(356 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the device's function as an emergency ventilator.
Yes
The device is an emergency ventilator, which is used to provide respiratory support to patients, directly impacting their physiological function and treating a medical condition.
No.
The device is described as an emergency ventilator designed to provide respiratory support, not to diagnose a condition.
No
The device description clearly states it is an "electrically controlled emergency ventilator that requires an external compressed gas source." This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the AHP300P is an "electrically controlled emergency ventilator" designed to provide "emergency respiratory support" by delivering gas to a patient's airway.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Lack of Diagnostic Function: The description focuses on providing mechanical support for breathing, not on analyzing biological samples to diagnose a condition.
The device is a therapeutic device, specifically a ventilator, used to support a patient's breathing.
N/A
Intended Use / Indications for Use
The AHP300P is intended to be used as an electrically controlled emergency ventilator that requires an external compressed gas source. This ventilator is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patients airway. The ventilator is intended for use on patients weighing greater than 5kg (11 lbs). The ventilator is intended to be used in the environments associated with emergency medical services (EMS), Inter-hospital transport and hospital facilities usage. The ventilator is intended to be used in temperatures of -18 C to 50 C (0 F to 122 F) and 5% to 95 % relative humidity non-condensing.
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 5kg (11 lbs)
Intended User / Care Setting
emergency medical services (EMS), Inter-hospital transport and hospital facilities usage.
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).
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of three human profiles facing right, overlaid and slightly offset from each other, creating a sense of depth. The graphic is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gibli9 Silver Spring, MD 20993-0002
April 9, 2014
Allied Healthcare C/O John Smith. M.D., J.D., Partner Hogan Lovells US LI_P 555 Thirteenth Street NW Washington, D.C. 20004
Re: K131098
Trade/Device Name: AHP300P Emergency Portable Ventilator Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: March 18, 2014 Received: March 18, 2014
Dear Dr. Smith:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
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Page 2 - Dr. John Smith
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 (OS) regulation (2) 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), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Te
C
DA
Tejashri Purohit-Sheth, M.D. Clinical Denuty Director
FOR
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for Allied Healthcare Products Inc. The logo is in black and white and features the word "Allied" in a stylized font. Below the word "Allied" is the text "HEALTHCARE PRODUCTS INC." in a smaller, sans-serif font. The logo is simple and professional, and it is likely used on the company's products and marketing materials.
Quality Assurance * St. Louis, MO 63110
1720 Sublette Avenue * St. Louis, MO 631110
Telephone: 314-771-2400 * Fax 314-268-1767
Indications for Use Statement
C:\WINDOWS\TEMP\Table of Contents_510k.doc
.
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: AHP300P, EMERGENCY PORTABLE VENTILATOR
Indications for Use: The AHP300P is intended to be used as an electrically controlled
emergency ventilator that requires an external compressed gas source. This ventilator is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patients airway. The ventilator is intended for use on patients weighing greater than 5kg (11 lbs). The ventilator is intended to be used in the environments associated with emergency medical services (EMS), Inter-hospital transport and hospital facilities usage. The ventilator is intended to be used in temperatures of -18 C to 50 C (0 F to 122 F) and 5% to 95 % relative humidity non-condensing.
Prescription Use: Yes
and/or
(Part 21 CFR 801 Subpart D)
Over-the-Counter Use: No
(Part 21 CFR Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anya C. Harry -S 2014.04.08 22:10:22 -04'00'
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