K Number

Device Name

Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines

Manufacturer

Salter Labs

Date Cleared

2016-03-10

(287 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K863703,K863883,K864199,K864902,K892406,K894350

Predicate For

K181981

Intended Use

The Nasal CO2 Sample Line is intended to be used to sample exhaled gas.

The O2 Delivery / CO2 Sampling Nasal Cannula is intended to be used where low flow oxygen is administered and exhaled gas is monitored.

The Oral / Nasal CO2 Sampling Cannula is intended to be used where exhaled gas is monitored.

The O2 Delivery with Oral / Nasal CO2 Sampling Cannula is intended to be used where low flow oxygen is administered and exhaled gas is monitored.

The Divided O2 Delivery / CO2 Sampling Nasal Cannula is intended to be used where low flow oxygen is administered and exhaled gas is monitored.

The Sample Lines are intended to be used where exhaled gas is monitored.

Environment of use - hospital, sub-acute, and pre-hospital settings.

Patient population - Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics.

Device Description

The devices are non-sterile, disposable, single patient use cannulas and sample lines intended for sampling exhaled gases and/or delivering supplemental oxygen. Specific descriptions for each device type are provided: Nasal CO2 Sample Line, O2 Delivery / CO2 Sampling Nasal Cannula, Oral / Nasal CO2 Sampling Cannula, O2 Delivery with Oral / Nasal CO2 Sampling Cannula, Divided O2 Delivery / CO2 Sampling Nasal Cannula, and Sample Lines.

AI/ML Overview

This document describes the equivalence of several CO2 sampling cannulas and lines (referred to as "Modified ETCO2 Devices") to previously cleared predicate devices. The primary change in the new devices is the material formulation.

Here's an analysis based on your requested information:

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

Criteria	Acceptance Criteria (Predicate Specifications)	Reported Device Performance (Modified ETCO2 Devices)
Back Pressure	Shall not have a back pressure that exceeds 3 psi at a maximum flow rate in ambient temperatures of 5°C, 20°C, and 40°C.	Maximum back pressure was found to be less than 2 psi.
Bond Strength	The bonded components of the set will have a bond strength that is ≥ 2 lbs. when pulled at a rate of 5 inches per minute.	The bond strength test achieved over 2 times the minimum allowable value.
Device Dimensions	Unchanged from predicate devices.	Unchanged (use the same molds as predicate devices).
Biocompatibility	(Implicit: Must meet biocompatibility standards for medical devices)	Passed all parameters: Irritation, Sensitization, Cytotoxicity, Particulate, Volatile organic compounds.
Shelf Life	None (for predicate devices listed)	3 years (performance testing after simulated 3-year aging was performed).

2. Sample sized used for the test set and the data provenance:

The document does not specify the exact sample sizes used for the performance tests (back pressure, bond strength, biocompatibility). It states "The test results demonstrate that the device is substantially equivalent" and "The materials passed all parameters" without providing numerical sample sizes.

The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted by Salter Labs for FDA clearance in the USA. The tests appear to be prospective in nature, performed on the newly modified devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this type of device and study. The "ground truth" here is based on quantifiable engineering and material performance standards (e.g., specific psi for back pressure, lbs for bond strength, and established biocompatibility testing protocols), not expert interpretation of clinical data or images.

4. Adjudication method for the test set:

Not applicable. This is a technical performance study, not a study requiring adjudication of human interpretation.

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 document describes material and mechanical performance testing of a medical device (CO2 sampling cannibal/line), not an AI algorithm or a study involving human readers.

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

Not applicable. This document is not about an algorithm.

7. The type of ground truth used:

The ground truth used for this study is based on engineering specifications and established material safety standards.

For back pressure and bond strength, the ground truth is the numerical threshold values (e.g., < 3 psi, ≥ 2 lbs).
For biocompatibility, the ground truth is the successful passing of standardized biocompatibility tests (Irritation, Sensitization, Cytotoxicity, Particulate, Volatile organic compounds).

8. The sample size for the training set:

Not applicable. This document describes a medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for a machine learning model.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2016

Salter Labs Margaret Caler Director, Regulatory Affairs 2365 Camino Vida Roble Carlsbad, California 92011

Re: K151421

Trade/Device Name: Nasal CO2 Sample Line; 02 Delivery / CO2 Sampling Nasal Cannula; Oral / Nasal CO2 Sampling Cannula; O2 Delivery with Oral / Nasal CO2 Sampling Cannula; Divided O2 Delivery / CO2 Sampling Nasal Cannula and Sample Lines Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: March 1. 2016 Received: March 3, 2016

Dear Margaret Caler:

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.

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

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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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Tejashri 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

Enclosure

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Indications for Use

510(k) Number (if known) K151421

Device Name

Nasal CO2 Sample Line; O2 Delivery / CO2 Sampling Nasal Cannula; Oral / Nasal CO2 Sampling Cannula; O2 Delivery with Oral / Nasal CO2 Sampling Cannula; Divided O2 Delivery / CO2 Sampling Nasal Cannula and Sample Lines

Indications for Use (Describe)