(389 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on standard mechanical and material properties of endotracheal tubes and a simple pressure indicator. There is no mention of AI/ML algorithms for analysis, prediction, or decision support.
Yes
This device, an endotracheal tube, is used for airway management, facilitating respiration, and preventing aspiration, which directly impacts a patient's health and well-being. The Accu-Cuff device helps manage intra-cuff pressures, which is critical for preventing complications and ensuring the efficacy of the intubation. These functions describe a device intended to treat or mitigate a disease or condition (respiratory failure, aspiration risk).
Yes.
The Accu-Cuff device described in the "Intended Use / Indications for Use" and "Device Description" sections is used to monitor intra-cuff pressures and provides information based on the location of a black line, indicating if the pressure is too low, in the green zone (optimal), or over-pressurizing. This monitoring and assessment of a physiological parameter (intra-cuff pressure) to guide clinical intervention (inflate or deflate the cuff) constitutes a diagnostic function.
No
The device description clearly details physical components made of materials like polyvinyl chloride, including a tube, cuff, lumen, pilot balloon, and a radio-opaque line. The Accu-Cuff also appears to be a physical device with a visual indicator.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device (Endotracheal Tube and Accu-Cuff) is used for airway management and monitoring intra-cuff pressure. It is a physical device inserted into the body to maintain an airway and manage the pressure of a cuff within that airway.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. It interacts directly with the patient's airway and provides information about the physical state of the cuff.
- Intended Use: The stated intended use is for oral or nasal intubation and airway management, and for inflating/monitoring cuff pressures. This aligns with a medical device used for direct patient care, not for laboratory analysis of specimens.
While the device is used in a medical setting and provides information relevant to patient care, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sterile Disposable Endotracheal Tube device is intended for oral or nasal intubation and for airway management.
The Accu-Cuff device is intended to inflate cuffs and to monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.
Product codes
BTR, BSK
Device Description
The tracheal tube is disposable and supplied as sterile. It is available in a number of sizes/variants. The tracheal tube is primarily made of polyvinyl chloride. The device is used for airway management by connecting to oxygen delivery equipment via a connector. Reinforced ETTs may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. All variants have a radio-opaque line embedded into the tube which enables identification the device when the patient is X-rayed. All variants have a hole at the tip called a Murphy's eye and a standard connector.
Cuffed variants are composed of an inflatable cuff, a lumen and pilot balloon with a one-way valve or pressure indicator. The cuff is specified with high volume and standard volume which is intended to be inflated in the trachea in order to seal the device to prevent loss of gas bypassing the tube and the inhalation of vomit.
The patient end, the cuff and the tubular body of these tracheal tubes have short-term contact (
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2017
Tianjin Medis Medical Device Co., Ltd. % Mike Gu Regulatory Affairs Manager Osmunda Medical Device Consulting Co., Ltd Level 7, Jin Gui Business Center, 982 Cunyun Road Baiyun District Guangzhou, 510420 CHINA
Re: K160694
Trade/Device Name: Disposable Endotracheal Tube, Sterile and Accu Cuff™ Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR, BSK Dated: March 8, 2017 Received: March 10, 2017
Dear Mike Gu:
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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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Tina Kiang, Ph.D. 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
510(k) Number (if known) K160694
Device Name Disposable Endotracheal tube, Sterile
Accu Cuff
Indications for Use (Describe)
The Sterile Disposable Endotracheal Tube device is intended for oral or nasal intubation and for airway management.
The Accu-Cuff device is intended to inflate cuffs and to monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.
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) |
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Image /page/3/Picture/0 description: The image shows the word "MEDIS" in blue, with a white leaf symbol above the "S". The word is in a bold, sans-serif font and is set against a blue background. The leaf symbol is stylized and positioned to the right of the word, adding a natural element to the design. The overall design is simple and clean, with a focus on the text and the leaf symbol.
510(k) Summary
Updated: April 07, 2017
In accordance with 21 CFR 807.87 the following summary of information is provided:
l. SUBMITTER
Tianjin Medis Medical Device Co., Ltd.
Address: 10-A Tianzhi Industrial Center, No.12 HongYuan Road, Xiqing Economic
Development Area, 300385 Tianjin City, and PEOPLE'S REPUBLIC OF CHINA
Phone: +86-022-83988488
Fax: +86- 022—83988486
| Primary Contact Person: | Mike Gu |
|---|---|
| Regulatory Affairs Manager | |
| OSMUNDA Medical Device Consulting Co., Ltd | |
| Tel: (+86) 20-6231 6262 | |
| Fax: (+86) 20-8633 0253 | |
| Secondary Contact Person: | Zhenchuang Yang |
| Technical Manager | |
| Tianjin Medis Medical Device Co., Ltd. | |
| Phone: +86-022-83988488 | |
| Fax: +86-022-83988486 |
DEVICE II.
| Name of Device: | Disposable Endotracheal Tube, Sterile
Accu CuffTM | |
|-----------------------|------------------------------------------------------|--|
| Common/Usual Name: | Tracheal tube | |
| Classification Panel: | Anesthesiology | |
| Classification: | 868.5730 (Tracheal tube) | |
| Class: | II | |
| Product Code: | BTR BSK | |
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PREDICATE DEVICES III.
Endotracheal Tubes Well Lead Endotracheal Tube (K042683) Well Lead Reinforced Endotracheal Tube( K073383) TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)( K041311)
Inflatable Tracheal Tube Cuff Cuff Pilot™ (K142103)
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The tracheal tube is disposable and supplied as sterile. It is available in a number of sizes/variants. The tracheal tube is primarily made of polyvinyl chloride. The device is used for airway management by connecting to oxygen delivery equipment via a connector. Reinforced ETTs may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. All variants have a radio-opaque line embedded into the tube which enables identification the device when the patient is X-rayed. All variants have a hole at the tip called a Murphy's eye and a standard connector.
Cuffed variants are composed of an inflatable cuff, a lumen and pilot balloon with a one-way valve or pressure indicator. The cuff is specified with high volume and standard volume which is intended to be inflated in the trachea in order to seal the device to prevent loss of gas bypassing the tube and the inhalation of vomit.
The patient end, the cuff and the tubular body of these tracheal tubes have short-term contact (