(235 days)
The Model 730 AEV ™ is intended to provide continuous ventilatory support for individuals during CPR or when positive-pressure ventilation is required to manage acute respiratory failure. It is appropriate for use with adults and children- in clinical, field hospital, fransport, aeromedical and pre-hospital (BLS through ATLS) environments.
Model 730 AEVTM is a portable, electronically controlled ventilator. It is controlled by an internal microprocessor (CPU), which continuously monitors and displays airway pressure, control settings, high-pressure alarm setpoint, gas volumes, and power signals. Two CPR and two Quick-Start Modes are available- one each is for use with unintubated patients (Mask) and one each is for use with intubated patients (Tube). This product operates from internal rechargeable batteries, external AC and 11-15 volts DC.
The provided text for the Uni-Vent® AEVTM Model 730 device describes its performance standards and guidelines but does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for a study.
Instead, the document states:
- Performance Standards: The Model 730 AEVTM complies with various voluntary standards like ASTM F920-99, ASTM F1100-97, ISO9703-1, ISO 9703-2, CGA V-5:2000, ISO 5356-1, EN1441, MIL-STD-1472F, ANSI/AAMI HE74:2001, MIL- STD-810F, and EN60601-1. It explicitly states, "No applicable mandatory performance standards or special controls exist for this device."
- Substantial Equivalence: The primary basis for its clearance is a "comparative examination and analysis of similarities and differences to its predicate devices" concluding that "no new safety and/or effectiveness issues have been raised."
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed study as the information is not present in the provided text. The device received 510(k) clearance based on its substantial equivalence to predicate devices and compliance with voluntary consensus standards, rather than a standalone performance study with defined acceptance criteria and human evaluation metrics.
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Image /page/0/Picture/0 description: The image shows the logo and contact information for IMPACT Instrumentation, Inc. The address is 27 Fairfield Place, West Caldwell, NJ 07006, and the P.O. Box is 508, West Caldwell, NJ 07007-0508. The image also includes a graphic of a world map and the date MAR 26 2004.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Impact, Uni-Vent® AEVTM Model 730 510(k) Number K 032386
| Manufacturer: | Impact Instrumentation, Inc.P.O. Box 508/27 Fairfield PlaceWest Caldwell, New Jersey 07006Phone: 973-882-1212Fax: 973-882-4993 |
|---|---|
| --------------- | ------------------------------------------------------------------------------------------------------------------------------------------------ |
Mr. Leslie H. Sherman Contact Person:
July 25, 2003 Date Summary Prepared:
Uni-Vent ® Model 730AEVTM Trade Name:
Powered Emergency Ventilator (21 CFR Sec. 868.5925) Classification Name:
Class II Classification:
BTL Product Code:
Predicate Devices:
IMPACT Instrumentation, Inc.
- Impact Models 701, 702, 703. 510(k) #K861272/A.
-
- Uni-Vent- MinuteVolume Ventilator, Model 750. 510(k) #K870861/B.
- 4, Smartvent 201 (CBK) Portable Ventilator. 510(k) #K981668
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electro-medical technology
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| Performance Standards: | The Model 730 AEVTM complies with the followingvoluntary standards ASTM F920-99, ASTM F1100-97,ISO9703-1, ISO 9703-2, CGA V-5:2000, ISO 5356-1,EN1441, MIL-STD-1472F, ANSI/AAMI HE74:2001,MIL- STD-810F, EN60601-1. No applicable mandatoryperformance standards or special controls exist for thisdevice. |
|---|---|
| Performance Guidelines: | International Guidelines 2000 for CPR and ECC.Standard-of-Care Ventilator Settings - originally describedby Radford (N. Engl. J. Med. 251:877-883, 1954).Reviewer Guidance for Premarket NotificationSubmissions Nov 1993.Reviewers Guidance for Ventilators July, 1995. |
| Device Description: | Model 730 AEVTM is a portable, electronically controlledventilator. It is controlled by an internal microprocessor(CPU), which continuously monitors and displays airwaypressure, control settings, high-pressure alarm setpoint, gasvolumes, and power signals. Two CPR and two Quick-StartModes are available- one each is for use with unintubatedpatients (Mask) and one each is for use with intubatedpatients (Tube). This product operates from internalrechargeable batteries, external AC and 11-15 volts DC. |
| Intended Use: | The Model 730 AEVTM is intended to provide continuousventilatory support for individuals during CPR or whenpositive-pressure ventilation is required to manage acuterespiratory failure. It is appropriate for use with adults andchildren - in clinical, field hospital, transport, aeromedicaland pre-hospital (BLS through ATLS) environments. |
| Substantial Equivalence: | The Impact, Model 730 AEVTM, is substantially equivalentto the Impact Instrumentation Inc. Models 701, 750, 754and the Versamed Smartvent 201 in that:- the intended use is the same- the principle performance attributes are the sameBased on safety and performance testing including acomparative examination and analysis of similarities anddifferences to its predicate devices no new safety and/oreffectiveness issues have been raised. |
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an image of an eagle.
Public Health Service
MAR 2 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Leslie H. Sherman President Impact Instrumentation, Incorporated 27 Fairfield Place PO Box 508 West Caldwell, New Jersey 07006
Re: K032386
Trade/Device Name: Uni-Vent Model 730AEV Regulation Number: 21 CFR 868.5925 Regulation Name: Emergency Powered Ventilator (Resuscitator) Regulatory Class: II Product Code: BTL Dated: not dated Received: February 25, 2004
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.
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.
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Page 2 – Mr. Leslie H. 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 mount that I Drima made 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 und instills (2 - set forth in the quality systems (QS) regulation (21 CFR Part 820); and if roquicable, the electronic product radiation control provisions (Sections 531-542 of the Act); appreadio, and 050. 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. 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/dsma/dsmamain.html.
Sincerely yours,
Clue
Shia-Lien, Ph.D.
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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IMPACT Instrumentation, Inc.
27 Fairfield Place, West Caldwell, NJ 07006 P.O. Box 508, West Caldwell, NJ 07007-0508
Image /page/4/Picture/3 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. A heart rate monitor line is drawn to the left of the word. The continents are outlined in black, and the oceans are left blank. The text "ONS FOR USE STATEMENT" is at the bottom of the image.
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K632386
Device Name: Uni-Vent ® Model 730AEV™ (Automatic Emergency Ventilator)
Indications for use:
The Model 730 AEV ™ is intended to provide continuous ventilatory support for individuals during CPR or when positive-pressure ventilation is required to manage acute respiratory failure. It is appropriate for use with adults and children- in clinical, field hospital, fransport, aeromedical and pre-hospital (BLS through ATLS) environments.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Auram. Pinto
Division Sich - Off Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number: 5
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Tel: 973.882.1212 Fax: 973.882.4993 Web Site & E-Mail: http://www.impactinstrumentation.com
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).