(112 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware and software modifications for Heliox delivery, not AI/ML capabilities.
Yes
A ventilator provides respiratory support, which is a form of treatment, making it a therapeutic device.
No
The device is a ventilator, which provides respiratory support, and is not described as diagnosing conditions.
No
The device description explicitly states that the modification is implemented through additional functionality in both hardware and software, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a ventilator, which is a device that provides respiratory support by delivering gas mixtures to a patient's lungs. This is a life support device that interacts directly with the patient's respiratory system, not with specimens taken from the body.
- Intended Use: The intended use clearly states the device is for "patients requiring respiratory support." This involves direct patient care, not laboratory testing of specimens.
The description of the Inspiration Ventilator aligns with the definition of a therapeutic device or a life support device, not an IVD.
N/A
Intended Use / Indications for Use
The Inspiration® Ventilator is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.
Product codes
73 CBK
Device Description
The Inspiration Ventilator System provides continuous ventilation to infant, pediatric and adult patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration Ventilator System, with the addition of the capability to deliver a Heliox gas mixture.
This modification is implemented on the Inspiration Ventilator through additional functionality in hardware and software. The existing modalities, pneumatic design, electrical circuitry and user interface mechanism have remained unchanged from the cleared Inspiration Ventilator device.
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
infant through adult
Intended User / Care Setting
hospitals and hospital-type facilities, which provide respiratory care for patients requiring respiratory support.
The device may be used for intra-hospital transport within a hospital or hospital-type facility.
The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for eVent Medical. The logo features a stylized lowercase "e" inside of a black oval. Below the oval, the words "eVent Medical" are written in a sans-serif font, with the "e" in "eVent" matching the style of the "e" in the oval.
K072590 page 1 of 3
Section D: 510(k) Summary
JAN - 4 2008
Inspiration® Ventilator System
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter: | eVent Medical, Inc.
81 Columbia, Suite 101
Aliso Viejo, CA 92656
eVent Medical Ltd
6A Lisoban Business Park
Tuam Road
Galway, Ireland | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Registration Number: | 3003638180 | |
| Contact Person: | Robert Lundberg
VP Regulatory Affairs and Quality Assurance
Phone: 949-360-8368 x232
Fax: 949-360-1924 | |
| Date Prepared: | September 13, 2007 | |
| Device Trade Name: | Inspiration® Ventilator System | |
| Common Name: | Continuous Ventilator | |
| Device Class: | Class II
per 21 CFR 868.5895 | |
| Product Code: | 73 CBK | |
| Predicate Device: | The predicate devices are: | |
| Manufacturer/Product | 510(k) | Classification |
| eVent Medical, Inc.
Inspiration® Ventilator System
(technological equivalence) | K051550 | Class II,
Continuous Ventilator
Per 21 CFR 868.5895 |
| VIASYS Respiratory Care, Inc.
AVEA Ventilator
(Heliox use equivalence) | K062093 | Class II,
Continuous Ventilator
Per 21 CFR 868.5895 |
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Image /page/1/Picture/1 description: The image shows the logo for eVent Medical. The logo consists of a stylized lowercase letter "e" inside of a black oval. Below the oval is the text "eVent Medical" in a smaller font size.
Device Description:
The Inspiration Ventilator System provides continuous ventilation to infant, pediatric and adult patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration Ventilator System, with the addition of the capability to deliver a Heliox gas mixture.
This modification is implemented on the Inspiration Ventilator through additional functionality in hardware and software. The existing modalities, pneumatic design, electrical circuitry and user interface mechanism have remained unchanged from the cleared Inspiration Ventilator device.
Intended Use:
The device intended use is the same as that of the cleared device, the Inspiration Ventilator system and is re-stated below.
Purpose and Function of the Device:
The Inspiration Ventilator System is intended to provide continuous ventilation for patients requiring respiratory support. This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions.
Intended Patient Population:
The intended patient population includes infant through adult patients who require pressure-based or volume-based continuous respiratory support with tidal volumes as low as 5 ml and inspiratory pressures as low as 1 cm H2O.
Intended Environment of Use:
The device is intended for use in hospitals and hospital-type facilities, which provide respiratory care for patients requiring respiratory support.
The device may be used for intra-hospital transport within a hospital or hospital-type facility. The device is not intended for transport between hospitals or hospital-type facilities.
The device is not to be used in the presence of flammable anesthetics.
The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel
Indication for Use:
The Inspiration Ventilator System is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.
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Image /page/2/Picture/1 description: The image shows the logo for eVent Medical. The logo consists of a black oval shape with a white lowercase letter 'e' inside. Below the oval, the words 'eVent Medical' are written in a smaller font size.
Substantial Equivalence:
The intended use of the Inspiration Ventilator is the same as that for standard, currently marketed critical care ventilators. The materials and design of this device are similar to those of the predicate devices. The technical characteristics of the Inspiration Ventilator System do not introduce new questions regarding safety or effectiveness of critical care ventilators. Furthermore, the labeling associated with the Inspiration Ventilator System provides similar information as the predicate devices.
Information provided in the 510(k) submission supports the determination of substantial equivalence to deliver a Heliox/Oxygen gas mixture. Software design and development, (including verification and validation testing, test and software quality procedures) was conducted using FDA's Guidance for the Content of Premarket Submissions for Software contained in medical devices, dated May 11 2005, as guidance and per internal company procedures. The Inspiration Ventilator device design and testing are also compliant with 21 CFR 820.30 Design Control and various voluntary, international standards identified in the Cover Letter.
Conclusion:
The Inspiration is a Heliox friendly ventilator that operates the same with Heliox as it does with compressed air and 100% O2. A review of the clinical literature on the operation of the Inspiration with Heliox is consistent with eVent Medical's bench studies of the Inspiration with high percentages of Helium.
The Inspiration is safe in that it is impossible to deliver an anoxic mixture of gas. FIO2 delivery is precisely accurate to FIO2 set.
All literature reviewed agrees that Heliox poses no increased health risk when used as a carrier gas in mechanical ventilators.
In summary, eVent Medical has demonstrated the Inspiration Ventilator System to be safe and effective. This device is equivalent to it predecessor and substantially equivalent to currently marketed devices which have been previously cleared by FDA.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.
JAN - 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Lundberg Vice President, Regulatory Affairs and Quality Assurance eVent Medical, Incorporated 81 Columbia, Suite 101 Aliso Viejo, California 92656
Rc: K072590
Trade/Device Name: Inspiration® Ventilator System Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 20, 2007 Received: December 26, 2007
Dear Mr. Lundberg:
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 such 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.
4
Page 2 - Mr. Lundberg
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Snytte H. Michie Omd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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:
| Section B: Indications for Use Statement | |
|---|---|
| 510(k) Number: | K072590 |
| Device Name: | Inspiration ® Ventilator System |
| Indications for Use: | The Inspiration ® Ventilator is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport. |
| Prescription Use | X |
| (Part 21 CFR 801 Subpart D) | AND/OR |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign. Off.
(Division Sign-Off) end may Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072590