(73 days)
The ETCO2 Nasal Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen, up to 4 L/min, to a patient while providing a means to sample expired gas. The target population is adult and pediatric patients.
The proposed devices consist of a bifurcated nasal prong with two separate gas conduits. One side of the divided cannula is connected to a gas source for delivering low flow oxygen through flexible tubing to the patient. The other side of the divided cannula directs exhaled gas through flexible tubing to a carbon dioxide monitoring device
The acceptance criteria and the study proving the device meets them are described below for the CareFusion ETCO2 Nasal Cannula.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: Evaluation and Testing | The device meets the requirements of ISO 10993-1:2009, indicating it is biologically compatible. |
| Performance - Luer Taper Fit (General) | ISO 594-1 Conical fitting with 6% (Luer) taper for syringes, needles and certain other medical equipment: Part 1 - General Requirements | The device meets the requirements of ISO 594-1, indicating proper conical fitting. |
| Performance - Luer Taper Fit (Locking) | ISO 594-2 Conical fitting with 6% (Luer) taper for syringes, needles and certain other medical equipment: Part 2 - Lock Fittings | The device meets the requirements of ISO 594-2, indicating proper locking luer fittings. |
| Performance - Tubing and Connectors | BS EN 13544-2:2002 + A1:2009 Respiratory Therapy Equipment - Part 2: Tubing and Connectors | The device meets the requirements of BS EN 13544-2:2002 + A1:2009, indicating conformance for respiratory tubing and connectors. |
| Performance - Conical Connectors | ANSI/ISO 5356-1:2004 (MOD) Anesthetic and respiratory equipment - conical connectors - Part 1: Cones and Sockets | The device meets the requirements of ANSI/ISO 5356-1:2004 (MOD), indicating conformance for anesthetic and respiratory conical connectors. |
| Risk Management | ISO 14971:2009 Medical devices — Application of Risk Management to Medical Devices | The device meets the requirements of ISO 14971:2009, indicating appropriate application of risk management. |
| Gas Flow Bench Testing (O2 Delivery Line) | Maximum Flow Resistance: 138 mmH2O per foot @ 4 lpm, Pediatric (Acceptance Criteria: Maximum 138 mmH2O/foot) Maximum Flow Resistance: 119 mmH2O per foot @ 4 lpm, Adult (Acceptance Criteria: Maximum 119 mmH2O/foot) | The device's O2 delivery line demonstrates flow resistance within the specified limits for both pediatric (≤138 mmH2O/foot) and adult (≤119 mmH2O/foot) applications at 4 lpm, meeting the performance criteria. The exact reported values are not explicitly stated as "X mmH2O/foot" but rather as "Maximum Flow Resistance" followed by the acceptance criteria, implying that the device's performance does not exceed these maximums. |
| Gas Flow Bench Testing (CO2 Cannula Sampling Line) | Maximum Flow Resistance: 51 mmH2O per foot @ 0.5 lpm, Pediatric (Acceptance Criteria: Maximum 51 mmH2O/foot) Maximum Flow Resistance: 65 mmH2O per foot @ 0.5 lpm, Adult (Acceptance Criteria: Maximum 65 mmH2O/foot) | The device's CO2 cannula sampling line demonstrates flow resistance within the specified limits for both pediatric (≤51 mmH2O/foot) and adult (≤65 mmH2O/foot) applications at 0.5 lpm, meeting the performance criteria. Similar to the O2 line, the reporting structure suggests adherence to these maximums. |
| Gas Flow Bench Testing (CO2 Sampling Line) | Maximum Flow Resistance: 64 mmH2O per foot @ 0.5 lpm (Acceptance Criteria: Maximum 64 mmH2O/foot) | The device's CO2 sampling line demonstrates flow resistance within the specified limit (≤64 mmH2O/foot) at 0.5 lpm, meeting the performance criteria. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "non-clinical tests" and "bench testing" without providing specific sample sizes for each test.
- Data Provenance: The tests are non-clinical, implying they were conducted in a laboratory or engineering setting ("bench testing"). There is no mention of country of origin for the data, but the manufacturer, CareFusion, is based in McGaw Park, IL, USA. The study design is not a clinical study, so the retrospective/prospective distinction is not directly applicable in the typical sense; these are device verification and validation tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable (N/A) as the study performed was non-clinical bench testing for a medical device (ETCO2 Nasal Cannula), not a study involving human data interpretation or diagnostic accuracy. Therefore, there was no "ground truth" to be established by human experts in the context of diagnostic performance. The "ground truth" for these tests would be the established engineering and safety standards themselves.
4. Adjudication method for the test set:
This information is not applicable (N/A) for the same reason as point 3. Adjudication methods are typically used in studies where there is subjective interpretation or disagreement among experts, which is not the case for non-clinical bench testing against objective standards.
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 MRMC comparative effectiveness study was done. This is a non-clinical submission for a physical medical device (nasal cannula) and does not involve AI or human readers for diagnostic assessment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable (N/A). The device is a physical medical device (nasal cannula) and does not involve an algorithm, AI, or software for standalone performance.
7. The type of ground truth used:
The "ground truth" for the non-clinical tests was the established technical and safety standards (e.g., ISO, BS EN, ANSI/ISO standards, and specific maximum flow resistance values determined by engineering specifications). The device was tested against these predefined performance requirements.
8. The sample size for the training set:
Not applicable (N/A). There was no training set, as this project involved non-clinical testing of a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable (N/A). As there was no training set, there was no ground truth for a training set to be established.
{0}------------------------------------------------
MAY - 4 2012
. !
Summary of Safety and Effectiveness
The Summary of 510(k) safety and effectiveness is in accordance with 21 CFR 807.92.
| Name | CareFusion |
|---|---|
| Address | 1500 Waukegan Road MPWM, McGaw Park, IL 60085 USA |
| Phone number | (847) 473-7208 |
| Fax number | (847) 473-7774 |
| Establishment RegistrationNumber | 8030673 |
| Name of contact person | Erika Fernandez |
| Date prepared | February 20, 2012 |
| NAME OF DEVICE | |
|---|---|
| Trade or proprietary name | ETCO2 Nasal Cannula |
| Common or usual name | Oxygen Delivery, CO2 Sampling Cannula |
| Classification name | Carbon Dioxide Gas Analyzer |
| Classification panel | 73 Anesthesiology |
| Regulation | Class II per 21CFR §868.1400 |
| Product Code(s) | CCK |
| Legally marketed device(s) towhich equivalence is claimed | K863883: Models 4002/4102/4202 Oxy. Delivery/CO2 CannulaK892406: Modified oxygen delivery/CO2 Sample Nasal Cannula |
| Device description | The proposed devices consist of a bifurcated nasal prong with two separate gasconduits. One side of the divided cannula is connected to a gas source fordelivering low flow oxygen through flexible tubing to the patient. The other side ofthe divided cannula directs exhaled gas through flexible tubing to a carbondioxide monitoring device |
| Intended use | The ETCO2 Nasal Cannula is an adjunct to oxygen therapy with its primaryfunction being that of delivering low flow oxygen, up to 4 L/min, to a patient whileproviding a means to sample expired gas. The target population is adult andpediatric patients. |
| CATALOG NUMBER /MODEL NUMBERS AND DESCRIPTION | |
| 2802M-10 | Pediatric with 7' O2 tube and 7' CO2 tube with male luer connector |
| 2802F-10 | Pediatric with 7' O2 tube and 7' CO2 tube with female luer connector |
| 2811M-10 | Adult with 7' O2 tube and 2" CO2 tube with male luer connector |
| 2811F-10 | Adult with 7' O2 tube and 2" CO2 tube with female luer connector |
| 2812M-10 | Adult with 7' O2 and 7' CO2 tube with male luer connector |
| 2812F-10 | Adult with 7' O2 and 7' CO2 tube with female luer connector |
| 28M2M | ETCO2 Sample Line10' Tube, Male/Male Connectors |
| 28M2F | ETCO2 Sample Line10' Tube, Male/Female Connectors |
{1}------------------------------------------------
| Characteristic | Predicate | New Device |
|---|---|---|
| Design | Divided Cannula | Same |
| Salter Eyes® (Side holes) in adult prongs | No Salter Eyes® (Side holes) in adult prongs | |
| 7' smooth O2 & 7' smooth CO2 paired tubing or | Same | |
| 7' crush resistant O2 tube & 2" smooth CO2 tube | Same | |
| Male or female luer connector | Same | |
| 10'Sample line with male and female connectors | Same | |
| 22mm x 6mm connector | Same | |
| Universal O2 connector | Same | |
| Material | ||
| Cannula; adult & pediatric | Flexible PVC | Same |
| All Tubing; 7' crush resistant & smooth, 10' & 2" smooth | Flexible PVC | Same |
| Sliding component (lariat) | Polyolefin | Similar |
| Luer Lock Connector, Male | Rigid thermoplastic | Similar |
| Luer Lock Connector, Female | Rigid thermoplastic | Similar |
| Tubing Connector (Y) | Flexible PVC | Similar |
| Universal Connector (Vinyl tip) | Flexible PVC | Similar |
| 22mm x 6mm connector | Polyolefin | Similar |
| Sterilization | Non sterile, single use | Same |
| Packaging configuration | Individually packaged in heat-sealed poly bag with product insert that includes the Instructions for Use.10 units per shipping carton. | Individually packaged in tape-sealed poly bag with product insert that includes the Instructions for Use.10 units per shipping carton. |
.
.
:
{2}------------------------------------------------
| PERFORMANCE DATA | |
|---|---|
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE | |
| Performance Test Summary | |
| Characteristic | Standard/Test/FDA Guidance |
| Biocompatibility | ISO 10993-1:2009Biological evaluation of Medical Devices Part 1: Evaluation and Testing |
| Performance | ISO 594-1Conical fitting with 6% (Luer) taper for syringes, needles and certain other medicalequipment: Part 1- General Requirements |
| Performance | ISO 594-2Conical fitting with 6% (Luer) taper for syringes, needles and certain other medicalequipment: Part 2- Lock Fittings |
| Performance | BS EN 13544-2:2002 + A1:2009Respiratory Therapy Equipment - Part 2: Tubing and Connectors |
| Performance | ANSI/ISO 5356-1:2004 (MOD)Anesthetic and respiratory equipment - conical connectors - Part 1: Cones andSockets |
| Performance | ISO 14971:2009Medical devices — Application of RiskManagement to Medical Devices |
| Performance | Gas Flow Bench Testing (O2 Delivery Line)Maximum Flow Resistance: 138 mmH2O per foot @ 4 lpm, PediatricMaximum Flow Resistance: 119 mmH2O per foot @ 4 lpm, Adult |
| Performance | Gas Flow Bench Testing (CO2 Cannula Sampling Line)Maximum Flow Resistance: 51 mmH2O per foot @ 0.5 lpm, PediatricMaximum Flow Resistance: 65 mmH2O per foot @ 0.5 lpm, Adult |
| Performance | Gas Flow Bench Testing (CO2 Sampling Line)Maximum Flow Resistance: 64 mmH2O per foot @ 0.5 lpm |
EQUIVALENCE AND/OR OF CLINICAL INFORMATION
N/A - No clinical tests were conducted for this submission
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The results of the non-clinical tests show that the ETCO2 Nasal Cannula meets all performance requirements, and is substantially equivalent to the predicate devices.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Erika Fernandez Regulatory Affairs Manager CareFusion 1500 Waukegan Road Waukegan, Illinois 60085
MAY - 4 2012
Re: K120518
Trade/Device Name: End-Tidal CO2 Nasal Cannula Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Das Analyzer Regulatory Class: II Product Code: CCK Dated: April 3, 2012 Received: April 5, 2012
Dear Ms. Fernandez:
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.
Page 2 - Ms. Fernandez
{4}------------------------------------------------
Page 2 - Ms. Fernandez
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm_for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image contains the logo for CareFusion. To the left of the company name is a circular graphic with a white heart shape inside. The company name is written in a simple, sans-serif font and is in black.
1500 Waukegan Road McGaw Park, Illinois 60085 phone: 847.473.1500
carefusion.com
Indication for Use
510(k) Number (if known): Unknown at this time Device Name: End-Tidal CO2 Nasal Cannula Indications for Use: The ETCO2 Nasal Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen, up to 4 Umin, to a patient while providing a means to sample expired gas. The target population is adult and pediatric patients. Over-The Counter Use ___ Prescription Use _____________________________________________________________________________________________________________________________________________________________ OL (Per 21 CFR 870 Subpart C) (Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE)
L. Schultz
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120519
§ 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).