(29 days)
Not Found
No
The document explicitly states that the modification is implemented through additional software functionality and that the existing breath delivery control algorithms have remained unchanged. There is no mention of AI or ML in the description or the "Mentions AI, DNN, or ML" section.
Yes.
Explanation: The device is a ventilator system intended for providing respiratory support to patients, which directly aligns with the definition of a therapeutic device.
No
The device is a ventilator system intended for respiratory support, delivering continuous ventilation. It does not mention any function for diagnosing conditions.
No
The device is a ventilator system, which is a hardware device with added software functionality. The description explicitly mentions pneumatic design, electrical circuitry, and user interface mechanism, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing respiratory support to patients. This involves directly interacting with the patient's respiratory system to assist with breathing.
- Device Description: The description details a ventilator system that delivers breaths to patients. This is a life-support device that acts on the patient's body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The provided information does not mention any analysis of biological specimens.
Therefore, the Inspiration™ Ventilator System is a medical device used for direct patient care and respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
The Inspiration™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options 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
CBK
Device Description
The Inspiration™ Ventilator System provides continuous ventilation to 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 set tidal volumes in volume targeted modes down to 5 ml, while 10 ml is the lower limit on the cleared device.
This modification is implemented on the Inspiration™ Ventilator through additional functionality in software only. The existing modalities, pneumatic design, breath delivery control algorithms, 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
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 User / Care Setting
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 hospitaltype facility. The device is not intended for transport between hospitals or hospitaltype 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
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)
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 a guidance and per internal company requirements. The Inspiration™ Ventilator device design and testing are also compliant with various voluntary, international standards including: EN60601-1:1990, EN 60601-1-2:1993, CAN/CSA C22.2 No. 601-1M90:1994, UL 2601-1:1994, EN 794-1 and 93/42/EEC Medical Device Directive.
The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use.
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
JUL 1 2 2005
051550
SUMMARY OF SAFETY AND EFFECTIVENESS
| SUBMITTER: | eVent Medical Ltd.. |
|---|---|
| DATE: | June 10, 2005 |
| COMMON NAME: | Continuous Ventilator |
| PROPRIETARY NAME: | Inspiration TM Ventilator System |
| CONTACT: | Robbie Walsh, VP Regulatory Affairs and |
| Quality Assurance | |
| eVent Medical Ltd. | |
| 6A Lisoban Business Park | |
| Tuam Road | |
| Galway, | |
| Ireland. | |
| Tel: + 353 91 764472 | |
| Fax: + 353 91 764379 | |
| CLASSIFICATION: | Class II per 21 CFR 868.5895 |
| Continuous Ventilator | |
| PREDICATE DEVICES: | eVent Medical Ltd.. is claiming substantial equivalence to the following two predicate medical devices: |
| Predicate Device | 510(k) Number | Classification |
|---|---|---|
| eVent Medical Ltd.. | ||
| InspirationTM Ventilator | K030341 | Class II, |
| Continuous Ventilator | ||
| per 21 CFR 868.5895 | ||
| Siemens - Elma AB. | ||
| Servoi Ventilator | K010925 | Class II, |
| Continuous Ventilator | ||
| per 21 CFR 868.5895 |
A Device Description:
The Inspiration™ Ventilator System provides continuous ventilation to 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
1
set tidal volumes in volume targeted modes down to 5 ml, while 10 ml is the lower limit on the cleared device.
This modification is implemented on the Inspiration™ Ventilator through additional functionality in software only. The existing modalities, pneumatic design, breath delivery control algorithms, electrical circuitry and user interface mechanism have remained unchanged from the cleared Inspiration™ ventilator device.
- B 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 hospitaltype facility. The device is not intended for transport between hospitals or hospitaltype 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 with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options 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.
2
Substantial Equivalence C
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 currently marketed 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. 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 a guidance and per internal company requirements. The Inspiration™ Ventilator device design and testing are also compliant with various voluntary, international standards including: EN60601-1:1990, EN 60601-1-2:1993, CAN/CSA C22.2 No. 601-1M90:1994, UL 2601-1:1994, EN 794-1 and 93/42/EEC Medical Device Directive.
The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use.
In summary eVent Medical Ltd. has demonstrated the Inspiration™ Ventilator System to be safe and effective. This device is considered to be substantially equivalent to currently marketed devices which have been previously cleared by FDA.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S.A." arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing wings and a stylized head and body.
Public Health Service
Jul. 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robbie Walsh, VP Regulatory Affairs and Quality Assurance eVent Medical Limited 6A Lisoban Business Park Tuam Road Galway, Ireland
Re: K051550
Trade/Device Name: Inspiration™ Ventilator System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: June 10, 2005 Received: June 14, 2005
Dear Mr. Walsh:
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. Walsh
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,
Auy Sulom be
Chin Lin, Ph.D.
Chiu Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
| 510(k) Number: | |
|---|---|
| Device Name: | Inspiration™ Ventilator |
| Indications for Use: | The Inspiration™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options 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 | AND/OR _ Over-The-Counter-Use |
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aver Sucion
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthesionsy, "Divises 0
510(k) Number: K0515
Page 1 of 1