(208 days)
No
The device description and intended use clearly define the device as a reusable rigid container for sterilizing other medical devices. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on physical properties and sterilization efficacy, not algorithmic performance.
No.
The device is described as reusable rigid containers intended to organize instruments for sterilization, not to treat a disease or condition.
No
Explanation: The device is described as reusable rigid containers intended for sterilizing and protecting other medical devices. It does not perform any diagnostic function.
No
The device description clearly states the device is a reusable rigid container made of injection molded resins, silicone grommets, and titanium, which are all hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the kits are for enclosing other medical devices for sterilization and maintaining their sterility. This is a function related to the preparation and handling of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description details the physical components of the kits (case, tray, lid, grommets, holder) and their materials. This aligns with a device designed for physical containment and organization, not for performing diagnostic tests.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a reusable rigid container system for sterilizing other medical devices, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Indications for Use for GM/WS Surgical Kit Case:
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/WS Surgical Kit Case and the associated instruments is 674.5 g. The weight of the empty Kit Case is 507 grams.
Neodent Instrument Kits are recommended not to be stacked during sterilization.
Indications for Use for GM Prosthetic Kit Case:
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
The combined weight of the GM Prosthetic Kit Case and the associated instruments is 250.5 g. The weight of the empty Kit Case is 210 grams.
Neodent Instrument Kits are recommended not to be stacked during sterilization.
Indications for Use for GM Try-In Kit Case:
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 require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilizable wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Fractionated vacuum (pre-vaccum) - 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 Try-In Kit Case and the associated instruments is 212.6 g. The weight of the empty Kit Case is 195 grams.
Neodent Instrument Kits are recommended not to be stacked during sterilization.
Indications for Use for GM Guided Surgery Kit Case:
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, 40-minute dry time.
Neodent Instrument Kits are intended for sterilization of non-porous loads.
The combined weight of the GM Guided Surgery Surgical Kit Case and the associated instruments is 728.4 g. The weight of the empty Kit Case is 567 grams.
Neodent Instrument Kits are recommended not to be stacked during sterilization.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The subject device kits are reusable rigid containers, comprising a case bottom (or base), a removable inner tray base (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 six (6) such kits. The lids are manufactured from injection molded polyphenylsulfone resin, the tray base and case bottoms are manufactured from injection molded polysulfone resin. The designs include grommets of various geometries manufactured from molded silicone that retain the instruments within the tray. Certain designs also incorporate a holder of a single geometry made of Ti-6Al-4V-ELI to position items in the trays. The subject device kits are provided nonsterile to the end- user. The dimensions for each model are presented in the table below:
Assembled set: 110.287, Assembled Set Dimension (L x W x H): 264 x 163 x 54 mm, Component Number: 212.294 (Lid), Component Dimension (L x W x H): 264 x 163 x 43 mm
Component Number: 212.310 (Tray), Component Dimension (L x W x H): 248 x 149 x 16 mm
Component Number: 212.318 (Bottom), Component Dimension (L x W x H): 256 x 155 x 22 mm
Assembled set: 110.294, Assembled Set Dimension (L x W x H): 195 x 90 x 54 mm, Component Number: 212.293 (Lid), Component Dimension (L x W x H): 195 x 90 x 36 mm
Component Number: 212.321 (Tray), Component Dimension (L x W x H): 180 x 76 x 17 mm
Component Number: 212.197 (Bottom), Component Dimension (L x W x H): 188 x 84 x 32 mm
Assembled set: 110.295, Assembled Set Dimension (L x W x H): 195 x 90 x 44 mm, Component Number: 212.293 (Lid), Component Dimension (L x W x H): 195 x 90 x 36 mm
Component Number: 212.323 (Tray), Component Dimension (L x W x H): 180 x 76 x 17 mm
Component Number: 212.092 (Bottom), Component Dimension (L x W x H): 188 x 84 x 22 mm
Assembled set: 110.296, Assembled Set Dimension (L x W x H): 264 x 163 x 58 mm, Component Number: 212.327 (Lid), Component Dimension (L x W x H): 264 x 163 x 49 mm
Component Number: 212.320 (Tray), Component Dimension (L x W x H): 248 x 148,5 x 16 mm
Component Number: 212.328 (Bottom), Component Dimension (L x W x H): 256 x 155 x 20,5 mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The nonclinical performance data includes:
- Manual cleaning validation (Custom method) - Passed
- Sterilization validation, including sterilant penetration and drying time (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2) - Passed
- Life cycle (simulate usage) testing (Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff) - Passed
- Cytotoxicity testing (ANSI/AAMI/ISO 10993-5) - Passed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 7, 2019
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: K182865
Trade/Device Name: Neodent Instruments Kits Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: April 8, 2019 Received: April 9, 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.
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For David Krause, PhD Acting 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
510(k) Number (if known)
K182865 Device Name Neodent Instrument Kits
Indications for Use (Describe)
Indications for Use for GM/WS Surgical Kit Case:
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/WS Surgical Kit Case and the associated instruments is 674.5 g. The weight of the empty Kit Case is 507 grams.
Neodent Instrument Kits are recommended 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
3
510(k) Number (if known)
K182865 Device Name Neodent Instrument Kits
Indications for Use (Describe)
Indications for Use for GM Prosthetic Kit Case:
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 Prosthetic Kit Case and the associated instruments is 250.5 g. The weight of the empty Kit Case is 210 grams.
Neodent Instrument Kits are recommended 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
4
510(k) Number (if known)
K182865 Device Name Neodent Instrument Kits
Indications for Use (Describe)
Indications for Use for GM Try-In Kit Case:
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 require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilizable wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Fractionated vacuum (pre-vaccum) - 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 Try-In Kit Case and the associated instruments is 212.6 g. The weight of the empty Kit Case is 195 grams.
Neodent Instrument Kits are recommended 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
5
510(k) Number (if known)
K182865 Device Name Neodent Instrument Kits
Indications for Use (Describe)
Indications for Use for GM Guided Surgery Kit Case:
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, 40-minute dry time.
Neodent Instrument Kits are intended for sterilization of non-porous loads.
The combined weight of the GM Guided Surgery Surgical Kit Case and the associated instruments is 728.4 g. The weight of the empty Kit Case is 567 grams.
Neodent Instrument Kits are recommended 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
6
510(k) Summary K182865
ADMINISTRATIVE INFORMATION
| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA
Av. Juscelino Kubitschek de Oliveira, 3291
Curitiba, Parana, Brazil 81270-200
Registration No.: 3008261720
Owner/Operator No.: 10031702 |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jennifer M. Jackson, MS
Director of Regulatory Affairs & Quality,
Straumann USA
E-Mail: jennifer.jackson@straumann.com
Telephone (978) 747-2509 |
| Date Prepared | 30/Apr/2019 |
| Preparer / Alternate Contact | Mariana Soares Hartmann
Regulatory Affairs Analyst
E-Mail: mariana.hartmann@neodent.com |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name
Common Name | Neodent Instrument Kits
Instrument Sterilization Trays |
| Classification Name
Accessories | Sterilization Wrap Containers, Trays, Cassettes & Other |
| Classification Regulations
Product Code | 21 CFR 880.6850, Class II
KCT |
| Classification Panel
Reviewing Branch | General Hospital
Infection Control Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Predicate Device | K171713 - Neodent Instrument Kits, JJGC Indústria e
Comércio de Materiais Dentários AS |
| Reference Devices | K142529, Genesis™ Reusable Rigid Sterilization Container
System, CareFusion 2200 Inc.
K180915, Sonicision Reusable Sterilization Tray, Covidien |
7
INDICATIONS FOR USE
Indications for Use for GM/WS Surgical Kit Case:
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/WS Surgical Kit Case and the associated instruments is 674.5 g. The weight of the empty Kit Case is 507 grams.
Neodent Instrument Kits are recommended not to be stacked during sterilization.
Indications for Use for GM Prosthetic Kit Case:
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
The combined weight of the GM Prosthetic Kit Case and the associated instruments is 250.5 g. The weight of the empty Kit Case is 210 grams.
Neodent Instrument Kits are recommended not to be stacked during sterilization.
Indications for Use for GM Try-In Kit Case:
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 require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilizable 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 Try-In Kit Case and the associated instruments is 212.6 g. The weight of the empty Kit Case is 195 grams.
Neodent Instrument Kits are recommended not to be stacked during sterilization.
Indications for Use for GM Guided Surgery Kit Case:
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
8
displacement - Exposure at 132 °C for 15 minutes, 40-minute dry time.
Neodent Instrument Kits are intended for sterilization of non-porous loads.
The combined weight of the GM Guided Surgery Surgical Kit Case and the associated instruments is 728.4 g. The weight of the empty Kit Case is 567 grams.
Neodent Instrument Kits are recommended not to be stacked during sterilization.
SUBJECT DEVICE DESCRIPTION
The subject device kits are reusable rigid containers, comprising a case bottom (or base), a removable inner tray base (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 six (6) such kits. The lids are manufactured from injection molded polyphenylsulfone resin, the tray base and case bottoms are manufactured from injection molded polysulfone resin. The designs include grommets of various geometries manufactured from molded silicone that retain the instruments within the tray. Certain designs also incorporate a holder of a single geometry made of Ti-6Al-4V-ELI to position items in the trays. The subject device kits are provided nonsterile to the end- user. The dimensions for each model are presented in the table below:
| Assembled
set | Assembled Set
Dimension
(L x W x H) | Component Number | Component Dimension
(L x W x H) |
|------------------|-------------------------------------------|------------------|------------------------------------|
| 110.287 | 264 x 163 x 54 mm | 212.294 (Lid) | 264 x 163 x 43 mm |
| | | 212.310 (Tray) | 248 x 149 x 16 mm |
| | | 212.318 (Bottom) | 256 x 155 x 22 mm |
| 110.294 | 195 x 90 x 54 mm | 212.293 (Lid) | 195 x 90 x 36 mm |
| | | 212.321 (Tray) | 180 x 76 x 17 mm |
| | | 212.197 (Bottom) | 188 x 84 x 32 mm |
| 110.295 | 195 x 90 x 44 mm | 212.293 (Lid) | 195 x 90 x 36 mm |
| | | 212.323 (Tray) | 180 x 76 x 17 mm |
| | | 212.092 (Bottom) | 188 x 84 x 22 mm |
| 110.296 | 264 x 163 x 58 mm | 212.327 (Lid) | 264 x 163 x 49 mm |
| | | 212.320 (Tray) | 248 x 148,5 x 16 mm |
| | | 212.328 (Bottom) | 256 x 155 x 20,5 mm |
9
TECHNOLOGICALCHARACTERISTICCOMPARISONTABLE
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | ||
|---|---|---|---|
| K182865 | |||
| Neodent Instrument Kits | |||
| JJGC Indústria e Comércio de Materiais | |||
| Dentários S.A. | K171713 | ||
| Neodent Instrument Kits | |||
| JJGC Indústria e Comércio de Materiais | |||
| Dentários S.A. | Comparison | ||
| Indications | |||
| for Use | Indications for Use for GM/WS Surgical Kit Case: | ||
| 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/WS | |||
| Surgical Kit Case and the associated | |||
| instruments is 674.5 g. The weight of the | |||
| empty Kit Case is 507 grams. | |||
| Neodent Instrument Kits are | |||
| recommended not to be stacked during | |||
| sterilization. | 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 GM/WS Surgical Kit Case | |||
| maximum load weight is 125 grams. | |||
| The GM Surgical Kit Case maximum load | |||
| weight is 113 grams. | |||
| Neodent Instrument Kits are | |||
| recommended not to be stacked during | |||
| sterilization. | Similar |
10
| SUBJECT DEVICE
K182865
Neodent Instrument Kits
JJGC Indústria e Comércio de Materiais
Dentários S.A. | PRIMARY PREDICATE DEVICE
K171713
Neodent Instrument Kits
JJGC Indústria e Comércio de Materiais
Dentários S.A. | Comparison |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for Use for GM Prosthetic
Kit Case:
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
Prosthetic Kit Case and the associated
instruments is 250.5 g. The weight of
the empty Kit Case is 210 grams.
Neodent Instrument Kits are
recommended not to be stacked
during sterilization. | | |
11
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
|---|---|---|
| K182865 | ||
| Neodent Instrument Kits | ||
| JJGC Indústria e Comércio de Materiais | ||
| Dentários S.A. | K171713 | |
| Neodent Instrument Kits | ||
| JJGC Indústria e Comércio de Materiais | ||
| Dentários S.A. | Comparison | |
| Indications for Use for GM Try-In Kit | ||
| Case: | ||
| 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 require the use of FDA- | ||
| cleared wrap to maintain the sterility of | ||
| the enclosed devices. | ||
| The kits are to be enclosed in a | ||
| sterilizable 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 | ||
| ºC for 15 minutes, 20-minute dry time. | ||
| Neodent Instrument Kits are intended | ||
| for sterilization of non-porous loads. | ||
| The combined weight of the GM Try-In | ||
| Kit Case and the associated instruments | ||
| is 212.6 g. The weight of the empty Kit | ||
| Case is 195 grams. | ||
| Neodent Instrument Kits are | ||
| recommended not to be stacked during | ||
| sterilization. |
12
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | ||
|---|---|---|---|
| K182865 | |||
| Neodent Instrument Kits | |||
| JJGC Indústria e Comércio de Materiais | |||
| Dentários S.A. | K171713 | ||
| Neodent Instrument Kits | |||
| JJGC Indústria e Comércio de Materiais | |||
| Dentários S.A. | Comparison | ||
| Indications for Use for GM Guided | |||
| Surgery Kit Case: | |||
| 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, 40-minute dry time.
Neodent Instrument Kits are intended
for sterilization of non-porous loads.
The combined weight of the GM Guided
Surgery Surgical Kit Case and the
associated instruments is 728.4 g. The
weight of the empty Kit Case is 567
grams.
Neodent Instrument Kits are
recommended not to be stacked during
sterilization. | | | |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
| | K182865
Neodent Instrument Kits
JJGC Indústria e Comércio de Materiais
Dentários S.A. | K171713
Neodent Instrument Kits
JJGC Indústria e Comércio de Materiais
Dentários S.A. | Comparison |
| Intended Use | 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. | 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. | Same |
| Product Code | KCT | KCT | Same |
| Design | Rigid polysulfone polymer base and
removable inner tray with a
polyphenylsulfone lid. | Rigid polysulfone polymer base and
removable inner tray with a
polyphenylsulfone lid. | Same |
| | Retention grommets of medical grade silicone. | Retention grommets of medical grade
silicone. | |
| | Retention fixtures of titanium alloy. | Retention fixtures of titanium alloy. | |
| Perforated | Yes; allows moist heat (steam) penetration
to achieve sterilization | Yes; allows moist heat (steam)
penetration to achieve sterilization | Same |
| Reusable | Yes | Yes | Same |
| Overall
dimensions | For 110.295: 195 L x 90 W x 44 H, mm
For 110.294: 195L x 90 W x 54 H, mm
For 110.287: 264L x 163 W x 54 H, mm
For 110.296: 264 L x 163 W x 58 H, mm | 264 L x 163 W x 54 H, mm | Similar |
| Vent to Volume
Ratio | 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) | 0.0102 cm2 / cm3 (0.0259 in2 / in3) | Similar |
| Useful Life | Yes, reusable up to 100 cycles
Assembled/disassembled, cleaned,
sterilized
Visual inspection Component dimensional fit
verification
Functional closure (lid-base latch) verification | Yes, reusable up to 100 cycles
Assembled/disassembled, cleaned,
sterilized
Visual inspection
Component dimensional fit verification
Functional closure (lid-base latch) | Same |
| Biocompatibility | The assessment to Biocompatibility was
performed per ISO 10993-1 and testing 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 and testing
was performed using methods described
in AAMI/ANSI/ISO 10993-5. The results
indicate that the subject devices are
biocompatible. | Same |
| Sterilization
Method | Moist heat (steam) | Moist heat (steam) | Same |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
| | Neodent Instrument Kits
JJGC Indústria e Comércio de Materiais
Dentários S.A. | K171713
Neodent Instrument Kits
JJGC Indústria e Comércio de Materiais
Dentários S.A. | Comparison |
| Cycles | Gravity displacement | Gravity displacement | Same |
| | Fractionated vacuum (pre-vacuum) | Fractionated vacuum (pre-vacuum) | |
| Parameters | Gravity
Sterilization temperature: 132 °C
Sterilization time: 15 minutes;
Drying time: 20 minutes or 40
minutes (model number 110.296) | Gravity
Sterilization temperature: 132 °C
Sterilization time: 15 minutes;
Drying time: 20 minutes | Similar |
| | Pre-Vacuum
Sterilization temperature: 132 °C
Sterilization time: 4 minutes;
Drying time: 20 minutes. | Pre-Vacuum
Sterilization temperature: 132 °C
Sterilization time: 4 minutes;
Drying time: 20 minutes. | |
13
14
The subject devices and the primary predicate device K171713 have the same intended use, the same product classification and product code (KCT) and have same Indications for Use statements. The subject devices (and the primary predicate device per K171713) are reusable rigid containers used to organize and protect the dental surgical instruments that are sterilized by the healthcare provider. The subject device and the primary predicate device K171713 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 device and the primary predicate device K171713 include components manufactured from polyphenylsulfone, polysulfone and silicone. The subject device also contains a holder fabricated from titanium alloy; while this differs from the predicate it is noted that certain instruments to be contained within the predicate cleared in K171713 are made of the same alloy. The subject device is provided in multiple sizes and configurations, whereas the primary predicate device K171713 is provided in a single size and two configurations.
The reference device cleared in K14259 was used to support the device dimensions and vent to volume ratio. The reference device cleared inK180915 was used to support the sterilization drying time of 40 minutes.
15
NON-CLINICAL PERFORMANCE DATA
| Standard or Test Method | Purpose of the Testing | Results |
|---|---|---|
| Custom | Manual cleaning validation | Passed |
| ANSI/AAMI/ISO 17665-1 | ||
| ANSI/AAMI/ISO 17665-2 | Sterilization validation, including sterilant penetration and drying time | Passed |
| Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff | Life cycle (simulate usage) testing | Passed |
| ANSI/AAMI/ISO 10993-5 | ||
| (Cytotoxicity) | Cytotoxicity testing | Passed |
CONCLUSION
The conclusions drawn from the nonclinical data demonstrate that the device is as sffective, and performs as well as or better than the legally marketed device K171713.