Disposable Endotracheal tube, sterile, AccuCuff

K160694 · Tianjin Medis Medical Device Co., Ltd. · BTR · Apr 7, 2017 · Anesthesiology

Device Facts

• Record ID: K160694
• Device Name: Disposable Endotracheal tube, sterile, AccuCuff
• Applicant: Tianjin Medis Medical Device Co., Ltd.
• Product Code: BTR · Anesthesiology
• Decision Date: Apr 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Disposable sterile endotracheal tube (ETT) used for oral/nasal intubation and airway management; connects to oxygen delivery equipment via standard connector. Features include Murphy's eye, radio-opaque line, and optional reinforced metal for kink resistance. Cuffed variants include inflatable cuff, lumen, and pilot balloon. Accu-Cuff™ component attaches to cuff inflation line via luer fitting to monitor intra-cuff pressure; uses diaphragm/bellows mechanism where pressure changes move a black line against color-coded zones (yellow/low, green/safe, red/high) to guide manual inflation/deflation. Used in hospitals, EMS, and clinics under medical supervision. Provides airway patency and gas seal; Accu-Cuff helps prevent over-pressurization or under-inflation of cuffs, reducing risk of gas leakage or mucosal damage.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1, 3, 5, 6, 10), dimensional analysis, leakage, kinking, radiopacity (ISO 5361, ASTM F640), seal strength (ASTM F88), and shelf-life/sterilization validation. No clinical data provided.

Technological Characteristics

Materials: Polyvinyl chloride, polypropylene, polycarbonate, silicone rubber, ABS. Sensing principle: Diaphragm/bellows-based mechanical pressure monitoring. Connectivity: None (mechanical). Sterilization: Ethylene Oxide (EO). Standards: ISO 10993, ISO 5361, ASTM F88, ASTM F640.

Indications for Use

Indicated for patients requiring oral or nasal intubation and airway management. Accu-Cuff indicated for monitoring intra-cuff pressures of endotracheal, supraglottic, or tracheostomy tubes in pediatric to adult populations.

Regulatory Classification

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.

Predicate Devices

• Well Lead Endotracheal Tube (K042683)
• Well Lead Reinforced Endotracheal Tube (K073383)
• TIGER ENDOTRACHEAL TUBES (K041311)
• Cuff Pilot™ (K142103)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/8 description: The image contains a signature and a name. The name is "Tina Kiang-S". The signature is to the left of the name and is a stylized scribble.

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)

| <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------|
| <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 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: [phone]

Fax: +86- 022—83988486

| Primary Contact Person: | Mike Gu |
|---------------------------|--------------------------------------------|
| | Regulatory Affairs Manager |
| | OSMUNDA Medical Device Consulting Co., Ltd |
| | Tel: [phone] |
| | Fax: [phone] |
| Secondary Contact Person: | Zhenchuang Yang |
| | Technical Manager |
| | Tianjin Medis Medical Device Co., Ltd. |
| | Phone: [phone] |
| | Fax: [phone] |

DEVICE II.

| Name of Device: | Disposable Endotracheal Tube, Sterile<br>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 (< 30 days) with mucous membrane of upper airway.

Separately, Accu-cuff™ is used for pre-use check and monitoring the cuff pressure in intubation, treatment and extubation process. The user can Judge the change of intra-cuff pressure by observing the change of black line's location. When the black line point to the zone between the Minimum level of green zone and white line, it means the intra-cuff is too low and need to inflate to cuff. When the black line point to the zone between the Maximum level of green zone and red line, it means the intra-cuff is over-pressurizing and need to deflate.

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#### V. INDICATION 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.

#### VI. SUBSTANTIAL EQUIVELENCE

Substantial equivalency is claimed against the following device:

| No. | Proposed Devices | Predicate Devices |
|-----|--------------------------------------------------------|-------------------|
| 1 | Standard Endotracheal Tube, cuffed and uncuffed series | k042683 |
| 2 | Endotracheal tube Reinforced, cuffed and uncuffed | k073383 |
| 3 | Endotracheal tube Nasal Preformed, cuffed and uncuffed | k041311 |
| 4 | Endotracheal tube Oral Preformed cuffed and uncuffed | |
| 5 | Accu Cuff™ | k142103 |

## Table 6.1 Substantial equivalency discussion

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| Specification | Predicate Device | Proposed Device | Discussion<br>of<br>Differences |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Device name | Well Lead Endotracheal Tube | Disposable Endotracheal<br>tube, sterile | |
| K number | k042683 | — | |
| Intended use | The device is intended for<br>oral or nasal intubation and<br>for airway management. | The device is intended for<br>oral or nasal intubation and<br>for airway management. | Identical |
| Outer diameter | cuffed :3.3-13.3mm<br>uncuffed :2.7-13.3mm | cuffed :3.3-13.3mm<br>uncuffed :2.7-13.3mm | Identical |
| Tube length | cuffed :145-330mm<br>uncuffed :140-330mm | cuffed :145-330mm<br>uncuffed :140-330mm | Identical |
| Cuff inflated<br>diameter | Standard cuff:12-27mm<br>High volume cuff:12-27mm | Standard cuff:12-27mm<br>High volume cuff:12-27mm | Identical |
| Cuff pressure<br>(if applicable ) | $20 cmH_20 \le P <30 cmH_20$ | $20 cmH_20 \le P \le 29 cmH_20$ | Identical |
| Materials | Polyvinyl chloride,<br>polypropylene | Polyvinyl chloride,<br>polypropylene | Identical |
| Structure<br>composition | Connector, inflating<br>tube,<br>Check valve (include Pilot<br>balloon), Airway Tube, Cuff (if<br>available). | Connector, Inflation<br>tube,<br>pilot<br>balloon and<br>valve<br>(cuffed), Airway Tube, Cuff (if<br>available), Accu CuffTM (if<br>available) | Similar.<br>The<br>proposed<br>device<br>has an extra Accu<br>CuffTM component,<br>refer to table 6.5. |
| Anatomical Sites | The tubular body and the cuff<br>have limited or prolonged<br>contact with mucous<br>membrane of oral/nasal<br>cavity and the tracheal. | The tubular body and the cuff<br>have limited or prolonged<br>contact with mucous<br>membrane of oral/nasal<br>cavity and the tracheal. | Identical |
| Contact<br>duration | Less than 30 days | Less than 30 days | Identical |
| Biocompatibility | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | Identical |
| Shelf life | 5 years | 5 years | Identical |
| Packing | PE / PET composite film and<br>dialysis paper | PE / PET composite film and<br>dialysis paper | Identical |
| Sterilization | EO | EO | Identical |
| Specification | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Device name | Well Lead Reinforced<br>Endotracheal Tube | Disposable Endotracheal<br>tube, sterile | / |
| K number | K 073383 | -- | / |
| Intended use | The Well Lead Reinforced<br>Endotracheal Tubes are<br>designed for oral or nasal<br>intubation for airway<br>management during<br>anaesthesia. The product<br>may be used where the<br>patient's neck is likely to be<br>moved or flexed or the<br>patient is in the prone<br>position so that a<br>non-reinforced tracheal tube<br>might become kinked. | The device is intended for<br>oral or nasal intubation and<br>for airway management. | Similar. Two<br>devices are both<br>used for airway<br>management |
| Size | Cuffed: in 0.5mm ID<br>increments from size 5.0 to<br>9.5 inclusive, totaling 10<br>sizes.<br>uncuffed: in 0.5mm ID<br>increments from size 3.0 to<br>9.5 inclusive, totaling 14<br>sizes. | Cuffed: in 0.5mm ID<br>increments from size 5.0 to<br>9.0 inclusive, totaling 10<br>sizes.<br>uncuffed: in 0.5mm ID<br>increments from size 3.0 to<br>9.5 inclusive, totaling 14<br>sizes. | Similar. The size<br>of proposed<br>device meets<br>the<br>requirement of<br>section 5 of<br>ISO 5361. |
| Outer diameter | Cuffed:7.0-13.0mm<br>Uncuffed: 4.3-13.0mm | Cuffed:7.0-13.0mm<br>Uncuffed: 4.3-13.0mm | Identical |
| Tube length | Cuffed:245-330mm<br>Uncuffed: 165-330mm | Cuffed:245-330mm<br>Uncuffed: 165-330mm | Similar. The size<br>of proposed<br>device meets<br>the requirement<br>of section 5 of<br>ISO 5361. |
| Cuff inflated<br>diameter | Cuffed:17-27mm<br>High volume cuff:12-27mm | Cuffed:17-27mm<br>High volume cuff:12-27mm | Identical |
| Cuff pressure<br>(if applicable ) | $20 cmH_20 \le P <30 cmH_20$ | $20 cmH_20 \le P \le 29 cmH_20$ | Identical |
| Specification | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Materials | Polyvinyl chloride,<br>polypropylene | Polyvinyl chloride,<br>polypropylene | Identical |
| Structure<br>composition | Connector, Inflating<br>tube,<br>Check valve (include pilot<br>balloon), reinforced metal,<br>Cuff (if available). | Connector, Inflation<br>tube,<br>pilot balloon and<br>valve<br>(cuffed), Airway<br>Tube,<br>reinforced metal, Cuff (if<br>available), Accu Cuff™ (if<br>available) | Similar. The<br>proposed device<br>has an extra<br>Accu Cuff™<br>component,<br>refer to table<br>6.5. |
| Anatomical Sites | The tubular body and the cuff<br>have limited or prolonged<br>contact with<br>mucous<br>membrane of<br>oral/nasal<br>cavity and the tracheal. | The tubular body and the cuff<br>have limited or prolonged<br>contact with<br>mucous<br>membrane of<br>oral/nasal<br>cavity and the tracheal. | Identical |
| Contact<br>duration | Less than 30 days | Less than 30 days | Identical |
| Biocompatibility | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | Identical |
| Shelf life | 5 years | 5 years | Identical |
| Packing | PE / PET composite film and<br>dialysis paper | PE / PET composite film and<br>dialysis paper | Identical |
| Sterilization | EO | EO | Identical |

## Table 6.2 Equivalency discussion of Standard Endotracheal Tube, cuffed and uncuffed series

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Table 6.3 Equivalency discussion of Endotracheal tube Reinforced, cuffed and uncuffed series

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Table 6.4 Equivalency discussion of Endotracheal tube Nasal and Oral Preformed cuffed and

uncuffed series

| Specification | Predicate Device | Proposed Device | Discussion of<br>Differences |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Device name | TIGER ENDOTRACHEAL TUBES<br>(VARIOUS MODELS AND SIZES) | Disposable Endotracheal<br>tube, sterile | / |
| K number | K041311 | -- | / |
| Specification | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Intended use | The intended use for all the<br>product variants is grouped<br>into different sections:<br>CATEGORY 2 (uncuffed. nasal<br>only) and CATEGORY 5 (cuffed,<br>nasal only):<br>The intended use of this device<br>is to be intubated into a<br>patient's trachea via the nose<br>for airway management,<br>specifically for use in surgical<br>procedures involving the head,<br>neck and face.<br>CATEGORY 3 (uncuffed, oral<br>only) and CATEGORY 6 (cuffed,<br>oral only):<br>The intended use of this device<br>is to be intubated into a<br>patient's trachea via the<br>mouth for airway<br>management, specifically for<br>use in surgical procedures<br>involving the head, neck and<br>face. | The device is intended for<br>oral or nasal intubation and<br>for airway management. | Similar.<br>Two<br>devices are both<br>used for airway<br>management |
| Size | Uncuffed (nasal only and oral<br>only): provide in 0.5mm ID<br>increments from sizes 2.0 to<br>10.0 inclusive, totaling 17Sizes.<br>Cuffed (nasal only and oral<br>only): provide in 0.5mm ID<br>increments from sizes 4.0 to<br>10.0 inclusive, totaling 13 sizes. | Nasal only (cuffed and<br>uncuffed): provide in 0.5mm<br>ID increments from sizes 3.0<br>to 10.0 inclusive, totaling 15<br>Sizes.<br>Oral only (cuffed and<br>uncuffed): provide in 0.5mm<br>ID increments from sizes 3.0<br>to 10.0 inclusive, totaling 15<br>Sizes. | Identical. The<br>size of proposed<br>device meets<br>the requirement<br>of section 5 of<br>ISO 5361. |
| Outer diameter | Not provided | Oral Preformed:4.0-13.3mm<br>Nasal Preformed:<br>4.0-13.3mm | Similar with the<br>predicate<br>devices in table<br>12.2. |
| Specification | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Tube length | Not provided | Oral Preformed:165-330mm<br>Nasal Preformed:290-400mm | The tube length<br>of proposed<br>device meets<br>the requirement<br>of section 5 of<br>ISO 5361. |
| Cuff<br>inflated<br>diameter | Not provided | Standard cuff:12-27mm<br>High volume cuff:12-27mm | / |
| Cuff pressure<br>(if applicable ) | $20 cmH_20 \le P <30 cmH_20$ | $20 cmH_20 \le P \le 29 cmH_20$ | Identical |
| Materials | Polyvinyl chloride,<br>polypropylene | Polyvinyl chloride,<br>polypropylene | Identical |
| Structure<br>composition | Connector, inflating tube,<br>Check valve (include Pilot<br>balloon), Airway Tube, Cuff (if<br>available). | Connector, Inflation tube,<br>pilot balloon and valve<br>(cuffed), Airway Tube, Cuff (if<br>available), Accu CuffTM (if<br>available) | Similar. The<br>proposed device<br>has an extra<br>Accu CuffTM<br>component,<br>refer to table<br>6.5. |
| Anatomical Sites | The tubular body and the cuff<br>have limited or prolonged<br>contact with mucous<br>membrane of oral/nasal cavity<br>and the tracheal. | The tubular body and the cuff<br>have limited or prolonged<br>contact with mucous<br>membrane of oral/nasal<br>cavity and the tracheal. | Identical |
| Contact<br>duration | Less than 30 days | Less than 30 days | Identical |
| Biocompatibility | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | Identical |
| Shelf life | 5 years | 5 years | Identical |
| Packing | PE / PET composite film and<br>dialysis paper | PE / PET composite film and<br>70g dialysis paper | Identical |
| Sterilization | EO | EO | Identical |

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| Attribute | Predicate Device<br>Cuff Pilot™ (K142103) | Proposed Device<br>Accu Cuff™ | Discussion of Differences |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | To monitor intra-cuff pressures of<br>supraglottic airways. | To inflate cuffs and to monitor<br>intra-cuff<br>pressures of<br>endotracheal,<br>supraglottic<br>airways, or tracheostomy tubes. | Similar. Two devices are<br>both used to indicate the<br>intra-cuff<br>pressure<br>of<br>artificial airway tube. |
| Environment<br>of use | To be used under medical<br>supervision in hospitals,<br>pre-hospital (EMS), extended<br>care facilities and outpatient<br>clinics, where a patient may have<br>an artificial airway. It may also be<br>used in MRI suites when attached<br>to airways that are MR<br>conditional or MR Safe. | To be used under medical<br>supervision in hospitals,<br>pre-hospital (EMS), extended<br>care facilities and outpatient<br>clinics, where a patient may be<br>intubated. The metal-contained<br>models are MR unsafe. | The<br>metal-contained<br>models of proposed device<br>are MR unsafe, and be<br>marked with MR unsafe in<br>labels. |
| Patient<br>population | Patients who have an artificial airway and for which the user would<br>like to monitor cuff pressure, pediatric to adult. | | Identical |
| Working<br>principle | Use the pressure difference between the pressure indicator cavity<br>and the atmospheric pressure, the elastic piece will be concaved and<br>then drive the black line on the joint lever move and indicate the<br>intra-cuff pressure. | | Identical |
| Technology | Bellows that move with changes<br>in pressure<br>Contracts with higher pressures<br>Expands with lower pressures | Diaphragm/bellows that<br>move with changes in pressure<br>Expands with higher pressures<br>Rebounds with lower pressures | Mechanisms are same. |
| Indication<br>method | The Bottom cover have Color<br>mark, when the black line move<br>to the white line ,which means<br>the intra -cuff pressure is<br>decreased, move to the red line<br>show the intra-cuff pressure is<br>increased. When the black line<br>site in the Green zone, the intra-<br>cuff pressure is safe. | The Outer Cylinder have Color<br>mark, the yellow zone, green<br>zone and red zone. When the<br>black line in the yellow zone<br>means the pressure is too low,<br>the red zone indicate the intra<br>cuff pressure is too large, that<br>need to deflate. The black line<br>in the green zone which means<br>the intra cuff pressure is safe. | The mechanism is identical,<br>only differ in color of<br>indication line. |
| Method of<br>inflating cuff | Use an independent syringe (normal practice). | Manual | Identical |
| Component | Outer Cylinder, Valve, plate,<br>Bellows, Black line, Bottom cover | Top cover, PP cap, Cross,<br>Gasket, Silicone tube, Bottom | Similar. The components of<br>proposed device can |
| Material | Color mark, Luer connector,<br>connector | cover of check valve, Sealing<br>cover, Supported ring ,Elastic<br>piece, Bottom cover, Silicone<br>ring(black line), Join lever , Color<br>mark | perform the designed<br>functions, refer to Appendix<br>Q4. |
| | Outer Cylinder, plate, Bottom<br>cover: Polycarbonate<br><br>Bellows, Valve :<br>Silicone Rubber | Top cover, Bottom cover,<br>Supported ring, Join lever,<br>Bottom cover of check valve:<br>Polycarbonate.<br>Sealing cover, Silicone tube,<br>Gasket, Silicone ring(black line),<br>Elastic piece: Silicone Rubber<br>PP cap: Polypropylene<br>Cross: ABS ( Acrylonitrile<br>Butadiene Styrene) | Similar. The materials of the<br>proposed device are safe in<br>biocompatibility, refer to<br>Appendix P. |
| Attaches to<br>the Cuff<br>Inflation Pilot | Yes, via a luer fitting may be<br>permanently attached to an<br>airway's cuff inflation line | Yes, via a luer fitting may be<br>permanently attached to an<br>airway's cuff inflation line | Identical |
| Types of<br>airways to<br>which it can<br>be used | Supraglottic airway | Endotracheal tube | Similar. The proposed<br>component is a pressure<br>monitoring device, refer to<br>Appendix Q4. |
| Single patient,<br>disposable | Yes | Yes | Identical |
| Pressure<br>Range of the<br>device | 0 to 80 cm H2O | 0-40 cm H2O | Similar. The proposed<br>device is used under range<br>20-29 cmH2O which is<br>under 40 cmH2O. |
| Detection<br>of<br>"good range" | Color coded zones | Color coded zones | Identical |
| Sterilization | Non-sterile and sterile | Sterile | Identical |
| Working<br>pressure<br>range | +/- 5 cmH2O up to 80 cmH2O | + 4 cmH2O at 20 cmH2O<br>- 4 cmH2O at29 cmH2O | The tolerance of pressure is<br>similar. Refer to Appendix S<br>and T for clinical evidence<br>of range 20 cmH2O-29<br>cmH2O. |
| Shelf-life | 3 years | 5 years | Similar. Refer to Appendix<br>O for shelf life validation. |

# Table 6.5 Equivalent discussion of pressure indicator (Accu Cuff™)

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#### VII. PERFORMANCE DATA

The disposable tracheal tube has been evaluated by biocompatibility testing, device performance, sterilization and shelf life validation and EO/ECH residue analysis.

The performance tests were conducted with the following standards.

- . ISO 10993-1:2009/(R) 2013, Biological Evaluation Of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process;
- . ISO 10993-3:2014 Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- . ISO 10993-5 :2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity;
- ISO 10993-6:2007 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
- . ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization;
- . ISO 5361:2012 Anaesthetic and respiratory equipment -- Tracheal tubes and connectors; including dimensional; leakage; kinking; and radiopacity testing.
- ASTM F88/F88M-09, Standard Test Method For Seal Strength Of Flexible Barrier Materials
- . ASTM F640-2012 Standard Test Methods for Determining Radiopacity for Medical Use

#### VIII. CONCLUSION

Tianjin Medis Medical Device Co., Ltd. considers the Disposable Endotracheal tube, Sterile and the Accu Cuff™ to be as safe, as effective, and performance is substantially equivalent to the predicate devices.