(442 days)
Not Found
Not Found
No
The summary describes a mechanical bellows-type ventilator and explicitly states that AI, DNN, or ML were not found in the document.
Yes
The device is described as an "artificial respiration" device for "a distressed person having temporarily no ability to breath by him/herself," which indicates it is used to treat a medical condition.
No
The device is described as a "pumping apparatus of the bellows type, which is adapted for artificial respiration," indicating it is a therapeutic device for breathing assistance, not for diagnosing conditions.
No
The device description explicitly states it is a "pumping apparatus of the bellows type," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "artificial respiration of a distressed person having temporarily no ability to breath by him/herself." This describes a device used on a patient to support a physiological function (breathing).
- Device Description: The description is "a pumping apparatus of the bellows type, which is adapted for artificial respiration." This further reinforces that it's a mechanical device used for breathing support.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status. The provided information does not mention any specimen analysis or in vitro testing.
Therefore, the Acuteventilator, as described, is a medical device used for respiratory support, not an IVD.
N/A
Intended Use / Indications for Use
The Acuteventilator is a pumping apparatus of the bellows type, which is adapted for artificial respiration of a distressed person having temporarily no ability to breath by him/herself.
Product codes
BTM
Device Description
The Acuteventilator is a pumping apparatus of the bellows type, which is adapted for artificial respiration of a distressed person having temporarily no ability to breath by him/herself.
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
Not Found
Intended User / Care Setting
Not Found
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
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): 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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, 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 features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 -
Ms. Rosina Robinson Senior Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
OCT 0 4 2002
Re: K012271 Trade/Device Name: Acuteventilator Regulation Number: 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: July 11, 2002 Received: July 12, 2002
Dear Ms. Robinson:
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.
1
Page 2 - Ms. Robinson
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K012271/,
Page 1 of 1
: :
510(K) Number (if known): K012271
Device Name: Acuteventilator _________________________________________________________________________________________________________________________________________________
Indications For Use:
The Acuteventilator is a pumping apparatus of the bellows type, which is adapted for artificial respiration of a distressed person having temporarily no ability to breath by him/herself.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801 109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K012271 |
|---|---|
| ---------------- | ---------------------------------------------------------- |
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