(114 days)
No
The device description and performance studies focus on the physical design and gas sampling capabilities, with no mention of AI/ML algorithms or data processing beyond basic measurement.
No
The device is intended to deliver oxygen and sample exhaled gases, which are diagnostic/monitoring functions, not therapeutic.
No
The device is intended to deliver supplemental oxygen and sample expired gases; it does not analyze or interpret the sampled gases for diagnostic purposes.
No
The device description clearly outlines physical components like nasal cannulas, tubing, and sampling lines, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver supplemental oxygen to patients and provide a means to sample expired gases." This describes a device used on a patient for therapeutic and monitoring purposes, not a device used to test samples taken from a patient in a laboratory setting.
- Device Description: The description details a nasal cannula and tubing, which are external devices applied to the patient.
- Performance Studies: The performance studies focus on the device's ability to deliver oxygen, sample gases, and maintain mechanical integrity under simulated breathing conditions. These are performance characteristics relevant to a medical device used on a patient, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
The device is a medical device used for patient care and monitoring, specifically for oxygen delivery and expired gas sampling.
N/A
Intended Use / Indications for Use
The Westmed nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases. Cumulative duration of use 10 kg.)
Intended User / Care Setting
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)
Bench Testing - We performed comparative testing which evaluated the ability to measure a breath, measure a gas, and breathe waveforms under several simulated breathing conditions.
The tests included:
- . Comparative CO2 sampling and waveform performance at 3 different breathing rates. CO2 concentrations (2% and 5%), and oxygen flow rates (1, 3, and 5 lpm).
- . Environmental and Age testing
- Mechanical testing ●
- o Luer Fitting
- o Flow
- Strength of bonds O
- Resistance to kinks O
The results presented show that the proposed Westmed Oxygen delivery / CO2 sampling cannula style devices performed equivalent to the predicates.
All testing demonstrated that the proposed devices are substantially equivalent to the identified predicate and reference - K010024 and K011050 - Oridion Nasal cannula sampling.
Biocompatibility - We have performed ISO 10993 testing on the component materials of the proposed devices which is considered as Externally Communicating and Surface Contact with the patient which means the following tests are required.
- Cytotoxicity ●
- Sensitization
- . Intracutaneous Irritation
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.
K010024 – Oridion
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.
K011050 - Oridion
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 features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2016
Westmed, Inc. c/o Paul Dryden Consultant 5580 S Nogales Hwy Tucson, Arizona 85706
Re: K162343
Trade/Device Name: Westmed Gas Sampling Cannula with O2 delivery Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK, CAT Dated: November 10, 2016 Received: November 14, 2016
Dear Paul Dryden:
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 devicerelated 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.
1
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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K162343
Device Name
Westmed Gas Sampling Cannula with O2 delivery
Indications for Use (Describe)
The Westmed nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases. Cumulative duration of use 10 kg.).
Type of Use (Select one or both, as applicable)
XX 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.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017 See PRA Statement on last page.
3
510(k) Summary Page 1 of 4
| Date Prepared: | 13-Dec-2016 |
|---|---|
| Westmed, Inc. | |
| 5580 S Nogales Hwy | |
| Tuscon, AZ 85706 | |
| Tel - (520) 294-7987 | |
| Official Contact: | Diana Upp, VP RA/QA |
| Proprietary or Trade Name: | Westmed Gas Sampling Cannula with O2 delivery |
| Common/Usual Name: | analyzer, gas, carbon-dioxide, gaseous phase (accessories) |
| Classification Name: | analyzer, gas, carbon-dioxide, gaseous phase (accessories) |
| CCK - CFR 868.1400 | |
| Class II | |
| Additional Product Code: | cannula, nasal, oxygen |
| CAT | |
| Predicate Device: | |
| Reference Device: | K010024 – Oridion |
| K011050 - Oridion |
Device Description: Westmed has designed several 0%CO2 nasal cannula / exhaled gas sampling devices. They include:
- . Nasal cannula style that can provide supplemental O2 and sample exhaled gases at only the nares and
- Nasal cannula style that can provide supplemental O2 and sample exhaled gases at both ● the nares and at the mouth
The device configurations include nasal cannula that have a division to deliver oxygen through one nare and to sample exhaled gases through the other. There is also an oral sampling style which is positioned near the mouth to sample exhaled gases if the patient is a mouth breather.
The device includes a length of standard oxygen tubing and gas sampling lines.
Indications for Use:
The Westmed nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases. Cumulative duration of use 10 kg.).
Substantial Equivalence Discussion -
Tables 1 and 2 below compare the key features of the proposed devices with the identified predicates and demonstrate that the proposed device can be found to be substantially equivalent.
4
| Attribute | Predicate
Oridion
K010024 | Proposed
Model 0581 |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | To sample exhaled gas via a nasal cannula and
simultaneously provide supplemental oxygen
near the nose and mouth for inhalation | The Westmed nasal cannula styles are intended to
deliver supplemental oxygen to patients and provide
a means to sample expired gases. Cumulative
duration of use 10 kg.) |
| Duration of use | Single patient use, disposable | Single patient use, disposable |
| Basic components | Channeled / split nasal cannula
Oxygen tubing
Gas sampling line | Channeled / split nasal cannula
Oxygen tubing
Gas sampling line |
| Sampling tubing specs | Not provided | ID - 0.060" / OD - 0.109"
Length - 2"
Luer fitting - Male / Female
Connected to customer supplied gas sampling line |
| Technological
characteristics / design | Split nasal cannula with sampling in one nares
and oxygen delivery in the other | Split nasal cannula with sampling in one nares and
oxygen delivery in the other |
| Materials | Flexible PVC for the cannula, oxygen tubing and
gas sampling line | Tested to ISO 10993-5 and 10993-10
Flexible PVC for the cannula, oxygen tubing and
gas sampling line |
| Performance testing | | Comparison End-tidal CO2 results and waveform at
various settings
Tensile strength of connections
Luer fitting testing
Age testing - Environmental
Mechanical testing |
Table 1 – Comparison - O2 delivery / CO2 sampling Cannula style
Table 2 – Comparison - O2 delivery / CO2 sampling Oral / Nasal Cannula style
| Attribute | Reference
Oridion
K011050 | Proposed
Model 0430 |
|---------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Used whenever the physician needs to measure
the CO2 in a patient's breathing in a non-
intubated patient | The Westmed nasal cannula styles are intended to
deliver supplemental oxygen to patients and provide
a means to sample expired gases. Cumulative
duration of use 10
kgs). |
| Multiple sizes | Adult to pediatric | Adult to pediatric |
| Duration of use | Single patient use, disposable | Single patient use, disposable |
5
510(k) Summary Page 3 of 4
| Attribute | Reference
Oridion
K011050 | Proposed
Model 0430 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basic components | Channeled / split nasal cannula
Mouth sampling option
Oxygen tubing
Gas sampling line | Channeled / split nasal cannula
Mouth sampling option
Oxygen tubing
Gas sampling line |
| Sampling tubing specs | Not provided | ID – 0.060" / OD –0.109"
Length –7 ft.
Luer fitting – Male / Female |
| Technological
characteristics / design | Split nasal cannula with sampling in one nares
and oxygen delivery in the other and a separate
gas sampling placed near the mouth | Split nasal cannula with sampling in one nares and
oxygen delivery in the other and a separate gas
sampling placed near the mouth |
| Materials | Flexible PVC for the cannula, oxygen tubing and
gas sampling line | Tested to ISO 10993-5 and 10993-10
Flexible PVC for the cannula, oxygen tubing and
gas sampling line |
| Performance testing | | Comparison End-tidal CO2 results and waveform at
various settings
Tensile strength of connections
Luer fitting testing
Age testing - Environmental
Mechanical testing |
Tables 1 and 2 above compare the key features of the proposed Westmed Oxygen delivery / CO2 sampling cannula style devices with the identified predicate and reference, K010024 and K011050 - Oridion Nasal cannula sampling, and it demonstrates that the proposed devices can be found to be substantially equivalent.
Discussion of Differences -
Indications for Use -
The indications for use are similar for the proposed device when compared to the identified predicate and reference - K010024 and K011050 - Oridion Nasal cannula sampling. Discussion - Each device is indicated for use delivering supplemental oxygen and sampling expired gases.
Technology and construction -
The design, fabrication, shape, size, etc. are equivalent to the identified predicate and reference -K010024 and K011050 - Oridion Nasal cannula sampling. The materials are similar: flexible PVC for the nasal cannula, oxygen tubing and gas sampling line.
Discussion – The design incorporates several styles of split / channeled nasal cannula where oxygen and expired gases are provided through the various ports within the cannula. For the oral / nasal style, there is an extra part which is placed near the mouth to sample expired gases which may be exhaled by the patient.
Environment of Use -
The environments of use are similar to identified predicate and reference - K010024 and K011050 - Oridion Nasal cannula sampling.
Discussion - The environments of use are not specifically disclosed in the predicate 510(k) Summary, but literature would support the listed environments of use. There are no differences in the requirements of each environment of use which would raise any new safety concerns when compared to the identified predicate and reference – K010024 and K011050 – Oridion Nasal cannula sampling.
6
Patient Population -
The patient population of pediatrics to adults is equivalent to the identified predicate and reference - K010024 and K011050 - Oridion Nasal cannula sampling. Discussion - The patient populations are equivalent to the identified predicate and reference -K010024 and K011050 - Oridion Nasal cannula sampling.
Non-Clinical Testing Summary -
Bench Testing -
We performed comparative testing which evaluated the ability to measure a breath, measure a gas, and breathe waveforms under several simulated breathing conditions.
The tests included:
- . Comparative CO2 sampling and waveform performance at 3 different breathing rates. CO2 concentrations (2% and 5%), and oxygen flow rates (1, 3, and 5 1pm).
- . Environmental and Age testing
- Mechanical testing ●
- o Luer Fitting
- o Flow
- Strength of bonds O
- Resistance to kinks O
The results presented show that the proposed Westmed Oxygen delivery / CO2 sampling cannula style devices performed equivalent to the predicates.
All testing demonstrated that the proposed devices are substantially equivalent to the identified predicate and reference - K010024 and K011050 - Oridion Nasal cannula sampling.
Biocompatibility -
We have performed ISO 10993 testing on the component materials of the proposed devices which is considered as Externally Communicating and Surface Contact with the patient which means the following tests are required.
- Cytotoxicity ●
- Sensitization
- . Intracutaneous Irritation
Substantial Equivalence Conclusion -
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate can be found to be substantially equivalent.