(248 days)
TwinGuard®, a nasal oxygen cannula and bite block, is used during endoscopy procedures to administer continuous oxygen to the nose and mouth. After endoscopy the bite block is removed, leaving the cannula in place during recovery, to continue delivering oxygen to the nose and mouth. In addition, the TwinGuard® contains an optional accessory which collects samples of the patient's breathing at the nose and mouth to measure CO2 with a capnograph during endoscopy procedures. It is intended for adult patients.
The TwinGuard® consists of an endoscopic bite block with an oxygen nasal cannula, which are Class I devices, excmpt from premarket notification. The optional capnograph accessory, which enables continuous CO2 monitoring during cndoscopy procedures, is a Class II device.
This 510(k) submission (K080527) for the TwinGuard® with Capnograph Accessory does not contain enough information to complete the requested table and answer all the questions. This document is a summary and an FDA letter of substantial equivalence, not a detailed study report. It primarily establishes substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria.
Information provided in the document:
- Device Name: TwinGuard® with Capnograph Accessory
- Intended Use: During endoscopy procedures, to administer continuous oxygen to the nose and mouth, and to collect samples of the patient's breathing at the nose and mouth to measure CO2 with a capnograph. Intended for adult patients.
- Predicate Devices:
Missing Information:
The document does not describe any specific studies conducted for K080527 to demonstrate the device meets acceptance criteria, beyond claiming substantial equivalence. Therefore, all sections related to specific study details (acceptance criteria, sample size, ground truth, experts, adjudication, MRMC, standalone performance, training set) cannot be answered.
Based on the provided text, the table and answers are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. | Not specified in the provided document beyond being substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. The submission is an Australian company (Trawax Pty Ltd), but no details on data origin are given.
- Retrospective or Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable, as no specific test set or ground truth establishment process is described.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Not applicable, as no specific test set or adjudication process is described.
5. 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
- Was an MRMC study done? No. This device is a physical medical device (bite block, cannula, capnograph accessory), not an AI-powered diagnostic tool involving human readers.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Was a standalone study done? No. This device is a physical medical device, not a standalone algorithm.
7. The type of ground truth used
- Not applicable, as no specific study involving ground truth establishment is described.
8. The sample size for the training set
- Not applicable, as no machine learning algorithm or training set is described.
9. How the ground truth for the training set was established
- Not applicable, as no machine learning algorithm or training set is described.
§ 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).