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.

Device Description

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.

AI/ML Overview

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:
- Stantex Pty Ltd's Oxyguard endoscopic bite block, 510(k) K914978
- Hudson Respiratory Care's nasal oxygen cannula, 510(k) K011125
- Oridion Medical's Smart BiteBloc™, 510(k) K042665

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.

Summary

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K080527

Traditional 510/k) Noti TwinGuard® with Capnograph Acc

510(k) SUMMARY

OCT 31 2008

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of The Safe Medical Devices Act of 1990 (SMDA 1990) and 21 CFR 807.92.

The assigned 510(k) number is:

1. ' Name of Submitter, Contact Person and Date Summary Prepared:
  Julic Nunn Managing Director Trawax Pty Ltd 101 Darcey Road Castle Hill NSW 2154 Australia Phone: 61 419 256 218 Fax: 61 2 8850 1265

Summary Prepared On: 25 February 2008

1. Device Name:
  Trade/Proprietary Name: TwinGuard® with Capnograph Accessory Common/Usual Name: Endoscopic bite block and nasal oxygen cannula with capnograph accessory Classification Name: Endoscopic bite block (Class I) Nasal oxygen cannula (Class I) Carbon dioxide analyzer (Class II)
1. Legally Marketed Equivalent Device Name:
  The TwinGuard with Capnograph Accessory is substantially equivalence to the following devices:

Stantex Pty Ltd's Oxyguard endoscopic bite block, 510(k) K914978 Hudson Respiratory Care's nasal oxygen cannula, 510(k) K011125 Oridion Medical's Smart BiteBloc™, 510(k) K042665

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510(k) SUMMARY

(Continued)

4. Intended Use of the Device:

TwinGuard®, a bitc block with a nasal oxygen cannula, 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.

5. Description of the Device:

ర. Device Comparison and Conclusion:

The TwinGuard® with Capnograph Accessory has the same intended use as the predicate devices, and any technological differences with the predicate devices do not raise any new safety or effectiveness issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 31 2008

model and and and the manned on the province of the finis of the comment

Trawax Pty Limited C/O Ms. Cindy Martin Regulatory Affairs Associate II 29662 Avante Laguna Niguel, California 92677

Re: K080527

Trade/Device Name: TwinGuard™ with Capnograph Accessory Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: I Product Code: MNK, CCK Dated: October 22, 2008 Received: October 23, 2008

Dear Ms. Martin:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Martin

The Comments of the comments of the many of the many of the many of the many of the may of the may of the may of the may of the may of the may of the may of the may of the ma

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Muhammad Ledner toell

A . Read Broom Book 2012 . 2012

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5.0 Indications for Use Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: TwinGuard™ with Capnograph Accessory

Indications For Use:

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Prescription Use X (Part 21 CFR 801 Subpart D) . OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Arimid

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510(k) Number: K080527

Traditional 510(k) February 2008

Regulation Number and Section

§ 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).