(274 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
Explanation: The device, an emergency ventilator, provides respiratory support, which is a therapeutic intervention aimed at treating a medical condition.
No
Explanation: The device is an emergency ventilator, designed to provide respiratory support, not to diagnose a condition.
No
The device description explicitly states "AHP300 (with internal compressor)" and "electrically controlled emergency ventilator," indicating the presence of hardware components (compressor, electrical controls) beyond just software.
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 AHP300 is an "electrically controlled emergency ventilator" designed to provide "emergency respiratory support" by delivering air to a patient's airway. This is a therapeutic and life-support function, not a diagnostic one.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The AHP300 does not perform any such tests on bodily samples.
- Lack of Diagnostic Elements: The description focuses on the mechanical and functional aspects of providing ventilation, not on analyzing biological samples or providing diagnostic information.
Therefore, the AHP300 is a medical device, but it falls under the category of a therapeutic or life-support device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The AHP300 (with internal compressor) is intended to be used as an electrically controlled emergency ventilator. This ventilator 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 5kg (11 1bs). The ventilator is intended to be used in the environments associated with emergency medical services (EMS), inter-hospital transport and hospital facilities usage by qualified, trained personnel under the direction of a physician. 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 (comma separated list FDA assigned to the subject device)
BTL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
patient's airway
Indicated Patient Age Range
patients weighing greater than 5kg
Intended User / Care Setting
qualified, trained personnel under the direction of a physician. The ventilator is intended to be used in the environments associated with emergency medical services (EMS), inter-hospital transport and hospital facilities usage
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 2, 2014
Allied Healthcare C/O Mr. John Smith Partner 555 Thirteenth Street NW WASHINGTON D.C. 20004
Re: K132021
Trade/Device Name: AHP300 Emergency Portable Ventilator Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: March 5, 2014 Received: March 5, 2014
Dear Mr. 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 that I DA has made a doloriniations administered by other Federal agencies. You must of any I edelal statutes and regulations anchuding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Cr K rat 607), acceing (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Smith
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), 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/Reportal":gblem/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 yours,
Digitally signed by Richard C. Chapman : 上一 Date: 2014.04.02 16:46:56 -04 00
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K132021
Device Name
AHP300 Emergency Portable Ventilator
Indications for Use (Describe)
The AHP300 (with internal compressor) is intended to be used as an electrically controlled emergency ventilator. This ventilator 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 5kg (11 1bs). The ventilator is intended to be used in the environments associated with emergency medical services (EMS), inter-hospital transport and hospital facilities usage by qualified, trained personnel under the direction of a physician. 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
CONTRACT FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR F Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Digitally signed by Richard C. Chapman Date: 2014.04.02 16:35:09 -04'00
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