(112 days)
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.
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.
The provided text does not contain detailed information regarding specific acceptance criteria applied to the Inspiration® Ventilator System regarding its performance with Heliox, nor does it describe a study that explicitly proves the device meets such criteria with detailed performance metrics.
However, based on the available information, we can infer the primary "acceptance criterion" being evaluated is substantial equivalence to existing devices, particularly concerning the addition of Heliox gas mixture delivery. The text focuses on demonstrating that the device operates safely and effectively with Heliox, similar to its operation with air and 100% O2, and does not introduce new safety or effectiveness concerns.
Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit numerical acceptance criteria for Heliox performance are not given, we will infer them from the safety and effectiveness claims.
| Acceptance Criteria (Inferred from claims) | Reported Device Performance (as stated in the document) |
|---|---|
| Safety: Device operates safely when delivering Heliox; impossible to deliver an anoxic mixture. | "The Inspiration is safe in that it is impossible to deliver an anoxic mixture of gas." |
| Accuracy: FIO2 delivery is precisely accurate to FIO2 set when using Heliox. | "FIO2 delivery is precisely accurate to FIO2 set." |
| Equivalent Operation: Device operates with Heliox similarly to how it operates with compressed air and 100% O2. | "The Inspiration is a Heliox friendly ventilator that operates the same with Heliox as it does with compressed air and 100% O2." |
| No Increased Health Risk: Use of Heliox as a carrier gas in the ventilator poses no increased health risk. | "All literature reviewed agrees that Heliox poses no increased health risk when used as a carrier gas in mechanical ventilators." |
| Software Integrity: Software design and development meets regulatory guidance and internal procedures. | "Software design and development... was conducted using FDA's Guidance for the Content of Premarket Submissions for Software... and per internal company procedures." |
| Design Control Compliance: Device design and testing compliant with 21 CFR 820.30. | "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." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "eVent Medical's bench studies of the Inspiration with high percentages of Helium." However, no specific sample size for a test set (e.g., number of test scenarios, ventilator units tested, or duration of tests) is provided.
The data provenance for the bench studies is internal to eVent Medical ("eVent Medical's bench studies"). It is implied to be prospective testing conducted by the manufacturer for this submission. The document also refers to a "review of the clinical literature on the operation of the Inspiration with Heliox," but this appears to be a separate supporting review rather than a primary study for this specific device modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The text refers to "eVent Medical's bench studies," implying internal testing, but does not detail the personnel or expert involvement in establishing ground truth for these tests.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the context of "bench studies," it's likely internal verification processes were used, but no specific adjudication method (like 2+1/3+1 expert review) is mentioned, as this is typically more relevant for clinical image interpretation or diagnostic device studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done; Effect Size
No, an MRMC comparative effectiveness study was not done or at least not described in this document. This type of study is more common for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. This document describes a continuous ventilator system and its ability to deliver Heliox.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The testing mentioned, "eVent Medical's bench studies," appears to be standalone testing of the device's performance characteristics (e.g., FIO2 accuracy, ability to deliver Heliox without anoxic mixtures). There is no mention of "human-in-the-loop" performance testing for this specific modification, although the overall device is used with human operation.
7. The Type of Ground Truth Used
For the "bench studies," the ground truth would be based on instrumentation and reference measurements of FIO2, gas mixture composition, and potentially other ventilator parameters, established through validated laboratory methods. For the claim that "Heliox poses no increased health risk," the ground truth is derived from a review of clinical literature.
8. The Sample Size for the Training Set
The document describes software modifications and bench studies for a ventilator, not a machine learning or AI-based diagnostic device that typically requires a "training set" in the context of model development. Therefore, the concept of a "training set sample size" as commonly understood in AI/ML is not applicable here and is not provided.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no training set in the AI/ML sense described here. The "ground truth" for the device's overall design and software development would be established through engineering specifications, regulatory guidelines, and internal validation processes.
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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 101Aliso Viejo, CA 92656eVent Medical Ltd6A Lisoban Business ParkTuam RoadGalway, Ireland | |
|---|---|---|
| Registration Number: | 3003638180 | |
| Contact Person: | Robert LundbergVP Regulatory Affairs and Quality AssurancePhone: 949-360-8368 x232Fax: 949-360-1924 | |
| Date Prepared: | September 13, 2007 | |
| Device Trade Name: | Inspiration® Ventilator System | |
| Common Name: | Continuous Ventilator | |
| Device Class: | Class IIper 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 VentilatorPer 21 CFR 868.5895 |
| VIASYS Respiratory Care, Inc.AVEA Ventilator(Heliox use equivalence) | K062093 | Class II,Continuous VentilatorPer 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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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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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.
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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
§ 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).