(389 days)
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.
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.
The provided text is a 510(k) summary for a Disposable Endotracheal Tube, Sterile, and Accu Cuff™. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and detailed device performance through a standalone study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, and training set details for an AI/algorithm-based device is not available in this document.
However, based on the information provided, I can extract details about the performance data and testing standards used to demonstrate equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative table with corresponding "reported device performance" in the context of an AI/algorithm. Instead, it compares the specifications of the proposed device to predicate devices to establish substantial equivalence.
For the Accu Cuff™, the key performance criterion mentioned is the working pressure range.
| Acceptance Criteria (from Predicate/Standard) | Reported Device Performance (Proposed Accu Cuff™) |
|---|---|
| Cuff pressure (if applicable): 20 cmH2O <= P < 30 cmH2O (from predicate ETTs) | 20 cmH2O <= P <= 29 cmH2O (for proposed ETTs with Accu Cuff™) |
| Working pressure range: +/- 5 cmH2O up to 80 cmH2O (from predicate Cuff Pilot™) | + 4 cmH2O at 20 cmH2O - 4 cmH2O at 29 cmH2O |
| Detection of "good range": Color coded zones | Color coded zones |
For the Disposable Endotracheal Tube, Sterile, the document lists various specifications and states that the proposed device's performance is either identical or similar and meets relevant ISO standards. No specific quantitative "acceptance criteria" for each parameter are explicitly listed in a comparative table against a particular performance study result for the proposed device itself, but rather through comparison to predicate devices and adherence to standards like ISO 5361.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the document as it describes a 510(k) submission for a medical device that does not involve AI/algorithm performance testing on a test set of data in the typical sense. The performance data listed (biocompatibility, sterilization, shelf life, dimensional, leakage, kinking, radiopacity) refer to physical device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available. The submission pertains to a physical medical device, not an AI/algorithm requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available. Adjudication methods are typically relevant for human review of AI output or complex clinical assessments, which is not the subject of this 510(k) submission.
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
There is no mention of an MRMC comparative effectiveness study. This document discusses a physical medical device (endotracheal tube and cuff pressure indicator), not an AI-assisted diagnostic or decision support tool that would typically involve a human-in-the-loop study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not done as this is not an AI/algorithm-based device. The "performance data" section (Section VII) refers to physical and biological tests of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This concept of "ground truth" as typically applied to AI/algorithmic devices is not applicable here. The performance data for the physical device focused on adherence to technical standards and predicate device specifications through various laboratory and bench tests (e.g., dimensional measurements, leakage tests, biocompatibility tests). These tests themselves serve as the "truth" for the mechanical and biological properties being evaluated.
8. The sample size for the training set
This information is not available. This device is not an AI/algorithm, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
This information is not available. Not an AI/algorithm-based device.
Summary of what is available from the document regarding performance:
- Study Title: Not explicitly a single study, but rather a collection of performance tests detailed under "VII. PERFORMANCE DATA."
- Device Tested: Disposable Endotracheal Tube, Sterile and Accu Cuff™
- Performance Tests Performed:
- Biocompatibility testing (ISO 10993-1, -3, -5, -6, -10)
- Device performance (e.g., dimensional, leakage, kinking, radiopacity testing per ISO 5361)
- Sterilization validation
- Shelf life validation
- EO/ECH residue analysis
- Seal strength (ASTM F88/F88M-09)
- Radiopacity (ASTM F640-2012)
- Conclusion: Tianjin Medis Medical Device Co., Ltd. considers the devices to be as safe, effective, and substantially equivalent to the predicate devices based on these performance data.
- Data Provenance: Not explicitly stated for specific tests, but the manufacturer is Tianjin Medis Medical Device Co., Ltd. in CHINA, suggesting laboratory tests were likely conducted by or for the manufacturer. The nature of the tests (bench testing, biocompatibility) implies controlled, prospective testing in a laboratory setting.
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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,
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: +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, SterileAccu 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 | DiscussionofDifferences |
|---|---|---|---|
| Device name | Well Lead Endotracheal Tube | Disposable Endotrachealtube, sterile | |
| K number | K042683 | — | |
| Intended use | The device is intended fororal or nasal intubation andfor airway management. | The device is intended fororal or nasal intubation andfor airway management. | Identical |
| Outer diameter | cuffed :3.3-13.3mmuncuffed :2.7-13.3mm | cuffed :3.3-13.3mmuncuffed :2.7-13.3mm | Identical |
| Tube length | cuffed :145-330mmuncuffed :140-330mm | cuffed :145-330mmuncuffed :140-330mm | Identical |
| Cuff inflateddiameter | Standard cuff:12-27mmHigh volume cuff:12-27mm | Standard cuff:12-27mmHigh volume cuff:12-27mm | Identical |
| Cuff pressure(if applicable ) | $20 cmH_20 \le P <30 cmH_20$ | $20 cmH_20 \le P \le 29 cmH_20$ | Identical |
| Materials | Polyvinyl chloride,polypropylene | Polyvinyl chloride,polypropylene | Identical |
| Structurecomposition | Connector, inflatingtube,Check valve (include Pilotballoon), Airway Tube, Cuff (ifavailable). | Connector, Inflationtube,pilotballoon andvalve(cuffed), Airway Tube, Cuff (ifavailable), Accu CuffTM (ifavailable) | Similar.Theproposeddevicehas an extra AccuCuffTM component,refer to table 6.5. |
| Anatomical Sites | The tubular body and the cuffhave limited or prolongedcontact with mucousmembrane of oral/nasalcavity and the tracheal. | The tubular body and the cuffhave limited or prolongedcontact with mucousmembrane of oral/nasalcavity and the tracheal. | Identical |
| Contactduration | Less than 30 days | Less than 30 days | Identical |
| Biocompatibility | ISO 10993-1ISO 10993-5ISO 10993-10 | ISO 10993-1ISO 10993-5ISO 10993-10 | Identical |
| Shelf life | 5 years | 5 years | Identical |
| Packing | PE / PET composite film anddialysis paper | PE / PET composite film anddialysis paper | Identical |
| Sterilization | EO | EO | Identical |
| Specification | Predicate Device | Proposed Device | Discussion ofDifferences |
| Device name | Well Lead ReinforcedEndotracheal Tube | Disposable Endotrachealtube, sterile | / |
| K number | K 073383 | -- | / |
| Intended use | The Well Lead ReinforcedEndotracheal Tubes aredesigned for oral or nasalintubation for airwaymanagement duringanaesthesia. The productmay be used where thepatient's neck is likely to bemoved or flexed or thepatient is in the proneposition so that anon-reinforced tracheal tubemight become kinked. | The device is intended fororal or nasal intubation andfor airway management. | Similar. Twodevices are bothused for airwaymanagement |
| Size | Cuffed: in 0.5mm IDincrements from size 5.0 to9.5 inclusive, totaling 10sizes.uncuffed: in 0.5mm IDincrements from size 3.0 to9.5 inclusive, totaling 14sizes. | Cuffed: in 0.5mm IDincrements from size 5.0 to9.0 inclusive, totaling 10sizes.uncuffed: in 0.5mm IDincrements from size 3.0 to9.5 inclusive, totaling 14sizes. | Similar. The sizeof proposeddevice meetstherequirement ofsection 5 ofISO 5361. |
| Outer diameter | Cuffed:7.0-13.0mmUncuffed: 4.3-13.0mm | Cuffed:7.0-13.0mmUncuffed: 4.3-13.0mm | Identical |
| Tube length | Cuffed:245-330mmUncuffed: 165-330mm | Cuffed:245-330mmUncuffed: 165-330mm | Similar. The sizeof proposeddevice meetsthe requirementof section 5 ofISO 5361. |
| Cuff inflateddiameter | Cuffed:17-27mmHigh volume cuff:12-27mm | Cuffed:17-27mmHigh volume cuff:12-27mm | Identical |
| Cuff pressure(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 ofDifferences |
| Materials | Polyvinyl chloride,polypropylene | Polyvinyl chloride,polypropylene | Identical |
| Structurecomposition | Connector, Inflatingtube,Check valve (include pilotballoon), reinforced metal,Cuff (if available). | Connector, Inflationtube,pilot balloon andvalve(cuffed), AirwayTube,reinforced metal, Cuff (ifavailable), Accu Cuff™ (ifavailable) | Similar. Theproposed devicehas an extraAccu Cuff™component,refer to table6.5. |
| Anatomical Sites | The tubular body and the cuffhave limited or prolongedcontact withmucousmembrane oforal/nasalcavity and the tracheal. | The tubular body and the cuffhave limited or prolongedcontact withmucousmembrane oforal/nasalcavity and the tracheal. | Identical |
| Contactduration | Less than 30 days | Less than 30 days | Identical |
| Biocompatibility | ISO 10993-1ISO 10993-5ISO 10993-10 | ISO 10993-1ISO 10993-5ISO 10993-10 | Identical |
| Shelf life | 5 years | 5 years | Identical |
| Packing | PE / PET composite film anddialysis paper | PE / PET composite film anddialysis 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 ofDifferences |
|---|---|---|---|
| Device name | TIGER ENDOTRACHEAL TUBES(VARIOUS MODELS AND SIZES) | Disposable Endotrachealtube, sterile | / |
| K number | K041311 | -- | / |
| Specification | Predicate Device | Proposed Device | Discussion ofDifferences |
| Intended use | The intended use for all theproduct variants is groupedinto different sections:CATEGORY 2 (uncuffed. nasalonly) and CATEGORY 5 (cuffed,nasal only):The intended use of this deviceis to be intubated into apatient's trachea via the nosefor airway management,specifically for use in surgicalprocedures involving the head,neck and face.CATEGORY 3 (uncuffed, oralonly) and CATEGORY 6 (cuffed,oral only):The intended use of this deviceis to be intubated into apatient's trachea via themouth for airwaymanagement, specifically foruse in surgical proceduresinvolving the head, neck andface. | The device is intended fororal or nasal intubation andfor airway management. | Similar.Twodevices are bothused for airwaymanagement |
| Size | Uncuffed (nasal only and oralonly): provide in 0.5mm IDincrements from sizes 2.0 to10.0 inclusive, totaling 17Sizes.Cuffed (nasal only and oralonly): provide in 0.5mm IDincrements from sizes 4.0 to10.0 inclusive, totaling 13 sizes. | Nasal only (cuffed anduncuffed): provide in 0.5mmID increments from sizes 3.0to 10.0 inclusive, totaling 15Sizes.Oral only (cuffed anduncuffed): provide in 0.5mmID increments from sizes 3.0to 10.0 inclusive, totaling 15Sizes. | Identical. Thesize of proposeddevice meetsthe requirementof section 5 ofISO 5361. |
| Outer diameter | Not provided | Oral Preformed:4.0-13.3mmNasal Preformed:4.0-13.3mm | Similar with thepredicatedevices in table12.2. |
| Specification | Predicate Device | Proposed Device | Discussion ofDifferences |
| Tube length | Not provided | Oral Preformed:165-330mmNasal Preformed:290-400mm | The tube lengthof proposeddevice meetsthe requirementof section 5 ofISO 5361. |
| Cuffinflateddiameter | Not provided | Standard cuff:12-27mmHigh volume cuff:12-27mm | / |
| Cuff pressure(if applicable ) | $20 cmH_20 \le P <30 cmH_20$ | $20 cmH_20 \le P \le 29 cmH_20$ | Identical |
| Materials | Polyvinyl chloride,polypropylene | Polyvinyl chloride,polypropylene | Identical |
| Structurecomposition | Connector, inflating tube,Check valve (include Pilotballoon), Airway Tube, Cuff (ifavailable). | Connector, Inflation tube,pilot balloon and valve(cuffed), Airway Tube, Cuff (ifavailable), Accu CuffTM (ifavailable) | Similar. Theproposed devicehas an extraAccu CuffTMcomponent,refer to table6.5. |
| Anatomical Sites | The tubular body and the cuffhave limited or prolongedcontact with mucousmembrane of oral/nasal cavityand the tracheal. | The tubular body and the cuffhave limited or prolongedcontact with mucousmembrane of oral/nasalcavity and the tracheal. | Identical |
| Contactduration | Less than 30 days | Less than 30 days | Identical |
| Biocompatibility | ISO 10993-1ISO 10993-5ISO 10993-10 | ISO 10993-1ISO 10993-5ISO 10993-10 | Identical |
| Shelf life | 5 years | 5 years | Identical |
| Packing | PE / PET composite film anddialysis paper | PE / PET composite film and70g dialysis paper | Identical |
| Sterilization | EO | EO | Identical |
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| Attribute | Predicate DeviceCuff Pilot™ (K142103) | Proposed DeviceAccu Cuff™ | Discussion of Differences |
|---|---|---|---|
| Indications forUse | To monitor intra-cuff pressures ofsupraglottic airways. | To inflate cuffs and to monitorintra-cuffpressures ofendotracheal,supraglotticairways, or tracheostomy tubes. | Similar. Two devices areboth used to indicate theintra-cuffpressureofartificial airway tube. |
| Environmentof use | To be used under medicalsupervision in hospitals,pre-hospital (EMS), extendedcare facilities and outpatientclinics, where a patient may havean artificial airway. It may also beused in MRI suites when attachedto airways that are MRconditional or MR Safe. | To be used under medicalsupervision in hospitals,pre-hospital (EMS), extendedcare facilities and outpatientclinics, where a patient may beintubated. The metal-containedmodels are MR unsafe. | Themetal-containedmodels of proposed deviceare MR unsafe, and bemarked with MR unsafe inlabels. |
| Patientpopulation | Patients who have an artificial airway and for which the user wouldlike to monitor cuff pressure, pediatric to adult. | Identical | |
| Workingprinciple | Use the pressure difference between the pressure indicator cavityand the atmospheric pressure, the elastic piece will be concaved andthen drive the black line on the joint lever move and indicate theintra-cuff pressure. | Identical | |
| Technology | Bellows that move with changesin pressureContracts with higher pressuresExpands with lower pressures | Diaphragm/bellows thatmove with changes in pressureExpands with higher pressuresRebounds with lower pressures | Mechanisms are same. |
| Indicationmethod | The Bottom cover have Colormark, when the black line moveto the white line ,which meansthe intra -cuff pressure isdecreased, move to the red lineshow the intra-cuff pressure isincreased. When the black linesite in the Green zone, the intra-cuff pressure is safe. | The Outer Cylinder have Colormark, the yellow zone, greenzone and red zone. When theblack line in the yellow zonemeans the pressure is too low,the red zone indicate the intracuff pressure is too large, thatneed to deflate. The black linein the green zone which meansthe intra cuff pressure is safe. | The mechanism is identical,only differ in color ofindication line. |
| Method ofinflating cuff | Use an independent syringe (normal practice). | Manual | Identical |
| Component | Outer Cylinder, Valve, plate,Bellows, Black line, Bottom cover | Top cover, PP cap, Cross,Gasket, Silicone tube, Bottom | Similar. The components ofproposed device can |
| Material | Color mark, Luer connector,connector | cover of check valve, Sealingcover, Supported ring ,Elasticpiece, Bottom cover, Siliconering(black line), Join lever , Colormark | perform the designedfunctions, refer to AppendixQ4. |
| Outer Cylinder, plate, Bottomcover: PolycarbonateBellows, Valve :Silicone Rubber | Top cover, Bottom cover,Supported ring, Join lever,Bottom cover of check valve:Polycarbonate.Sealing cover, Silicone tube,Gasket, Silicone ring(black line),Elastic piece: Silicone RubberPP cap: PolypropyleneCross: ABS ( AcrylonitrileButadiene Styrene) | Similar. The materials of theproposed device are safe inbiocompatibility, refer toAppendix P. | |
| Attaches tothe CuffInflation Pilot | Yes, via a luer fitting may bepermanently attached to anairway's cuff inflation line | Yes, via a luer fitting may bepermanently attached to anairway's cuff inflation line | Identical |
| Types ofairways towhich it canbe used | Supraglottic airway | Endotracheal tube | Similar. The proposedcomponent is a pressuremonitoring device, refer toAppendix Q4. |
| Single patient,disposable | Yes | Yes | Identical |
| PressureRange of thedevice | 0 to 80 cm H2O | 0-40 cm H2O | Similar. The proposeddevice is used under range20-29 cmH2O which isunder 40 cmH2O. |
| Detectionof"good range" | Color coded zones | Color coded zones | Identical |
| Sterilization | Non-sterile and sterile | Sterile | Identical |
| Workingpressurerange | +/- 5 cmH2O up to 80 cmH2O | + 4 cmH2O at 20 cmH2O- 4 cmH2O at29 cmH2O | The tolerance of pressure issimilar. Refer to Appendix Sand T for clinical evidenceof range 20 cmH2O-29cmH2O. |
| Shelf-life | 3 years | 5 years | Similar. Refer to AppendixO 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.
§ 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).