(115 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other indicators of AI/ML technology.
Yes
The device is used to provide lung ventilation to individuals whose breathing is inadequate, which directly involves treating a medical condition or assisting with a bodily function.
No
Explanation: The device is described as providing "lung ventilation to individuals whose breathing is inadequate," which indicates a therapeutic or life-support function rather than a diagnostic one. It does not mention identifying or characterizing a disease or condition.
No
The summary describes a device for lung ventilation, which inherently requires hardware to deliver air. The lack of a device description prevents confirmation, but the intended use strongly suggests 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 to provide lung ventilation to individuals with inadequate breathing in emergency situations. This is a therapeutic or life-support function, not a diagnostic one.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the examination of such specimens.
The device's function is to directly assist with breathing, which is a physiological process, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
To be used in emergency situations to provide lung ventilation to individuals whose breathing is inadequate.
Product codes
BTM
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
emergency situations
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
§ 868.5915 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 and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
AUG 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Lu Official Correspondent David Medical Products Company Limited No. 88, Fuda Road, Ludu Taicang, Suzhou, Jiangsu, CHINA 215412
Re: K051177
Trade/Device Name: PVC Manual Resusciator, DA-00131, DA-00132, DA-00133; Silicone Manual Resusciator, DA-00171, DA-00172, DA-00173 Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: August 20, 2005 Received: August 26, 2005
Dear Mr. Lu:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinone, or to actived Cosmetic Act (Act) that do not require approval of a premarket the Fouch application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provided by an an 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 Cc :1trols) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mrs), it may be subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can oo found in the announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Lu
Please be advised that FDA's issuance of a substantial equivalence determination does not Fleast be advisod that I D11 o lobalization that your device complies with other requirements modi that I Dr mas made a aves and regulations administered by other Federal agencies. of the Act of any I ederal can its requirements, including, but not limited to: registration 1 ou must comply with and art any, labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 067), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality is a 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) This feter will anon yourse bogan and equivalence of your device of your device to a premairer notified.com - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at not to read in (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 may other 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,
Syvette 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
David Medical Products ( SUZHOV) Co., Ltd. Address: No. 88, Fuda Rd. Ludu, Taicang, Suzhou, Jiangsu, CHINA 215412 Tel: 86-512-53456709 Fax: 86-512-53456719 E-mail: davidmed@pub.sz.jsinfo.net http:// www.triad-orthopedic.com.tw
Indications for Use
510 (K) NUMBER ( IF KNOW ):_ ] くのS//フフ
DEVICE NAME: PVC Manual Resusciator, DA-00131, DA-00132, DA-00133;
Silicone Manual Resusciator, DA-00171, DA-00172, DA-00173
INDICATIONS FOR USE:
To be used in emergency situations to provide lung ventilation to individuals whose breathing is inadequate.
Prescription Use V (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)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K051177 |
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