(50 days)
Not Found
No
The summary describes a physical device for oxygen delivery and CO2 monitoring with no mention of AI or ML algorithms for data analysis or interpretation.
Yes
The device is used to deliver supplemental oxygen and monitor CO2, which are therapeutic interventions for patients requiring them.
No
The device is described as an "O2 Nasal cannula with CO2 monitoring" which delivers oxygen and monitors CO2. While it measures a physiological parameter (CO2), its primary stated purpose within the "Intended Use / Indications for Use" is monitoring, not diagnosing a disease or condition. Diagnostic devices are typically used to identify the presence or absence of a disease or condition, or to monitor the progression of a disease. This device appears to be for general patient monitoring and supplemental oxygen delivery.
No
The device description explicitly states it is a "O2 Nasal cannula with CO2 monitoring" and describes physical components like "prongs" and "co-extruded tubes," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "supplemental oxygen delivery and CO2 monitoring" in adult patients. This describes a device that interacts directly with the patient's respiratory system to deliver a substance (oxygen) and measure a physiological parameter (CO2 in exhaled breath).
- Device Description: The description details a physical device (nasal cannula) that is placed on the patient and has tubes for oxygen delivery and CO2 monitoring.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status. This device does not involve the analysis of a specimen outside the body.
The device described is a medical device used for patient monitoring and therapy, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
O2 Nasal cannula with CO2 monitoring is intended for use in Adult patients who require supplemental oxygen delivery and CO2 monitoring
Product codes (comma separated list FDA assigned to the subject device)
CCK
Device Description
O2 Nasal cannula with CO2 monitoring is intended to situate under the patient’s nose, with the prongs of the cannula inserted into patient’s nostrils. From here, oxygen is administered and CO2 monitoring can be carried out. The O2 Nasal cannula with CO2 monitoring features O2 delivering prongs with co-extruded tubes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nostrils
Indicated Patient Age Range
Adult
Intended User / Care Setting
Hospital/Emergency Use
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)
Tests Performed: Visual inspection, Nipple dimensions (on venturi barrel supplied with cannula), Strength of nipple(on venturi barrel supplied with cannula), Tubing flow resistance, O2 Connector to tubing tensile strength, O2 Connector to nipple tensile strength, Tube resistance to kinking, Dimensional inspection of luer conical, Gauging tests on luer, Liquid leakage from luer, Air leakage from luer, Luer separation force, Luer unscrewing torque.
All Samples passed the performance testing when tested against methods House test methods and relevant BS EN standards. The results of this testing show that the O2 Nasal cannula with CO2 monitoring passed all performance tests and performs at least as well as marketed predicate device Unomedical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Passed all performance tests.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows a logo with the word "flex" in a stylized font. The "f" is designed with two curved lines, and the rest of the letters are in a bold, sans-serif typeface. Below the word "flex" are the words "TOTAL QUALITY" in a smaller, sans-serif font.
510(k) Summary
Trade name
C.F.R Section Product Code:
Manufacturer:
O2 Nasal cannula with CO2 monitorin
21 CFR 868.1400. Carbon Dioxide ga CCK
Flexicare Medical Limited Cynon Valley Business Park Mountain Ash, Mid. Glam. CF45 4ER. United Kingdom
Christopher Watkins Quality Regulatory & Technical Direct Flexicare Medical Limited Cynon Valley Business Park Mountain Ash, Mid. Glam. CF45 4ER. United Kingdom
00 44 1443 471 593
March 2014
Nasal cannula with CO2 monitoring
Class 2
Unomedical - Mac-Safe (was Hospita sampling/oxygen delivery cannula") w marketing by 510(k) No K915228.
02 Nasal cannula with CO2 monitorin that is intended to situate under the p prongs of the cannula inserted into pa oxygen is administered and CO2 mor The O2 Nasal cannula with CO2 mon administaring pronos tuto slide co-e
Telephone:
Date Summary Prepared:
Regulatory Affairs Contact:
Common Name:
Classification:
Predicate Device
Description:
1
Image /page/1/Picture/0 description: The image shows a stylized logo. The logo features a stylized letter 'f' with curved lines, followed by the letters 'le'. Below the letters 'le' is the word 'TOTAL'. The logo appears to be for a company or organization, but without additional context, the specific nature of the company is unclear.
The O2 Nasal cannula with CO2 mon extruded tubes
Part Numbers:
| Nasal cannula with CO2 monitoring | |
|---|---|
| 020-10-123U | O2 NASAL CANNULA WITH CO2 MONITORING - ADULT - MALE PIGT |
| 020-10-124U | O2 NASAL CANNULA WITH CO2 MONITORING - ADULT - FEMALE PI |
| 020-10-125U | O2 NASAL CANNULA WITH CO2 MONITORING - ADULT - MALE LUE |
| 020-10-125AU | O2 NASAL CANNULA WITH CO2 MONITORING - ADULT - MALE LUE |
| 020-10-126U | O2 NASAL CANNULA WITH CO2 MONITORING - ADULT - FEMALE L |
| 020-10-126AU | O2 NASAL CANNULA WITH CO2 MONITORING - ADULT - FEMALE L |
| 020-10-127U | O2 NASAL CANNULA WITH CO2 MONITORING - ADULT - MALE LUE |
| 020-10-128U | O2 NASAL CANNULA WITH CO2 MONITORING - ADULT - FEMALE L |
Intended Use:
02 Nasal cannula with CO2 monitoring is patients who require supplemental oxyge monitoring
Substantial Equivalence
02 Nasal cannula with CO2 monitorir use as predicate device:
- Unomedical Mac-Safe (was Hospita . sampling/oxygen delivery cannula") w marketing by 510(k) No K915228.
Both O2 delivering/CO2 monitoring de use devices.
Neither device is life supporting or life
Neither device uses software/ and are
Both O2 delivering/CO2 monitoring de sterile in individual poly bags.
Both O2 delivering/CO2 monitoring de came intended use in the same intent
2
Image /page/2/Picture/0 description: The image shows a logo with a stylized letter "f" in a bold, black font. The letter "f" is composed of two parallel lines that curve and extend upwards. To the right of the "f", the letters "le" are visible, also in a bold, black font. Below the letters, the word "TOTAL" is written in a smaller, sans-serif font.
| | FlexicareO2 Nasal cannula with CO2
monitoring
K: Unknown | Unomedical - M
CO2 gas sampling
was c |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Conforms to: | Yes | |
| BS EN 13544-2:
2002 +A1:2009
Annex A4
And
BS EN 13544-2:
2002 +A1:2009
Annex A5 | | |
| Components | Co extruded O2/CO2 tubing
luer connector (male/female)
Cannula delivery/cannula prongs
O2 Connector
Tube slide
Y-piece
Venturi barrel
Hydrophilic filter (option) | Co ex
luer c
Cannula |
| Materials | PVC
Polypropylene
ABS | |
| Assembly
method | Bonded - Solvent adhesive | Bon |
| Target
population | Adult | |
| Home use | No | |
| Hospital/
emergency use | Yes | |
| Connectable to
Capnograph? | Yes | |
3
Image /page/3/Picture/0 description: The image shows a logo with a stylized letter "f" that appears to be part of a word. The letters are thick and bold, with a unique design. Below the letter, there is the word "TOT" in smaller, sans-serif font.
| Colour/ size/
material | Devices displayed a high level of substantial equivalence. All
within 0.1mm of each other. ID's are classed as critical dir
resistance/rate through tub
All materials are the same, with any differences being min
e.g. colour/finish. | | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| ID/ OD/ length | ID: 3.9mm | | |
| 02 tubing | OD: 5.0mm | | |
| | Length: 2100mm | | |
| CO2 tubing | ID: 1.4 | | |
| | OD: 2.7 | | |
| | Length: 2100mm | | |
Tests Performed:
| Test | Standard? / In-House? |
|---|---|
| Visual inspection | In-House |
| Nipple dimensions (on venturi barrel | |
| supplied with cannula) | |
| Strength of nipple(on venturi barrel | |
| supplied with cannula) | BS EN13544-2: 2002 +A1:2009 |
| Annex A5 | |
| Tubing flow resistance | |
| O2 Connector to tubing tensile strength | |
| O2 Connector to nipple tensile strength | |
| Tube resistance to kinking | |
| Dimensional inspection of luer conical | ISO 594-1 / BS EN 20594-1:1994 |
| Dimensional inspection of luer conical | |
| Gauging tests on luer | |
| Liquid leakage from luer | |
| Air leakage from luer | |
| Luer separation force | ISO 594-2 (BS EN 1707:1997) |
| Luer unscrewing torque |
4
Image /page/4/Picture/0 description: The image shows a stylized logo, possibly for a company or brand. The logo features a bold, stylized letter 'f' with a double-line design, giving it a unique and modern appearance. Below the 'f', there is a smaller word, 'TOTAL', in capital letters, suggesting that the logo might be associated with a company named 'Total' or a product line with that name.
All Samples passed the performance testing when tested against methods House test methods and relevant BS EN standards.
The results of this testing show that the O2 Nasal cannula with CO2 monite performance tests and performs at least as well as marketed predicate dev Unomedical.
5
Image /page/5/Picture/0 description: The image shows a partial view of a logo or emblem. On the left side, there is a circular seal with text around the perimeter, including the words "HUMAN SERVICES" and "USA". Inside the seal, there is a stylized design that resembles an abstract representation of a human figure or a symbol related to health and human services. On the right side of the image, the word "DEPAR" is visible, suggesting that it is part of a larger word, likely "DEPARTMENT".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 6, 2014
Flexicare Medical Limited C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25TH Street NW Buffalo, MN 55313
Re: K140113
Trade/Device Name: 02 Nasal Cannula with CO2 Monitoring Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: February 18, 2014 Received: February 21, 2014
Dear Mr. Job:
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.
6
Please be advised that FDA's issuance of a substantial equivalence detern that FDA has made a determination that your device complies with other or any Federal statutes and regulations administered by other Federal agen comply with all the Act's requirements, including, but not limited to: regi CFR Part 807); labeling (21 CFR Part 801); medical device reporting (rep device-related adverse events) (21 CFR 803); good manufacturing practic forth in the quality systems (QS) regulation (21 CFR Part 820); and if app product radiation control provisions (Sections 531-542 of the Act); 21 CF
If you desire specific advice for your device on our labeling regulation (2 contact the Division of Small Manufacturers, International and Consumer free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.ht the regulation entitled, "Misbranding by reference to premarket notification 807.97). For questions regarding the reporting of adverse events under th CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under Division of Small Manufacturers, International and Consumer Assistance (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.h
Sincerely yours,
Image /page/6/Picture/5 description: The image shows a logo with the text "Tejashri Purohit-Sheth, M.D., Clinical Deputy Director, DAGRID". The logo is black and white and has a stylized design. The text is arranged in a way that it is easy to read. The logo is likely for a medical or clinical organization.
Erin I. Keith, M.S. Acting Director
7
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 on lest page.
510(k) Number (if known) K 1401 13
Device Name
..
O2 Nasal Cannula with CO2 monitoring
Indications for Use (Describe)
O2 Nasal Cannula with CO2 monitoring is intended for use in Adult patients who require supplemental oxygen delivery and CO2 monitoring
Type of Use (Select one or both, as epplicable)
. . ..
[X] 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.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/7/Picture/14 description: The image shows a combination of text and symbols. The text includes 'Todd D', '2014.03.06', and '-05'00'. There are also some illegible symbols and characters present in the image. The text and symbols are arranged in a somewhat disorganized manner.
FORM FDA 3881 (1/14)
Page Lot 1
es (104) 445-6