(42 days)
Not Found
Not Found
No
The summary describes a cannula for gas detection and delivery, with no mention of AI or ML capabilities.
No
The device is used for detection and delivery of gases, which are diagnostic and supportive functions, not directly therapeutic.
Yes
The device is intended for "simultaneous detection of respiratory airflow" and "sampling, or delivery, of gases, such as EtC02 or oxygen," which indicates it is used to gather information about the patient's physiological state. Detection and sampling for diagnostic purposes fall under the definition of a diagnostic device.
No
The 510(k) summary describes a "Pro-Flow MultiPurpose Cannula," which is a physical device used for respiratory airflow detection and gas sampling/delivery. This is clearly a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for "simultaneous detection of respiratory airflow and sampling, or delivery, of gases, such as EtC02 or oxygen." This involves interacting directly with the patient's respiratory system and analyzing gases from the patient, not analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Performing tests on samples in a laboratory setting
- Providing diagnostic information based on the analysis of samples
The Pro-Flow MultiPurpose Cannula appears to be a device used for monitoring and delivering gases directly to a patient, which falls under the category of a medical device used for patient monitoring and therapy, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Intended for use for simultaneous detection of respiratory airflow and sampling, or delivery, of gases, such as EtCO2 or oxygen.
Product codes
CCK
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
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked on top of each other.
Public Health Service
DEC 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Neil Sheller Pro-Tech Services, Incorporated 4338 Harbour Pointe Boulevard, S.W. Mukilteo, Washington 98275
Re: K053063
Trade/Device Name: Pro-Flow MultiPurpose Cannula Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: October 20, 2005 Received: November 3, 2005
Dear Mr. Sheller:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the received above and have and have a molosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device merslate commerce prior to way to was reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket the I cuclar I vou, Drag, and Osbu may, therefore, market the device, subject to the general approval uppreadion (The Act. The general controls provisions of the Act include controls providens of an 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 If your device is classified (oos assile) in a controls. Existing major regulations affecting (1 Mr), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear of toundsh further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Sheller
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. or the rice of any a with all the Act's requirements, including, but not limited to: registration 1 od into compry 7 11 CFR Part 801); labeling (21 CFR Part 801); good manufacturing practice and ifsing (s 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) rrent reter 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), n from and the Office of Compliance at (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 maj obtain 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,
Cluts
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
510(k) Number (if known): K053063
Device Name: Pro-Flow MultiPurpose Cannula
Indication for Use:
indocuses not of the may be intended for use for simultaneous detection of respiratory airflow
MultiPurpose of the county as a such as EfC02 or oxygen Pro-Flow MultiPurpose - Cannalde are International and sampling, or oxygen.
and sampling, or delivery, of gases, such as EtC02 or oxygen.
Prescription Use ____________ Over-The-Counter Use_________________________________________________________________________
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
(Posted July 1, 1998)
Arny Safram
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental B 510(k) Number: