(50 days)
O2 Nasal Cannula with CO2 monitoring is intended for use in Adult patients who require supplemental oxygen delivery and CO2 monitoring
O2 Nasal cannula with CO2 monitoring that is intended to situate under the patients nose with the prongs of the cannula inserted into patients nostrils where oxygen is administered and CO2 monitored. The O2 Nasal cannula with CO2 monitoring has two co-extruded tubes
This document is a 510(k) Summary for the Flexicare O2 Nasal cannula with CO2 monitoring. It details the device's characteristics and its substantial equivalence to a predicate device, but it does not describe acceptance criteria for an AI/ML powered device nor a study proving performance against such criteria.
The document addresses a medical device that does not incorporate AI/ML. Therefore, much of the requested information regarding AI/ML-specific testing (e.g., sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable and is not present in the provided text.
Here's an analysis based on the information provided, highlighting the absence of AI/ML-specific details:
1. Table of Acceptance Criteria and Reported Device Performance
The document sets out various physical and functional tests, comparing the Flexicare O2 Nasal cannula with CO2 monitoring to established standards and the predicate device. The "acceptance criteria" here are generally compliance with physical dimensions, material properties, and functional performance as outlined by relevant EN and ISO standards, or as performing "at least as well as" the predicate device.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Material & Physical Properties | |||
| 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) | Matches predicate and described components. | Not explicitly stated as "passed," but implied by substantial equivalence claim. |
| Materials | PVC, Polypropylene, ABS | Matches predicate and described materials. | Not explicitly stated as "passed," but implied by substantial equivalence claim. |
| Assembly Method | Bonded - Solvent adhesive | Matches predicate and described method. | Not explicitly stated as "passed," but implied by substantial equivalence claim. |
| Dimensional Specifications | |||
| Color/Size/Material | Devices displayed a high level of substantial equivalence. All within 0.1mm of each other. ID's are classed as critical for resistance/rate through tube. All materials are the same, with any differences being minor (e.g., color/finish). | Met criteria. | "All Samples passed the performance testing." |
| O2 Tubing ID | 3.9mm | 3.9mm | Confirmed by dimensional inspection. |
| O2 Tubing OD | 5.0mm | 5.0mm | Confirmed by dimensional inspection. |
| O2 Tubing Length | 2100mm | 2100mm | Confirmed by dimensional inspection. |
| CO2 Tubing ID | 1.4mm | 1.4mm | Confirmed by dimensional inspection. |
| CO2 Tubing OD | 2.7mm | 2.7mm | Confirmed by dimensional inspection. |
| CO2 Tubing Length | 2100mm | 2100mm | Confirmed by dimensional inspection. |
| Functional Performance | |||
| Nipple dimensions (on venturi barrel supplied with cannula) | In-House Test | Passed. | "All Samples passed the performance testing." |
| Strength of nipple (on venturi barrel supplied with cannula) | BS EN13544-2: 2002 +A1:2009 Annex A5 | Passed. | "All Samples passed the performance testing." |
| Tubing flow resistance | In-House Test | Passed. | "All Samples passed the performance testing." |
| O2 Connector to tubing tensile strength | In-House Test | Passed. | "All Samples passed the performance testing." |
| O2 Connector to nipple tensile strength | In-House Test | Passed. | "All Samples passed the performance testing." |
| Tube resistance to kinking | In-House Test | Passed. | "All Samples passed the performance testing." |
| Dimensional inspection of luer conical | ISO 594-1 / BS EN 20594-1:1994 | Passed. | "All Samples passed the performance testing." |
| Gauging tests on luer | In-House Test | Passed. | "All Samples passed the performance testing." |
| Liquid leakage from luer | In-House Test | Passed. | "All Samples passed the performance testing." |
| Air leakage from luer | In-House Test | Passed. | "All Samples passed the performance testing." |
| Luer separation force | ISO 594-2 (BS EN 1707:1997) | Passed. | "All Samples passed the performance testing." |
| Luer unscrewing torque | In-House Test | Passed. | "All Samples passed the performance testing." |
| Compliance with Standards | BS EN 13544-2: 2002 +A1:2009 Annex A4 and A5 | Yes | Implied by the "Conforms to: Yes" statement and successful testing. |
The study proving the device meets these criteria is described as "Tests Performed" on page 3 and summarized on page 4. It states: "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 monitor...performs at least as well as marketed predicate dev Unomedical."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the "test set" (i.e., the number of cannulas tested). It generically refers to "All Samples."
- Data Provenance: Not applicable in the context of device performance testing. The tests are physical and functional evaluations of manufactured units, not data-driven intelligence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the device is a physical medical device, not an AI/ML system requiring expert ground truth for classification or diagnosis. The "ground truth" for this device's performance is objective measurement against engineering specifications and industry standards.
4. Adjudication Method for the Test Set
This is not applicable as there is no human interpretation or classification involved that would require adjudication. Performance is measured objectively.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC study was not done, and this question is not applicable because the device is a physical nasal cannula, not an AI-assisted diagnostic or clinical decision support system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering specifications, dimensional tolerances, and compliance with recognized industry standards (e.g., BS EN 13544-2, ISO 594-1, ISO 594-2). In-house test methods are also used for aspects not covered by specific standards. The implicit ground truth for "at least as well as" is the performance of the predicate device.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI/ML system and does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI/ML system and does not have a "training set."
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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:
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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
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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 CO2monitoringK: Unknown | Unomedical - MCO2 gas samplingwas c | |
|---|---|---|
| Conforms to: | Yes | |
| BS EN 13544-2:2002 +A1:2009Annex A4AndBS EN 13544-2:2002 +A1:2009Annex A5 | ||
| Components | Co extruded O2/CO2 tubingluer connector (male/female)Cannula delivery/cannula prongsO2 ConnectorTube slideY-pieceVenturi barrelHydrophilic filter (option) | Co exluer cCannula |
| Materials | PVCPolypropyleneABS | |
| Assemblymethod | Bonded - Solvent adhesive | Bon |
| Targetpopulation | Adult | |
| Home use | No | |
| Hospital/emergency use | Yes | |
| Connectable toCapnograph? | Yes |
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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. Allwithin 0.1mm of each other. ID's are classed as critical dirresistance/rate through tubAll materials are the same, with any differences being mine.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 barrelsupplied with cannula) | |
| Strength of nipple(on venturi barrelsupplied with cannula) | BS EN13544-2: 2002 +A1:2009Annex 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 |
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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.
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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.
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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
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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
§ 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).