(108 days)
Not Found
No
The document describes a microprocessor-controlled ventilator with a user interface and alarms. There is no mention of AI, ML, or any related concepts in the intended use, device description, or the sections specifically checked for AI/ML mentions.
Yes
The device is a ventilator that provides positive-pressure ventilation for patients with respiratory failure, which is a therapeutic intervention.
No
The device is a ventilator used for providing continuous positive-pressure ventilation. While it monitors oxygen saturation and pulse rate using an internal pulse oximeter, its primary function is therapeutic (ventilation), not diagnostic. The monitoring capabilities support the therapeutic function.
No
The device description clearly outlines hardware components such as a microprocessor, internal compressor, internal DC battery, impact resistant polycarbonate case, and an internal pulse oximeter. It is a physical ventilator with software control, not a software-only device.
Based on the provided text, 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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a ventilator. Its function is to provide positive-pressure ventilation to patients with respiratory failure. It directly interacts with the patient's respiratory system, not with specimens taken from the body.
- Intended Use: The intended use describes managing patients with respiratory failure by providing ventilation. This is a direct patient treatment/support function, not a diagnostic test performed on a sample.
- Device Description: The description details the mechanical and electronic components of a ventilator, including gas delivery, power sources, and monitoring of patient parameters like oxygen saturation and pulse rate (which are measured directly from the patient, not from a sample).
Therefore, the Model 731EMV+ is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Model 731EMV+ (EMV+) is indicated for use in the management of infant through adult patients weighing ≥5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. It is appropriate for use in hospitals, outside the hospital, during transport and in austere environments where it may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, it may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). It is not intended to operate in explosive environments. The EMV+ is intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers.
Product codes
CBK, DOA
Device Description
The Uni-Vent ® Model 731EMV+ is a portable, microprocessor controlled, electrically or pneumatically powered intensive care ventilator designed to use either oxygen (02) from a 55 psig source or ambient air using an internal compressor power to deliver a positive pressure breaths. The unit can be electrically powered from an externating current source, external direct current (DC) source or the internal DC battery. An intuitive point-turn-and click interface allows the operator to set and monitor ventilation in all operating environments. A series of alarms alert the user operator to all conditions that affect the ventilator's operation and/or performance and provide context sensitive help relevant to the alarm condition. Ambient air is filtered using a particulate filter or when the operating environment requires either a bacterial/viral or chemical/biologic (NATO No: 4240-01-361-1319) filter. The unit is contained in an impact resistant polycarbonate case which protects of the controls from damage and inadvertent manipulation.
The Uni-Vent ® Model 731EMV+ internal pulse oximeter connects to the patient using noninvasive sensors to monitor oxygen saturation and pulse rate. Pulse oximeter specific alarms and instructions are presented to the operator through the user interface. Isolated DC power is provided to the pulse oximeter.
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 patients weighing ≥5 kg
Intended User / Care Setting
skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers.
Use in hospitals, outside the hospital, during transport and in austere environments.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
IMPACT Instrumentation, Inc.
27 Fairfield Place, West Caldwell, NJ 07006 P.O. Box 508, West Caldwell, NJ 07007-0508
Image /page/0/Picture/2 description: The image shows a black and white drawing of a world map with the word "IMPACT" written in large, bold letters across the center. Above the map, there is a handwritten number "X091238". To the left of the word "IMPACT", there is a drawing of a heartbeat line.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
AUG 1 8 2009
Impact, Uni-Vent® Model 731EMV+ 510(k) Number -
Manufacturer:
Impact Instrumentation, Inc. P.O. Box 508/27 Fairfield Place West Caldwell, New Jersey 07006 Phone: 973-882-1212 Fax: 973-882-4993
Contact Person:
Date Summary Prepared: April 23, 2009
Trade Name: Uni-Vent ® Model 731EMV+
Continuous Ventilator (per 21 CFR 868.5895)
Mr. Leslie H. Sherman
Classification Name:
Classification: Class II
Product Code: CBK, DOA
Device Description:
The Uni-Vent ® Model 731EMV+ is a portable, microprocessor controlled, electrically or pneumatically powered intensive care ventilator designed to use either oxygen (02) from a 55 psig source or ambient air using an internal compressor power to deliver a positive pressure breaths. The unit can be electrically powered from an externating current source, external direct current (DC) source or the internal DC battery. An intuitive point-turn-and click interface allows the operator to set and monitor ventilation in all operating environments. A series of alarms alert the user operator to all conditions that affect the ventilator's operation and/or performance and provide context sensitive help relevant to the alarm condition. Ambient air is filtered using a particulate filter or when the operating environment requires either a bacterial/viral or chemical/biologic (NATO No: 4240-01-361-1319) filter. The unit is contained in an impact resistant polycarbonate case which protects of the controls from damage and inadvertent manipulation.
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electro-medical technology
Tel: 973.882.1212 Fax 973.882.4993 Web Site & E-Mail: http://www.impactinstrumentation.com
1
Description of Noninvasive Pulse Oximeter
The Uni-Vent ® Model 731EMV+ internal pulse oximeter connects to the patient using noninvasive sensors to monitor oxygen saturation and pulse rate. Pulse oximeter specific alarms and instructions are presented to the operator through the user interface. Isolated DC power is provided to the pulse oximeter.
Intended Use:
The Model 731EMV+ (EMV+) is indicated for use in the management of infant through adult patients weighing ≥5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. It is appropriate for use in hospitals, outside the hospital, during transport and in austere environments where it may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, it may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). It is not intended to operate in explosive environments. The EMV+ is intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers.
Substantial Equivalence:
The Impact, Model 731EMV+, is substantially equivalent to the predicate devices listed below:
Predicate Devices:
-
- Impact, Model 731EMV. 510(k) # K071526
-
- Pulmonetic Systems, Inc. LTV 1200 Ventilator. 510(k) #K060647
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of three overlapping shapes that resemble a bird or a symbol representing health and human services. The image is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Leslie H. Sherman President IMPACT Instrumentation, Incorporated 27 Fairfield Place West Caldwell, New Jersey 07006
AUG 1 8 2009
Re: K091238
Trade/Device Name: Uni-Vent ® Model 731 EMV+ Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK, DQA Dated: July 10, 2009 Received: July 14, 2009
Dear Mr. Sherman:
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 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.
3
Page 2- Mr. Sherman
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasc go to
http://www.fda.gov/AboutFDA/CcntersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Cinton V. Ancion ho
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): Device Name: Uni-Vent ® Model 731EMV+
Indications for Use:
The Model 731EMV+ (EMV+) is indicated for use in the management of infant through adult patients weighing ≥5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. It is appropriate for use in hospitals, outside the hospital, during transport and in austere environments where it may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, it may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). It is not intended to operate in explosive environments. The EMV+ is intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Per 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 of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K0911236
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