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 prong while allowing sampling of the patient's exhaled gas from the corresponding nasal prong.

AI/ML Overview

The provided text is a 510(k) summary for the SOFTECH® Plus ETCO2 Cannula, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of diagnostic accuracy or a similar performance claim.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully addressed from the given text because the study presented is primarily for demonstrating substantial equivalence based on physical and performance characteristics, particularly related to shelf-life and a material change, rather than a clinical performance study with diagnostic endpoints.

However, I can extract and infer information where possible based on the provided text.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly list "acceptance criteria" in the traditional sense of a diagnostic performance study (e.g., sensitivity, specificity thresholds). Instead, it describes performance testing to ensure the device performs comparably to its predicate after a design change (shelf-life addition and material change). The implied acceptance criterion for these tests is "substantially equivalent performance" to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
ETCO2 Performance after 1-year simulated aging: Maintain comparable ETCO2 sampling performance to the predicate device at various oxygen flow rates.	"The test results demonstrate that the device is substantially equivalent to the predicate device."
Connector Performance (Leak and Disconnection): Ensure the material change to the oxygen connector does not negatively impact strength or performance (leakage, disconnection).	"The test results demonstrate that the device is substantially equivalent to the predicate device." (after material change)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the sample size for the "test set" in terms of number of devices or number of data points collected during the ETCO2 and connector performance testing.
Data Provenance: Not specified. The testing was likely conducted by the manufacturer, Teleflex Medical, Inc., which has an address in Research Triangle Park, NC, USA. The study design appears to be a prospective engineering/performance test rather than a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. For engineering performance tests like ETCO2 sampling and connector strength, "ground truth" as established by medical experts for diagnostic accuracy is not relevant. The "ground truth" or reference standard would be the performance of the predicate device or a defined physical standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication is typically used in clinical studies involving interpretation by multiple readers.

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

Not applicable. This is not an AI-based diagnostic device, nor is it a study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm or AI device. The device's performance is standalone in the sense that its physical characteristics and gas sampling capabilities are tested directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated in the context of "ground truth" for diagnostic purposes. However, for the performance tests:

ETCO2 Performance: The "ground truth" would likely be the known CO2 concentration of gases being sampled or the performance of the predicate device under similar conditions. This involves direct measurement and comparison.
Connector Performance: The "ground truth" would be established engineering standards for leak and disconnection forces.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning/AI device.

9. How the ground truth for the training set was established

Not applicable. There is no "training set."

Summary of Study:

The studies described are engineering and performance validation tests to support a 510(k) submission for a modified medical device, the SOFTECH® Plus ETCO2 Cannula. The purpose was to demonstrate that adding a 1-year shelf-life and changing the durometer of the oxygen connector material did not negatively impact the device's performance compared to its legally marketed predicate.

Study Type: Performance validation testing (not a clinical or diagnostic accuracy study).
Key Tests:
- ETCO2 performance at various oxygen flow rates after simulated 1-year aging (per ASTM F1980-07).
- Connector performance (leak and disconnection testing) after a material change.
Conclusion: The device was found to be "substantially equivalent" to the predicate, meaning its performance was comparable and the changes did not raise new questions of safety or effectiveness.

Summary

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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)

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

G. Indications for Use

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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	PredicateK132946SOFTECH® PlusETCO2 Cannula	ProposedSOFTECH® PlusETCO2 Cannula	Performance Testing
Shelf-Life	None	1 year Shelf-life	ETCO2 Performance Testing withSimultaneous Oxygen Delivery aftersimulated 1 year aging
Material –OxygenConnector	PVC, Non-DEHP	PVC, Non-DEHP(softer durometer)	Connector Performance Testing (Leakand 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
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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.

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).