(69 days)
Not Found
No
The summary describes a physical medical device for oxygen delivery and gas sampling, with no mention of software, algorithms, or AI/ML capabilities.
No
The device delivers oxygen and samples expired gas, which are supportive functions for patient monitoring and care, but not direct therapeutic interventions aimed at treating a disease or condition. Its purpose is to facilitate monitoring and oxygen delivery, not to provide therapy itself.
No
The device primarily focuses on delivering oxygen and sampling expired gas to determine ventilatory rate, which is a measurement rather than a diagnostic interpretation of a patient's condition. While the data collected (expired gas) can be used diagnostically by a clinician, the device itself is not performing the diagnostic function.
No
The device description clearly indicates it is a physical, disposable medical device (nasal cannula) used for oxygen delivery and gas sampling, not a software application.
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 to determine ventilatory rate. This is a physiological measurement related to respiration, not an in vitro test performed on a sample outside the body to diagnose a disease or condition.
- Device Description: It's a cannula for delivering oxygen and sampling exhaled gas directly from the patient's nose.
- No mention of testing biological samples: The description focuses on gas sampling, not the analysis of blood, urine, tissue, or other biological specimens.
- Performance Studies: The studies mentioned relate to the device's ability to sample ETCO2 at various oxygen flow rates and the strength of the oxygen connector, not the accuracy of a diagnostic test performed on a biological sample.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Hudson RCI SOFTECH® Plus ETCO2 Nasal Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen to a patient while providing a means to sample expired gas. It is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate.
Product codes (comma separated list FDA assigned to the subject device)
CCK, CAT
Device Description
The SOFTECH Plus ETCO2 Cannula is a non-sterile disposable, single patient use device that acts as an adjunct to oxygen therapy with its primary function providing a means to deliver low flow oxygen, while sampling part of the patients exhaled gas. The SOFTECH Plus ETCO2 Cannula has a split nare blank with oxygen delivery through one nasal prong while allowing sampling of the patient's exhaled gas from the corresponding nasal prong.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription 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)
The proposed device was tested for ETCO2 sampling at various oxygen flow rates after simulated 1 year aging per ASTM F1980-07 - Standard Guide For Accelerated Aging Of Sterile Barrier Systems For Medical Devices. The test results demonstrate that the device is substantially equivalent to the predicate device.
The proposed device was tested to ensure the material change did not impact the strength or performance of the oxygen connector after a material change. The test results demonstrate that the device is substantially equivalent to the predicate device.
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2015
Teleflex Medical, Inc. Mr. Brian Gall Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709
Re: K143469
Trade/Device Name: SOFTECH® Plus ETCO2 Cannula Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK, CAT Dated: January 12, 2015 Received: January 13, 2015
Dear Mr. Gall:
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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Page 2 - Mr. Gall
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Teiashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K143469
Device Name SOFTECH® Plus ETCO2 Cannula
Indications for Use (Describe)
The Hudson RCI SOFTECH® Plus ETCO2 Nasal Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen to a patient while providing a means to sample expired gas. It is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------- |
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510(k) SUMMARY
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-544-8000 x 682514 Fax: 919-361-3914
B. Contact Person
Brian Gall Regulatory Affairs Specialist
C. Date Prepared
December 3, 2014
D. Device Name
| Trade Name: | SOFTECH® Plus ETCO2 Cannula |
|---|---|
| Classification Name: | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Product Code: | CCK, CAT |
| Regulation Number: | 868.1400 |
| Classification: | II |
| Classification Panel: | Anesthesiology |
E. Predicate Device
This submission demonstrates substantial equivalence to the predicate device SOFTECH® Plus ETCO2 Cannula – K132946, with the addition of a shelf-life.
F. Device Description
The SOFTECH Plus ETCO2 Cannula is a non-sterile disposable, single patient use device that acts as an adjunct to oxygen therapy with its primary function providing a means to deliver low flow oxygen, while sampling part of the patients exhaled gas. The SOFTECH Plus ETCO2 Cannula has a split nare blank with oxygen delivery through one nasal prong while allowing sampling of the patient's exhaled gas from the corresponding nasal prong.
G. Indications for Use
The Hudson RCI SOFTECH® Plus ETCO2 Nasal Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen to a patient while providing a means to sample expired gas. It is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate.
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H. Technological Characteristics Comparison to the predicate
The proposed SOFTECH Plus ETCO2 Cannula is substantially equivalent to the predicate device listed above in that the indications for use, the intended use, and fundamental scientific technology remain unchanged. Table 011.1 summarizes the differences between the proposed and predicate devices (full substantial equivalence discussion can be found in Section 014 - Substantial Equivalence Discussion of this submission).
| Features | Predicate
K132946
SOFTECH® Plus
ETCO2 Cannula | Proposed
SOFTECH® Plus
ETCO2 Cannula | Performance Testing |
|-----------------------------------|--------------------------------------------------------|--------------------------------------------|------------------------------------------------------------------------------------------------|
| Shelf-Life | None | 1 year Shelf-life | ETCO2 Performance Testing with
Simultaneous Oxygen Delivery after
simulated 1 year aging |
| Material –
Oxygen
Connector | PVC, Non-DEHP | PVC, Non-DEHP
(softer durometer) | Connector Performance Testing (Leak
and Disconnection testing) |
Table 011.1 - Differences Between the Proposed and Predicate Devices
I. Performance Data
The proposed device was tested for ETCO2 sampling at various oxygen flow rates after simulated 1 year aging per ASTM F1980-07 - Standard Guide For Accelerated Aging Of Sterile Barrier Systems For Medical Devices. The test results demonstrate that the device is substantially equivalent to the predicate device.
The proposed device was tested to ensure the material change did not impact the strength or performance of the oxygen connector after a material change. The test results demonstrate that the device is substantially equivalent to the predicate device. Note: No biocompatibility testing was performed as the material was previously cleared in K132946 for the same contact type and duration (see Section 019 -Biocompatibility of this submission for further information).
The tests performed are summarized in Table 011.2 below.
| Table 011.2 - Performance Testing Summary | |
|---|---|
| ------------------------------------------- | -- |
| General Description |
|---|
| ETCO2 performance in simulated conditions at various oxygen flow rates |
| Connector performance in simulated conditions |
J. Conclusion
The device data and test results demonstrate that the device is substantially equivalent to the predicate device.