Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a rigid container for sterilizing medical instruments and the description focuses on materials, sterilization methods, and performance testing related to these functions. There is no mention of AI or ML.

Therapeutic

No

The device is a rigid container intended to enclose other medical devices for sterilization and maintain their sterility, not to treat or diagnose a disease or condition directly.

Diagnostic

No
The device is described as reusable rigid containers intended to enclose other medical devices for sterilization. Its purpose is to allow sterilization of enclosed medical devices, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical instrument kit case made of injection molded resins and silicone, intended for sterilizing other medical devices. It is clearly a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as being 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.
Device Description: The description details a "reusable rigid container" made of specific materials, designed to organize and protect 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 treatment decisions based on sample analysis
- Reagents, calibrators, or controls

The device is a sterilization container, which is a type of medical device used in the healthcare setting for infection control, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Indications for Use for GM Zygomatic 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

Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.

The GM Zygomatic Surgical Kit Case maximum load weight is 220 grams.

Neodent Instrument Kit Cases should not to be stacked during sterilization.

Indications for Use for GM Helix LG 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 LG Compact Kit Case and the instruments is 297.3 g. The weight of the empty kit case is 236 g.

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

healthcare 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)

Non-Clinical Performance Data:

Manual cleaning instructions were validated using microbiological, protein, and hemoglobin assays.
Sterilization validation, including sterilant penetration and drying time, was performed according to ANSI/AAMI/ISO 17665-1 and 17665-2.
Life cycle (simulated usage) testing was performed, which included visual inspection, component dimensional fit verification, and functional closure (lid- bottom latch) verification.
Biocompatibility testing was performed using methods described in ANSI/AAMI/ISO 10993-5 (cytotoxicity).
No clinical data were included in this submission.

Results:
Manual cleaning validation: Passed
Sterilization validation: SAL of 10⁻⁶, Passed
Life cycle (simulate usage) testing: Visual and functional inspection following 100 cycles, Passed
Cytotoxicity testing:

Regulation Number and Section

§ 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).

Summary

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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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below it. The logo is simple and professional, and it is easily recognizable.

December 23, 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: K190665

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: October 11, 2019 Received: October 15, 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.

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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 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.

Sreekanth Gutala, Ph.D. Acting Assistant Director for the Sterility Devices Team DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K190665

Device Name Neodent Instrument Kit Cases

Indications for Use (Describe)

Indications for Use for GM Zygomatic 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

Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.

The GM Zygomatic Surgical Kit Case maximum load weight is 220 grams.

Neodent Instrument Kit Cases should not to be stacked during sterilization.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Indications for Use

510(k) Number (if known)

K190665 Device Name

Neodent Instrument Kit Cases