(235 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description is for a basic automatic resuscitator.
Yes
The device is described as an "Automatic Resuscitator" that delivers "emergency, short term, constant flow - pressure cycled ventilatory support," which are therapeutic actions.
No
The device is described as an "Automatic Resuscitator" intended to "deliver emergency, short term, constant flow - pressure cycled ventilatory support," which indicates it is a therapeutic device rather than one used for diagnosis.
No
The device description "RespirTech PRO™ 2000 - Automatic Resuscitator" strongly suggests a hardware device, not software only. The intended use also describes delivering ventilatory support, which is a physical action typically performed by hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver emergency, short term, constant flow - pressure cycled ventilatory support." This describes a device that directly interacts with a patient's respiratory system to provide life support.
- Device Description: The device is described as an "Automatic Resuscitator." This further confirms its function as a life-support device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Using reagents or other laboratory components
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to provide mechanical ventilation, which is a therapeutic intervention, not a diagnostic one.
N/A
Intended Use / Indications for Use
The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.
Product codes
73 BTL
Device Description
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Mentions image processing
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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
properly trained personnel
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): 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
§ 868.5925 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, which is a symbol of medicine, with three lines representing the staff and two snakes intertwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 12 1998
Gordon A. Wong, M.D. VORTRAN Medical Technology, Inc. 3941 J Street, Suite 354 Sacramento, CA 95819-3633
Re: K973975 RespirTech PRO™ - Automatic Resuscitator Regulatory Class: II (two) Product Code: 73 BTL March 10, 1998 Dated: Received: March 17, 1998
Dear Dr. Wong:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Gordon A. Wong, M.D.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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VORTRAN Medical Technology, Inc.
Page 1 of 1
510(k) Number (if known):
Device Name: RespirTech PRO™ 2000 Indication for Use:
The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.
(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 Cardiovascular, Respiratory, and Neurological Devices | |
|---|---|
| 510(k) Number | K973975 |
| Prescription Use : | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 810.109) |
(Optional Format 1-2-96)
RT-IUSE.DOC