(84 days)
Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases 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, 40-minute dry time.
Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.
The combined weight of the GM Surgical Kit Case and the associated instruments is 613.1 g. The weight of the empty Kit Case is 510 grams.
Neodent Instrument Kit Cases should not to be stacked during sterilization.
Indications for Use for GM Helix Compact Surgical Kit Case:
Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases 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 Kit Cases are intended for sterilization of non-porous loads.
The combined weight of the GM Helix Compact Surgical Kit Case and the associated instruments is 308.2 g. The weight of the empty Kit Case is 231 grams.
Neodent Instrument Kit Cases should not to 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 devices include two (2) such kit cases. The lids are manufactured from injection molded polyphenylsulfone resin, the tray and base are manufactured from injection molded polysulfone resin. The designs include grommets and inserts of various geometries manufactured from molded silicone that retain the instruments within the tray and base. The subject device kit cases are provided nonsterile to the end-user.
The provided text describes the acceptance criteria and a study proving the device meets these criteria for the Neodent Instrument Kit Cases (K192670).
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Manual Cleaning Validation | |
| Hemoglobin Test: < 0.50 µg/mL | Passed |
| Hemoglobin Test: < 55 µg/article | Passed |
| Hemoglobin Test: < 0.0078 µg/cm² | Passed |
| Micro BCA Protein Test: < 1.1 µg/mL | Passed |
| Micro BCA Protein Test: < 220 µg/article | Passed |
| Micro BCA Protein Test: < 0.018 µg/cm² | Passed |
| Sterilization Validation (including sterilant penetration and drying time) | |
| SAL (Sterility Assurance Level) of 10⁻⁶ | Passed |
| Life Cycle (simulate usage) Testing | |
| Visual and functional inspection following 100 cycles (assembled/disassembled, cleaned, sterilized; component dimensional fit verification; functional closure verification) | Passed |
| Biocompatibility (Cytotoxicity) | |
| < 30% inhibition of proliferation of protein content | Passed |
| Sterilization Parameters for GM Surgical Kit Case (110.288): | |
| Fractionated vacuum (pre-vacuum): Exposure at 132 °C for 4 minutes, 20-minute dry time | Validated (implicitly by "Passed" for sterilization validation) |
| Gravity displacement: Exposure at 132 °C for 15 minutes, 40-minute dry time | Validated (implicitly by "Passed" for sterilization validation) |
| Sterilization Parameters for GM Helix Compact Surgical Kit Case (110.297): | |
| Fractionated vacuum (pre-vacuum): Exposure at 132 °C for 4 minutes, 20-minute dry time | Validated (implicitly by "Passed" for sterilization validation) |
| Gravity displacement: Exposure at 132 °C for 15 minutes, 20-minute dry time | Validated (implicitly by "Passed" for sterilization validation) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size for the test set" in terms of number of devices or data points used for each test. However, it indicates that testing was performed on the "subject devices" (plural), which refers to the two models: GM Surgical Kit Case (110.288) and GM Helix Compact Surgical Kit Case (110.297).
The data provenance is from Brazil, as the sponsor is "JJGC Indústria e Comércio de Materiais Dentários SA" located in Curitiba, Parana, Brazil. The study appears to be retrospective in the sense that the testing was conducted and results presented as evidence for the premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document refers to validation testing (e.g., manual cleaning validation, sterilization validation, life cycle testing, cytotoxicity) according to established standards (Custom, 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," ANSI/AAMI/ISO 10993-5). These tests rely on objective measurements against defined criteria rather than expert consensus on "ground truth" in the way an AI diagnostic study might.
4. Adjudication Method for the Test Set
This information is not applicable for this type of device and testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data, and a robust method is needed to establish a "ground truth" diagnosis. The tests performed here are objective performance tests (e.g., chemical residue levels, sterility assurance level, physical integrity).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not performed. This type of study is relevant for AI-assisted diagnostic devices, which is not the nature of the "Neodent Instrument Kit Cases."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not performed in the context of an AI algorithm. The device is a physical instrument kit case, not a software algorithm. The "standalone" performance here refers to the physical device's ability to meet performance criteria (e.g., cleaning, sterilization, durability) without human intervention beyond the standardized operating procedures for use.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by objective laboratory measurements and tests against predefined acceptance criteria derived from recognized industry standards and guidance documents (e.g., Hemoglobin concentration readings, protein concentration readings, Sterility Assurance Level of 10⁻⁶, visual and functional inspection results after simulated use, cytotoxicity inhibition percentage). It is not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This information is not applicable. The "Neodent Instrument Kit Cases" is a physical medical device, not a machine learning or AI algorithm, therefore there is no "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 device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.
December 18, 2019
JJGC Industria e Comercio de Materiais Dentarios S.A. % Jennifer Jackson Director of Regulatory Affairs & Ouality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K192670
Trade/Device Name: Neodent Instrument Kit Cases Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 23, 2019 Received: September 25, 2019
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.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 mediation-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,
Sreekanth Gutala, PhD 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)
K192670
Device Name Neodent Instrument Kit Cases
Indications for Use (Describe)
Indications for Use for GM Surgical Kit Case:
Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases 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, 40-minute dry time.
Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.
The combined weight of the GM Surgical Kit Case and the associated instruments is 613.1 g. The weight of the empty Kit Case is 510 grams.
Neodent Instrument Kit Cases should not to 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)
Device Name Neodent Instrument Kit Cases
Indications for Use (Describe)
Indications for Use for GM Helix Compact Surgical Kit Case:
Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases 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 Kit Cases are intended for sterilization of non-porous loads.
The combined weight of the GM Helix Compact Surgical Kit Case and the associated instruments is 308.2 g. The weight of the empty Kit Case is 231 grams.
Neodent Instrument Kit Cases should not to 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}------------------------------------------------
510(K) Summary K192670
ADMINISTRATIVE INFORMATION
| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SAAv. Juscelino Kubitschek de Olivera, 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 | 16/Dec/2019 |
| Preparer / Alternate Contact | Luiza Vaccari ToppelRegulatory Affairs CoordinatorJJGC Indústria e Comércio de Materiais Dentários SAluiza.toppel@neodent.com |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary NameCommon Name | Neodent Instrument Kit CasesInstrument Sterilization Trays |
| Classification NameAccessories | Sterilization Wrap Containers, Trays, Cassettes & Other |
| Classification RegulationsProduct Code | 21 CFR 880.6850, Class IIKCT |
| Classification PanelReviewing Branch | General HospitalInfection Control Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K182865 - Neodent Instrument Kit Cases, JJGC IndústriaComércio de Materiais Dentários SA |
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INDICATIONS FOR USE
Indications for Use for GM Surgical Kit Case:
Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases 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, 40-minute dry time.
Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.
The combined weight of the GM Surgical Kit Case and the associated instruments is 613.1 g. The weight of the empty Kit Case is 510 grams.
Neodent Instrument Kit Cases should not to be stacked during sterilization.
Indications for Use for GM Helix Compact Surgical Kit Case:
Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases 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 Kit Cases are intended for sterilization of non-porous loads.
The combined weight of the GM Helix Compact Surgical Kit Case and the associated instruments is 308.2 g. The weight of the empty Kit Case is 231 grams.
Neodent Instrument Kit Cases should not to 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 devices include two (2) such kit cases. The lids are manufactured from injection molded polyphenylsulfone resin, the tray and base are manufactured from injection molded polysulfone resin. The designs include grommets and inserts of various geometries manufactured from molded silicone that retain the instruments within the tray and base. 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 | Assembled KitCase Dimension(L x W x H) | Component Number | Component Dimension(L x W x H) |
|---|---|---|---|---|
| 110.288 | GM Surgical Kit Case | 264 x 163 x 54,mm | 212.294 (Lid) | 264 x 163 x 43 mm |
| 212.311 (Tray) | 248 x 149 x 16 mm | |||
| 212.318 (Base) | 256 x 155 x 22 mm | |||
| 110.297 | GM Helix CompactSurgical Kit Case | 195 x 90 x 64,mm | 212.293 (Lid) | 195 x 90 x 36 mm |
| 212.330 (Tray) | 180 x 76 x 27 mm | |||
| 212.331 (Base) | 188 x 84 x 42 mm |
Note: The instruments and accessory devices that are sterilized and stored within the subject Kit Cases are not the subject devices of this submission.
{7}------------------------------------------------
TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | ||
|---|---|---|---|
| K192670Neodent Instrument Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A. | K182865Neodent Instrument KitsJJGC Indústria e Comércio de Materiais Dentários S.A. | COMPARISON | |
| Indications forUse Statement | Indications for Use for GM Surgical Kit Case:Neodent Instrument Kit Cases are intended to be used to enclose othermedical devices that are to be sterilized by a health care provider. NeodentInstrument Kit Cases are intended to allow sterilization of the enclosedmedical devices. Neodent Instrument Kit Cases require the use of FDAcleared wrap to maintain the sterility of the enclosed devices.The kits are to be enclosed in a sterilization wrap that is FDA-cleared for theindicated cycles, and moist heat (steam) sterilized using one of the followingcycles:Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-minute dry time.Gravity displacement – Exposure at 132 °C for 15 minutes, 40-minute drytime.Neodent Instrument Kit Cases are intended for sterilization of non-porousloads.The combined weight of the GM Surgical Kit Case and the associatedinstruments is 613.1 g. The weight of the empty Kit Case is 510 grams.Neodent Instrument Kit Cases should not to be stacked during sterilization.Indications for Use for GM Helix Compact Surgical Kit Case:Neodent Instrument Kit Cases are intended to be used to enclose othermedical devices that are to be sterilized by a health care provider. NeodentInstrument Kit Cases are intended to allow sterilization of the enclosedmedical devices. Neodent Instrument Kit Cases require the use of FDAcleared wrap to maintain the sterility of the enclosed devices.The kits are to be enclosed in a sterilization wrap that is FDA-cleared for theindicated cycles, and moist heat (steam) sterilized using one of the followingcycles:Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-minute dry timeGravity displacement - Exposure at 132 °C for 15 minutes, 20-minute drytime.Neodent Instrument Kit Cases are intended for sterilization of non-porousloads.The combined weight of the GM Helix Compact Surgical Kit Case and theassociated instruments is 308.2 g. The weight of the empty Kit Case is 231grams.Neodent Instrument Kit Cases should not to be stacked during sterilization. | Indications for Use for GM/WS Surgical Kit Case:Neodent Instrument Kits are intended to be used to enclose other medicaldevices that are to be sterilized by a health care provider. NeodentInstrument Kits are intended to allow sterilization of the enclosed medicaldevices. Neodent Instrument Kits require the use of FDA cleared wrap tomaintain the sterility of the enclosed devices.The kits are to be enclosed in a sterilization wrap that is FDA-cleared for theindicated cycles, and moist heat (steam) sterilized using one of the followingcycles:Fractionated vacuum (pre-vacuum) — Exposure at 132 °C for 4 minutes, 20minute dry time.Gravity displacement – Exposure at 132 °C for 15 minutes, 20 minute drytimeNeodent Instrument Kits are intended for sterilization of non-porous loads.The combined weight of the GM/WS Surgical Kit Case and the associatedinstruments is 674.5 g. The weight of the empty Kit Case is 507 grams.Neodent Instrument Kits are recommended not to be stacked duringsterilization.Indications for Use for GM Prosthetic Kit Case:Neodent Instrument Kits are intended to be used to enclose other medicaldevices that are to be sterilized by a health care provider. NeodentInstrument Kits are intended to allow sterilization of the enclosed medicaldevices. Neodent Instrument Kits require the use of FDA-cleared wrap tomaintain the sterility of the enclosed devices.The kits are to be enclosed in a sterilization wrap that is FDA-cleared for theindicated cycles, and moist heat (steam) sterilized using one of the followingcycles:Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-minute dry timeGravity displacement – Exposure at 132 °C for 15 minutes, 20-minute drytime.Neodent Instrument Kits are intended for sterilization of non-porous loads.The combined weight of the GM Prosthetic Kit Case and the associatedinstruments is 250.5 g. The weight of the empty Kit Case is 210 grams.Neodent Instrument Kits are recommended not to be stacked duringsterilization.Indications for Use for GM Try-In Kit Case: | Similar |
| Neodent Instrument Kits are intended to be used to enclose other medical | |||
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | ||
| K192670Neodent Instrument Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A. | K182865Neodent Instrument KitsJJGC Indústria e Comércio de Materiais Dentários S.A. | COMPARISON | |
| devices that are to be sterilized by a health care provider NeodentInstrument Kits require the use of FDA-cleared wrap to maintain the sterilityof the enclosed devices. | |||
| The kits are to be enclosed in a sterilizable wrap that is FDA-cleared for theindicated cycles, and moist heat (steam) sterilized using one of the followingcycles: | |||
| Fractionated vacuum (pre-vaccum) - Exposure at 132 °C for 4 minutes, 20-minute dry time. | |||
| Gravity displacement – Exposure at 132 ºC for 15 minutes, 20-minute drytime. | |||
| Neodent Instrument Kits are intended for sterilization of non-porous loads. | |||
| The combined weight of the GM Try-In Kit Case and the associatedinstruments is 212.6 g. The weight of the empty Kit Case is 195 grams. | |||
| Neodent Instrument Kits are recommended not to be stacked duringsterilization. | |||
| Indications for Use for GM Guided Surgery Kit Case: | |||
| Neodent Instrument Kits are intended to be used to enclose other medicaldevices that are to be sterilized by a health care provider. Neodent InstrumentKits are intended to allow sterilization of the enclosed medical devices.Neodent Instrument Kits require the use of FDA-cleared wrap to maintain thesterility of the enclosed devices. | |||
| The kits are to be enclosed in a sterilization wrap that is FDA-cleared for theindicated cycles, and moist heat (steam) sterilized using one of the followingcycles: | |||
| Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-minute dry time | |||
| Gravity displacement – Exposure at 132 °C for 15 minutes, 40-minute drytime. | |||
| Neodent Instrument Kits are intended for sterilization of non-porous loads. | |||
| The combined weight of the GM Guided Surgery Surgical Kit Case and theassociated instruments is 728.4 g. The weight of the empty Kit Case is 567grams. | |||
| Neodent Instrument Kits are recommended not to be stacked duringsterilization. |
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| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | COMPARISON | |
|---|---|---|---|
| K192670Neodent Instrument Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A. | K182865Neodent Instrument KitsJJGC Indústria e Comércio de Materiais Dentários S.A. | ||
| Intended Use | Neodent Instrument Kit Cases are intended to be used to enclose othermedical devices that are to be sterilized by a health care provider. NeodentInstrument Kit Cases are intended to allow sterilization of the enclosedmedical devices. Neodent Instrument Kit Cases require the use of FDA clearedwrap to maintain the sterility of the enclosed devices. | Neodent Instrument Kits are intended to be used to enclose other medicaldevices that are to be sterilized by a health care provider. Neodent InstrumentKits are intended to allow sterilization of the enclosed medical devices.Neodent Instrument Kits require the use of FDA cleared wrap to maintain thesterility of the enclosed devices. | Same |
| Design | Rigid polysulfone polymer base and removable inner tray with apolyphenylsulfone lid.Retention grommets of medical grade silicone. | Rigid polysulfone polymer base and removable inner tray with apolyphenylsulfone lid.Retention grommets of medical grade silicone.Retention fixtures of titanium alloy. | Same |
| Perforated | Yes; allows moist heat (steam) penetration to achieve sterilization | Yes; allows moist heat (steam) penetration to achieve sterilization | Same |
| Reusable | Yes | Yes | Same |
| Overalldimensions | 110.288: 264 L x 163 W x 54 H, mm110.297: 195 L x 90 W x 64 H, mm | For 110.295: 195 L x 90 W x 44 H, mmFor 110.294: 195L x 90 W x 54 H, mmFor 110.287: 264L x 163 W x 54 H, mmFor 110.296: 264 L x 163 W x 58 H, mm | Similar |
| Vent to VolumeRatio | 110.288: 0.0102 cm²/cm³ (0.0259 in²/in³)110.297: 0.0157 cm²/cm³ (0.0400 in²/in³) | 110.296: 0.0093 cm²/cm3 (0.0236 in²/in3)110.287: 0.0102 cm²/cm3 (0.0259 in²/in3)110.294: 0.0191 cm²/cm3 (0.0485 in²/in3)110.295: 0.0247 cm²/cm3 (0.0627 in²/in3) | Similar |
| Useful Life | Yes, reusable up to 100 cyclesAssembled/disassembled, cleaned, sterilizedVisual inspectionComponent dimensional fit verificationFunctional closure (lid-base latch) verification | Yes, reusable up to 100 cyclesAssembled/disassembled, cleaned, sterilizedVisual inspectionComponent dimensional fit verificationFunctional closure (lid-base latch) verification | Same |
| Biocompatibility | The assessment to Biocompatibility was performed per ISO 10993-1 andtesting was performed using methods described in AAMI/ANSI/ISO 10993-5.The results indicate that the subject devices are biocompatible. | The assessment to Biocompatibility was performed per ISO 10993-1 andtesting was performed using methods described in AAMI/ANSI/ISO 10993-5.The results indicate that the subject devices are biocompatible. | Same |
| SterilizationMethod | Moist heat (steam) | Moist heat (steam) | Same |
| Cycles | Gravity displacementFractionated vacuum (pre-vacuum) | Gravity displacementFractionated vacuum (pre-vacuum) | Same |
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | COMPARISON | |
| K192670Neodent Instrument Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A. | K182865Neodent Instrument KitsJJGC Indústria e Comércio de Materiais Dentários S.A. | ||
| Parameters | GravitySterilization temperature: 132 °CSterilization time: 15 minutes;Drying time: 40 minutes (model number 110.288) or 20 minutes (modelnumber 110.297) | GravitySterilization temperature: 132 °CSterilization time: 15 minutes;Drying time: 20 minutes or 40 minutes (model number 110.296) | Similar |
| Pre-VacuumSterilization temperature: 132 °CSterilization time: 4 minutes;Drying time: 20 minutes. | Pre-VacuumSterilization temperature: 132 °CSterilization time: 4 minutes;Drying time: 20 minutes. | ||
| Sterile Barrier | Sterilization wrap, FDA-cleared for indicated method and cycles | Sterilization pouch, FDA-cleared for indicated method and cycles | Same |
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The subject devices and the primary predicate device per K182865 have the same intended use and have similar Indications for Use Statements. The subject devices (and the primary predicate device per K182865) 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 K182865 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.
| Standard or Test Method | Purpose of the Testing | Acceptance Criteria | Results |
|---|---|---|---|
| Custom | Manual cleaning validation | Hemoglobin Test:• <0.50 µg/mL• <55 µg/article• <0.0078 µg/cm2Micro BCA Protein Test:• <1.1 µg/mL• <220 µg/article• <0.018 µg/cm2 | Passed |
| ANSI/AAMI/ISO 17665-1ANSI/AAMI/ISO 17665-2 | Sterilization validation, including sterilant penetration and drying time | SAL of 10-6 | Passed |
| Reprocessing MedicalDevices in Health CareSettings: ValidationMethods and LabelingGuidance for Industryand Food and DrugAdministration Staff | Life cycle (simulate usage) testing | Visual and functional inspection following 100 cycles | Passed |
| ANSI/AAMI/ISO 10993-5(Cytotoxicity) | Cytotoxicity testing | <30% inhibition of proliferation of protein content | Passed |
NON-CLINICAL PERFORMANCE DATA
CONCLUSION
The conclusions drawn from the nonclinical and clinical tests that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices per K182865.
§ 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).