(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:
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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.
§ 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).