(231 days)
Not Found
No
The description focuses on standard ventilator components, microprocessor control of pneumatic systems, and operator-determined parameters. There is no mention of AI, ML, or related concepts like learning, adaptation, or data-driven decision making beyond programmed settings.
Yes
The device is a ventilator system, which is used to provide respiratory support to patients, thereby treating respiratory conditions.
No
Explanation: The device is described as a "Ventilator System" that provides "respiratory support" and delivers "air and oxygen to the patient system." Its function is to deliver operator-determined parameters for breathing, not to diagnose a condition.
No
The device description explicitly details hardware components such as a metallic enclosure, display screen, controls, pneumatic system, electrical/electronic system, and various physical connections (oxygen, air, patient breathing circuit). It is a physical ventilator system controlled by software, not a software-only device.
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 providing respiratory support to patients. This is a direct medical intervention on a living being, not a test performed on samples taken from the body.
- Device Description: The description details a system for delivering air and oxygen to a patient, controlling breathing parameters, and monitoring the patient's respiratory status. This aligns with the function of a ventilator, which is a life-support device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances or markers, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This ventilator does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Inspiration™ Ventilator System is intended 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 is housed in a metallic enclosure, comprising clear anodized aluminum with painted finish and is mounted on a mobile stand. User controls and display screen are located on the front face of the Ventilator. Display and controls operation is described in the Ventilator Settings and Controls section of the User Manual (See Section 14 of this Submission). Ventilation parameters are programmed by the operator, using the function and navigation keys plus the Push & Turn control device on the Ventilator front panel, in conjunction with selectable display screens. The programmed data from the User Interface is processed by the main microprocessor and stored in ventilator non-volatile memory. The microprocessor uses the stored data in the control of breath delivery. Oxygen and air supply connections are located on the back of the Ventilator. The patient breathing circuit connection is located below the front face of the unit, together with a pneumatic outlet for driving an optional accessory jet nebulizer. The Ventilator stand serves to support the main Ventilator unit, breathing circuit tubing and accessory equipment, facilitating connection to the Ventilator. The Inspirations Ventilator System incorporates three communications interfaces, namely, a Nurse Call interface, an RS-232 and an Ethernet interface. The Nurse Call interface comprises normally open and normally closed relay contacts (changeover switch) acting simultaneously with an alarm condition. Both the RS232 and Ethernet interfaces enable the same data transmission to receiving terminals such as nurse and physician workstations and PC equipment. The Inspiration ... Ventilator System consists of two major systems, the pneumatic system and the electrical/electronic system, which combine under software control to deliver respiratory support at operator-determined parameters. The pneumatic system, under microprocessor control, supplies air and oxygen to the patient system, external to the device. The electricallelectronic system inputs and supervises one of three alternative power sources to the unit and provides electronic control of the ventilator's pneumatic system components. The Inspiration™ Ventilator System can operate with a range of standard ventilator accessories, such as breathing circuits, nebulizer and humidifier.
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
hospital, hospital-type facilities and intra-hospital transport.
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).
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Image /page/0/Picture/0 description: The image contains the text 'KD2112'. The text appears to be handwritten in black ink on a white background. The characters are slightly slanted and have a casual, informal style.
NOV 2 2 2002
Section 16. 510(k) Summary
Section 16.a Date Summary Prepared
01 March 2002
Section 16.b Company Information
Establishment:
6a Liosban Business Park Tuam Road Galway, Ireland
eVent Medical Ltd.,
Official Correspondent:
Mike Griffiths CEO eVent Medical Ltd., 800 Grand Avenue, Suite C-3 Carlsbad, CA 92008 760 497-3553 760-434-1334 (Fax)
Section 16.c Name of Device
| Proprietary: | Inspiration ™ Ventilator System |
|---|---|
| Common/Usual: | Respiratory Ventilator |
| Classification: | Continuous Ventilator (§868.5895/73CBK) |
Section 16.d Equivalent Devices
Substantial equivalence to the following legally marketed predicate devices with the same or similar indications for use has been demonstrated by a comparison of product features as described in the labeling and promotional literature for predicate devices and the Inspiration ~ Ventilator System, as well as testing to accepted industry standards. The predicate devices are as follows:
Section 16.e Device Description
The Inspiration™ Ventilator System is housed in a metallic enclosure, comprising clear anodized aluminum with painted finish and is mounted on a mobile stand. User controls and display screen are located on the front face of the Ventilator. Display and controls operation is described in the Ventilator Settings and Controls section of the User Manual (See Section 14 of this Submission). Ventilation parameters are programmed by the operator, using the function and navigation keys plus the Push & Turn control device on the Ventilator front panel, in conjunction with selectable display screens.
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Image /page/1/Picture/0 description: The image contains the word "CONFIDENTIAL" in all caps. The word is written in a bold, sans-serif font. The letters are slightly distressed, giving the word a textured appearance.
The programmed data from the User Interface is processed by the main microprocessor and stored in ventilator non-volatile memory. The microprocessor uses the stored data in the control of breath delivery.
Oxygen and air supply connections are located on the back of the Ventilator. The patient breathing circuit connection is located below the front face of the unit, together with a pneumatic outlet for driving an optional accessory jet nebulizer. The Ventilator stand serves to support the main Ventilator unit, breathing circuit tubing and accessory equipment, facilitating connection to the Ventilator.
The Inspirations Ventilator System incorporates three communications interfaces, namely, a Nurse Call interface, an RS-232 and an Ethernet interface. The Nurse Call interface comprises normally open and normally closed relay contacts (changeover switch) acting simultaneously with an alarm condition. Both the RS232 and Ethernet interfaces enable the same data transmission to receiving terminals such as nurse and physician workstations and PC equipment.
Section 16.f Intended Use
The Inspiration -- Ventilator System is intended 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 intended use, patient population and environment of use are the same or similar to the predicate devices, the Servo Ventilator 300, Siemens-Elema AB and the 760 Ventilator, Puritan Bennett Inc.
Section 16.g Technological Characteristics
The Inspiration Wentilator System provides continuous ventilation to patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The system operates on AC, internal battery, or external battery power and includes an integral compressor. This enables the system to operate both in the hospital environment and also during intra-hospital transport.
Ventilation modes are selected using the display screens and associated controls. The following ventilation modes are available:
Volume-based synchronized mandatory ventilation; V-CMV.
Volume-based synchronized intermittent mandatory ventilation: V-SIMV
Pressure-based synchronized mandatory ventilation; P-CMV
Pressure-based synchronized intermittent mandatory ventilation; P-SIMV
Spontaneous ventilation: SPONT
Pressure support: PSV
The User Manual, Section 14 of this submission, describes the procedures for selecting individual modes, plus performance specifications. Please refer to sections 3.2, 3.3, 8.5 of the User Manual.
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Image /page/2/Picture/0 description: The image shows the word "CONFIDENTIAL" in large, bold letters. The letters are slightly distorted, giving them a textured appearance. The word is oriented horizontally across the image.
The Inspiration ... Ventilator System consists of two major systems, the pneumatic system and the electrical/electronic system, which combine under software control to deliver respiratory support at operator-determined parameters. The pneumatic system, under microprocessor control, supplies air and oxygen to the patient system, external to the device. The electricallelectronic system inputs and supervises one of three alternative power sources to the unit and provides electronic control of the ventilator's pneumatic system components.
The Inspiration™ Ventilator System can operate with a range of standard ventilator accessories, such as breathing circuits, nebulizer and humidifier.
Section 16.h Certification Statement
In accordance with the requirements of 21 CFR 807.87(j), the following certification is provided:
eVent Medical believes that all data and information submitted in this premarket notification are truthful and accurate and no material fact has been omitted.
Mike Griffiths Chief Executive Officer eVent Medical Ltd.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mike Griffiths Chief Executive Officer eVent Medical Limited 800 Grand Avenue, Suite C3 Carlsbad, California 92008
Re: K021112
Trade/Device Name: Inspiration™ Ventilator System Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: August 20, 2002 Received: August 26, 2002
Dear Mr. Griffiths:
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. Griffiths
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 (301) 594-4646 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
CONFIDENTIAL
INDICATIONS FOR USE STATEMENT 2.g
Applicant:
eVent Medical Ltd
510(k) Number:
Device Name:
InspirationTM Ventilator System
Indications for Use:
The InspirationTM 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-type facilities and intra-hospital transport.
Yes (Per 21 CFR 801.109) Prescription Use:
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)
FAUch
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
KOZIIIZ 510(k) Number ._
Prescription Use
or
OTC Use