(555 days)
The Model 731EMV (EMV) is indicated for use in the management of adolescent and adult patients weighing ≥30 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.
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 external alternating 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.
This 510(k) summary describes a medical device, specifically a continuous ventilator, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found for AI/ML-driven devices.
The document focuses on:
- Device Description: The Uni-Vent® Model 731EMV is a portable, microprocessor-controlled intensive care ventilator. It uses oxygen or ambient air, can be electrically powered, and has an intuitive interface. It also includes a noninvasive pulse oximeter.
- Intended Use: For adolescent and adult patients (≥30 kg) with acute or chronic respiratory failure, or during resuscitation. It's for use in hospitals, outside hospitals, during transport, and in austere environments. It can operate with a third-party filter in chemical/biological toxin environments but not explosive ones. Intended users are skilled care providers, EMS personnel, and first responders under direction.
- Substantial Equivalence: The device is deemed substantially equivalent to several predicate devices, including other Impact Uni-Vent models, a Masimo pulse oximeter, Versamed SmartVent, and Vela Bird Products.
- Regulatory Information: Classification as Class II, Product Codes CBK and DQA.
Therefore, the requested information regarding acceptance criteria and performance study results cannot be extracted from the provided text. This type of detail is more common in submissions for AI/ML devices where specific performance metrics are critical for regulatory clearance. For devices like this ventilator, substantial equivalence to existing devices often forms the primary basis for clearance, along with adherence to relevant performance standards (which are not detailed here).
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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 the word "IMPACT" in large, bold letters. The word is positioned in the center of the image, with a world map outline above and below it. There is also a heart rate line to the left of the word, and some handwritten text in the upper right corner.
DEC10 2008
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Impact, Uni-Vent® Model 731EMV 510(k) Number K071526
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:
December 10, 2008 Date Summary Prepared:
Uni-Vent 10 Model 731EMV Trade Name:
Continuous Ventilator (per 21 CFR 868.5895) Classification Name:
Mr. Leslie H. Sherman
Classification: Class II
Product Code: CBK, DQA
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 external alternating 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-medica
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K071526
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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 adolescent and adult patients weighing ≥30 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positivepressure 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 Uni-Vent Model 730. 510(k) #K032386
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- Impact Uni-Vent Model 73X. 510(k) #K051476.
-
- Masimo SET RAD 5 MS-11 PCB 510(k) #K033296, Masimo Corp, Irvine, CA
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- Versamed SmartVent™ 201, 510(k) #K061627, Versamed Medical Systems, Inc., Pearl River, NY
-
- Vela Bird Products, Palm Springs, CA, 510(k) # K032451
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2008
Mr. Leslie H. Sherman President PACT Instrumentation, Incorporated 27 Fairfield Place West Caldwell, New Jersey 07006
Re: K071526
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: December 3, 2008 Received: December 3, 2008
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 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. 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); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Sybil y. Mckain PhD.
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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INDICATIONS FOR USE
510(k) Number (if known): K071526 Device Name: Uni-Vent @ Model 731EMV
Indications for Use:
The Model 731EMV (EMV) is indicated for use in the management of adolescent and adult patients weighing ≥30 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.
X Prescription Use (Per 21 CFR 801 Subpart D) (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)
Suage y. Michie Ous
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:_大07 15 こん
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§ 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).