Neodent Instrument 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 using one of the following cycles:

Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-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 Complement Case and the associated instruments is 75,7 g. The weight of the empty Kit Case is 53.62 grams.

Neodent Instrument Kit Cases should not be stacked during sterilization.

Indications for Use for Nuvo Complement Kit Cases:

Nuvo™ Instrument 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. Nuvo™ Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo™ 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 using one of the following cycles:

Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-minute dry time.

Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.

Nuvo™ Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Complement Case and the associated instruments is 75.7 g. The weight of the empty Kit Case is 52.72 grams.

Nuvo™ Instrument Kit Cases should not be stacked during sterilization.

Device Description

The subject devices Complement Kit Cases consist of a storage case for Neodent and Nuvo instruments set. They are made of autoclavable polymer, the case has silicone holders to store and hold each instrument securely during sanitization and surgical procedures. The case can be equipped according to the procedure.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Complement Kit Cases), focusing on the device's substantial equivalence to a predicate device. It details non-clinical performance data.

Here's the information extracted and organized according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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)	Manual cleaning validation	Visual Inspection: No Visible SoilHemoglobin Test: <2.2 µg/cm²Protein Test: <6.4 µg/cm²	Passed
ANSI/AAMI/ISO 17665-1ANSI/AAMI/ISO 17665-2	Sterilization validation, including sterilant penetration and drying time	All Biological Indicators must be incubated for at least 7 days at 55-60°C.All positive controls for SAL testing must show characteristic growth of the indicator organism.	Passed
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff	Life cycle (simulate usage) testing	The tested samples must withstand 100 cycles of use (cleaning, sterilization and functional tests) without compromising their functionalities	Passed
ANSI/AAMI/ISO 10993-5 (Cytotoxicity)	Cytotoxicity testing	Less than 30% cell proliferation inhibition	Passed

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document mentions "Six simulated use cycles" for manual cleaning validation and refers to "the tested worst case devices" for life cycle validation. It does not explicitly state the number of individual devices or test runs beyond these general descriptions for all tests.
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. These are non-clinical (laboratory) tests, not clinical studies involving patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This document describes non-clinical performance testing for a medical device (sterilization kit cases), not a diagnostic AI/ML device that requires expert-established ground truth from images or clinical data. Therefore, this section is not applicable. The "ground truth" here is based on validated laboratory methods and established material/sterilization standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. Performance is measured against physical and biological criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a non-clinical performance study for a physical medical device (sterilization kit cases), not an AI/ML clinical study. Therefore, no MRMC study was performed, and no effect size for human readers improving with AI assistance is provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an AI/ML device; it is a physical medical device. The performance evaluated is of the device itself (e.g., its ability to withstand sterilization cycles, its biocompatibility).

7. The Type of Ground Truth Used

The "ground truth" in these non-clinical performance tests is based on:

Established Standards: ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, AAMI TIR30:2011, ISO 10993-1, ISO 10993-5, and FDA Guidance documents.
Physical and Biological Parameters: Visual inspection for soil, quantifiable levels of hemoglobin and protein (for cleaning), sterility assurance level (SAL) of 1 x 10⁻⁶ (for sterilization), structural integrity after 100 cycles, and cell proliferation inhibition percentages (for biocompatibility).

These are objective, measurable criteria defined by regulatory and industry standards.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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: K230804

Trade/Device Name: Complement Kit Cases Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 5, 2023 Received: June 5, 2023

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 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

July 7, 2023

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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,

Eileen
Digitally signed by
Eileen Cadel -S
Date: 2023.07.07
Cadel -S 12:15:20-04'00'

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230804

Device Name Complement Kit Cases

Indications for Use (Describe)

Indications for Use for Neodent Complement Kit Cases:

Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-minute dry time.

Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.

Neodent Instrument Kit Cases should not be stacked during sterilization.

Indications for Use for Nuvo Complement Kit Cases:

Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-minute dry time.

Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.

Nuvo™ Instrument Kit Cases should not 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

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510(K) Summary

ADMINISTRATIVE INFORMATION

Sponsor	JJGC Indústria e Comércio de Materiais Dentários SA(dba Neodent)Av. Juscelino Kubitschek de Oliveira, 3291Curitiba, Parana, Brazil 81270-200Registration No.: 3008261720Owner/Operator No.: 10031702
Contact Person	Jennifer M. Jackson, MSDirector of Regulatory Affairs,Straumann USAE-mail: jennifer.jackson@straumann.comTelephone (978) 747-2509
Date Prepared	7 July 2023
Preparer / AlternateContact	Bárbara UzaeRegulatory Affairs AnalystJJGC Indústria e Comércio de Materiais Dentários SAE-mail: barbara.uzae@neodent.com

DEVICE NAME AND CLASSIFICATION

Product Code

Trade/ Proprietary Name	Complement 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	K182865 – Neodent Instrument Kit Cases, JJGC Indústria e

Comércio de Materiais Dentários S.A Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other 21 CFR 880.6850, Class II Classification Regulation

КСТ

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INDICATIONS FOR USE

Indications for Use for Neodent Complement Kit Cases:

Dynamic Air Removal (pre-vacuum)- Exposure at 132 °C for 4 minutes, 30-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 Complement Case and the associated instruments is 75.7 g. The weight of the empty Kit Case is 53.62 grams.

Neodent Instrument Kit Cases should not be stacked during sterilization.

Indications for Use for Nuvo Complement Kit Cases:

Dynamic Air Removal (pre-vacuum)- Exposure at 132 °C for 4 minutes, 30-minute dry time. Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.

Nuvo™ Instrument Kit Cases should not be stacked during sterilization.

SUBJECT DEVICE DESCRIPTION

The dimensions for each part of the model and the overall dimensions are presented in the table below:

AssembledKit Case	Description	Assembled KitCase Dimension(L x W x H)	ComponentNumber	ComponentDimension(L x W x H)
110.335	Complement Case(model 2)	81 x 67 x 60 mm	212.304 (Lid)	50 x 80 x 30 mm
			212.087 (Base)	59 x 81 x 35 mm
CD1099002	Complement Case(model 2)	81 x 67 x 60 mm	702989 (Lid)	58 x 80 x 30 mm
			212.087 (Base)	59 x 81 x 35 mm

Note: The instrument and accessory devices that are sterilized and stored within the subject Kit Cases are provided separately and they are not subject devices of this submission.

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TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
	Complement Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.	K182865Neodent Instrument Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.	COMPARISON
Indications forUse Statement	Indications for Use for Neodent Complement Kit Cases:Neodent Instrument Kit Cases are indicated for organization of surgical and/orprosthetic instruments during sterilization, storage and transport. The use ofthis product facilitates storage and organization of instruments during andafter surgical procedures. Neodent Instrument Kit Cases are intended to allowsterilization of the enclosed medical devices. Neodent Instrument Kit Casesrequire the use of FDA cleared wrap to maintain the sterility of the encloseddevices. The kits are to be enclosed in a sterilization wrap that is FDA-clearedfor the indicated cycles, and moist heat (steam) sterilized using one of thefollowing cycles:Dynamic Air Removal (pre-vacuum) - Exposure at 132 °C for 4 minutes, 30-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-porousloads. The combined weight of the Complement Case and the associatedinstruments is 75.7 g. The weight of the empty Kit Case is 53.62 grams.Neodent Instrument Kit Cases should not be stacked during sterilization.Indications for Use for Nuvo Complement Kit Cases:Nuvo™ Instrument Kit Cases are indicated for organization of surgical and/orprosthetic instruments during sterilization, storage and transport. The use ofthis product facilitates storage and organization of instruments during andafter surgical procedures. Nuvo™ Instrument Kit Cases are intended to allowsterilization of the enclosed medical devices. Nuvo™ Instrument Kit Casesrequire the use of FDA cleared wrap to maintain the sterility of the encloseddevices. The kits are to be enclosed in a sterilization wrap that is FDA-clearedfor the indicated cycles, and moist heat (steam) sterilized using one of thefollowing cycles:Dynamic Air Removal (pre-vacuum)- Exposure at 132 °C for 4 minutes, 30-minute dry time.Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.Nuvo™ Instrument Kit Cases are intended for sterilization of non-porous loads.The combined weight of the Complement Case and the associatedinstruments is 75.7 g. The weight of the empty Kit Case is 52.72 grams.Nuvo™ Instrument Kit Cases should not 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 thatare to be sterilized by a health care provider. Neodent Instrument Kits are intended toallow sterilization of the enclosed medical devices. Neodent Instrument Kits require theuse of FDA cleared wrap to maintain the sterility of the enclosed devices. The kits are tobe enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moistheat (steam) sterilized using one of the following cycles:Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20 minute dry timeGravity displacement - Exposure at 132 °C for 15 minutes, 20 minute dry timeNeodent Instrument Kits are intended for sterilization of non-porous loads. The combinedweight of the GM/WS Surgical Kit Case and the associated instruments is 674.5 g. Theweight of the empty Kit Case is 507 grams. Neodent Instrument Kits are recommended notto 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 thatare to be sterilized by a health care provider. Neodent Instrument Kits are intended toallow sterilization of the enclosed medical devices. Neodent Instrument Kits require theuse of FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are tobe enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moistheat (steam) sterilized using one of the following cycles:Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-minute dry timeGravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.Neodent Instrument Kits are intended for sterilization of non-porous loads.The GM Prosthetic Kit Case maximum load weight is 50 grams. Neodent Instrument Kitsare recommended not to be stacked during sterilization.Indications for Use for GM Try-In Kit Case:Neodent Instrument Kits are intended to be used to enclose other medical devices thatare to be sterilized by a health care provider Neodent Instrument Kits require the use ofFDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to beenclosed in a sterilizable wrap that is FDA-cleared for the indicated cycles, and moist heat(steam)sterilized using one of the following cycles:Fractionated vacuum (pre-vacuum) – Exposure at 132 °C for 4 minutes, 20-minute drytime. 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 combinedweight of the GM Try-In Kit Case and the associated instruments is 212.6 g. The weight ofthe empty Kit Case is 195 grams. Neodent Instrument Kits are recommended not to bestacked during sterilization.	EquivalentAlthough the language isslightly different, theindications for use areequivalent. Both subject andpredicate devices areintended to alloworganization and sterilizationof the enclosed medicaldevices. The difference in thetext is specific due to theweight of each device in theirmaximum load configuration.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
	Complement Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.	K182865Neodent Instrument Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.	COMPARISON
Indications forUse Statement		Indications for Use for GM Guided Surgery Kit Case:Neodent Instrument Kits are intended to be used to enclose other medical devices thatare to be sterilized by a health care provider. Neodent Instrument Kits are intended toallow sterilization of the enclosed medical devices.Neodent Instrument Kits require the use of FDA-cleared wrap to maintain the sterility ofthe enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-clearedfor 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 timeGravity displacement - Exposure at 132 °C for 15 minutes, 40-minute dry time. NeodentInstrument Kits are intended for sterilization of non-porous loads. The combined weightof the GM Guided Surgery Surgical Kit Case and the associated instruments is 728.4 g. Theweight of the empty Kit Case is 567 grams. Neodent Instrument Kits are recommended notto be stacked during sterilization.	EquivalentAlthough the language isslightly different , theindications for use areequivalent. Both subject andpredicate devices areintended to alloworganization and sterilizationof the enclosed medicaldevices. The difference in thetext is specific due to theweight of each device in theirmaximum load configuration.
Intended Use	This product is intended to hold and store surgical and/or prostheticinstruments during their use and sterilization. Use of this product streamlinesthe storage and organization od instruments during and after the dentalprocedure.	Neodent Instrument Kits are intended to be used to enclose other medical devices thatare to be sterilized by a health care provider. Neodent Instrument Kits are intended toallow sterilization of the enclosed medical devices. Neodent Instrument Kits require theuse of FDA cleared wrap to maintain the sterility of the enclosed devices.	EquivalentSubject and predicatedevice are intended to safestorage surgical instrumentsand provide support duringsterilization.
DeviceClassification	Class II	Class II	Identical
ClassificationName	Sterilization Wrap Containers, Trays, Cassettes & Other	Sterilization Wrap Containers, Trays, Cassettes & Other	Identical
Product Code	NHA	NHA	Identical
Design	Rigid polysulfone polymer base and removable inner tray with apolyphenylsulfone 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.	EquivalentSubject and primarypredicate devices have thesame 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
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
	Complement Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.	K182865Neodent Instrument Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.	COMPARISON
Overalldimensions	110.335: 81 L x 67 W x 60 H, mmCD1099002: 81 L x 67 W x 60 H, mm	For 110.295: 195 L x 90 W x 44 H, mmFor 110.294: 195 L x 90 W x 54 H, mmFor 110.287: 264 L x 163 W x 54 H, mmFor 110.296: 264 L x 163 W x 58 H, mm	EquivalentSubject Kit Cases haveoverall dimensions withinthe overall dimensions ofthe predicate devices, notrepresenting a critical case.The difference betweenthem does not compromisesafety and efficacy as isbetter discussed along thissubmission.
Volume to VentRatio	110.335: 27.4 cm³/cm² (10.78 in³/in²)CD1099002: 27.4 cm³/cm² (10.78 in³/in²)	110.296: 107.5 cm³ / cm² (42.32 in³/in²)110.287: 98.04 cm³ / cm² (38.60 in³/in²)110.294: 52.3 cm³ / cm² (20.59 in³/ in²)110.295: 40.5 cm³ / cm² (15.94 in³/ in²)	EquivalentThe primary predicatedevices have volume to ventratio bigger than the subjectdevices. Thus, the subjectdevices do not representcriticality for sterilizationprocedure and thedifference between themand predicate devices doesnot compromise safety andefficacy, as is proved by thepresented sterilizationvalidation.
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 andtesting 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 wasperformed using methods described in AAMI/ANSI/ISO 10993-5. The results indicate thatthe subject devices are biocompatible.	Identical
SterilizationMethod	Moist heat (steam) to a SAL of 10⁻⁶	Moist heat (steam) to a SAL of 10⁻⁶	Identical
Cycles	Gravity displacementDynamic Air Removal (pre-vacuum)	Gravity displacementGravity displacement (pre-vacuum)	Identical
SUBJECT DEVICE		PRIMARY PREDICATE DEVICE		COMPARISON
Complement Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.		K182865Neodent Instrument Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.
	Parameters		Gravity	Equivalent
			Sterilization temperature: 132 °C	The subject devices have the
			Sterilization time: 15 minutes;	same cycle parameters already
			Drying time: 20 minutes.	cleared for the predicatedevices.

			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

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The subject devices and the primary predicate devices cleared per K182865 have similar intended use and equivalent Indications for Use Statements. Both are reusable rigid containers used to organize and protect dental surgical instruments that are sterilized by the healthcare provider. The subject device and 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 primary predicate device 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 equivalent to the range of overall dimensions cleared for the predicate devices. The subject device and the primary predicate device 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).

NON-CLINICAL PERFORMANCE DATA

To evaluate the performance of the subject kit cases, the tests described in the following table were performed.

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: <2.2 µg/cm2 Protein Test: <6.4 µg/cm2	Passed
ANSI/AAMI/ISO 17665-1ANSI/AAMI/ISO 17665-2	Sterilization validation, including sterilant penetration and drying time	All Biological Indicators must be incubated for at least 7 days at 55-60°C. All positive controls for SAL testing must show characteristic growth of the indicator organism.	Passed
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff	Life cycle (simulate usage) testing	The tested samples must withstand 100 cycles of use (cleaning, sterilization and functional tests) without compromising their functionalities	Passed
ANSI/AAMI/ISO 10993-5 (Cytotoxicity)	Cytotoxicity testing	Less than 30% cell proliferation inhibition	Passed

Manual cleaning and sterilization validation

Manual cleaning of the subject kit cases following the manufacturer's recommended cleaning procedures has been validated according to AAMI TIR30:2011. Six simulated use cycles consisting of contamination, cleaning and sterilization were performed. All test method acceptance criteria were met for visual inspection and residuals levels.

Sterilization of the subject kit cases via steam process in autoclave has been validated according to ISO 17665 – 1 "Sterilization of Health Care Products – Moist Heat – Part 1: Requirements for the Development, Validation and Routine of a Sterilization Process for Medical Devices using the "Overkill" method to demonstrate the achievement of a sterility assurance level (SAL) of 10%". A minimum Sterility Assurance Level (SAL) of 1 x 10-6 has been validated.

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Life cycle validation

Life cycle testing of the subject kit cases was performed to validate the recommendations provided by the manufacturer in the Instructions for Use. The reference method consists of cleaning and sterilization cycles (simulated usage) interspersed with visual and functional analyzes. The tested worst case devices passed the visual and functional inspections, validating the recommendations provided in the draft Instructions for Use.

Biocompatibility

A biological assessment was performed according to ISO 10993-1:2018 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993- 1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff". No new issues of biocompatibility are raised for the subject devices and no additional biocompatibility testing was required.

CONCLUSION

The subject devices and the primary predicate device have equivalent instructions for use, intended use, design, technological characteristics and overall dimensions. They also present same materials, sterilization method and sterile barrier. Based on that, it is possible to assess that the new devices do not constitute a new critical case, do not raise the risks and present performance equivalent to the presented predicate. The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate device K182865.

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).