Instrument kits

K160730 · Anthogyr · KCT · Apr 27, 2017 · General Hospital

Device Facts

• Record ID: K160730
• Device Name: Instrument kits
• Applicant: Anthogyr
• Product Code: KCT · General Hospital
• Decision Date: Apr 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

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 Story

Instrument kits are reusable cassettes designed to hold dental surgical drills and tools during steam sterilization and storage. Cassettes are constructed from Radel R-5000/R-5100 and medical-grade silicone. The device is used in clinical settings by healthcare providers. The cassette is loaded with instruments, placed inside an FDA-cleared steam sterilizable pouch, and subjected to a pre-vacuum steam sterilization cycle (134°C for 3 minutes, 16 minutes drying). The device organizes instruments and facilitates sterilization; it does not maintain sterility on its own. The Axiom range surgery kit (34 instruments) serves as the worst-case validated load. The output is a sterilized, organized set of dental instruments ready for surgical use. The device benefits patients by ensuring dental tools are properly sterilized and organized for procedures.

Clinical Evidence

No clinical data. Bench testing only. Validations included cleaning (AAMI TIR 30, AAMI TIR 12, ISO 17665), steam sterilization (ISO 17665) using worst-case loads, drying time verification, and cytotoxicity testing (ISO 10993-5).

Technological Characteristics

Materials: Radel R-5000, Radel R-5100, medical-grade silicone, stainless steel. Form factor: Single size (129x156x47.5 mm) tray with locking lid and silicone brackets. Sterilization: Pre-vacuum steam (134°C). Connectivity: None. Software: None.

Indications for Use

Indicated for use by healthcare providers to organize, steam sterilize, and protect dental surgical drills and tools. Not intended to maintain sterility independently; must be used with an FDA-cleared steam sterilizable pouch.

Regulatory Classification

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.

Predicate Devices

• InterActive Complete Surgical Tray (K142519)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 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.

| 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 ([e-mail]) 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

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).

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### 5.5 INTENDED USE

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.

| | ANTHOGYR (K160730)<br>Surgical kits | Implant Direct<br>(K142519)<br>InterActive Complete<br>Surgical Tray | Comparison |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 21CFR | 880.6850 | | Same part section |
| Indications<br>for use | The instrument kits are<br>designed to hold various<br>dental surgical drills and<br>tools in order to organize,<br>steam sterilize, and protect<br>the instruments that are<br>sterilized by healthcare<br>provider. The cassette is to<br>be enclosed in an FDA<br>cleared steam sterilizable<br>pouch. The cassettes are<br>not intended on their own<br>to maintain sterility. | The InterActive<br>Complete Surgical Tray<br>is designed to hold<br>various dental surgical<br>drills and tools in order<br>to organize, steam<br>sterilize, and transport<br>the instruments between<br>uses. The tray is to be<br>enclosed in an FDA<br>cleared steam<br>sterilizable wrap and<br>sterilized in an FDA<br>cleared sterilizer. | Same indications for<br>use |
| Raw material | Radel R5000<br>Radel R5100<br>Medical grade silicone<br>Stainless steel | Polymer resin Radel-<br>5000<br>Biomedical grade silicone | Some materials are<br>common.<br>Radel R5100 meets<br>USP class VI<br>requirements and<br>compatibility testing<br>demonstrated safety<br>and efficacy |
| Design | Plastic tray with locking lid and silicone containments<br>brackets | | Same design |
| Sterilization<br>method | Pre-vacuum steam | | Same sterilization<br>method |
| Reusable | Yes | | Both are reusable<br>devices |

#### TECHNOLOGICAL CHARACTERISTICS 5.6

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| Material<br>compatibility<br>with<br>sterilization<br>process | Yes | | Both devices<br>demonstrate material<br>compatibility with<br>sterilization process |
|---------------------------------------------------------------|-------------------------------------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Microbial<br>barrier<br>properties | To be used in conjunction with an approved<br>sterilization pouch | | Both are used with an<br>approved sterilization<br>pouch to maintain<br>sterility |
| Vent/volume<br>ratio | $0.049 \frac{in^2}{in^3}$ | $0.184 \frac{in^2}{in^3}$ | The vent to volume<br>ratio is lower for the<br>candidate device, but<br>sterilant penetration<br>testing demonstrates<br>safety 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.