(172 days)
The device is intended for airway management by oral intubation and aid in the removal of subglottic secretions.
The proposed device, Endotracheal Tube is indicated for airway management and aid in the removal of subglottic secretions. The proposed device is available in ETT-X32 and ETT-X22 two types, the difference between these two types is that the ETT-X32 is provided with pressure indicator which is used to monitor intra-cuff pressure. Both two types are available in a series sizes from 6.0mm in an increment of 0.5mm. The proposed device is intended for adult, provided in sterile and single use.
The provided text describes the regulatory clearance of an Endotracheal Tube (K190274) and details some of the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices. However, it does not contain information about a study that uses 'acceptance criteria' in the context of device performance against specific metrics like accuracy, sensitivity, or specificity, which are typically found in clinical effectiveness studies or standalone algorithm performance evaluations for AI/ML devices.
The document focuses on demonstrating substantial equivalence through non-clinical testing (physical, mechanical, chemical, biocompatibility, sterilization, and packaging) and comparison to predicate devices, rather than a clinical effectiveness study with defined performance acceptance criteria.
Therefore, the following points will be addressed based on the available information, noting where the requested information is not present in the provided document:
1. A table of acceptance criteria and the reported device performance
The document provides a list of non-clinical tests conducted and states that the test results "met all design specifications" or "comply with related standards requirements" or "can meet the requirements of ISO 10993 series standards." However, it does not explicitly list quantitative acceptance criteria for each test and then report a specific numerical performance result against that criterion. Instead, it broadly states compliance.
Here's an example of the closest information available, framed as acceptance criteria and performance based on the general statements:
| Test Category | Specific Test / Parameter | Acceptance Criteria (Inferred from text) | Reported Device Performance (As stated in text) |
|---|---|---|---|
| Physical, Mechanical, Chemical | Dimension | Clause 5.2 of ISO 5361:2016 | "met all design specifications." |
| Material | Clause 5.3 of ISO 5361:2016 | "met all design specifications." | |
| Tracheal tube bevel | Clause 5.4 of ISO 5361:2016 | "met all design specifications." | |
| Tracheal tube cuffs | Clause 5.5 of ISO 5361:2016 | "met all design specifications." | |
| Inflating system for cuffs | Clause 5.6 of ISO 5361:2016 | "met all design specifications." | |
| Curvature of the tube | Clause 5.7 of ISO 5361:2016 | "met all design specifications." | |
| Radiopaque marker | Clause 5.8 of ISO 5361:2016 | "met all design specifications." | |
| Kink resistance | Clause 5.9 of ISO 5361:2016 | "met all design specifications." | |
| Conical connectors | Clause 5.1 of ISO 5356-1:2004 | "met all design specifications." | |
| Gauging | Clause 4.1 of ISO 594-1:1986 | "met all design specifications." | |
| Liquid leakage | Clause 4.2 of ISO 594-1:1986 | "met all design specifications." | |
| Air leakage | Clause 4.3 of ISO 594-1:1986 | "met all design specifications." | |
| Separation force | Clause 4.4 of ISO 594-1:1986 | "met all design specifications." | |
| Stress cracking | Clause 4.5 of ISO 594-1:1986 | "met all design specifications." | |
| Sterile Barrier Packaging | Seal strength | ASTM F88/F88-15 | "can maintain its integrity during transportation." and "can maintain the sterility of the product during its claimed shelf life" |
| Dye penetration | ASTM F1929-15 | "can maintain its integrity during transportation." and "can maintain the sterility of the product during its claimed shelf life" | |
| Sterilization & Shelf Life | EO residue | ISO 10993-7:2008 | Device complies with related standards. |
| ECH residue | ISO 10993-7:2008 | Device complies with related standards. | |
| Bacteria Endotoxin Limit | USP <85> | Device complies with related standards. | |
| Shelf Life Evaluation | Verification of claimed shelf life through Physical, Mechanical, Chemical, and Package Tests on accelerated aging samples. | "can demonstrate that the package of the proposed device can maintain the sterility of the product during its claimed shelf life and the performance test result can meet the requirements of related standards." | |
| Biocompatibility | Cytotoxicity, Sensitization, etc. | ISO 10993 standards requirements (e.g., No Cytotoxicity, No Sensitization, No Irritation, No Systemic Toxicity, Non-mutagenic, Non-irritant to subcutaneous tissue, No pyrogen) | "can meet the requirements of ISO 10993 series standards." and specifically states "No Cytotoxicity", "No Irritation", "No Sensitization", "No Systemic Toxicity", "Non-mutagenic", "Non-irritant", "No pyrogen". |
| Simulated Transportation | Package integrity during transportation | ASTM D 4169 | "can demonstrate the device package can maintain its integrity during transportation." |
| Bond Strength | All joints bond strength | Unspecified acceptance criteria, but must "meet acceptance criteria." | "can meet acceptance criteria." |
| Air Flow Resistance | Comparison to equivalent device | No significant difference from equivalent device. | "have no significant difference between proposed device and equivalent device." |
| Sterilization Assurance Level | SAL | 10-6 | 10-6 |
| Pressure Range (ETT-X32 only) | Pressure range | $20cm H_2O \le P \le 29cm H_2O$ (matching predicate) | "identical to predicate device K160694" |
| Pressure Accuracy (ETT-X32 only) | Pressure measurement accuracy | $\pm 4cm H_2O$ at $20cm H_2O$ and $-4cm H_2O$ at $29cm H_2O$ (matching predicate) | "identical to predicate device K160694" for range and accuracy, implying these specific values are met. |
regarding clinical efficacy or AI/ML performance, is not discussed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical bench testing. For these tests, specific sample sizes are not explicitly provided (e.g., how many tubes were tested for kink resistance or biocompatibility). Data provenance in a geographic sense is not applicable as these are laboratory tests rather than human subject data. The tests are prospective in the sense that they were conducted for the purpose of this submission.
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 question is not applicable as the document describes non-clinical engineering and biological safety testing, not clinical studies requiring expert ground truth for interpretation (e.g., image annotation for an AI device).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reasons as point 3.
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
This question is not applicable. The device is an Endotracheal Tube, not an AI/ML-powered diagnostic or assistive tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests performed, the "ground truth" refers to the established international and national standards (e.g., ISO 5361, ISO 10993, ASTM standards, USP). Compliance with these standards serves as the "ground truth" for confirming the physical, mechanical, chemical, and biological safety and performance of the device.
8. The sample size for the training set
This question is not applicable as the device is not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 30, 2019
Tianjin Medis Medical Device Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 Cn
Re: K190274
Trade/Device Name: Endotracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: June 26, 2019 Received: July 3, 2019
Dear Diana Hong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
{1}------------------------------------------------
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Endotracheal Tube
Indications for Use (Describe)
The device is intended for airway management by oral intubation and aid in the removal of subglottic secretions.
| 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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Exhibit #8 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K190274
-
- Date of Preparation: 07/12/2019
-
- Sponsor Identification
Tianjin Medis Medical Device Co., Ltd.
No.15-A, Saida One Avenue, Xiqing Economic Development Area, Tianjin, P.R. China
Establishment Registration Number: 3004992992
Contact Person: Yongzhi Wu Position: Quality Manager Tel: +86-13920213115 Fax: +86-22-83988486 Email: wuyongzhi3115@126.com
- Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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-
- Identification of Proposed Device
Trade Name: Endotracheal Tube Common Name: Tracheal Tube
- Identification of Proposed Device
Regulatory Information Classification Name: Tracheal Tube; Classification: II: Product Code: BTR Regulation Number: 21 CFR 868.5730; Review Panel: Anesthesiology;
Intended Use Statement:
The device is intended for airway management by oral intubation and aid in the removal of subglottic secretions.
Device Description:
The proposed device, Endotracheal Tube is indicated for airway management and aid in the removal of subglottic secretions. The proposed device is available in ETT-X32 and ETT-X22 two types, the difference between these two types is that the ETT-X32 is provided with pressure indicator which is used to monitor intra-cuff pressure. Both two types are available in a series sizes from 6.0mm in an increment of 0.5mm. The proposed device is intended for adult, provided in sterile and single use.
-
- Identification of Predicate Devices
Predicate Device 1 510 (k) Number: K141939 Product Name: TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port
- Identification of Predicate Devices
Predicate Device 2 510 (k) Number: K160694 Product Name: Disposable Endotracheal Tube, Sterile
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test provided in this submission include:
- Non-Clinical Test Conclusion
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| Physical, Mechanical and Chemical Tests performed on the proposed device | |
|---|---|
| Dimension | Clause 5.2 of ISO 5361:2016 |
| Material | Clause 5.3 of ISO 5361:2016 |
| Tracheal tube bevel | Clause 5.4 of ISO 5361:2016 |
| Tracheal tube cuffs | Clause 5.5 of ISO 5361:2016 |
| Inflating system for cuffs | Clause 5.6 of ISO 5361:2016 |
| Curvature of the tube | Clause 5.7 of ISO 5361:2016 |
| Radiopaque marker | Clause 5.8 of ISO 5361:2016 |
| Kink resistance | Clause 5.9 of ISO 5361:2016 |
| Conical connectors | Clause 5.1 of ISO 5356-1:2004 |
| Gauging | Clause 4.1 of ISO 594-1:1986 |
| Liquid leakage | Clause 4.2 of ISO 594-1:1986 |
| Air leakage | Clause 4.3 of ISO 594-1:1986 |
| Separation force | Clause 4.4 of ISO 594-1:1986 |
| Stress cracking | Clause 4.5 of ISO 594-1:1986 |
mical Tests performed on the proposed devic d Che DI include
Sterile Barrier Packaging Testing performed on the proposed device include Seal strength ASTM F88/F88-15 Dye penetration ASTM F1929-15
Sterilization and Shelf Life Testing performed on the proposed device include
| EO residue | ISO 10993-7:2008 |
|---|---|
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP <85> |
| Shelf Life Evaluation | Physical, Mechanical, Chemical and Package Testswere performed on accelerated aging samples to verifythe claimed shelf life of the device |
Biocompatibility Testing:
The patient-contact materials of the proposed device are identified and biocompatibility testing is performed according to ISO 10993 standards. The test items include Cytotoxicity, Sensitization, Intracutaneous, Systemic Toxicity, Subchronic Systemic Toxicity, Bacterial Reverse Mutation, Gene Mutation, Implantation and Pyrogen.
Simulated Transportation Testing
Simulated transportation test is performed per ASTM D 4169 on the final product and the test result can demonstrate the device package can maintain its integrity during transportation.
Bond strength test
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All joints for the proposed device are tested for its bond strength and the test result can meet acceptance criteria.
Air flow resistance test
Air flow resistance rest are conducted on the proposed device and equivalent device and the test result have no significant difference between proposed device and equivalent device.
The test results demonstrated that the proposed device complies with the following standards:
-
ISO 5361:2016 Anaesthetic and Respiratory Equipment-Tracheal Tubes and Connectors
- A ISO 594-1:1986 Conical Fittings With a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment-Part 1: General Requirements
-
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
-
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
-
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 10993-6:2016 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 10993-11:2017 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
-
ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
-
USP 41-NF36:2017 <151> Pyrogen Test
-
- Clinical Test Conclusion
No clinical study is included in this submission.
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8. Substantially Equivalent (SE) Comparison
| Table 1 Comparison of Technology Characteristics for ETT-X22 | ||||
|---|---|---|---|---|
| -- | -- | -- | -------------------------------------------------------------- | -- |
| Item | Proposed Device | Predicate Device 1 | Remark |
|---|---|---|---|
| K141939 | |||
| Classification | II | II | SE |
| Product Code | BTR | BTR | SE |
| Regulation Number | 21CFR 868.5730 | 21 CFR 868.5730 | SE |
| Intended Use | The device is intended for airwaymanagement by oral intubationand aid in the removal ofsubglottic secretions. | The Teleflex ISIS™ HVTTM TrachealTube, Cuffed with Subglottic SecretionSuction Port is indicated for airwaymanagement by oral intubation duringmechanical ventilation and anesthesiaincluding the capability to aid in theremoval of subglottic secretions | SE |
| Configuration | ConnectorInflating TubeCheck Valve (with pilot balloon)Airway TubeCuffSuction TubeSuction ConnectorSuction Cap | ConnectorMain TubeInflation linePilot balloonBi-directional ValveCuff BalloonSuction lumen Connector | Discussion 1 |
| Materials | Polypropylene;Polyvinyl chloride;Acrylonitrile butadiene styrene;Silicone gel | Polyvinyl chloride; | Discussion 2 |
| Size (mm) | 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm | 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm | SE |
| Intended population | Adult | Adult | SE |
| Anatomical Site | Oral | Oral | SE |
| Single Use | Single Use | Single Use | SE |
| Cuff inflamed diameter | 20~27mm | Unknown | Discussion 3 |
| Tube length | 285~330mm | Unknown | |
| Ink marks | Yes | Yes | SE |
| Radiopaque markers | Yes | Yes | SE |
| Murphy's eye | Yes | Yes | SE |
| Beveled tip | Yes | Yes | SE |
| Patient contact duration | Less than 30 days | Less than 30 days | SE |
| Packing material | 60g French paper and polythyleneterephthalate | 10 individually packaged in either bananapack or Tyvek pouches per dispenser box | Discussion 4 |
| Shelf-life | 5 years | 12 months (extending to 60 months as data becomes available) | |
| Label/labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | SE |
| Cytotoxicity | No Cytotoxicity | ||
| Intracutaneous Irritation | No Irritation | ||
| Skin Sensitization | No Sensitization | ||
| Acute Toxicity | No Systemic Toxicity | ||
| Subchronic Toxicity | No Subchronic Toxicity | Comply with ISO 10993 standards requirements | SE |
| Bacterial Reverse Mutation | Not induce backward mutation | ||
| Gene Mutation Test | Non-mutagenic | ||
| Implantation | Non-irritant to the subcutaneous tissue | ||
| Pyrogen Test | No pyrogen | ||
| Method | Ethylene Oxide | Ethylene Oxide | SE |
| SAL | 10-6 | 10-6 | SE |
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Discussion 1
The components airway tube and suction tube are not listed by predicate device, however, these two tubes are included in the main tube of predicate device and the function for these two components are same as predicate device. Therefore, the difference in components does not raise difference questions of safety or effectiveness.
Discussion 2
The material of proposed device is different from predicate device. However, the biocompatibility tests have been conducted on the proposed device and the test result can meet the requirements of ISO 10993 series standards. Therefore, this difference does not raise difference questions of safectiveness between proposed device and predicate device.
Discussion 3
The cuff inflamed diameter and tube length for predicate device is unknown and the substantially equivalence between proposed device and equivalent device cannot be determined. However, the performance test has been conducted on the proposed device and the test result comply with related standards requirements. Therefore, this difference does not raise difference questions of safety or effectiveness between proposed device and predicate device.
Discussion 4
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The packing materials and shelf life for proposed device are different from predicate device. The function of package is used to protected device from damaging during transportation, store. The simulated transportation test and package integrity test has been conducted on the proposed device, the results can demonstrate that the package is still integrity and there is no damage for device. In addition, the package integrity and device performance after accelerated aging can demonstrate that the package of the proposed device can maintain the sterility of the product during its claimed shelf life and the performance test result can meet the requirements of related standards. Therefore, this difference does not raise difference questions of safety or effectiveness between proposed device and predicate device.
{10}------------------------------------------------
| Table 2 Comparison of Technology Characteristics for ETT-X32 | ||
|---|---|---|
| Item | Proposed Device | Predicate Device 1 | Predicate Device 2 | Remark |
|---|---|---|---|---|
| K141939 | K160694 | |||
| Classification | II | II | II | SE |
| Product Code | BTR | BTR | BTR | SE |
| Regulation Number | 21CFR 868.5730 | 21 CFR 868.5730 | 21 CFR 868.5730 | SE |
| Intended Use | The device is intended for airwaymanagement by oral intubation and aidin the removal of subglottic secretions. | The Teleflex ISISTM HVTTM TrachealTube, Cuffed with Subglottic SecretionSuction Port is indicated for airwaymanagement by oral intubation duringmechanical ventilation and anesthesiaincluding the capability to aid in theremoval of subglottic secretions | The sterile Disposable EndotrachealTube is intended for oral or nasalintubation and for airwaymanagement. | SE |
| Configuration | ConnectorInflating TubeAirway TubeCuffSuction TubeSuction ConnectorSuction CapPressure Indicator | ConnectorMain TubeInflation linePilot balloonBi-directional ValveCuff BalloonSuction lumen Connector | ConnectorInflation tubePilot balloonCheck ValveAirway tubeCuffAccu CuffTM | Discussion 1 |
| Size (mm) | 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm | 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm | Cuffed: in 0.5mm ID increments fromsize 5.0 to 9.0 inclusive, totaling 10sizes.Uncuffed: in 0.5mm ID incrementsfrom size 3.0 to 9.5 inclusive, totaling14 sizes. | Discussion 2 |
| Intended population | ||||
| Intended population | Adult | Adult | Adult | SE |
| Anatomical Site | Oral | Oral | Oral or Nasal | Discussion 3 |
| Single Use | Single Use | Single Use | Single Use | SE |
| Pressure range | $20cm H_2O≤P≤29cm H_2O$ | Not provided with pressure indicator | $20cm H_2O≤P≤29cm H_2O$ | |
| Pressuremeasurement | +4cm H2O at 20cm H2O | Not provided with pressure indicator | +4cm H2O at 20cm H2O-4 cm H2O at 29cm H2O | Discussion 4 |
| accuracy | -4 cm H2O at 29cm H2O | |||
| Cuff inflamed diameter | 20~27mm | Unknown | 12~27mm | |
| Tube length | 285~330mm | Unknown | Oral tube:165 | Discussion 5 |
| Ink marks | Yes | Yes | Yes | SE |
| Radiopaque markers | Yes | Yes | Yes | SE |
| Murphy's eye | Yes | Yes | Yes | SE |
| Beveled tip | Yes | Yes | Yes | SE |
| Patient contact duration | Less than 30 days | Less than 30 days | Less than 30 days | SE |
| Packing material | 60g French paper and polyethyleneterephthalate | 10 individually packaged in eitherbanana pack or Tyvek pouches perdispenser box. | PE/PET composite film and dialysispaper. | Discussion 6 |
| Shelf-life | 5 years | 12 months (extending to 60 months asdata becomes available) | 5 years | |
| Material | Polypropylene;Polyvinyl chloride;Acrylonitrile butadiene styrene;Silicone gel | Polyvinyl chloride; | Polyvinyl chloride;Polypropylene | Discussion 7 |
| Label/labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | SE |
| Biocompatibility | ||||
| Cytotoxicity | No Cytotoxicity | Comply with ISO 10993 standardsrequirements | Comply with ISO 10993 standardsrequirements | |
| Intracutaneous Irritation | No Irritation | Comply with ISO 10993 standardsrequirements | Comply with ISO 10993 standardsrequirements | SE |
| Skin Sensitization | No Sensitization | |||
| Acute Toxicity | No Systemic Toxicity | |||
| Subchronic Toxicity | No Subchronic Toxicity | |||
| Bacterial Reverse Mutation | Not induce backward mutation | |||
| Gene Mutation Test | Non-mutagenic | |||
| Implantation | Non-irritant to the subcutaneous tissue | |||
| Pyrogen Test | No pyrogen | |||
| Sterilization | ||||
| Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | SE |
| SAL | 10-6 | 10-6 | 10-6 | SE |
{11}------------------------------------------------
E8 510(k) Summary
{12}------------------------------------------------
Discussion 1
The components airway tube and suction tube are not listed by predicate device K141939, however, these two tube of predicate device and the function for these two components are same as predicate device K141939, additionally, the predicate device K141939, while this component is same as the Accu CuffTM included by predicate device K160694. Therefore, in components does not raise difference questions of safety or effectiveness.
Discussion 2
The sizes for proposed device is same as predicate devices K160694. However, the sizes K160694. However, the sizes for proposed device are covered by the predicate device K160694. Therefore, the difference in the sizes difference questions of safety or effectiveness
Discussion 3
The intended anatomical site of proposed device is different from predicate device K160694. However, the oral intubation is also included by this predicate device. Therefore, the difference in components does not raise difference questions of safety or effectiveness
Discussion 4
The predicate device K141939 does not contain the component of pressure range and pressure range and pressure accuracy requirement for this device. The pressure indicator contained is same as the predicate device K160694, therefore, the pressure range for proposed device is
{13}------------------------------------------------
identical to predicate device K160694 which can demonstrate the substantially equivalence between proposed device.
Discussion 5
The cuff inflamed diameter and tube length for predicate device K141939 is unknown and the substantially equivalence and equivalent device K141939 cannot be deternine test has been conducted on the proposed device and the test result oney, with related standards requirements. Besides, although the conth for proposed device is different from predicate device K16069, the diameter and length can be covered by predicate device this difference does not raise difference questions of safety or effectiveness between proposed device and predicate device.
Discussion 6
The packing materials and shelf life for proposed device. The function of package is used to protected device from damaging during transportation, store. The simulation test and package integrity test has been conducted on the results can demonstrate that the package is still integrity and the In addition, the package integrity and device performance after accelerated aging can demonstrate that the package of the can maintain the sterility of the product during its claimed shelf life and the performance test result can meet the requirements of related standards. Therence does not raise difference questions of safety or effectiveness between proposed device and predicate device.
Discussion 7
The material of proposed device is different from predicate device. However, the biocompatibility tests have been conducted on the proposed device and the test result can meet the requirements of ISO 10993 series standards. Therefore, this difference questions of safety or effectiveness between proposed device and predicate device.
{14}------------------------------------------------
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above and the nonclinical tests conducted, the proposed devices are determined to be as safe, as effective, and performs as well as 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).