(248 days)
Not Found
No
The summary describes a physical device (cannula, bite block, optional capnograph) and its intended use for oxygen delivery and CO2 monitoring. There is no mention of AI, ML, image processing, or any data analysis beyond basic CO2 measurement.
No.
The primary use of the device is to administer oxygen and potentially monitor CO2, which are supportive functions during and after endoscopy. While oxygen administration can be beneficial, it is not a "therapeutic" treatment in the sense of curing or treating a disease, but rather maintaining physiological function. The device also describes itself as a Class I medical device exempt from premarket notification, which are typically low-risk devices.
Yes
The TwinGuard® contains an optional accessory that collects samples of the patient's breathing to measure CO2 with a capnograph, which is a diagnostic function.
No
The device description explicitly states it consists of a nasal oxygen cannula and bite block, which are physical hardware components. It also mentions an optional capnograph accessory, also a hardware component.
Based on the provided information, the TwinGuard® device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- TwinGuard® Function: The TwinGuard® device is used during a medical procedure (endoscopy) to administer oxygen and, optionally, monitor CO2 levels directly from the patient's breath. It does not involve testing samples taken from the body.
- Device Classification: The device components are classified as Class I and Class II medical devices, which are typical classifications for devices used in patient care, not for in vitro diagnostic tests.
The TwinGuard® is a medical device used for patient support and monitoring during a procedure, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
MNK, CCK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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:
-
- ' 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
- ' Name of Submitter, Contact Person and Date Summary Prepared:
Summary Prepared On: 25 February 2008
-
- 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)
- Device Name:
-
- Legally Marketed Equivalent Device Name:
The TwinGuard with Capnograph Accessory is substantially equivalence to the following devices:
- Legally Marketed Equivalent Device Name:
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
1
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:
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.
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.
2
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.
3
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
4
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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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.
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
(Division Sign-Off) ומו Infection Control, Dental Devices
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510(k) Number: K080527
Traditional 510(k) February 2008