(88 days)
Not Found
No
The device description and intended use focus on a reusable rigid container for organizing and sterilizing instruments. There is no mention of any computational or analytical functions, let alone AI/ML. The performance studies are related to cleaning, sterilization, and durability, not algorithmic performance.
No
Explanation: The device is intended for sterilizing and organizing other medical devices, not for treating any condition or disease.
No
The device is described as a reusable rigid container intended for organizing and protecting instruments to be sterilized, not for diagnosing any medical condition.
No
The device description clearly states it is a reusable rigid container made of autoclavable polymer with silicone grommets, indicating it is a physical hardware device.
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 Neodent Instruments Kits are used to "enclose other medical devices that are to be sterilized" and to "allow sterilization of the enclosed medical devices." This describes a device used in the process of preparing other medical devices for use, not a device used to perform a diagnostic test on a biological sample.
- Device Description: The device is described as "reusable rigid containers" used to "organize and protect instruments and accessories that are to be sterilized." This aligns with a sterilization container, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The focus is entirely on the sterilization process.
Therefore, the Neodent Instruments Kits are medical devices used for sterilization purposes, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
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.
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)
Manual cleaning validation: Test Soil: Blood Soil (BLSO), Cleaning Method: Manual, Residuals Tested: Hemoglobin and Protein. Results: No visible soil;
§ 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 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, 3291
Curitiba, Parana, Brazil 81270-200
Registration No.: 3008261720
Owner/Operator No.: 10031702 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jennifer M. Jackson, MS
Director of Regulatory Affairs,
Straumann USA
E-mail: jennifer.jackson@straumann.com
Telephone (978) 747-2509 |
| Date Prepared | 09/March/2021 |
| Preparer / Alternate Contact | Camila da Silva Esteves
Regulatory Affairs Supervisor
JJGC Indústria e Comércio de Materiais Dentários SA
E-mail: camila.esteves@neodent.com |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name | Neodent EasyGuide Kit Cases |
| Common Name | Instrument Sterilization Trays |
| Classification Name | Sterilization Wrap Containers, Trays, Cassettes & Other |
| Classification Regulations | 21 CFR 880.6850, Class II |
| Product Code | KCT |
| Classification Panel | General Hospital |
| Reviewing Branch | Infection Control Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K192670 – Neodent Instrument Kit Cases, JJGC Indústria e Comércio de |
Materiais Dentários S.A
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:
| Assembled
Kit Case | Description | Assembled
Kit Case
Dimension
(L x W x H) | Component Number | Component Dimension
(L x W x H) |
|-----------------------|-------------------------------------------------------------------|---------------------------------------------------|------------------|------------------------------------|
| 110.313 | GM EasyGuide Surgical Kit
Case Narrow/Regular Diam
Implants | 195 x 90 x
64 mm | 212.293 (Lid) | 195 x 90 x 36 mm |
| | | | 703861 (Tray) | 180 x 76 x 27 mm |
| | | | 703863 (Base) | 188 x 84 x 42 mm |
| 110.314 | GM EasyGuide Surgical Kit
Case Regular/Large Diam
Implants | 195 x 90 x
64 mm | 212.293 (Lid) | 195 x 90 x 36 mm |
| | | | 703862 (Tray) | 180 x 76 x 27 mm |
| | | | 703863 (Base) | 188 x 84 x 42 mm |
Note: The instrument and accessory devices that are sterilized and stored within the subject Kit Cases are not themselves subject devices of this submission.
7
TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | ||
|---|---|---|---|
| K203618 | |||
| Neodent EasyGuide Kit Cases | |||
| JJGC Indústria e Comércio de Materiais Dentários | |||
| S.A. | K192670 | ||
| Neodent Instrument Kit Cases | |||
| JJGC Indústria e Comércio de Materiais Dentários | |||
| S.A. | COMPARISON | ||
| Indications for | |||
| Use Statement | Indications for Use for GM EasyGuide Surgical Kit | ||
| Case Narrow/Regular Diam 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 | 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 | Similar | ||
| The indications for | |||
| use are equivalent. | |||
| The difference in | |||
| the text is specific | |||
| due to the weight of | |||
| each device in their | |||
| maximum load | |||
| configuration. | |||
| 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: | 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. | 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. | Gravity displacement – Exposure at 132 °C for | ||
| 15 minutes, 40-minute dry time. | |||
| Neodent Instrument Kits are intended for | |||
| sterilization of non-porous loads. | Neodent Instrument Kit Cases are intended for | ||
| sterilization of non-porous loads. | |||
| The combined weight of the 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. | 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 | |||
| Neodent GM EasyGuide Kit Cases should not be | |||
| stacked during sterilization | not to be stacked during sterilization. | ||
| Indications for Use for GM Helix Compact | |||
| Indications for Use for GM EasyGuide Surgical Kit | |||
| Case Regular/Large Diam Implants: | 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. | 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: | 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. | 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. | Gravity displacement - Exposure at 132 °C for | ||
| 15 minutes, 20-minute dry time. | |||
| Neodent Instrument Kits are intended for | |||
| sterilization of non-porous loads. | Neodent Instrument Kit Cases 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 EasyGuide Kit Cases should not be | |||
| stacked during sterilization. | 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 | PRIMARY PREDICATE DEVICE | ||
| K203618 | |||
| Neodent EasyGuide Kit Cases | |||
| JJGC Indústria e Comércio de Materiais Dentários | |||
| S.A. | K192670 | ||
| Neodent Instrument Kit Cases | |||
| JJGC Indústria e Comércio de Materiais Dentários | |||
| S.A. | COMPARISON | ||
| Intended Use | The GM EasyGuide Kit Cases are used for the | ||
| safe storage of surgical instruments, as well as | |||
| for support during sterilization. | The GM Helix Compact Surgical Kit Case is | ||
| suitable for safe storage of surgical and | |||
| prosthetic instruments, organizing the | |||
| instruments in the sequence in which they will | |||
| be used, as well as for sterilization of such | |||
| instruments. | Same | ||
| Both subject and | |||
| predicate devices | |||
| are intended to safe | |||
| storage surgical | |||
| instruments and | |||
| provide support | |||
| during sterilization. | |||
| Design | Rigid polysulfone polymer base and removable | ||
| inner tray with a polyphenylsulfone lid. | |||
| Retention grommets of medical grade silicone. | Rigid polysulfone polymer base and removable | ||
| inner tray with a polyphenylsulfone lid. | |||
| Retention grommets of medical grade silicone. | Identical | ||
| Both subject and | |||
| predicate devices | |||
| have the same | |||
| materials. | |||
| Perforated | Yes; allows moist heat (steam) penetration to | ||
| achieve sterilization | Yes; allows moist heat (steam) penetration to | ||
| achieve sterilization | Identical | ||
| Reusable | Yes | Yes | Identical |
| Overall | |||
| dimensions | 110.313: 195 L x 90 W x 64 H, mm | ||
| 110.314: 195 L x 90 W x 64 H, mm | 110.288: 264 L x 163 W x 54 H, mm | ||
| 110.297: 195 L x 90 W x 64 H, mm | Similar | ||
| Subject Kit Cases | |||
| have the same size | |||
| of the article | |||
| 110.297 of the | |||
| predicate device. | |||
| Both devices | |||
| cleared per | |||
| K192670 are equal | |||
| or bigger than the | |||
| subject devices, | |||
| this characteristic | |||
| suggests that the | |||
| predicate devices | |||
| can be considered | |||
| worst case | |||
| representative to | |||
| the subject | |||
| devices. This | |||
| statement is | |||
| better discussed | |||
| along this | |||
| submission. | |||
| Volume to Vent | |||
| Ratio | 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) | Similar | ||
| The predicate device | |||
| have volume to vent | |||
| ratio equal or bigger | |||
| than the subject | |||
| devices. | |||
| Useful Life | Yes, reusable up to 100 cycles | Yes, reusable up to 100 cycles | Identical |
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | COMPARISON | |
| K203618 | |||
| Neodent EasyGuide Kit Cases | |||
| JJGC Indústria e Comércio de Materiais Dentários | |||
| S.A. | K192670 | ||
| Neodent Instrument Kit Cases | |||
| JJGC Indústria e Comércio de Materiais Dentários | |||
| S.A. | |||
| 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. | Similar | ||
| Sterilization | |||
| Method | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6 | Identical |
| Cycles | Gravity displacement | ||
| Fractionated vacuum (pre-vacuum) | Gravity displacement | ||
| Fractionated vacuum (pre-vacuum) | Same | ||
| Parameters | Gravity | ||
| Sterilization temperature: 132 °C | |||
| Sterilization time: 15 minutes; | |||
| Drying time: 20 minutes (model number | |||
| 110.313) or 45 minutes (model number | |||
| 110.314) |
Pre-Vacuum
Sterilization temperature: 132 °C
Sterilization time: 4 minutes;
Drying time: 20 minutes. | Gravity
Sterilization temperature: 132 °C
Sterilization time: 15 minutes;
Drying time: 40 minutes (model number
110.288) or 20 minutes (model number
110.297)
Pre-Vacuum
Sterilization temperature: 132 °C
Sterilization time: 4 minutes;
Drying time: 20 minutes. | Same
The subject devices
have the same cycle
parameters,
however the subject
devices require a
longer drying cycle
when sterilized via
Gravity
Displacement. |
| Sterile Barrier | Sterilization wrap, FDA-cleared for indicated
method and cycles | Sterilization pouch, FDA-cleared for indicated
method 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 or
Test Method | Purpose of the
Testing | Acceptance Criteria | Results | | | | | | | | | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|
| AAMI
TIR30:2011
• The validation
follows the
standard, but
the cleaning
procedures are
according to
what is
recommended
by the
manufacturer. | Manual cleaning
validation
• Test Soil:
Blood Soil
(BLSO)
• Cleaning
Method:
Manual
• Residuals
Tested:
Hemoglobin
and Protein | • Visual
Inspection: No
Visible Soil
• Hemoglobin
Test: