(44 days)
DualGuard™ is intended for use in Adult patients who require supplemental oxygen delivery and CO2 monitoring during endoscopy procedures and recovery.
The complete device with bite block is to be used during endoscopy procedures. The DualGuard™ Bite Block is to be removed after endoscopy, leaving the O2 delivering/CO2 sampling cannula in place for patient recovery period.
DualGuard™ is an endoscopic bite block which is designed to fit into the nose and mouth of the patient during an endoscopy procedure.
DualGuard™ consists of a bite block with a removable oxygen delivering/ CO2 monitoring cannula, which when attached located under the patient nose. The bite block also has an Oral CO2 monitoring line attached at the mouth opening. DualGuard™ is able to deliver oxygen via the nose, whilst sampling CO2 from the nose and mouth.
When the Endoscopy is complete the bite block of DualGuard™ can be removed whilst leaving the cannula in place on patient, delivering oxygen and monitoring CO2.
DualGuard™ has a soft TPE over molded Bite block to reduce the risk of damage to teeth, a tube slide for securing, and an adjustable head strap for a secure comfortable fit.
The CO2 line from the DualGuard™ has a self sealing "luersafe" luer port which allows the oral CO2 line to be removed with the bite block without any leaking of CO2 or ingress of air that may cause an inaccurate reading.
DualGuard™ is available in adult size only.
Here's an analysis of the acceptance criteria and study findings for the DualGuard™ device based on the provided document:
Acceptance Criteria and Device Performance
| Test | Standard / Pre-Determined Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual inspection | Pre-Determined Acceptance Criteria | All Samples pass |
| Tubing flow resistance | Pre-Determined Acceptance Criteria | All Samples pass |
| O2 Connector to tubing tensile strength | BS EN13544-2: 2002 +A1:2009. | All Samples pass |
| O2 Connector to nipple tensile strength | BS EN13544-2: 2002 +A1:2009. (Implied, same standard) | All Samples pass |
| Tube resistance to kinking | Pre-Determined Acceptance Criteria | All Samples pass |
| Dimensional inspection of luer conical | ISO 594-1 / BS EN 20594-1:1994. | All Samples pass |
| Dead Space | Pre-Determined Acceptance Criteria | DualGuard Dead space is less than marketed predicate. |
| Dimensional inspection of luer conical | ISO 594-1 / BS EN 20594-1:1994. (Implied, same standard) | All Samples pass |
| Gauging tests on luer | ISO 594-1 / BS EN 20594-1:1994. (Implied, same standard) | All Samples pass |
| Liquid leakage from luer | ISO 594-1 / BS EN 20594-1:1994. (Implied, same standard) | All Samples pass |
| Air leakage from luer | ISO 594-1 / BS EN 20594-1:1994. (Implied, same standard) | All Samples pass |
| Luer separation force | ISO 594-2 (BS EN 1707:1997) | All Samples pass |
| Luer unscrewing torque | ISO 594-2 (BS EN 1707:1997) | All Samples pass |
| Luer ease of assembly | ISO 594-2 (BS EN 1707:1997) (Implied, same standard) | All Samples pass |
| Luer resistance to overriding | ISO 594-2 (BS EN 1707:1997) (Implied, same standard) | All Samples pass |
| Luer testing for stress cracking | ISO 594-2 (BS EN 1707:1997) (Implied, same standard) | All Samples pass |
| Leak testing of all bonded components | Pre-Determined Acceptance Criteria | All Samples pass |
| Co2 monitoring function test | Pre-Determined Acceptance Criteria | All Samples pass |
| Tensile testing - CO2 & O2 lines to connector and/or cannula | Pre-Determined Acceptance Criteria | All Samples pass |
| Dimensional characteristics | Pre-Determined Acceptance Criteria | All Samples pass |
| Accelerated age testing | ASTM F1980 | All Samples pass |
| Cytotoxicity, Irritation, sensitization | BS EN ISO 10993-10:2010 BS EN ISO 10993-5:2009 | All Samples pass |
The document states that "All Samples passed the performance testing when tested against methods and criteria from pre-determined acceptance criteria In-House test methods and relevant BS EN, ISO & ASTM FDA recognized standards." and that "The results of this testing show that DualGuard™ passes all performance tests and performs at least as well as the marketed predicate device 'TwinGuard' by Trawax."
Study Information:
-
Sample size used for the test set and the data provenance:
- Sample size: The document consistently states "All Samples" passed testing, but it does not specify the numerical sample size for each test or for the overall test set.
- Data provenance: The document is from Flexicare Medical Limited, located in the UK. The standards referenced (BS EN, ISO, ASTM) are international. The document does not specify if the testing was performed in the UK or elsewhere. No information on retrospective or prospective data is provided, as the tests appear to be laboratory performance tests of the device itself rather than clinical data from human subjects.
-
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 the type of testing described. The document describes non-clinical performance and design verification testing against established engineering standards and pre-determined acceptance criteria. There is no mention of human expert evaluation to establish ground truth for the device's technical performance. -
Adjudication method for the test set:
This information is not applicable. As mentioned above, the testing described is technical performance testing against objective standards, not interpretation by human adjudicators. -
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:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical accessory (bite block, cannula for O2 delivery and CO2 monitoring), not an AI-powered diagnostic tool. Therefore, a study comparing human readers with and without AI assistance is irrelevant and not mentioned. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, a standalone (algorithm only) performance study was not done. This device does not involve an algorithm for performance, as it is a physical medical device for oxygen delivery and CO2 sampling. It is intended for use with other medical devices (like a capnograph machine) and by humans during procedures. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical performance testing was the established engineering standards (e.g., BS EN13544-2, ISO 594-1, ISO 594-2, ASTM F1980, BS EN ISO 10993-10, BS EN ISO 10993-5) and pre-determined acceptance criteria specific to the device's design and intended function. For attributes like "Dead Space," the "ground truth" or benchmark was the performance of the legally marketed predicate device. -
The sample size for the training set:
This information is not applicable. The DualGuard™ is a physical medical device and does not involve AI or machine learning algorithms that would require a "training set." -
How the ground truth for the training set was established:
This information is not applicable, as there is no training set for this device.
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Cynon Valley Business Park, Mountain Mid Glamorgan. CF45 4ER UK. Tel: +44 (0) 1443 474647 APR 1 0 2014 Fax: +44 (0) 1443 474222 Customer Services: +44 (0) | 443 471580 Purchasing Fax: +44 (0) 1443 476332
· K140473
Email: enquiries@flexicare.com www.flexicare.com
510(k) Summary
510(k) Sponsor, Contact Person and Date Summary Prepared:
Flexicare Medical Limited Cynon Valley Business Park Mountain Ash, Mid. Glamorgan CF45 4ER. United Kingdom
Christopher Watkins Quality Regulatory & Technical Director Telephone: 00 44 1443 471 593 Fax: 00 44 1443 474 222
Summary prepared on: 10th April 2014
Device Name:
Trade Name: DualGuard™ Common/Usual Name: Endoscopic bite block and nasal oxygen cannula with CO2 monitoring accessory
Classification Name: Primary Classification: Carbon dioxide analyzer 21 CFR 868.1400 Primary Product Code: CCK Secondary Product Codes: Endoscopic bite block (MNK), Nasal oxygen cannula (CAT)
Legally Marketed Equivalent Device:
The DualGuard™ is substantially equivalent to Trawax's TwinGuard® cleared under 510(k) K080527.
Device Description:
DualGuard™ is an endoscopic bite block which is designed to fit into the nose and mouth of the patient during an endoscopy procedure.
DualGuard™ consists of a bite block with a removable oxygen delivering/ CO2 monitoring cannula, which when attached located under the patient nose. The bite block also has an Oral CO2 monitoring line attached at the mouth opening. DualGuard™ is able to deliver oxygen via the nose, whilst sampling CO2 from the nose and mouth.
When the Endoscopy is complete the bite block of DualGuard™ can be removed whilst leaving the cannula in place on patient, delivering oxygen and monitoring CO2.
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Image /page/1/Picture/2 description: The image shows the logo for "Flexicare". The logo is in black and white and features a stylized "F" followed by the word "lexicare" in a bold, sans-serif font. Below the word "lexicare" is the tagline "TOTAL QUALITY - TOTAL CARE" in a smaller font.
DualGuard™ has a soft TPE over molded Bite block to reduce the risk of damage to teeth, a tube slide for securing, and an adjustable head strap for a secure comfortable fit.
The CO2 line from the DualGuard™ has a self sealing "luersafe" luer port which allows the oral CO2 line to be removed with the bite block without any leaking of CO2 or ingress of air that may cause an inaccurate reading.
DualGuard™ is available in adult size only.
Intended Use:
DualGuard™ is intended for use in Adult patients who require supplemental oxygen delivery and CO2 monitoring during endoscopy procedures and recovery.
The complete device with bite block is to be used during endoscopy procedures. The DualGuard™ Bite Block is to be removed after endoscopy, leaving the O2 delivering/CO2 sampling cannula in place for patient recovery period.
Substantial Equivalence:
DualGuard™ has the same intended use as the predicate device.
Both the DualGuard and TwinGuard are single patient use devices. Supplied in Adult size onlv.
Neither device is life supporting or life sustaining.
Patient Contact -Bite block - Invasive - Mucosal membrane - Limited duration (>24hrs) Cannula & tubing - skin contact (intact) and externally communicating - Limited duration (>24hrs)
Neither the DualGuard nor the TwinGuard uses software/ neither are electronically driven. Both devices are supplied non-sterile in individual poly bags.
Both devices are able to be used with industry standard devices such as oxygen cylinders/connectors and Capnograph machines.
Both the DualGuard and TwinGuard devices are designed for the same intended use in the same intended conditions.
Both designs consist of 10+ components made from injection molded & extruded plastics.
From comparison testing it was determined that the only invasive components of the two devices were the bite blocks.
The DualGuard bite blocks are manufactured from Polypropylene with a soft TPE section over molded.
TwinGuard bite blocks are also manufactured from Polypropylene but do not have an over molded section.
The Oxygen tubing, cannula, CO2 line and oxygen connector of both the DualGuard and TwinGuard devices are manufactured from PVC.
The Trawax "TwinGuard" bite block is Green in color with clear tubing. The Flexicare Duale, Luard TM in Dlun 9 aranan in antar uith aloar fuhina Thia diffaran
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Image /page/2/Picture/2 description: The image shows the logo for "Flexicare". The logo has a stylized "F" on the left, followed by the text "lexicare" in a serif font. Below the name is the text "TOTAL QUALITY - TOTAL CARE" in a smaller, sans-serif font.
manufacturer's choice/ branding, and is not related to sizing, intended use, gender of patient or performance of device.
Both the DualGuard and Predicate devices have 2M oxygen & CO2 lines.
| Flexicare DualGuard™ | Trawax "TwinGuard" | |
|---|---|---|
| K: Unknown | K080527 | |
| Components | O2 tube | O2 tube |
| O2 connector | O2 connector | |
| CO2 line | CO2 line | |
| CO2 luer | CO2 luer | |
| Bite block | Bite block | |
| TPE over mold | Nasal cannula | |
| Nasal cannula | Head strap | |
| Head strap | Tube slide | |
| Tube slide | Oral CO2 tube link | |
| Oral CO2 tube link | ||
| Self sealing CO2 Y-piece | ||
| Oral CO2 luer | ||
| 0.45µm Hydrophobic filter | ||
| Medical grade PVC | ||
| Materials | Medical grade PVC | |
| Medical grade Polypropylene | Medical grade Polypropylene | |
| Medical grade ABS | Medical grade ABS | |
| Medical grade TPE | ||
| Medical grade ABS/Nylon (filter) | ||
| Target | Adult | Adult |
| population | ||
| Home use | No | No |
| Emergency use | Yes | Yes |
| Assembly | Bonded - Solvent adhesive | Bonded - Solvent adhesive |
| method | ||
| Connectable to | Yes | Yes |
| Capnograph? | ||
| Monitors CO2? | Yes | Yes |
| Nasal CO2 | Yes | Yes |
| monitoring? | ||
| Oral CO2 | Yes | Yes |
| monitoring? | ||
| Use | Single use | Single use |
| Supplied sterile | No | No |
| Soft molded bite | Yes | No |
| area? | ||
| Indications foruse | DualGuard™ is intended for use in Adultpatients who require supplemental oxygendelivery and CO2 monitoring duringendoscopy procedures and recovery.The complete device with bite block is to beused during endoscopy procedures.The DualGuard™ Bite Block is to be removedafter endoscopy, leaving the 02delivering/CO2 sampling cannula in place forpatient recovery period. | TwinGuard®, a bite block with a nasal oxygencannula, is used during endoscopyprocedures to administer continuous oxygento the nose and mouth.After endoscopy the bite block is removed,leaving the cannula in place during recovery,to continue delivering oxygen to the noseand mouth.In addition, the TwinGuard® contains anoptional accessory which collects samples ofthe patient's breathing at the nose andmouth to measure CO2 with a capnographduring endoscopy procedures. It is intendedfor adult patients. |
| Prescription Use? | Yes | Yes |
| Processes carriedout | Injection mouldingTube extrusionSolvent bondingPackaging | Injection mouldingTube extrusionSolvent bondingPackaging |
| Componentinteractions | O2 & CO2 Tube - non-Invasive, skin contact(intact) and Externally communicating.Limited use (<24hr)Connectors - skin contact (hands), limiteduse (<24h)Bite Block - invasive (natural orifice)mucosal membrane, limited use(<24h) | O2 & CO2 Tube - non-Invasive, skin contact(intact) and Externally communicating.Limited use (<24hr)Connectors - skin contact (hands), limiteduse (<24h)Bite Block - invasive (natural orifice)mucosal membrane, limited use(<24h) |
| Storageconditions | Store in a cool, dry place out of directsunlight | Store in a cool, dry place out of directsunlight |
| Available sizes | Adult | Adult |
| Available lengths | 2.0m | 2.0m |
| O2 tubedimensions | ID: 3.9mmOD: 5.0mm | ID: 3.9mmOD: 5.6mm |
| CO2 tubedimensions | ID: 1.2mmOD: 2.7mm | ID: 1.4mmOD: 2.7mm |
| Colour | Blue, Orange, Clear/Colorless | Green, Clear/ Colorless |
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Image /page/3/Picture/2 description: The image shows the logo for Flexicare. The logo consists of a stylized "F" followed by the word "lexicare" in a sans-serif font. Below the word "lexicare" is the tagline "TOTAL QUALITY - TOTAL CARE" in a smaller font.
.
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Image /page/4/Picture/1 description: The image shows the logo for Flexicare. The logo consists of a stylized "F" symbol followed by the word "lexicare" in a bold, sans-serif font. Below the word "lexicare" is the tagline "TOTAL QUALITY - TOTAL CARE" in a smaller font. The logo is simple and professional, and it conveys a sense of quality and care.
Although very similar in design and function, there are some differences (described below) between the Flexicare DualGuard™ and the predicate device. However, these differences do not raise and new safety or effectiveness issues.
The Flexicare DualGuard™ has an over molded soft TPE section around the bite area of the bite block whilst the predicate Trawax "TwinGuard" does not have this feature.
The Flexicare DualGuard TM also differs from the Trawax "TwinGuard" predicate as DualGuard™ includes a nasal CO2 sampling cannula. This cannula is bonded side-by-side with the Oxygen delivering cannula and samples CO2 through its prongs that locate beneath the nostrils. This nasal sampling cannula is not present on the predicate device, which obtains its nasal CO2 samples via a plug & monitoring line that is inserted into one nostril. This does however restrict oxygen delivery to one nostril.
Image /page/4/Picture/5 description: The image shows two different medical devices, labeled as "DualGuard™M" and "TwinGuard". The DualGuard device has three tubes connected to a central piece, with arrows indicating the direction of flow. The TwinGuard device has a knob on top and a black, circular base with a hole in the center.
DualGuard™ also features a self sealing Y-Piece, allowing CO2 to be sampled from the nose and mouth simultaneously or from the nose only, without the need to cap a disconnected port.
Another difference between DualGuard™ and its predicate device "TwinGuard", although not critical, is strap securing locations. Flexicare's device features flexible molded wings which the strap secures onto, which keeps the bite block secure in the mouth. The "TwinGuard" features a hook on location each side of the bite block to secure head strap.
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Image /page/5/Picture/2 description: The image shows the logo for "flexicare". The logo has a stylized "f" on the left side of the word. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE".
Summary of Testing:
DualGuard™ has been evaluated in accordance with standards listed in table:
| Test | Standard / Pre-DeterminedAcceptance Criteria | Outcome |
|---|---|---|
| Visual inspection | Pre-Determined AcceptanceCriteria | All Samples pass |
| Tubing flow resistance | All Samples pass | |
| O2 Connector to tubing tensile strength | BS EN13544-2: 2002+A1:2009. | All Samples pass |
| O2 Connector to nipple tensile strength | All Samples pass | |
| Tube resistance to kinking | All Samples pass | |
| Dimensional inspection of luer conical | ISO 594-1 / BS EN 20594-1:1994. | All Samples pass |
| Dead Space | Pre-Determined AcceptanceCriteria | DualGuard Deadspace is less thanmarketed predicate. |
| Dimensional inspection of luer conical | All Samples pass | |
| Gauging tests on luer | All Samples pass | |
| Liquid leakage from luer | All Samples pass | |
| Air leakage from luer | All Samples pass | |
| Luer separation force | All Samples pass | |
| Luer unscrewing torque | ISO 594-2 (BS EN 1707:1997) | All Samples pass |
| Luer ease of assembly | All Samples pass | |
| Luer resistance to overriding | All Samples pass | |
| Luer testing for stress cracking | All Samples pass | |
| Leak testing of all bonded components | Pre-Determined AcceptanceCriteria | All Samples pass |
| Co2 monitoring function test | Pre-Determined AcceptanceCriteria | All Samples pass |
| Tensile testing - CO2 & O2 lines toconnector and/or cannula prongs | Pre-Determined AcceptanceCriteria | All Samples pass |
| Dimensional characteristics | Pre-Determined AcceptanceCriteria | All Samples pass |
| Accelerated age testing | ASTM F1980 | All Samples pass |
| Cytotoxicity, Irritation, sensitization | BS EN ISO 10993-10:2010BS EN ISO 10993-5:2009 | All Samples pass |
All Samples passed the performance testing when tested against methods and criteria from pre-determined acceptance criteria In-House test methods and relevant BS EN, ISO & ASTM FDA recognized standards.
The results of this testing show that DualGuard™ passes all performance tests and performs at least as well as the marketed predicate device "TwinGuard" by Trawax
The conclusions drawn from the nonclinical performance comparison testing demonstrate that DualGuard™ is as safe, as effective, and performs as well as or better than the legally marketed Predicate device "TwinGuard" by Trawax.
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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines that curve and flow. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2014 ,
Flexicare Medical Limited c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313
Re: K140473
Trade/Device Name: DualGuardTM Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK, MNK, CAT Dated: March 25, 2014 Received: March 26, 2014
Dear Mr. Job:
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. Job
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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/7/Picture/8 description: The image contains a logo with the text "Tejashri Purohit-Sheth, M.D." and "Clinical Deputy Director". Below this text is the word "DAGRID" in a stylized font. The word "FOR" is located in the bottom right corner of the image. The logo appears to be a stamp or seal.
Erin I. Keith, M.S. Acting 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
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name DualGuardin
Indications for Use (Describe)
DualCourd™ is intended for use in Adult patients who require supplemental oxygen delivery and CO2 monitoring during endoscopy procedures and recovery.
The complete device with bite block is to be used during endoscopy procedures.
The DualGuard™ Bitc Block is to be removed after endoscopy, baving the O2 delivering/CO2 sampling cannula in place for palient recovery period.
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)
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)
| Todd D-Courtney-S | |
|---|---|
| 2014.04.09 12:58:53 -04'00' |
FORM FDA 3881 (9/13)
PSC Publishing Services ( 1015 641474) - EF
§ 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).