(210 days)
Not Found
Not Found
No
The summary describes a standard emergency ventilator and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML device submissions.
Yes
The device is an emergency ventilator providing respiratory support, which is a therapeutic intervention.
No
The device is described as an emergency ventilator providing respiratory support, not as a tool for diagnosing medical conditions.
No
The intended use clearly describes a "gas powered emergency ventilator," which is a hardware device. The summary does not mention any software-only components or functions.
Based on the provided information, the EPV100 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is an "electronically controlled gas powered emergency ventilator" designed to provide "emergency respiratory support." This is a life-support device that directly interacts with the patient's respiratory system.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The EPV100 does not perform any such tests.
- Lack of IVD-related information: The provided text does not mention any analysis of biological samples, diagnostic testing, or any other activities typically associated with IVD devices.
Therefore, the EPV100 falls under the category of a medical device used for direct patient treatment and support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The EPV100 is intended to be used as an electronically controlled gas powered emergency ventilator, which is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patient's airway. The ventilator is intended for use on patients weighing greater than 20kg (44 lbs). This ventilator is intended to be used in the environments associated with emergency medical services (EMS), interhospital transport and hospital facility usage.
Product codes
BTL
Device Description
Not Found
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
patients weighing greater than 20kg (44 lbs)
Intended User / Care Setting
emergency medical services (EMS), interhospital transport and hospital facility
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol on the right, which is a staff with a serpent coiled around it. To the left of the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 6 2008
Mr. Wayne Karcher Regulatory Affairs Coordinator Allied Healthcare Products, Incorporated 1720 Sublette Avenue St. Louis, Missouri 63110
Re: K072214
Trade/Device Name: EPV-100, Portable Ventilator Regulation Number: 21CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: February 28, 2008 Received: February 29, 2008
Dear Mr. Karcher:
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.
1
Page 2 – Mr. Karcher
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,
Sutia Y. Michael Davis.
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
2
INDICATIONS FOR USE
510(k) Number K072214
Device Name: EPV-100, Portable Ventilator
Indications for Use: The EPV100 is intended to be used as an electronically controlled gas powered emergency ventilator, which is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patient's airway. The ventilator is intended for use on patients weighing greater than 20kg (44 lbs). This ventilator is intended to be used in the environments associated with emergency medical services (EMS), interhospital transport and hospital facility usage.
Prescription Use: Yes (Part 21CFR 801 Subpart D) AND/OR Over-the Counter Use: No (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIAS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Minh Thanh
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072214