The instrument kits are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility.

The cycle of sterilization is:

Pre-vacuum steam: 134 °C during 3 minutes with 16 minutes drying time

Anthogyr does not make any lumen claims for the instrument kits.

The Axiom range surgery kit represents the worst case validated load due to the number of components (34 instruments).

The cassettes are not intended to be stacked during sterilization process.

Device Description

Instrument kits are cassettes used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage. The cassettes by themselves do not maintain sterility. They are to be used with an FDA cleared steam sterilizable pouch.

The cassette is available in only one size (129x156x47.5 mm) marketed in different variations, including different number of tools.

The tools included in the kits are class I exempt or already have class II pre-market notification clearance.

The cassettes are reusable and made of the same materials as the predicate device (Radel R-5000 and R-5100 for tray and lid and medical grade silicone for circular brackets holding the tools).

AI/ML Overview

The provided document is a 510(k) premarket notification for "Instrument Kits" by Anthogyr. It details performance testing related to cleaning, sterilization, and material compatibility, but it does not describe a study involving acceptance criteria for device performance in terms of clinical or algorithmic outcomes. Instead, it focuses on the device's ability to be cleaned and sterilized effectively.

Here's an analysis of the information, tailored to the request but acknowledging the different nature of this medical device (sterilization kits vs. a performance-based device like AI):

1. Table of Acceptance Criteria and Reported Device Performance

The device is an instrument kit designed for sterilization of dental tools. The "performance" in this context relates to its ability to be effectively cleaned and sterilized, and its material safety. There are no clinical performance metrics like sensitivity, specificity, or accuracy for this type of device.

Acceptance Criteria Category	Specific Acceptance Criteria (Implied/Direct)	Reported Device Performance
Cleaning Validation	Demonstrated effectiveness of cleaning for both manual and automatic methods (as per AAMI TIR 30, AAMI TIR 12, ISO 17665).	Cleaning validations were conducted and support the effectiveness of both manual and automatic cleaning.
Sterilization Validation	Achieves sterility when used with an FDA cleared steam sterilizable pouch, under specified pre-vacuum steam cycle (134 °C for 3 min with 16 min drying time) (as per ISO 17665).	Sterilization validation was performed on the most complete instrument kit (worst-case scenario) and validated the sterilization cycle.
Drying Time	Adequate drying time within the sterilization cycle.	Validated in the steam sterilization report according to ISO 17665.
Toxicological Properties	No cytotoxicity observed (as per ISO 10993-5).	Cytotoxicity tests were conducted and demonstrate safety.
Material Compatibility	Materials are compatible with the sterilization process.	Radel technical data sheet indicates material compatibility.
Vent/Volume Ratio	Sterilant penetration is demonstrated despite the vent/volume ratio being lower than the predicate device.	Sterilant penetration testing demonstrates safety and efficacy.

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

This is not applicable in the traditional sense for this device. The "test sets" would be the actual instrument kits subjected to cleaning and sterilization validation.

Test Set Description: The "Axiom range surgery kit" was identified as the "worst case validated load" due to having the highest number of components (34 instruments). This indicates the most challenging configuration for sterilization was tested.
Sample Size: The document does not specify a numerical sample size (e.g., how many kits were tested, or how many cycles were performed). It states "Sterilization validation was performed [...] on the most complete instrument kit".
Data Provenance: The studies were conducted as part of the regulatory submission process, implying they are prospective studies performed by the manufacturer/authorized labs. The manufacturer's location is France (Sallanches, France).

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

This concept is not applicable here as the "ground truth" is based on objective scientific standards for cleaning, sterilization, and material safety, not expert interpretation of outputs. The standards themselves (e.g., ISO 17665, AAMI TIR 30) are established by experts in the field of medical device sterilization.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" is determined by established physical and biological testing standards and results, not by human adjudication of nuanced interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This is a physical medical device (instrument kit), not an AI algorithm or a diagnostic tool that involves human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The ground truth is based on:

Scientific Standards: Adherence to recognized national and international standards for cleaning (AAMI TIR 30, AAMI TIR 12), sterilization (ISO 17665), and biocompatibility (ISO 10993-5).
Biological Endpoints: Sterilization validation typically involves sterility testing (e.g., absence of microbial growth), while cleaning validation may involve residual soil detection.
Material Properties: Technical data sheets for the materials (Radel) providing evidence of their properties.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device requiring a "training set."

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

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 27, 2017

Anthogyr Therese Candau Regulatory Affairs Manager 2237 Avenue Andre Lasquin Sallanches. 74700 FR

Re: K160730

Trade/Device Name: Instrument Kits Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: March 20, 2017 Received: March 24, 2017

Dear Therese Candau:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160730

Device Name Instrument kits

Indications for Use (Describe)

The cycle of sterilization is:

Pre-vacuum steam: 134 °C during 3 minutes with 16 minutes drying time

Anthogyr does not make any lumen claims for the instrument kits.

The Axiom range surgery kit represents the worst case validated load due to the number of components (34 instruments).

The cassettes are not intended to be stacked during sterilization process.

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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510(k) SUMMARY K160730

SUBMITTER'S CONTACT INFORMATION 5.1

ANTHOGYR SAS

2237, avenue André Lasquin SALLANCHES, FRANCE 74700 Registration Number: 8020776 Phone number: (33) (0)4 50 58 02 37 Fax number: (33) (0)4 50 93 78 60 Contact person: Thérèse CANDAU (m.candau@anthogyr.com) Preparation date: 04/12/2017

DEVICE 5.2

Trade name: Instrument kits Classification name: STERILIZATION CASSETTE Class II Product Code: KCT CFR Section: 21CFR 880.6850 Device panel: GENERAL HOSPITAL

5.3 PREDICATE DEVICE

InterActive Complete Surgical Tray (K142519), manufactured by Implant Direct

DEVICE DESCRIPTION 5.4

The cassette is available in only one size (129x156x47.5 mm) marketed in different variations, including different number of tools.

The tools included in the kits are class I exempt or already have class II pre-market notification clearance.

The cassettes are reusable and made of the same materials as the predicate device (Radel R-5000 and R-5100 for tray and lid and medical grade silicone for circular brackets holding the tools).

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5.5 INTENDED USE

Pre-vacuum steam: 134 °C during 3 minutes with 16 minutes drying time Anthogyr does not make any lumen claims for the instrument kits.

The Axiom range surgery kit represents the worst case validated load due to the number of components (34 instruments).

The cassettes are not intended to be stacked during sterilization process.

	ANTHOGYR (K160730)Surgical kits	Implant Direct(K142519)InterActive CompleteSurgical Tray	Comparison
21CFR	880.6850		Same part section
Indicationsfor use	The instrument kits aredesigned to hold variousdental surgical drills andtools in order to organize,steam sterilize, and protectthe instruments that aresterilized by healthcareprovider. The cassette is tobe enclosed in an FDAcleared steam sterilizablepouch. The cassettes arenot intended on their ownto maintain sterility.	The InterActiveComplete Surgical Trayis designed to holdvarious dental surgicaldrills and tools in orderto organize, steamsterilize, and transportthe instruments betweenuses. The tray is to beenclosed in an FDAcleared steamsterilizable wrap andsterilized in an FDAcleared sterilizer.	Same indications foruse
Raw material	Radel R5000Radel R5100Medical grade siliconeStainless steel	Polymer resin Radel-5000Biomedical grade silicone	Some materials arecommon.Radel R5100 meetsUSP class VIrequirements andcompatibility testingdemonstrated safetyand efficacy
Design	Plastic tray with locking lid and silicone containmentsbrackets		Same design
Sterilizationmethod	Pre-vacuum steam		Same sterilizationmethod
Reusable	Yes		Both are reusabledevices

TECHNOLOGICAL CHARACTERISTICS 5.6

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Materialcompatibilitywithsterilizationprocess	Yes		Both devicesdemonstrate materialcompatibility withsterilization process
Microbialbarrierproperties	To be used in conjunction with an approvedsterilization pouch		Both are used with anapproved sterilizationpouch to maintainsterility
Vent/volumeratio	$0.049 \frac{in^2}{in^3}$	$0.184 \frac{in^2}{in^3}$	The vent to volumeratio is lower for thecandidate device, butsterilant penetrationtesting demonstratessafety and efficacy

5.7 PERFORMANCE TESTING

Performance characteristics of the device are supported by cleaning validation, sterilization validation and cytotoxicity tests.

No clinical tests were conducted.

Cleaning instructions for reusable devices

Cleaning validations were conducted as per AAMI TIR 30, AAMI TIR 12, ISO 17665 for both manual and automatic cleaning.

Sterilization validation

Sterilization validation was performed with a legally marketed pouch on the most complete instrument kit, taking into account worst case scenarios. Steam sterilization validations were conducted as per ISO 17665

Drying time

Validated in steam sterilization report according to ISO 17665

Toxicological properties

Cytotoxicity tests were conducted as per ISO 10993-5

Material compatibility

Radel technical data sheet

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5.8 CONCLUSION

ANTHOGYR INSTRUMENT KITS are substantially equivalent to their predicate devices in terms of intended use, material, design, mechanical properties and function.

All the kits have the same vent to volume ratio, so the most challenging container to achieve sterilization is the most loaded one.

Non clinical performance testing (sterilization and cleaning validation, cytotoxicity test) according to special control demonstrate that ANTHOGYR INSTRUMENT KITS are as safe, as effective, and perform as safely and effectively as their predicate device.

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).