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

K151421 · Salter Labs · CCK · Mar 10, 2016 · Anesthesiology

Device Facts

• Record ID: K151421
• Device Name: Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
• Applicant: Salter Labs
• Product Code: CCK · Anesthesiology
• Decision Date: Mar 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

Indications for 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.

Device Story

Non-sterile, disposable, single-patient-use cannulas and sample lines; used for supplemental oxygen delivery and/or sampling of exhaled gases (CO2) for monitoring. Devices feature nasal inserts, some with divided channels for simultaneous O2 delivery and CO2 sampling; includes Salter Eyes® (aperture to minimize occlusions) and Oral-Trac® (oral sampling feature). Operated by clinicians in hospital, sub-acute, or pre-hospital settings. Output is gas sample delivered to external CO2 analyzer; enables real-time monitoring of patient respiratory status; assists clinical decision-making regarding oxygenation and ventilation.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing (irritation, sensitization, cytotoxicity, particulate, volatile organic compounds) passed. Performance testing verified back pressure (<2 psi) and bond strength (>2x minimum requirement) met specifications after simulated 3-year aging.

Technological Characteristics

Materials: PVC with DINCH, DOTP, and DINCH plasticizers. Form factor: Flexible extruded plastic tubing and nasal cannulas. Connectivity: Passive interface to external gas analyzers. Sterilization: Non-sterile. Design: Includes Salter Eyes® aperture and Oral-Trac® sampling features.

Indications for Use

Indicated for patients requiring supplemental oxygen and/or expired gas monitoring, ranging from pediatric to adult populations, in hospital, sub-acute, and pre-hospital settings.

Regulatory Classification

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.

Predicate Devices

• Nasal CO2 Sample Line (K863703)
• O2 Delivery / CO2 Sampling Nasal Cannula (K863883)
• Oral / Nasal CO2 Sampling Cannula (K864199)
• O2 Delivery with Oral / Nasal CO2 Sampling Cannula (K864902)
• Divided O2 Delivery / CO2 Sampling Nasal Cannula (K892406)
• Sample Lines (K894350)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a symbol of care and protection.

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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

Type of Use (Select one or both, as applicable)

| <div> <span style="font-size:10pt"> <span style="font-family:Wingdings">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
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| <div> <span style="font-size:10pt"> <span style="font-family:Wingdings">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

# 510 (k) Summary

### A. Submitter:

Salter Labs 2365 Camino Vida Robles Carlsbad, CA 92011 Telephone: [phone] Fax: [phone]

## B. Contact Person:

Mara Caler Director, Regulatory Affairs

## C. Date Prepared:

09 March 2016

#### Device Names: D.

Tra

| Trade Name: | Nasal CO2 Sample Line; O2 Delivery / CO2 Sampling<br>Nasal Cannula; Oral / Nasal CO2 Sampling Cannula; O2<br>Delivery with Oral / Nasal CO2 Sampling Cannula;<br>Divided O2 Delivery / CO2 Sampling Nasal Cannula and<br>Sample Lines |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Product Code: | CCK |
| Regulation Number: | 868.1400 |
| Classification: | II |
| Classification Panel: | Anesthesiology (73) |

| Trade Name | Common Name |
|----------------------------------------------------|----------------------------------------------|
| Nasal CO2 Sample Line | Nasal CO2 Sample Line |
| O2 Delivery / CO2 Sampling Nasal Cannula | Oxygen delivery / CO2 Sampling Nasal Cannula |
| Oral / Nasal CO2 Sampling Cannula | Oral / Nasal CO2 Sampling Cannula |
| O2 Delivery with Oral / Nasal CO2 Sampling Cannula | Oxygen Delivery-Oral /Nasal CO2 Sampling |
| Divided O2 Delivery / CO2 Sampling Nasal Cannula | Infusion / Aspiration Cannula |
| Sample Lines | Sample Lines |

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# Predicate Devices:

This submission demonstrates substantial equivalence to the predicate devices: K863703, Nasal CO2 Sample Line K863883, O2 Delivery / CO2 Sampling Nasal Cannula K864199, Oral / Nasal CO2 Sampling Cannula K864902, O2 Delivery with Oral / Nasal CO2 Sampling Cannula K892406, Divided O2 Delivery / CO2 Sampling Nasal Cannula K894350, Sample Lines The proposed devices that correspond to these predicates have identical names and are listed in the table below.

### Device Descriptions E.

| Device Name | Device Description |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nasal CO2 Sample<br>Line | The device is a non-sterile, disposable, single patient use<br>cannula that allows sampling of patients exhaled gases. |
| O2 Delivery / CO2<br>Sampling Nasal<br>Cannula | The device is a non-sterile, disposable, single patient use cannula<br>that provides supplemental oxygen while sampling patients<br>exhaled gases. |
| Oral / Nasal CO2<br>Sampling Cannula | The device is a non-sterile, disposable, single patient use<br>cannula that allows sampling of patients exhaled gases from<br>both the nares and orally. |
| O2 Delivery with<br>Oral / Nasal CO2<br>Sampling Cannula | The device is a non-sterile, disposable, single patient use<br>cannula that provides supplemental oxygen while sampling<br>patients exhaled gases, using two nasal inserts. One insert<br>samples the CO2 while the other delivers the oxygen. The<br>Cannula includes Salter Eyes®, an aperature in the nasal prong<br>intended to minimize occlusions and Oral-Trac, a method of<br>sampling orally exhaled gases. The ETCO2 Cannula with<br>oxygen delivery can also be purchased with the Oral-Trac®<br>feature to allow oral (mouth) ETCO2 sampling. |
| Divided O2<br>Delivery / CO2<br>Sampling Nasal<br>Cannula | The Salter Labs ETCO2 Cannula provides O2 delivery in one<br>nostril and samples exhaled CO2 from the other nostril using<br>a divided nasal insert. |
| Sample Lines | The Salter Labs ETCO2 Tubing consists of flexible extruded<br>plastic tubes with connectors on each end, with differing<br>configurations. |

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#### F. Indications for Use

The Intended/Indications for Use Statement is described below:

# Intended / Indications for Use

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

The On 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 On 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.

#### Comparison of Technological Characteristics with the Predicate Device G.

The proposed Modified ETCO2 Devices are substantially equivalent to the predicate devices listed above in that the indications for use, the intended use, device dimensions, device specifications and fundamental scientific technology remain unchanged.

The differences between the Modified ETCO2 Devices and predicate devices are:

| Features | Predicate ETCO2 Devices | Modified ETCO2 Devices | Performance Testing |
|----------------------|-------------------------|------------------------|-----------------------------------------------------------|
| Material Formulation | PVC, DIDP | PVC, DINCH | Biocompatibility |
| Material Formulation | PVC, DEHP | PVC, DOTP & DINCH | Biocompatibility |
| Shelf life | None | 3 years | Performance<br>testing after<br>simulated 3 year<br>aging |

### H. Performance Data

The proposed device was tested to verify that the new material did not affect the bond and performance characteristics of flow rate, back pressure. The test results demonstrate that the device is substantially equivalent to the predicate devices

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# Performance Testing Summary

| Criteria | Predicate<br>specifications | Modified devices | Comments |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Back pressure<br>(flow rates): | Shall not have a back<br>pressure that exceeds<br>3 psi at a maximum<br>flow rate in ambient<br>of 5°C, 20°C, and<br>40°C. | Maximum back<br>pressure was found<br>to be less than 2 psi. | The modified<br>devices passed all<br>specifications |
| Bond Strength<br>(tensile<br>strength): | The bonded<br>components of the set<br>will have a bond<br>strength that is ≥ 2<br>lbs. when pulled at a<br>rate of 5 inches per<br>minute. | The bond strength<br>test achieved over 2<br>times the minimum<br>allowable value. | The modified<br>devices passed<br>all specifications |
| Device<br>dimensions: | Unchanged. | Unchanged. | The modified<br>devices use the<br>same molds and are<br>unchanged from the<br>predicate devices |

The modified ETCO2 Devices meet established Salter Labs performance specifications.

## Clinical / Non-Clinical I.

No clinical testing was required for this submission.

The following biocompatibility testing was performed. The materials passed all parameters:

- Irritation .
- Sensitization ●
- Cytotoxicity .
- Particulate ●
- Volatile organic compounds ●

### J. Conclusions

ETCO2 device data and test results demonstrate that the device is substantially equivalent to the predicate devices.