(84 days)
Not Found
No
The device description and intended use clearly define the device as a physical container for sterilization, with no mention of software, algorithms, or data processing.
No
The device is described as an instrument kit case used for the sterilization and organization of other medical devices, not for therapeutic purposes.
No
This device is a reusable rigid container designed to hold other medical devices for sterilization, not to diagnose medical conditions.
No
The device is a physical container (kit case) made of plastic and silicone, intended for sterilizing other medical devices. It has no software components mentioned.
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 device is used to "enclose other medical devices that are to be sterilized by a health care provider" 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 tests on samples from the human body to diagnose conditions.
- Device Description: The description details a "reusable rigid container" for organizing and protecting instruments during sterilization. This aligns with the intended use and does not suggest any diagnostic function.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device's function is related to the sterilization of other medical instruments, which is a process within healthcare but not a diagnostic test itself.
N/A
Intended Use / 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.
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 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.
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)
Nonclinical performance data:
Study Type: Manual cleaning validation
Test Method: Custom
Acceptance Criteria:
Hemoglobin Test:
§ 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 & 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
2
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 SA
Av. Juscelino Kubitschek de Olivera, 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 | 16/Dec/2019 |
| Preparer / Alternate Contact | Luiza Vaccari Toppel
Regulatory Affairs Coordinator
JJGC Indústria e Comércio de Materiais Dentários SA
luiza.toppel@neodent.com |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name
Common Name | Neodent Instrument Kit Cases
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 | |
| Primary Predicate Device | K182865 - Neodent Instrument Kit Cases, JJGC Indústria
Comércio de Materiais Dentários SA |
5
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:
| Assembled
Kit Case | Description | Assembled Kit
Case 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 Compact
Surgical 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 | ||
|---|---|---|---|
| K192670 | |||
| Neodent Instrument Kit Cases | |||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K182865 | ||
| Neodent Instrument Kits | |||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | COMPARISON | ||
| Indications for | |||
| Use Statement | 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. | 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 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: | Similar | ||
| Neodent Instrument Kits are intended to be used to enclose other medical | |||
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | ||
| K192670 | |||
| Neodent Instrument Kit Cases | |||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K182865 | ||
| Neodent Instrument Kits | |||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | COMPARISON | ||
| 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 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. | |||
| 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. |
8
9
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | COMPARISON | |
|---|---|---|---|
| K192670 | |||
| Neodent Instrument Kit Cases | |||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K182865 | ||
| Neodent Instrument Kits | |||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | |||
| Intended Use | 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. | 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 | ||
| 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. | |||
| 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 |
| Overall | |||
| dimensions | 110.288: 264 L x 163 W x 54 H, mm | ||
| 110.297: 195 L x 90 W x 64 H, mm | 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 | Similar | ||
| Vent to Volume | |||
| Ratio | 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 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) verification | 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 |
| Cycles | Gravity displacement | ||
| Fractionated vacuum (pre-vacuum) | Gravity displacement | ||
| Fractionated vacuum (pre-vacuum) | Same | ||
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | COMPARISON | |
| K192670 | |||
| Neodent Instrument Kit Cases | |||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K182865 | ||
| Neodent Instrument Kits | |||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | |||
| Parameters | Gravity | ||
| Sterilization temperature: 132 °C | |||
| Sterilization time: 15 minutes; | |||
| Drying time: 40 minutes (model number 110.288) or 20 minutes (model | |||
| number 110.297) | Gravity | ||
| Sterilization temperature: 132 °C | |||
| Sterilization time: 15 minutes; | |||
| Drying time: 20 minutes or 40 minutes (model number 110.296) | 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. | |||
| Sterile Barrier | Sterilization wrap, FDA-cleared for indicated method and cycles | Sterilization pouch, FDA-cleared for indicated method and cycles | Same |
10
11
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: | |
| • |