(287 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and material properties of cannulas and sample lines for gas monitoring and oxygen delivery, with no mention of AI or ML.
Yes
The device delivers supplemental oxygen, which is a therapeutic intervention, in addition to monitoring exhaled gases.
No
Explanation: The device is intended to sample exhaled gas and deliver oxygen. While monitoring exhaled gas can provide data useful for diagnosis, the device itself is a collection/delivery tool and not an instrument that analyzes the sampled gas to provide a diagnosis. The performance tests also focus on physical properties and gas flow, not diagnostic accuracy.
No
The device description explicitly states the devices are "non-sterile, disposable, single patient use cannulas and sample lines," which are physical hardware components. The performance studies also focus on physical characteristics like back pressure, bond strength, and dimensions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to sample exhaled gas and/or deliver supplemental oxygen. This is a direct interaction with the patient's respiratory system for monitoring and treatment purposes.
- Device Description: The devices are described as cannulas and sample lines for sampling exhaled gases and/or delivering oxygen.
- Lack of In Vitro Activity: IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) outside of the body (in vitro). This device is used on the patient to collect gas directly from their airway.
- Performance Studies: The performance studies focus on physical characteristics (back pressure, bond strength, dimensions) and biocompatibility, which are typical for medical devices that interact directly with the patient, not for devices that analyze samples in a lab setting.
The device is a medical device used for respiratory monitoring and oxygen delivery, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Environment of use - hospital, sub-acute, and pre-hospital settings.
Patient population - Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics.
Product codes (comma separated list FDA assigned to the subject device)
CCK
Device Description
Nasal CO2 Sample Line: The device is a non-sterile, disposable, single patient use cannula that allows sampling of patients exhaled gases.
O2 Delivery / CO2 Sampling Nasal Cannula: The device is a non-sterile, disposable, single patient use cannula that provides supplemental oxygen while sampling patients exhaled gases.
Oral / Nasal CO2 Sampling Cannula: The device is a non-sterile, disposable, single patient use cannula that allows sampling of patients exhaled gases from both the nares and orally.
O2 Delivery with Oral / Nasal CO2 Sampling Cannula: The device is a non-sterile, disposable, single patient use cannula that provides supplemental oxygen while sampling patients exhaled gases, using two nasal inserts. One insert samples the CO2 while the other delivers the oxygen. The Cannula includes Salter Eyes®, an aperature in the nasal prong intended to minimize occlusions and Oral-Trac, a method of sampling orally exhaled gases. The ETCO2 Cannula with oxygen delivery can also be purchased with the Oral-Trac® feature to allow oral (mouth) ETCO2 sampling.
Divided O2 Delivery / CO2 Sampling Nasal Cannula: The Salter Labs ETCO2 Cannula provides O2 delivery in one nostril and samples exhaled CO2 from the other nostril using a divided nasal insert.
Sample Lines: The Salter Labs ETCO2 Tubing consists of flexible extruded plastic tubes with connectors on each end, with differing configurations.
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
adult to pediatrics.
Intended User / Care Setting
Environment of use - hospital, sub-acute, and pre-hospital settings.
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 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.
Performance Testing Summary:
- Back pressure (flow rates): Predicate specifications: Shall not have a back pressure that exceeds 3 psi at a maximum flow rate in ambient of 5°C, 20°C, and 40°C. Modified devices: Maximum back pressure was found to be less than 2 psi. Comments: The modified devices passed all specifications.
- Bond Strength (tensile strength): Predicate specifications: 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. Modified devices: The bond strength test achieved over 2 times the minimum allowable value. Comments: The modified devices passed all specifications.
- Device dimensions: Predicate specifications: Unchanged. Modified devices: Unchanged. Comments: The modified devices use the same molds and are unchanged from the predicate devices.
The modified ETCO2 Devices meet established Salter Labs performance specifications.
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 ●
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.
K863703, K863883, K864199, K864902, K892406, K894350
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
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
1
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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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: 760-795-7100 Fax: 760-683-6797
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
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 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
4
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 | |
| Line | The device is a non-sterile, disposable, single patient use |
| cannula that allows sampling of patients exhaled gases. | |
| O2 Delivery / CO2 | |
| Sampling Nasal | |
| Cannula | The device is a non-sterile, disposable, single patient use cannula |
| that provides supplemental oxygen while sampling patients | |
| exhaled gases. | |
| Oral / Nasal CO2 | |
| Sampling Cannula | The device is a non-sterile, disposable, single patient use |
| cannula that allows sampling of patients exhaled gases from | |
| both the nares and orally. | |
| O2 Delivery with | |
| Oral / Nasal CO2 | |
| Sampling Cannula | The device is a non-sterile, disposable, single patient use |
| cannula that provides supplemental oxygen while sampling | |
| patients exhaled gases, using two nasal inserts. One insert | |
| samples the CO2 while the other delivers the oxygen. The | |
| Cannula includes Salter Eyes®, an aperature in the nasal prong | |
| intended to minimize occlusions and Oral-Trac, a method of | |
| sampling orally exhaled gases. The ETCO2 Cannula with | |
| oxygen delivery can also be purchased with the Oral-Trac® | |
| feature to allow oral (mouth) ETCO2 sampling. | |
| Divided O2 | |
| Delivery / CO2 | |
| Sampling Nasal | |
| Cannula | The Salter Labs ETCO2 Cannula provides O2 delivery in one |
| nostril and samples exhaled CO2 from the other nostril using | |
| a divided nasal insert. | |
| Sample Lines | The Salter Labs ETCO2 Tubing consists of flexible extruded |
| plastic tubes with connectors on each end, with differing | |
| configurations. |
5
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 |
| testing after | |||
| simulated 3 year | |||
| 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
6
Performance Testing Summary
| Criteria | Predicate
specifications | Modified devices | Comments |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Back pressure
(flow rates): | Shall not have a back
pressure that exceeds
3 psi at a maximum
flow rate in ambient
of 5°C, 20°C, and
40°C. | Maximum back
pressure was found
to be less than 2 psi. | The modified
devices passed all
specifications |
| Bond Strength
(tensile
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. | The modified
devices passed
all specifications |
| Device
dimensions: | Unchanged. | Unchanged. | The modified
devices use the
same molds and are
unchanged from the
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.