(258 days)
Not Found
No
The summary describes a physical medical device (nasal cannula) for oxygen delivery and gas sampling, with no mention of software, algorithms, or data processing that would indicate AI/ML technology.
No
The device delivers oxygen and samples expired gas, which are supportive functions for patient care and monitoring, not direct therapeutic interventions to treat or prevent disease.
Yes.
The device's description indicates its function is to "sample expired gas" and "is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate," which are diagnostic functions.
No
The device description clearly states it is a physical, disposable nasal cannula, which is a hardware component.
Based on the provided information, the Hudson RCI SOFTECH® Plus ETCO2 Nasal Cannula is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- The SOFTECH Plus ETCO2 Nasal Cannula is a device that is applied to the patient (nasal) to deliver oxygen and sample expired gas directly from the patient. It's a medical device used for patient monitoring and therapy, not for analyzing samples in a lab setting.
The device's function of "sampling expired gas to determine ventilatory rate" is a form of in vivo monitoring (monitoring within the living body), not in vitro diagnostic testing.
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 prongs while allowing sampling of the patient's exhaled gas from the corresponding nasal prongs.
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
Infant, Pediatric, Adult
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)
The proposed device was tested for ETCO2 sampling at various oxygen flow rates, biocompatibility, and DEHP testing.
The tests performed are summarized in Table 2 below.
General Description:
ETCO2 performance in simulated conditions at various oxygen flow rates
Biocompatibility testing as per ISO 10993-1: cytotoxicity, sensitization, irritation, genotoxicity and implantation testing
DEHP Testing
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).
0
Additional Information Response
510(k) SUMMARY
A. Name, Address, Phone and Fax Number of Applicant
JUN 0 4 2014
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8050 919-433-4996 Fax:
B. Contact Person
Angela Bouse Senior Regulatory Affairs Specialist
C. Date Prepared
June 3, 2014
D. Device Name
| Trade Name: | SOFTECH® Plus ETCO2 Cannula |
|---|---|
| Classification Name: | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Product Code: | CCK |
| Additional Product Code: | CAT |
| Regulation Number: | 868.1400 |
| Classification: | II |
| Classification Panel: | Anesthesiology |
E. Predicate Device
This submission demonstrates substantial equivalence to the predicate device Double Lumen Oxygen Delivery Gas Sampling Nasal Cannula, Hudson RCI Bi-Flo -K961150.
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 prongs while allowing sampling of the patient's exhaled gas from the corresponding nasal prongs.
1
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.
Patient Population: Infant, Pediatric, Adult
H. Technological Characteristics and Material 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 1 summarizes the differences between the proposed and predicate devices.
| Features | Predicate
K961150
Double Lumen Oxygen
Delivery Gas Sampling
Nasal Cannula, Hudson
RCI Bi-Flo | Proposed
SOFTECH® Plus ETCO2 Cannula | Performance
Testing |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Nasal Prongs
(Nares) | Dual-channel nasal prong
that allows oxygen delivery
and gas sampling from both
nares | Split nasal prong that directs oxygen
flow into one nare and samples
expired gas from the other nare | ETCO2
Performance
Testing with
Simultaneous
Oxygen Delivery |
| Oxygen supply
tubing and CO2
sampling line
length | Oxygen supply tubing: 7 ft
CO2 sampling line: 7 in | Oxygen supply tubing: 7 ft and 14 ft
CO2 sampling line: 2 in, 7 ft and 14 ft | ETCO2
Performance
Testing with
Simultaneous
Oxygen Delivery |
| Materials | | | |
| Nares | Polyvinylchloride | Polyvinylchloride | Biocompatibility
Testing: |
| Bolo Slide | Polycarbonate or
Polyvinylchloride | Polyvinylchloride | Testing:
Cytotoxicity, |
| Tubing Clip | None | Polypropylene | Sensitization, |
| Lariat Tubing | Polyvinylchloride | Polyvinylchloride | Irritation, |
| Oxygen Supply
Tubing | Polyvinylchloride | Polyvinylchloride | Genotoxicity,
Implantation |
| CO2 Sampling
Line | Polyvinylchloride | Polyvinylchloride | |
| Oxygen
Connector | Polyvinylchloride | Polyvinylchloride | |
| Tubing Connector | Polyvinylchloride | Polyvinylchloride | |
| Male and Female
Luer Lock
Connectors | Acrylic | Polycarbonate | |
| 22mm Oxygen | None | Polypropylene | |
| Table 1 - Differences Between the Proposed and Predicate Devices
|
| ---------------------------------------------------------------------- |
|---|
Teleflex Medical, Inc.
2
Additional Information Response
K132946 – SOFTECH Plus ETCO2 Cannula Tab 006 - Section 011 - 510(k) Summary
| Tubing Adaptor | |||
|---|---|---|---|
| Adhesive | Cyclohexanone | Cyclohexanone | |
| PVC | PVC with DEHP | Non-DEHP PVC | DEHP Testing |
I. Performance Data
The proposed device was tested for ETCO2 sampling at various oxygen flow rates, biocompatibility, and DEHP testing. The test results demonstrate that the device is substantially equivalent to the predicate device.
The tests performed are summarized in Table 2 below.
| 114 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 | Table 2 - Performance Testing Summary | ||
|---|---|---|---|
| General Description |
|---|
| ETCO2 performance in simulated conditions at various oxygen flow rates |
| Biocompatibility testing as per ISO 10993-1: cytotoxicity, sensitization, irritation, |
| genotoxicity and implantation testing |
| DEHP Testing |
J. Conclusion
The device data and test results demonstrate that the device is substantially equivalent to the predicate device.
3
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
June 4, 2014
Teleflex Medical, Inc. Angela Bouse Senior Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709
Re: K132946
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: May 02, 2014 Received: May 05, 2014
Dear Ms. Bouse:
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 general voluless provincitive, 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.
4
Page 2 - Ms. Angela Bouse
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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
MarySuBunner-S
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
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132946
Device Name
Hudson RCI SOFTECH® Plus ETCO2 Nasal 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.
Patient Population: Infant, Pediatric, Adult
Type of Use (Select one or both, as applicable)
2 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.
Paul Career For Comment FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR SECTION CONSE
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Todd D. Courtney -S
2014.06.03 16:33:20 -0400
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