(88 days)
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
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.
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.
Here's a summary of the acceptance criteria and study information for the Neodent EasyGuide Kit Cases, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Performance Test / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Manual Cleaning Validation | ||
| Visual Inspection | No Visible Soil | No visible soil |
| Hemoglobin Test (against Blood Soil - BLSO) | < 2.2 µg/cm² | < 0.012 µg/cm² |
| Protein Test (against Blood Soil - BLSO) | < 6.4 µg/cm² | < 0.028 µg/cm² |
| Sterilization Validation | ||
| Sterility Assurance Level (SAL) | All Biological Indicators must be incubated for at least 7 days at 55-60°C. All positive controls for SAL testing must show characteristic growth of the indicator organism. | SAL 10⁻⁶ approved |
| Drying Time (Pre-vacuum 132°C, 4 min exposure) | (Implied to achieve sufficient dryness to maintain sterility) | Approved (20 minutes dry time) |
| Drying Time (Gravity 132°C, 15 min exposure) | (Implied to achieve sufficient dryness to maintain sterility) | Approved (20 minutes dry time for model 110.313, 45 minutes for model 110.314) |
| Life Cycle (Simulated Usage) Testing | The tested samples must withstand 100 cycles of use (cleaning, sterilization, and functional tests) without compromising their functionalities. | All evaluated cassettes were approved after 100 cycles of use, respecting the established acceptance criteria. Functional and visual analysis showed perfect assembly, no difficulty in instrument insertion, and no failure of locking mechanisms. No damage or breakdown observed that could compromise functionality. |
| Biocompatibility (Cytotoxicity) | Less than 30% cell proliferation inhibition | In the presence of the test extract proliferation of L929 cell culture was not affected compared to untreated reagent control cultures, indicating substances were not released in cytotoxic concentrations. The results of controls confirmed sensitivity and accuracy. |
2. Sample Sizes and Data Provenance
- Test Set Sample Size: The document does not explicitly state the numerical sample size for each test. For the cleaning validation, it refers to "tests" and "All the acceptance criteria were met," implying multiple runs. For sterilization validation, it mentions "All Biological Indicators," suggesting multiple BIs were used per cycle. For life cycle testing, it states "All evaluated cassettes," suggesting multiple devices were tested. For cytotoxicity, "L929 cell culture" refers to a cell line, not human subjects.
- Data Provenance: The document generally indicates that the testing was performed by JJGC Indústria e Comércio de Materiais Dentários S.A. (Neodent). The country of origin for the data is implied to be Brazil, where the sponsor is located. The studies are non-clinical performance data, likely prospective in nature as they describe validation processes for the device.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the document. The studies described are technical performance validations (cleaning, sterilization, life cycle, biocompatibility), which rely on objective measurements and established scientific standards rather than expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are focused on objective device performance rather than interpretations that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an instrument kit case for sterilization, not an AI-powered diagnostic or assistive tool for human readers.
6. Standalone Performance (Algorithm Only)
This information is not applicable. The device is a physical medical device (sterilization kit case), not a software algorithm.
7. Type of Ground Truth Used
The ground truth used for these studies is based on:
- Objective Measurements/Standards: For cleaning validation (hemoglobin, protein levels), sterilization (Sterility Assurance Level - SAL, dryness), life cycle (functional integrity after cycles), and biocompatibility (cell proliferation).
- Established Industry Standards: The tests were performed according to recognized standards like AAMI TIR30:2011, ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff," and ANSI/AAMI/ISO 10993-5 (Cytotoxicity).
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
{0}------------------------------------------------
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
{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,
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
{2}------------------------------------------------
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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ 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."
{3}------------------------------------------------
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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."
{4}------------------------------------------------
ADMINISTRATIVE INFORMATION
| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA(dba Neodent)Av. Juscelino Kubitschek de Oliveira, 3291Curitiba, Parana, Brazil 81270-200Registration No.: 3008261720Owner/Operator No.: 10031702 |
|---|---|
| Contact Person | Jennifer M. Jackson, MSDirector of Regulatory Affairs,Straumann USAE-mail: jennifer.jackson@straumann.comTelephone (978) 747-2509 |
| Date Prepared | 09/March/2021 |
| Preparer / Alternate Contact | Camila da Silva EstevesRegulatory Affairs SupervisorJJGC Indústria e Comércio de Materiais Dentários SAE-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
{5}------------------------------------------------
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.
{6}------------------------------------------------
The dimensions for each part of the model and the overall dimensions are presented in the table below:
| AssembledKit Case | Description | AssembledKit CaseDimension(L x W x H) | Component Number | Component Dimension(L x W x H) |
|---|---|---|---|---|
| 110.313 | GM EasyGuide Surgical KitCase Narrow/Regular DiamImplants | 195 x 90 x64 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 KitCase Regular/Large DiamImplants | 195 x 90 x64 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.
{7}------------------------------------------------
TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | ||
|---|---|---|---|
| K203618Neodent EasyGuide Kit CasesJJGC Indústria e Comércio de Materiais DentáriosS.A. | K192670Neodent Instrument Kit CasesJJGC Indústria e Comércio de Materiais DentáriosS.A. | COMPARISON | |
| Indications forUse Statement | Indications for Use for GM EasyGuide Surgical KitCase Narrow/Regular Diam Implants:Neodent Instrument Kits are intended to be usedto enclose other medical devices that are to besterilized by a health care provider. NeodentInstrument Kits are intended to allow sterilizationof the enclosed medical devices. NeodentInstrument Kits require the use of FDA-cleared | Indications for Use for GM Surgical Kit Case:Neodent Instrument Kit Cases are intended tobe used to enclose other medical devices thatare to be sterilized by a health care provider.Neodent Instrument Kit Cases are intended toallow sterilization of the enclosed medicaldevices. Neodent Instrument Kit Cases require | SimilarThe indications foruse are equivalent.The difference inthe text is specificdue to the weight ofeach device in theirmaximum loadconfiguration. |
| wrap to maintain the sterility of the encloseddevices.The Kits are to be enclosed in a sterilization wrapthat is FDA-cleared for the indicated cycles, andmoist heat (steam) sterilized using one of thefollowing cycles: | the use of FDA cleared wrap to maintain thesterility of the enclosed devices.The kits are to be enclosed in a sterilizationwrap that is FDA-cleared for the indicatedcycles, and moist heat (steam) sterilized usingone of the following cycles: | ||
| Fractionated vacuum (pre-vacuum) – Exposure at132 °C for 4 minutes, 20-minute dry time. | Fractionated vacuum (pre-vacuum) — Exposureat 132 °C for 4 minutes, 20-minute dry time. | ||
| Gravity displacement - Exposure at 132 °C for 15minutes, 20-minute dry time. | Gravity displacement – Exposure at 132 °C for15 minutes, 40-minute dry time. | ||
| Neodent Instrument Kits are intended forsterilization of non-porous loads. | Neodent Instrument Kit Cases are intended forsterilization of non-porous loads. | ||
| The combined weight of the GM EasyGuideSurgical Kit Case Narrow/Regular Diam Implantsand the associated instruments is 310,18 g. Theweight of the empty Kit Case is 263,63 g. | The combined weight of the GM Surgical KitCase and the associated instruments is 613.1g. The weight of the empty Kit Case is 510grams. Neodent Instrument Kit Cases should | ||
| Neodent GM EasyGuide Kit Cases should not bestacked during sterilization | not to be stacked during sterilization.Indications for Use for GM Helix Compact | ||
| Indications for Use for GM EasyGuide Surgical KitCase Regular/Large Diam Implants: | Surgical Kit Case: | ||
| Neodent Instrument Kits are intended to be usedto enclose other medical devices that are to besterilized by a health care provider. NeodentInstrument Kits are intended to allow sterilizationof the enclosed medical devices. NeodentInstrument Kits require the use of FDA-clearedwrap to maintain the sterility of the encloseddevices. | Neodent Instrument Kit Cases are intended tobe used to enclose other medical devices thatare to be sterilized by a health care provider.Neodent Instrument Kit Cases are intended toallow sterilization of the enclosed medicaldevices. Neodent Instrument Kit Cases requirethe use of FDA cleared wrap to maintain thesterility of the enclosed devices. | ||
| The Kits are to be enclosed in a sterilization wrapthat is FDA-cleared for the indicated cycles, andmoist heat (steam) sterilized using one of thefollowing cycles: | The kits are to be enclosed in a sterilizationwrap that is FDA-cleared for the indicatedcycles, and moist heat (steam) sterilized usingone of the following cycles: | ||
| Fractionated vacuum (pre-vacuum) – Exposure at132 °C for 4 minutes, 20-minute dry time. | Fractionated vacuum (pre-vacuum) — Exposureat 132 °C for 4 minutes, 20-minute dry time | ||
| Gravity displacement - Exposure at 132 °C for 15minutes, 45-minute dry time. | Gravity displacement - Exposure at 132 °C for15 minutes, 20-minute dry time. | ||
| Neodent Instrument Kits are intended forsterilization of non-porous loads. | Neodent Instrument Kit Cases are intended forsterilization of non-porous loads. | ||
| The combined weight of the GM EasyGuideSurgical Kit Case Regular/Large Diam Implants andthe associated instruments is 346,45 g. Theweight of the empty Kit Case is 264,12 g.Neodent EasyGuide Kit Cases should not bestacked during sterilization. | The combined weight of the GM HelixCompact Surgical Kit Case and the associatedinstruments is 308.2 g. The weight of theempty Kit Case is 231 grams. NeodentInstrument Kit Cases should not to be stackedduring sterilization. | ||
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | ||
| K203618Neodent EasyGuide Kit CasesJJGC Indústria e Comércio de Materiais DentáriosS.A. | K192670Neodent Instrument Kit CasesJJGC Indústria e Comércio de Materiais DentáriosS.A. | COMPARISON | |
| Intended Use | The GM EasyGuide Kit Cases are used for thesafe storage of surgical instruments, as well asfor support during sterilization. | The GM Helix Compact Surgical Kit Case issuitable for safe storage of surgical andprosthetic instruments, organizing theinstruments in the sequence in which they willbe used, as well as for sterilization of suchinstruments. | SameBoth subject andpredicate devicesare intended to safestorage surgicalinstruments andprovide supportduring sterilization. |
| Design | Rigid polysulfone polymer base and removableinner tray with a polyphenylsulfone lid.Retention grommets of medical grade silicone. | Rigid polysulfone polymer base and removableinner tray with a polyphenylsulfone lid.Retention grommets of medical grade silicone. | IdenticalBoth subject andpredicate deviceshave the samematerials. |
| Perforated | Yes; allows moist heat (steam) penetration toachieve sterilization | Yes; allows moist heat (steam) penetration toachieve sterilization | Identical |
| Reusable | Yes | Yes | Identical |
| Overalldimensions | 110.313: 195 L x 90 W x 64 H, mm110.314: 195 L x 90 W x 64 H, mm | 110.288: 264 L x 163 W x 54 H, mm110.297: 195 L x 90 W x 64 H, mm | SimilarSubject Kit Caseshave the same sizeof the article110.297 of thepredicate device.Both devicescleared perK192670 are equalor bigger than thesubject devices,this characteristicsuggests that thepredicate devicescan be consideredworst caserepresentative tothe subjectdevices. Thisstatement isbetter discussedalong thissubmission. |
| Volume to VentRatio | 110.313: 63.5 cm³/ cm² (25.0 in³/in²)110.314: 63.5 cm³/ cm² (25.0 in³/in²) | 110.288: 98.04 cm³/ cm² (38.6 in³/ in²)110.297: 63.5 cm³/ cm² (25.0 in³/in²) | SimilarThe predicate devicehave volume to ventratio equal or biggerthan the subjectdevices. |
| Useful Life | Yes, reusable up to 100 cycles | Yes, reusable up to 100 cycles | Identical |
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | COMPARISON | |
| K203618Neodent EasyGuide Kit CasesJJGC Indústria e Comércio de Materiais DentáriosS.A. | K192670Neodent Instrument Kit CasesJJGC Indústria e Comércio de Materiais DentáriosS.A. | ||
| Biocompatibility | The assessment to Biocompatibility wasperformed per ISO 10993-1 and testing wasperformed using methods described inAAMI/ANSI/ISO 10993-5. The results indicatethat the subject devices are biocompatible. | The assessment to Biocompatibility wasperformed per ISO 10993-1 and testing wasperformed using methods described inAAMI/ANSI/ISO 10993-5. The results indicatethat the subject devices are biocompatible. | Similar |
| SterilizationMethod | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6 | Identical |
| Cycles | Gravity displacementFractionated vacuum (pre-vacuum) | Gravity displacementFractionated vacuum (pre-vacuum) | Same |
| Parameters | GravitySterilization temperature: 132 °CSterilization time: 15 minutes;Drying time: 20 minutes (model number110.313) or 45 minutes (model number110.314)Pre-VacuumSterilization temperature: 132 °CSterilization time: 4 minutes;Drying time: 20 minutes. | GravitySterilization temperature: 132 °CSterilization time: 15 minutes;Drying time: 40 minutes (model number110.288) or 20 minutes (model number110.297)Pre-VacuumSterilization temperature: 132 °CSterilization time: 4 minutes;Drying time: 20 minutes. | SameThe subject deviceshave the same cycleparameters,however the subjectdevices require alonger drying cyclewhen sterilized viaGravityDisplacement. |
| Sterile Barrier | Sterilization wrap, FDA-cleared for indicatedmethod and cycles | Sterilization pouch, FDA-cleared for indicatedmethod and cycles | Identical |
{8}------------------------------------------------
510(K) Summary – K203618
{9}------------------------------------------------
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).
{10}------------------------------------------------
NON-CLINICAL PERFORMANCE DATA
| Standard orTest Method | Purpose of theTesting | Acceptance Criteria | Results | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AAMITIR30:2011• The validationfollows thestandard, butthe cleaningprocedures areaccording towhat isrecommendedby themanufacturer. | Manual cleaningvalidation• Test Soil:Blood Soil(BLSO)• CleaningMethod:Manual• ResidualsTested:Hemoglobinand Protein | • VisualInspection: NoVisible Soil• HemoglobinTest: <2.2µg/cm2• Protein Test:<6.4 µg/cm2 | • No visible soil• < 0.012 µg/cm2• < 0.028 µg/cm2All the acceptance criteria were met | ||||||||||||
| ANSI/AAMI/ISO17665-1ANSI/AAMI/ISO17665-2 | Sterilizationvalidation,includingsterilantpenetration anddrying time | All BiologicalIndicators must beincubated for atleast 7 days at 55-60°C. All positivecontrols for SALtesting must showcharacteristicgrowth of theindicator organism. | • SAL 10-6 approved• Dry time of 20 minutes: approvedValidated Parameters Approved:SterilizerType Temperature FullCycleTime DryTime Prevacuum 132 °C 4minutes 20minutes Gravity 132 °C 15minutes 20minutes | ||||||||||||
| ReprocessingMedicalDevices inHealth CareSettings:ValidationMethods andLabelingGuidance forIndustry andFood and DrugAdministrationStaff | Life cycle(simulate usage)testing | The tested samplesmust withstand 100cycles of use(cleaning,sterilization andfunctional tests)withoutcompromising theirfunctionalities | All evaluated cassettes were approved after 100cycles of use, respecting the establishedacceptance criteria. Through the functional andvisual analysis, an obligatory requirement forcontinuation of the cycles of use, it can beconcluded that the assembly of all the componentsof the cassette (cover, bottom, tray base), occurredperfectly, in addition, that was no difficulty ininsertion of the instruments used in the cassettesor failure of the locking mechanism (of the cassettethat have this mechanism), not being observed anytype of damage or breakdown that couldcompromise the functionality of the cassettes. |
{11}------------------------------------------------
| ANSI/AAMI/ISO10993-5(Cytotoxicity) | Cytotoxicitytesting | Less than 30% cellproliferationinhibition | In the presence of the test extract proliferation ofL929 cell culture was not affected compared tountreated reagent control cultures which indicatesthat substances were not released in cytotoxicconcentrations under the test conditions described.The results of the reagent control and theexperimental controls confirm the sensitivity andaccuracy of the test system. |
|---|---|---|---|
| -------------------------------------------- | ------------------------- | --------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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.
§ 880.6850 Sterilization wrap.
(a)
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.(b)
Classification. Class II (performance standards).