPRIETARY NAME: | INSPIRE 6M Hollow Fiber Oxygenator
INSPIRE 7M Hollow Fiber Oxygenator
INSPIRE 8M Hollow Fiber Oxygenator |
|-----------------------|----------------------------------------------------------------------------------------------------------------|
| COMMON/ USUAL NAME: | INSPIRE 6M; INSPIRE 7M; INSPIRE 8M. |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Oxygenator,
Cardiopulmonary Bypass Heat Exchanger. |
| REGULATION NUMBER: | 21 CFR 870.4350 |
| PRODUCT CODE: | DTZ, DTR |
| CLASSIFICATION: | Class II |
| CLASSIFICATION PANEL: | Cardiovascular |
III. Predicate Devices
The INSPIRE 6M Hollow Fiber Oxygenator, INSPIRE 7M Hollow Fiber Oxygenator and INSPIRE 8M Hollow Fiber Oxygenator are substantially equivalent to the following cleared predicate devices. All models have the same
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fundamental scientific technology and intended use
| 510(k) NUMBER: | K180448 |
|---|---|
| PROPRIETARY NAME: | INSPIRE 6M Hollow Fiber Oxygenator, |
| INSPIRE 8M Hollow Fiber Oxygenator. | |
| COMMON/ USUAL NAME: | INSPIRE 6M; INSPIRE 8 M. |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Oxygenator |
| REGULATION NUMBER: | 21 CFR 870.4350 |
| CLASSIFICATION: | Class II |
| CLASSIFICATION PANEL: | Cardiovascular |
| 510(k) NUMBER: | K190690 |
|---|---|
| PROPRIETARY NAME: | INSPIRE 7M Hollow Fiber Oxygenator |
| COMMON/ USUAL NAME: | INSPIRE 7M |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Oxygenator |
| REGULATION NUMBER: | 21 CFR 870.4350 |
| CLASSIFICATION: | Class II |
| CLASSIFICATION PANEL: | Cardiovascular |
Device Description IV.
The INSPIRE 6M, INSPIRE 7M and INSPIRE 8M oxygenators (hereinafter identified as INSPIRE) consist of an oxygenator with an integrated heat exchanger.
The INSPIRE devices 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 consist of the following main components
- a heat exchanger consisting of a bundle of polyurethane hollow fibers ● that are wound on a cylindrical core. it controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery.
- an oxygenating module element made of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The hollow fiber membrane provides oxygenation and carbon dioxide removal from venous blood or suction blood.
The modified devices are modified versions of the currently marketed INSPIRE 6M, INSPIRE 7M and INSPIRE 8M products.
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V. Indications for use
The subject devices (i.e., the INSPIRE 6M, INSPIRE 7M and INSPIRE 8M) are intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. They all provide gas exchange support and blood temperature control. All the devices are intended to be used for 6 hours or less. Note: The intended use of the subject devices is identical to the intended use of the respective predicates
VI. Summary of technical characteristics
The INSPIRE subject devices have the same principles of operation and control mechanisms as the INSPIRE unmodified device. The INSPIRE subject devices and the INSPIRE 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 purge line unidirectional valve present in the recirculation line of the INSPIRE devices was changed with another valve from a different supplier. made with different materials and having different performances;
-
- A warning in the Instructions for Use was revised to reflect the evidence found during V&V testing.
No change to the intended use has been made as a result of these modifications. Also, there are no differences in packaging type and material between INSPIRE and INSPIRE 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 can be deemed to be substantially equivalent to its predicate device, the Unmodified INSPIRE The INSPIRE as designed and manufactured, does not raise new questions reqarding safety and effectiveness as compared to its predicate device and is determined to be substantially equivalent to its predicate device, the Unmodified INSPIRE
VIII. Non clinical performance data
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
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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 (oxyqenators)".
In vitro testing was performed to compare devices with the modified and unmodified purqe line unidirectional valve.
This performance testing was conducted on sterile aged devices; accelerated aging for a period of time equivalent to at least 3 years as per device labeling The oxygenating module with the modified purge line unidirectional valve.
successfully met all acceptance criteria for the recirculation line handling.
The results of in vitro studies demonstrate that the subject INSPIRE performs in a manner substantially equivalent to the Unmodified INSPIRE predicate device with respect to the relevant functional parameters.
IX. Clinical performance data
No clinical testing was conducted in support of the INSPIRE, 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.
X. Statement of Substantial Equivalence
As designed and manufactured and based on the intended use, technological characteristics, and performance testing, the modified INSPIRE do not raise new questions reqarding their safety and effectiveness as compared to their predicates devices and are determined to be substantially equivalent to the predicate devices.