Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are focused on physical organization and sterilization of surgical instruments, with no mention of AI or ML capabilities.

Therapeutic

No
The device is a kit case intended for organizing and sterilizing surgical instruments, not for directly treating a disease or condition.

Diagnostic

No

Explanation: The device is described as a reusable rigid container for organizing, protecting, and sterilizing surgical and/or prosthetic instruments. Its intended use is for sterilization, storage, and transport of instruments, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical container made of autoclavable polymer and silicone, designed for organizing and sterilizing surgical instruments. It is a hardware device, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is clearly stated as "organization of surgical and/or prosthetic instruments during sterilization, storage and transport" and to "allow sterilization of the enclosed medical devices." This describes a device used for handling and sterilizing medical instruments, not for performing diagnostic tests on biological samples.
Device Description: The device is described as a "reusable rigid container" made of "autoclavable polymer" with features for organizing and protecting instruments. This aligns with a sterilization and organization system for surgical tools.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or screening. There is no mention of reagents, calibrators, controls, or any other components typically associated with IVD devices.

Therefore, the device described is a medical device used for the sterilization and organization of surgical instruments, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Helix NGM Compact Surgical Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures.

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 Surgical Kit Case and the associated instruments is 268.0 g. The weight of the empty Kit Case is 208.15 grams. Neodent Instrument 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 include grommets manufactured from medical grade silicone that retain the instruments within the tray. They also presents markings that guide instrument use during procedures. The subject device kit cases are provided nonsterile to the end-user.

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) |
|---|---|---|---|---|
| 110.315 | Helix NGM Compact
Surgical Kit Case | 195 x 90 x
54 mm | 212.293 (Lid) | 195 x 90 x 36 mm |
| | | | 704346 (Tray) | 180 x 76 x 16.5 mm |
| | | | 704345 (Base) | 188 x 84 x 32 mm |
| 110.316 | Pre-Mounted Helix NGM
Compact Surgical Kit Case | 195 x 90 x
54 mm | 212.293 (Lid) | 195 x 90 x 36 mm |
| | | | 704346 (Tray) | 180 x 76 x 16.5 mm |
| | | | 704345 (Base) | 188 x 84 x 32 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.

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)

Nonclinical performance data includes:

Manual cleaning validation with Test Soil: Blood Soil (BLSO), Cleaning Method: Manual, and Residuals Tested: Hemoglobin and Protein. Results: Passed based on Visual Inspection: No Visible Soil, Hemoglobin Test:

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

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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

April 13, 2022

JJGC Indústria e Comércio de Materiais Dentários S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K214051

Trade/Device Name: Neodent Implant System-Helix NGM Compact Surgical Kit Cases Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: March 18, 2022 Received: March 23, 2022

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, PhD Assistant Director 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

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Indications for Use

510(k) Number (if known) K214051

Device Name

Neodent Implant System - Helix NGM Compact Surgical Kit Cases

Indications for Use (Describe)

Helix NGM Compact Surgical Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures.

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 Surgical Kit Case and the associated instruments is 268.0 g. The weight of the empty Kit Case is 208.15 grams. Neodent Instrument 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)

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3

510(K) Summary

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 | 5/Apr/2022 |
| Preparer / Alternate Contact | Mariana Hartmann
Regulatory Affairs Analyst
JJGC Indústria e Comércio de Materiais Dentários SA
E-mail: mariana.hartmann@neodent.com |

DEVICE NAME AND CLASSIFICATION

Trade/ Proprietary Name	Neodent Implant System – Helix NGM Compact Surgical 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

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INDICATIONS FOR USE

Indications for Use for Helix NGM Compact Surgical Kit Case and Pre-Mounted Helix NGM Compact Surgical Kit Case:

Helix NGM Compact Surgical Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures.

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 Surgical Kit Case and the associated instruments is 268.0 g. The weight of the empty Kit Case is 208.15 grams. Neodent Instrument 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 include grommets manufactured from medical grade silicone that retain the instruments within the tray. They also presents markings that guide instrument use during procedures. The subject device kit cases are provided nonsterile to the end-user.

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) |
|-----------------------|----------------------------------------------------|---------------------------------------------------|---------------------|------------------------------------|
| 110.315 | Helix NGM Compact
Surgical Kit Case | 195 x 90 x
54 mm | 212.293 (Lid) | 195 x 90 x 36 mm |
| | | | 704346 (Tray) | 180 x 76 x 16.5 mm |
| | | | 704345 (Base) | 188 x 84 x 32 mm |
| 110.316 | Pre-Mounted Helix NGM
Compact Surgical Kit Case | 195 x 90 x
54 mm | 212.293 (Lid) | 195 x 90 x 36 mm |
| | | | 704346 (Tray) | 180 x 76 x 16.5 mm |
| | | | 704345 (Base) | 188 x 84 x 32 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.

5

TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
	Helix NGM Compact Surgical 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 Helix NGM Compact
Surgical Kit Case
Helix NGM Compact Surgical Kit Cases are
indicated for organization of surgical and/or
prosthetic instruments during sterilization,
storage and transport. The use of this
product facilitates storage and organization
of instruments during and after surgical
procedures.
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 Surgical Kit
Case and the associated instruments is 268.0
g. The weight of the empty Kit Case is 208.15
grams. Neodent Instrument Kit Cases should
not be stacked during sterilization.
Indications for Use for Pre-Mounted Helix
NGM Compact Surgical Kit Case
Product indicated for conditioning and safe
fastening surgical and/or prosthetic
instruments during their use and
sterilization. The use of this product
facilitates storage and organization of
instruments during and after surgical
procedures.
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 Surgical Kit
Case and the associated instruments is 268.0
g. The weight of the empty Kit Case is 208.15
grams. Neodent Instrument Kit Cases should	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.	Similar
	not be stacked during sterilization.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
	Helix NGM Compact Surgical 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 Helix Narrow GM Compact Surgical
Kit Cases 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.	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
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
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	110.315: 195 L x 90 W x 54 H, mm
110.316: 195 L x 90 W x 54 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
Volume to Vent
Ratio	110.315: 52.3 cm³/cm² (20.59 in³/in²)
110.316: 52.3 cm³/cm² (20.59 in³/in²)	110.288: 98.04 cm³/cm² (38.6 in³/in²)
110.297: 63.5 cm³/cm² (25.0 in³/in²)	Similar
Useful Life	Yes, reusable up to 100 cycles	Yes, reusable up to 100 cycles	Identical
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) 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	Gravity
Sterilization temperature: 132 °C
Sterilization time: 15 minutes;
Drying time: 40 minutes (model number
110.288) or 20 minutes (model number
110.297)	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	Identical

6

The subject devices and the primary predicate device per K192670 have same intended use and similar 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

7

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.

Standard or Test Method	Purpose of the Testing	Acceptance Criteria	Results
Custom	Manual cleaning validation Test Soil: Blood Soil (BLSO) Cleaning Method: Manual Residuals Tested: Hemoglobin and Protein	Visual Inspection: No Visible Soil Hemoglobin Test: