K Number
K190274
Device Name
Endotracheal Tube
Date Cleared
2019-07-30

(172 days)

Product Code
Regulation Number
868.5730
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The summary describes a standard endotracheal tube with a pressure indicator, and the performance studies focus on physical, mechanical, and biocompatibility testing. There is no mention of AI, ML, image processing, or data-driven performance metrics.

Yes

The device, an Endotracheal Tube, is used for airway management and aiding in the removal of subglottic secretions, which are therapeutic interventions.

No

The device is an endotracheal tube intended for airway management and removal of subglottic secretions, describing functions related to treatment and support rather than diagnosis. While one variant has a pressure indicator to "monitor intra-cuff pressure," this monitoring serves to ensure proper device function and patient safety during treatment, not to diagnose a medical condition.

No

The device description clearly describes a physical Endotracheal Tube, a hardware medical device, and details physical, mechanical, and chemical testing.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "airway management by oral intubation and aid in the removal of subglottic secretions." This is a direct medical intervention on a patient's body, not a test performed on a sample taken from the body to diagnose a condition.
  • Device Description: The device is an "Endotracheal Tube," which is a physical device inserted into the airway. It's used for mechanical support and secretion removal, not for analyzing biological samples.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic testing procedures.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

N/A

Intended Use / Indications for Use

The device is intended for airway management by oral intubation and aid in the removal of subglottic secretions.

Product codes (comma separated list FDA assigned to the subject device)

BTR

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral (for K190274)
Oral or Nasal (for K160694)

Indicated Patient Age Range

Adult

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non clinical tests were conducted to verify that the proposed device met all design specifications. The test provided in this submission include: Physical, Mechanical and Chemical Tests performed on the proposed device, Sterile Barrier Packaging Testing performed on the proposed device, Sterilization and Shelf Life Testing performed on the proposed device, Biocompatibility Testing, Simulated Transportation Testing, Bond strength test, and Air flow resistance test.
The test results demonstrated that the proposed device complies with standards such as ISO 5361:2016, ISO 594-1:1986, ASTM D4169-16, ASTM F88/F88M-15, ASTM F1929-15, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2016, ISO 10993-10:2010, ISO 10993-11:2017, ISO 10993-7:2008, and USP 41-NF36:2017 .
No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K141939, K160694

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

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)

K190274

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

    1. Date of Preparation: 07/12/2019
    1. 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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    1. Identification of Proposed Device
      Trade Name: Endotracheal Tube Common Name: Tracheal Tube

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.

    1. Identification of Predicate Devices
      Predicate Device 1 510 (k) Number: K141939 Product Name: TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port

Predicate Device 2 510 (k) Number: K160694 Product Name: Disposable Endotracheal Tube, Sterile

    1. 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:

5

Physical, Mechanical and Chemical Tests performed on the proposed device
DimensionClause 5.2 of ISO 5361:2016
MaterialClause 5.3 of ISO 5361:2016
Tracheal tube bevelClause 5.4 of ISO 5361:2016
Tracheal tube cuffsClause 5.5 of ISO 5361:2016
Inflating system for cuffsClause 5.6 of ISO 5361:2016
Curvature of the tubeClause 5.7 of ISO 5361:2016
Radiopaque markerClause 5.8 of ISO 5361:2016
Kink resistanceClause 5.9 of ISO 5361:2016
Conical connectorsClause 5.1 of ISO 5356-1:2004
GaugingClause 4.1 of ISO 594-1:1986
Liquid leakageClause 4.2 of ISO 594-1:1986
Air leakageClause 4.3 of ISO 594-1:1986
Separation forceClause 4.4 of ISO 594-1:1986
Stress crackingClause 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 residueISO 10993-7:2008
ECH residueISO 10993-7:2008
Bacteria Endotoxin LimitUSP
Shelf Life EvaluationPhysical, Mechanical, Chemical and Package Tests
were performed on accelerated aging samples to verify
the 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 Pyrogen Test

    1. 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
----------------------------------------------------------------------
ItemProposed DevicePredicate Device 1Remark
K141939
ClassificationIIIISE
Product CodeBTRBTRSE
Regulation Number21CFR 868.573021 CFR 868.5730SE
Intended UseThe device is intended for airway
management by oral intubation
and aid in the removal of
subglottic secretions.The Teleflex ISIS™ HVTTM Tracheal
Tube, Cuffed with Subglottic Secretion
Suction Port is indicated for airway
management by oral intubation during
mechanical ventilation and anesthesia
including the capability to aid in the
removal of subglottic secretionsSE
ConfigurationConnector
Inflating Tube
Check Valve (with pilot balloon)
Airway Tube
Cuff
Suction Tube
Suction Connector
Suction CapConnector
Main Tube
Inflation line
Pilot balloon
Bi-directional Valve
Cuff Balloon
Suction lumen ConnectorDiscussion 1
MaterialsPolypropylene;
Polyvinyl chloride;
Acrylonitrile butadiene styrene;
Silicone gelPolyvinyl chloride;Discussion 2
Size (mm)6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mmSE
Intended populationAdultAdultSE
Anatomical SiteOralOralSE
Single UseSingle UseSingle UseSE
Cuff inflamed diameter20~27mmUnknownDiscussion 3
Tube length285~330mmUnknown
Ink marksYesYesSE
Radiopaque markersYesYesSE
Murphy's eyeYesYesSE
Beveled tipYesYesSE
Patient contact durationLess than 30 daysLess than 30 daysSE
Packing material60g French paper and polythylene
terephthalate10 individually packaged in either banana
pack or Tyvek pouches per dispenser boxDiscussion 4
Shelf-life5 years12 months (extending to 60 months as data becomes available)
Label/labelingConform with 21CFR Part 801Conform with 21CFR Part 801SE
CytotoxicityNo Cytotoxicity
Intracutaneous IrritationNo Irritation
Skin SensitizationNo Sensitization
Acute ToxicityNo Systemic Toxicity
Subchronic ToxicityNo Subchronic ToxicityComply with ISO 10993 standards requirementsSE
Bacterial Reverse MutationNot induce backward mutation
Gene Mutation TestNon-mutagenic
ImplantationNon-irritant to the subcutaneous tissue
Pyrogen TestNo pyrogen
MethodEthylene OxideEthylene OxideSE
SAL10-610-6SE

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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

9

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.

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Table 2 Comparison of Technology Characteristics for ETT-X32
ItemProposed DevicePredicate Device 1Predicate Device 2Remark
K141939K160694
ClassificationIIIIIISE
Product CodeBTRBTRBTRSE
Regulation Number21CFR 868.573021 CFR 868.573021 CFR 868.5730SE
Intended UseThe device is intended for airway
management by oral intubation and aid
in the removal of subglottic secretions.The Teleflex ISISTM HVTTM Tracheal
Tube, Cuffed with Subglottic Secretion
Suction Port is indicated for airway
management by oral intubation during
mechanical ventilation and anesthesia
including the capability to aid in the
removal of subglottic secretionsThe sterile Disposable Endotracheal
Tube is intended for oral or nasal
intubation and for airway
management.SE
ConfigurationConnector
Inflating Tube
Airway Tube
Cuff
Suction Tube
Suction Connector
Suction Cap
Pressure IndicatorConnector
Main Tube
Inflation line
Pilot balloon
Bi-directional Valve
Cuff Balloon
Suction lumen ConnectorConnector
Inflation tube
Pilot balloon
Check Valve
Airway tube
Cuff
Accu CuffTMDiscussion 1
Size (mm)6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mmCuffed: in 0.5mm ID increments from
size 5.0 to 9.0 inclusive, totaling 10
sizes.
Uncuffed: in 0.5mm ID increments
from size 3.0 to 9.5 inclusive, totaling
14 sizes.Discussion 2
Intended population
Intended populationAdultAdultAdultSE
Anatomical SiteOralOralOral or NasalDiscussion 3
Single UseSingle UseSingle UseSingle UseSE
Pressure range$20cm H_2O≤P≤29cm H_2O$Not provided with pressure indicator$20cm H_2O≤P≤29cm H_2O$
Pressure
measurement+4cm H2O at 20cm H2ONot provided with pressure indicator+4cm H2O at 20cm H2O
-4 cm H2O at 29cm H2ODiscussion 4
accuracy-4 cm H2O at 29cm H2O
Cuff inflamed diameter20~27mmUnknown12~27mm
Tube length285~330mmUnknownOral tube:165~330mm
Nasal tube: 290~400mmDiscussion 5
Ink marksYesYesYesSE
Radiopaque markersYesYesYesSE
Murphy's eyeYesYesYesSE
Beveled tipYesYesYesSE
Patient contact durationLess than 30 daysLess than 30 daysLess than 30 daysSE
Packing material60g French paper and polyethylene
terephthalate10 individually packaged in either
banana pack or Tyvek pouches per
dispenser box.PE/PET composite film and dialysis
paper.Discussion 6
Shelf-life5 years12 months (extending to 60 months as
data becomes available)5 years
MaterialPolypropylene;
Polyvinyl chloride;
Acrylonitrile butadiene styrene;
Silicone gelPolyvinyl chloride;Polyvinyl chloride;
PolypropyleneDiscussion 7
Label/labelingConform with 21CFR Part 801Conform with 21CFR Part 801Conform with 21CFR Part 801SE
Biocompatibility
CytotoxicityNo CytotoxicityComply with ISO 10993 standards
requirementsComply with ISO 10993 standards
requirements
Intracutaneous IrritationNo IrritationComply with ISO 10993 standards
requirementsComply with ISO 10993 standards
requirementsSE
Skin SensitizationNo Sensitization
Acute ToxicityNo Systemic Toxicity
Subchronic ToxicityNo Subchronic Toxicity
Bacterial Reverse MutationNot induce backward mutation
Gene Mutation TestNon-mutagenic
ImplantationNon-irritant to the subcutaneous tissue
Pyrogen TestNo pyrogen
Sterilization
MethodEthylene OxideEthylene OxideEthylene OxideSE
SAL10-610-610-6SE

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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.

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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.