Neodent EasyGuide Kit Cases
Device Facts
| Record ID | K203618 |
|---|---|
| Device Name | Neodent EasyGuide Kit Cases |
| Applicant | Jjgc Industria E Comercio DE Materiais Dentarios S.A. |
| Product Code | KCT · General Hospital |
| Decision Date | Mar 9, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
Indications for Use
Neodent Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instruments Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instruments Kits require the use of FDA-cleared wrap to maintain the sterility of enclosed devices. The kits are to be enclose in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20 minutes dry time. Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minutes dry-time. Neodent Instruments Kits are intended for sterilization of non-porous loads. The combined weight of GM EasyGuide Surgical Kit Case Narrow/Regular Diam Implants and the associated instruments is 310,18 g. The weight of the empty Kit Case is 263,63 g Neodent GM EasyGuide Kit Cases should not be stacked during sterilization. Neodent Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instruments Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instruments Kits require the use of FDA-cleared wrap to maintain the sterility of enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20 minutes dry-time. Gravity displacement - Exposure at 132 °C for 15 minutes, 45-minutes dry-time. Neodent Instruments Kits are intended for sterilization of non-porous loads. The combined weight of the GM EasyGuide Surgical Kit Case Regular/Large Diam Implants and the associated instruments is 346,45 g. The weight of the empty Kit Case is 264,12 g. Neodent GM EasyGuide Kit Cases should not be stacked during sterilization.
Device Story
Reusable rigid container system for organizing, protecting, and sterilizing dental surgical instruments. Comprises polysulfone base, removable inner tray, and polyphenylsulfone lid with medical-grade silicone grommets for instrument retention. Perforated design allows steam penetration. Used by healthcare providers in clinical settings. Devices are placed inside, wrapped in FDA-cleared sterilization wrap, and processed via gravity displacement or fractionated vacuum steam cycles. Protects instruments during sterilization and storage; ensures sterility maintenance post-processing.
Clinical Evidence
Bench testing only. Validated cleaning (AAMI TIR30), sterilization (ISO 17665-1/2), and 100-cycle life cycle testing. Cytotoxicity testing (ISO 10993-5) confirmed no cytotoxic concentrations. All acceptance criteria met.
Technological Characteristics
Materials: Polysulfone (base), polyphenylsulfone (lid), medical-grade silicone (grommets). Perforated rigid container. Sterilization: Moist heat (steam) via gravity displacement or fractionated vacuum. Reusable up to 100 cycles.
Indications for Use
Indicated for use by healthcare providers to enclose and sterilize non-porous medical devices via moist heat (steam) sterilization. Requires FDA-cleared sterilization wrap. Not for stacking during sterilization.
Regulatory Classification
Identification
A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
Predicate Devices
- Neodent Instrument Kit Cases (K192670)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 9, 2021
JJGC Industria e Comercio de Materiais Dentarios S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K203618
Trade/Device Name: Neodent EasyGuide Kit Cases Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: December 11, 2020 Received: December 11, 2020
Dear Jennifer Jackson:
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
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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,
Clarence W. Murray, III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K203618
Device Name Neodent EasyGuide Kit Cases
#### Indications for Use (Describe)
Indications for Use for GM EasyGuide Surgical Kit Case Narrow/Regular Diam Implants:
Neodent Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instruments Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instruments Kits require the use of FDA-cleared wrap to maintain the sterility of enclosed devices. The kits are to be enclose in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20 minutes dry time.
Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minutes dry-time.
Neodent Instruments Kits are intended for sterilization of non-porous loads.
The combined weight of GM EasyGuide Surgical Kit Case Narrow/Regular Diam Implants and the associated instruments
is 310,18 g. The weight of the empty Kit Case is 263,63 g
Neodent GM EasyGuide Kit Cases should not be stacked during sterilization
| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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# Indications for Use
510(k) Number (if known) K203618
Device Name Neodent EasyGuide Kit Cases
#### Indications for Use (Describe)
Indications for Use for GM EasyGuide Surgical Kit Case Regular/Large Diam Implants:
Neodent Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instruments Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instruments Kits require the use of FDA-cleared wrap to maintain the sterility of enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20 minutes dry-time.
Gravity displacement - Exposure at 132 °C for 15 minutes, 45-minutes dry-time.
Neodent Instruments Kits are intended for sterilization of non-porous loads.
The combined weight of the GM EasyGuide Surgical Kit Case Regular/Large Diam Implants and the associated
instruments is 346,45 g. The weight of the empty Kit Case is 264,12 g.
Neodent GM EasyGuide Kit Cases should not be stacked during sterilization.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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# ADMINISTRATIVE INFORMATION
| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA<br>(dba Neodent)<br>Av. Juscelino Kubitschek de Oliveira, 3291<br>Curitiba, Parana, Brazil 81270-200<br>Registration No.: 3008261720<br>Owner/Operator No.: 10031702 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs,<br>Straumann USA<br>E-mail: jennifer.jackson@straumann.com<br>Telephone (978) 747-2509 |
| Date Prepared | 09/March/2021 |
| Preparer / Alternate Contact | Camila da Silva Esteves<br>Regulatory Affairs Supervisor<br>JJGC Indústria e Comércio de Materiais Dentários SA<br>E-mail: camila.esteves@neodent.com |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name | Neodent EasyGuide Kit Cases |
| Common Name | Instrument Sterilization Trays |
| Classification Name | Sterilization Wrap Containers, Trays, Cassettes & Other |
| Classification Regulations | 21 CFR 880.6850, Class II |
| Product Code | KCT |
| Classification Panel | General Hospital |
| Reviewing Branch | Infection Control Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K192670 – Neodent Instrument Kit Cases, JJGC Indústria e Comércio de |
Materiais Dentários S.A
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### INDICATIONS FOR USE
#### Indications for Use for GM EasyGuide Surgical Kit Case Narrow/Regular Diameter Implants:
Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kits require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices.
The Kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Fractionated vacuum (pre-vacuum) – Exposure at 132 °C for 4 minutes, 20-minute dry time.
Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.
Neodent Instrument Kits are intended for sterilization of non-porous loads.
The combined weight of the GM EasyGuide Surgical Kit Case Narrow/Regular and the associated instruments is 310,18 g. The weight of the empty Kit Case is 263,63 g.
Neodent GM EasyGuide Kit Cases should not be stacked during sterilization
### Indications for Use for GM EasyGuide Surgical Kit Case Regular/Large Diameter Implants:
Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kits require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices.
The Kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Fractionated vacuum (pre-vacuum) – Exposure at 132 °C for 4 minutes, 20-minute dry time.
Gravity displacement - Exposure at 132 °C for 15 minutes, 45-minute dry time.
Neodent Instrument Kits are intended for sterilization of non-porous loads.
The combined weight of the GM EasyGuide Surgical Kit Case Regular/Large and the associated instruments is 346,45 g. The weight of the empty Kit Case is 264,12 g.
Neodent GM EasyGuide Kit Cases should not be stacked during sterilization.
### SUBJECT DEVICE DESCRIPTION
The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject kit cases are manufactured in autoclavable polymer. The design of the subject devices includes grommets manufactured from medical grade silicone that retain the instruments within the tray. The subject device kit cases are provided nonsterile to the end-user.
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The dimensions for each part of the model and the overall dimensions are presented in the table below:
| Assembled<br>Kit Case | Description | Assembled<br>Kit Case<br>Dimension<br>(L x W x H) | Component Number | Component Dimension<br>(L x W x H) |
|-----------------------|-------------------------------------------------------------------|---------------------------------------------------|------------------|------------------------------------|
| 110.313 | GM EasyGuide Surgical Kit<br>Case Narrow/Regular Diam<br>Implants | 195 x 90 x<br>64 mm | 212.293 (Lid) | 195 x 90 x 36 mm |
| | | | 703861 (Tray) | 180 x 76 x 27 mm |
| | | | 703863 (Base) | 188 x 84 x 42 mm |
| 110.314 | GM EasyGuide Surgical Kit<br>Case Regular/Large Diam<br>Implants | 195 x 90 x<br>64 mm | 212.293 (Lid) | 195 x 90 x 36 mm |
| | | | 703862 (Tray) | 180 x 76 x 27 mm |
| | | | 703863 (Base) | 188 x 84 x 42 mm |
Note: The instrument and accessory devices that are sterilized and stored within the subject Kit Cases are not themselves subject devices of this submission.
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# TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K203618<br>Neodent EasyGuide Kit Cases<br>JJGC Indústria e Comércio de Materiais Dentários<br>S.A. | K192670<br>Neodent Instrument Kit Cases<br>JJGC Indústria e Comércio de Materiais Dentários<br>S.A. | COMPARISON |
| Indications for<br>Use Statement | Indications for Use for GM EasyGuide Surgical Kit<br>Case Narrow/Regular Diam Implants:<br>Neodent Instrument Kits are intended to be used<br>to enclose other medical devices that are to be<br>sterilized by a health care provider. Neodent<br>Instrument Kits are intended to allow sterilization<br>of the enclosed medical devices. Neodent<br>Instrument Kits require the use of FDA-cleared | Indications for Use for GM Surgical Kit Case:<br>Neodent Instrument Kit Cases are intended to<br>be used to enclose other medical devices that<br>are to be sterilized by a health care provider.<br>Neodent Instrument Kit Cases are intended to<br>allow sterilization of the enclosed medical<br>devices. Neodent Instrument Kit Cases require | Similar<br>The indications for<br>use are equivalent.<br>The difference in<br>the text is specific<br>due to the weight of<br>each device in their<br>maximum load<br>configuration. |
| | wrap to maintain the sterility of the enclosed<br>devices.<br>The Kits are to be enclosed in a sterilization wrap<br>that is FDA-cleared for the indicated cycles, and<br>moist heat (steam) sterilized using one of the<br>following cycles: | the use of FDA cleared wrap to maintain the<br>sterility of the enclosed devices.<br>The kits are to be enclosed in a sterilization<br>wrap that is FDA-cleared for the indicated<br>cycles, and moist heat (steam) sterilized using<br>one of the following cycles: | |
| | Fractionated vacuum (pre-vacuum) – Exposure at<br>132 °C for 4 minutes, 20-minute dry time. | Fractionated vacuum (pre-vacuum) — Exposure<br>at 132 °C for 4 minutes, 20-minute dry time. | |
| | Gravity displacement - Exposure at 132 °C for 15<br>minutes, 20-minute dry time. | Gravity displacement – Exposure at 132 °C for<br>15 minutes, 40-minute dry time. | |
| | Neodent Instrument Kits are intended for<br>sterilization of non-porous loads. | Neodent Instrument Kit Cases are intended for<br>sterilization of non-porous loads. | |
| | The combined weight of the GM EasyGuide<br>Surgical Kit Case Narrow/Regular Diam Implants<br>and the associated instruments is 310,18 g. The<br>weight of the empty Kit Case is 263,63 g. | The combined weight of the GM Surgical Kit<br>Case and the associated instruments is 613.1<br>g. The weight of the empty Kit Case is 510<br>grams. Neodent Instrument Kit Cases should | |
| | Neodent GM EasyGuide Kit Cases should not be<br>stacked during sterilization | not to be stacked during sterilization.<br>Indications for Use for GM Helix Compact | |
| | Indications for Use for GM EasyGuide Surgical Kit<br>Case Regular/Large Diam Implants: | Surgical Kit Case: | |
| | Neodent Instrument Kits are intended to be used<br>to enclose other medical devices that are to be<br>sterilized by a health care provider. Neodent<br>Instrument Kits are intended to allow sterilization<br>of the enclosed medical devices. Neodent<br>Instrument Kits require the use of FDA-cleared<br>wrap to maintain the sterility of the enclosed<br>devices. | Neodent Instrument Kit Cases are intended to<br>be used to enclose other medical devices that<br>are to be sterilized by a health care provider.<br>Neodent Instrument Kit Cases are intended to<br>allow sterilization of the enclosed medical<br>devices. Neodent Instrument Kit Cases require<br>the use of FDA cleared wrap to maintain the<br>sterility of the enclosed devices. | |
| | The Kits are to be enclosed in a sterilization wrap<br>that is FDA-cleared for the indicated cycles, and<br>moist heat (steam) sterilized using one of the<br>following cycles: | The kits are to be enclosed in a sterilization<br>wrap that is FDA-cleared for the indicated<br>cycles, and moist heat (steam) sterilized using<br>one of the following cycles: | |
| | | | |
| | Fractionated vacuum (pre-vacuum) – Exposure at<br>132 °C for 4 minutes, 20-minute dry time. | Fractionated vacuum (pre-vacuum) — Exposure<br>at 132 °C for 4 minutes, 20-minute dry time | |
| | Gravity displacement - Exposure at 132 °C for 15<br>minutes, 45-minute dry time. | Gravity displacement - Exposure at 132 °C for<br>15 minutes, 20-minute dry time. | |
| | Neodent Instrument Kits are intended for<br>sterilization of non-porous loads. | Neodent Instrument Kit Cases are intended for<br>sterilization of non-porous loads. | |
| | The combined weight of the GM EasyGuide<br>Surgical Kit Case Regular/Large Diam Implants and<br>the associated instruments is 346,45 g. The<br>weight of the empty Kit Case is 264,12 g.<br>Neodent EasyGuide Kit Cases should not be<br>stacked during sterilization. | The combined weight of the GM Helix<br>Compact Surgical Kit Case and the associated<br>instruments is 308.2 g. The weight of the<br>empty Kit Case is 231 grams. Neodent<br>Instrument Kit Cases should not to be stacked<br>during sterilization. | |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
| | K203618<br>Neodent EasyGuide Kit Cases<br>JJGC Indústria e Comércio de Materiais Dentários<br>S.A. | K192670<br>Neodent Instrument Kit Cases<br>JJGC Indústria e Comércio de Materiais Dentários<br>S.A. | COMPARISON |
| Intended Use | The GM EasyGuide Kit Cases are used for the<br>safe storage of surgical instruments, as well as<br>for support during sterilization. | The GM Helix Compact Surgical Kit Case is<br>suitable for safe storage of surgical and<br>prosthetic instruments, organizing the<br>instruments in the sequence in which they will<br>be used, as well as for sterilization of such<br>instruments. | Same<br>Both subject and<br>predicate devices<br>are intended to safe<br>storage surgical<br>instruments and<br>provide support<br>during sterilization. |
| Design | Rigid polysulfone polymer base and removable<br>inner tray with a polyphenylsulfone lid.<br>Retention grommets of medical grade silicone. | Rigid polysulfone polymer base and removable<br>inner tray with a polyphenylsulfone lid.<br>Retention grommets of medical grade silicone. | Identical<br>Both subject and<br>predicate devices<br>have the same<br>materials. |
| Perforated | Yes; allows moist heat (steam) penetration to<br>achieve sterilization | Yes; allows moist heat (steam) penetration to<br>achieve sterilization | Identical |
| Reusable | Yes | Yes | Identical |
| Overall<br>dimensions | 110.313: 195 L x 90 W x 64 H, mm<br>110.314: 195 L x 90 W x 64 H, mm | 110.288: 264 L x 163 W x 54 H, mm<br>110.297: 195 L x 90 W x 64 H, mm | Similar<br>Subject Kit Cases<br>have the same size<br>of the article<br>110.297 of the<br>predicate device.<br>Both devices<br>cleared per<br>K192670 are equal<br>or bigger than the<br>subject devices,<br>this characteristic<br>suggests that the<br>predicate devices<br>can be considered<br>worst case<br>representative to<br>the subject<br>devices. This<br>statement is<br>better discussed<br>along this<br>submission. |
| Volume to Vent<br>Ratio | 110.313: 63.5 cm³/ cm² (25.0 in³/in²)<br>110.314: 63.5 cm³/ cm² (25.0 in³/in²) | 110.288: 98.04 cm³/ cm² (38.6 in³/ in²)<br>110.297: 63.5 cm³/ cm² (25.0 in³/in²) | Similar<br>The predicate device<br>have volume to vent<br>ratio equal or bigger<br>than the subject<br>devices. |
| Useful Life | Yes, reusable up to 100 cycles | Yes, reusable up to 100 cycles | Identical |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | COMPARISON |
| | K203618<br>Neodent EasyGuide Kit Cases<br>JJGC Indústria e Comércio de Materiais Dentários<br>S.A. | K192670<br>Neodent Instrument Kit Cases<br>JJGC Indústria e Comércio de Materiais Dentários<br>S.A. | |
| Biocompatibility | The assessment to Biocompatibility was<br>performed per ISO 10993-1 and testing was<br>performed using methods described in<br>AAMI/ANSI/ISO 10993-5. The results indicate<br>that the subject devices are biocompatible. | The assessment to Biocompatibility was<br>performed per ISO 10993-1 and testing was<br>performed using methods described in<br>AAMI/ANSI/ISO 10993-5. The results indicate<br>that the subject devices are biocompatible. | Similar |
| Sterilization<br>Method | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6 | Identical |
| Cycles | Gravity displacement<br>Fractionated vacuum (pre-vacuum) | Gravity displacement<br>Fractionated vacuum (pre-vacuum) | Same |
| Parameters | Gravity<br>Sterilization temperature: 132 °C<br>Sterilization time: 15 minutes;<br>Drying time: 20 minutes (model number<br>110.313) or 45 minutes (model number<br>110.314)<br><br>Pre-Vacuum<br>Sterilization temperature: 132 °C<br>Sterilization time: 4 minutes;<br>Drying time: 20 minutes. | Gravity<br>Sterilization temperature: 132 °C<br>Sterilization time: 15 minutes;<br>Drying time: 40 minutes (model number<br>110.288) or 20 minutes (model number<br>110.297)<br><br>Pre-Vacuum<br>Sterilization temperature: 132 °C<br>Sterilization time: 4 minutes;<br>Drying time: 20 minutes. | Same<br>The subject devices<br>have the same cycle<br>parameters,<br>however the subject<br>devices require a<br>longer drying cycle<br>when sterilized via<br>Gravity<br>Displacement. |
| Sterile Barrier | Sterilization wrap, FDA-cleared for indicated<br>method and cycles | Sterilization pouch, FDA-cleared for indicated<br>method and cycles | Identical |
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# 510(K) Summary – K203618
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## 510(K) Summary – K203618
The subject devices and the primary predicate device per K192670 have the same intended use and have equivalent Indications for Use Statements. The subject devices and the primary predicate devices are reusable rigid containers used to organize and protect dental surgical instruments that are sterilized by the healthcare provider. The subject device and the primary predicate device components are perforated to allow for penetration of the moist heat (steam) sterilant and require the use of an FDA-cleared wrap or pouch to maintain sterility.
The subject devices and the primary predicate devices include components manufactured from polyphenylsulfone and polysulfone. The subject devices have the same size, whereas the primary predicate device is provided in two different size and configurations. The overall dimensions of the subject device are similar to the range of overall dimensions cleared for the predicate devices. The subject device and the predicate devices are manufactured from materials with a history biocompatibility and clinical use for the cleared indications. The subject device and the predicate devices are to be used according to the validated labeling (sterilization processes and cycles).
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# NON-CLINICAL PERFORMANCE DATA
| Standard or<br>Test Method | Purpose of the<br>Testing | Acceptance Criteria | Results | | | | | | | | | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|
| AAMI<br>TIR30:2011<br>• The validation<br>follows the<br>standard, but<br>the cleaning<br>procedures are<br>according to<br>what is<br>recommended<br>by the<br>manufacturer. | Manual cleaning<br>validation<br>• Test Soil:<br>Blood Soil<br>(BLSO)<br>• Cleaning<br>Method:<br>Manual<br>• Residuals<br>Tested:<br>Hemoglobin<br>and Protein | • Visual<br>Inspection: No<br>Visible Soil<br>• Hemoglobin<br>Test: <2.2<br>µg/cm2<br>• Protein Test:<br><6.4 µg/cm2 | • No visible soil<br>• < 0.012 µg/cm2<br>• < 0.028 µg/cm2<br><br>All the acceptance criteria were met | | | | | | | | | | | | |
| ANSI/AAMI/ISO<br>17665-1<br><br>ANSI/AAMI/ISO<br>17665-2 | Sterilization<br>validation,<br>including<br>sterilant<br>penetration and<br>drying time | All Biological<br>Indicators must be<br>incubated for at<br>least 7 days at 55-<br>60°C. All positive<br>controls for SAL<br>testing must show<br>characteristic<br>growth of the<br>indicator organism. | • SAL 10-6 approved<br>• Dry time of 20 minutes: approved<br><br>Validated Parameters Approved:<br>Sterilizer<br>Type Temperature Full<br>Cycle<br>Time Dry<br>Time Prevacuum 132 °C 4<br>minutes 20<br>minutes Gravity 132 °C 15<br>minutes 20<br>minutes | | | | | | | | | | | | |
| Reprocessing<br>Medical<br>Devices in<br>Health Care<br>Settings:<br>Validation<br>Methods and<br>Labeling<br>Guidance for<br>Industry and<br>Food and Drug<br>Administration<br>Staff | Life cycle<br>(simulate usage)<br>testing | The tested samples<br>must withstand 100<br>cycles of use<br>(cleaning,<br>sterilization and<br>functional tests)<br>without<br>compromising their<br>functionalities | All evaluated cassettes were approved after 100<br>cycles of use, respecting the established<br>acceptance criteria. Through the functional and<br>visual analysis, an obligatory requirement for<br>continuation of the cycles of use, it can be<br>concluded that the assembly of all the components<br>of the cassette (cover, bottom, tray base), occurred<br>perfectly, in addition, that was no difficulty in<br>insertion of the instruments used in the cassettes<br>or failure of the locking mechanism (of the cassette<br>that have this mechanism), not being observed any<br>type of damage or breakdown that could<br>compromise the functionality of the cassettes. | | | | | | | | | | | | |
{11}------------------------------------------------
| ANSI/AAMI/ISO<br>10993-5<br>(Cytotoxicity) | Cytotoxicity<br>testing | Less than 30% cell<br>proliferation<br>inhibition | In the presence of the test extract proliferation of<br>L929 cell culture was not affected compared to<br>untreated reagent control cultures which indicates<br>that substances were not released in cytotoxic<br>concentrations under the test conditions described.<br>The results of the reagent control and the<br>experimental controls confirm the sensitivity and<br>accuracy of the test system. |
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## CONCLUSION
The conclusions drawn from the nonclinical data demonstrate that the Neodent EasyGuide Kit Cases are as safe, as effective, and performs as well as or better than the legally marketed device.
