(73 days)
Not Found
No
The device description and intended use describe a physical medical device for delivering oxygen and sampling gas, with no mention of software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device delivers low-flow oxygen, which is a therapeutic function, but its primary purpose is sampling expired gas for monitoring, making it more of a diagnostic or monitoring accessory rather than a standalone therapeutic device.
No
Explanation: The device's primary function is delivering oxygen and sampling expired gas. While the gas sampling component could be used with a diagnostic device (a carbon dioxide monitor), the cannula itself is an accessory that facilitates gas delivery and sampling, not a diagnostic device that interprets or analyzes data to make a diagnosis.
No
The device description clearly outlines a physical, bifurcated nasal cannula with tubing for oxygen delivery and expired gas sampling, 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 primary function is delivering oxygen and sampling expired gas. This is a direct interaction with the patient's respiratory system, not the analysis of a biological sample in vitro (outside the body).
- Device Description: The device is a nasal cannula designed for gas delivery and sampling from the patient's airway.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests to diagnose conditions based on such analysis. The device is a tool for monitoring a physiological parameter (expired gas/CO2) in vivo.
IVD devices are typically used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device facilitates the collection of a sample (expired gas) for analysis by a separate monitoring device, but the cannula itself is not performing the diagnostic test.
N/A
Intended Use / 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 L/min, to a patient while providing a means to sample expired gas. The target population is adult and pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
CCK
Device Description
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
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
adult and pediatric patients.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted.
Performance tests included evaluation against ISO 10993-1:2009 (Biocompatibility), ISO 594-1, ISO 594-2, BS EN 13544-2:2002 + A1:2009, ANSI/ISO 5356-1:2004 (MOD) (Performance of conical fittings), and ISO 14971:2009 (Risk Management).
Gas Flow Bench Testing was performed for both O2 Delivery Line and CO2 Cannula Sampling Line.
Gas Flow Bench Testing (O2 Delivery Line): Maximum Flow Resistance: 138 mmH2O per foot @ 4 lpm, Pediatric; Maximum Flow Resistance: 119 mmH2O per foot @ 4 lpm, Adult.
Gas Flow Bench Testing (CO2 Cannula Sampling Line): Maximum Flow Resistance: 51 mmH2O per foot @ 0.5 lpm, Pediatric; Maximum Flow Resistance: 65 mmH2O per foot @ 0.5 lpm, Adult.
Gas Flow Bench Testing (CO2 Sampling Line): Maximum Flow Resistance: 64 mmH2O per foot @ 0.5 lpm.
No clinical tests were conducted for this submission. 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.
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.
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
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 Registration | |
| Number | 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) to | |
| which equivalence is claimed | K863883: Models 4002/4102/4202 Oxy. Delivery/CO2 Cannula |
| K892406: Modified oxygen delivery/CO2 Sample Nasal Cannula | |
| Device description | 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 | |
| Intended 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 L/min, to a patient while | |
| providing a means to sample expired gas. The target population is adult and | |
| pediatric 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 OF | |
| SUBSTANTIAL EQUIVALENCE | |
| Performance Test Summary | |
| Characteristic | Standard/Test/FDA Guidance |
| Biocompatibility | ISO 10993-1:2009 |
| Biological evaluation of Medical Devices Part 1: Evaluation and Testing | |
| Performance | ISO 594-1 |
| Conical fitting with 6% (Luer) taper for syringes, needles and certain other medical | |
| equipment: Part 1- General Requirements | |
| Performance | ISO 594-2 |
| Conical fitting with 6% (Luer) taper for syringes, needles and certain other medical | |
| equipment: Part 2- Lock Fittings | |
| Performance | BS EN 13544-2:2002 + A1:2009 |
| Respiratory Therapy Equipment - Part 2: Tubing and Connectors | |
| Performance | ANSI/ISO 5356-1:2004 (MOD) |
| Anesthetic and respiratory equipment - conical connectors - Part 1: Cones and | |
| Sockets | |
| Performance | ISO 14971:2009 |
| Medical devices — Application of Risk | |
| Management to Medical Devices | |
| Performance | Gas Flow Bench Testing (O2 Delivery Line) |
| Maximum Flow Resistance: 138 mmH2O per foot @ 4 lpm, Pediatric | |
| Maximum 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, Pediatric | |
| Maximum 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