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.

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.

AI/ML Overview

Here's an analysis of the SOFTECH Plus ETCO2 Cannula's acceptance criteria and the supporting study information, based on the provided text:

Acceptance Criteria and Device Performance for SOFTECH Plus ETCO2 Cannula

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device in comparison to a predicate device, focusing on substantial equivalence. The "acceptance criteria" are implied by the nature of the performance testing conducted to demonstrate this equivalence. The stated performance testing for the SOFTECH Plus ETCO2 Cannula primarily validates its functionality in:

ETCO2 Performance: Ability to sample expired gas accurately at various oxygen flow rates.
Biocompatibility: Safety for patient contact.
Material Composition: Specifically, the absence or presence of DEHP.

Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are generally aligned with demonstrating that the SOFTECH Plus ETCO2 Cannula performs as safely and effectively as the predicate device (Double Lumen Oxygen Delivery Gas Sampling Nasal Cannula, Hudson RCI Bi-Flo -K961150) for its intended use. Exact quantitative performance metrics (e.g., specific ETCO2 measurement accuracy ranges) are not explicitly provided in this summary but are implied by the successful completion of the tests.

Acceptance Criteria (Implied)	Reported (or Demonstrated) Device Performance (Summary)
ETCO2 Performance with Simultaneous Oxygen Delivery	Demonstrated effective ETCO2 sampling in simulated conditions at various oxygen flow rates. The test results demonstrate substantial equivalence to the predicate device.
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Implantation)	Passed biocompatibility testing as per ISO 10993-1.
DEHP Content	Passed DEHP testing (implying it meets the predicate's DEHP characteristics or has demonstrated acceptable differences).

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size for the individual performance tests (ETCO2, biocompatibility, DEHP). It merely states that "The proposed device was tested."

Sample Size: Not specified.
Data Provenance: The studies were conducted by Teleflex Medical, Inc. (the manufacturer). The text does not specify the country of origin of the data itself (e.g., patient data, if any were used), but mentions tests were performed in "simulated conditions." Given the 510(k) submission to the FDA, it can be inferred the testing was conducted in a manner compliant with US regulatory requirements, likely in the US or an equivalent regulatory jurisdiction. The studies appear to be prospective insofar as they were conducted to test the newly proposed device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

This document does not refer to experts establishing ground truth in the context of clinical data or image interpretation. The testing performed (ETCO2 performance in simulated conditions, biocompatibility, DEHP testing) relies on standardized testing methodologies and laboratory analysis, not expert clinical consensus for "ground truth." Therefore, this information is not applicable to the details provided in this summary.

4. Adjudication Method for the Test Set:

Not applicable, as the tests are objective measurements (e.g., ETCO2 readings, biological responses, chemical composition) rather than interpretations requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human reader performance (with and without AI assistance) is being evaluated. The SOFTECH Plus ETCO2 Cannula is a gas sampling and oxygen delivery device, not a diagnostic imaging device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Yes, the performance testing described is inherently "standalone" in the sense that the device's functional characteristics (ETCO2 sampling, biocompatibility) were evaluated directly, independent of human interaction beyond the setup and operation of the test environment. There is no "algorithm" in the sense of AI or image interpretation here; it is a physical medical device being tested for its specified functions.

7. The Type of Ground Truth Used:

The ground truth for the performance testing would be established by:

Defined Standards and Measurable Outputs: For ETCO2 performance, the "ground truth" would be the actual concentration of CO2 in the simulated exhaled gas, independently measured by a calibrated reference instrument. The cannula's reading would then be compared against this reference.
ISO Standards for Biocompatibility: The "ground truth" for biocompatibility is whether the device materials elicit adverse biological responses as defined by ISO 10993-1.
Chemical Analysis for Material Composition: For DEHP testing, the "ground truth" is the quantitative chemical analysis confirming the presence or absence (or concentration) of DEHP.

8. The Sample Size for the Training Set:

Not applicable. This device is a passive gas sampling and oxygen delivery cannula. It does not employ an algorithm or machine learning component that requires a "training set." The performance tests are for the physical device itself.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

Summary

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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

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G. Indications for Use

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	PredicateK961150Double Lumen OxygenDelivery Gas SamplingNasal Cannula, HudsonRCI Bi-Flo	ProposedSOFTECH® Plus ETCO2 Cannula	PerformanceTesting
Nasal Prongs(Nares)	Dual-channel nasal prongthat allows oxygen deliveryand gas sampling from bothnares	Split nasal prong that directs oxygenflow into one nare and samplesexpired gas from the other nare	ETCO2PerformanceTesting withSimultaneousOxygen Delivery
Oxygen supplytubing and CO2sampling linelength	Oxygen supply tubing: 7 ftCO2 sampling line: 7 in	Oxygen supply tubing: 7 ft and 14 ftCO2 sampling line: 2 in, 7 ft and 14 ft	ETCO2PerformanceTesting withSimultaneousOxygen Delivery
Materials
Nares	Polyvinylchloride	Polyvinylchloride	BiocompatibilityTesting:
Bolo Slide	Polycarbonate orPolyvinylchloride	Polyvinylchloride	Testing:Cytotoxicity,
Tubing Clip	None	Polypropylene	Sensitization,
Lariat Tubing	Polyvinylchloride	Polyvinylchloride	Irritation,
Oxygen SupplyTubing	Polyvinylchloride	Polyvinylchloride	Genotoxicity,Implantation
CO2 SamplingLine	Polyvinylchloride	Polyvinylchloride
OxygenConnector	Polyvinylchloride	Polyvinylchloride
Tubing Connector	Polyvinylchloride	Polyvinylchloride
Male and FemaleLuer LockConnectors	Acrylic	Polycarbonate
22mm Oxygen	None	Polypropylene

Table 1 - Differences Between the Proposed and Predicate Devices
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Teleflex Medical, Inc.

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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.

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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.

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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

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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)

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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Regulation Number and Section

§ 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).