KLOCKNER SURGICAL BOX

K173642 · SOADCO, S.L. · KCT · Oct 2, 2018 · General Hospital

Device Facts

• Record ID: K173642
• Device Name: KLOCKNER SURGICAL BOX
• Applicant: SOADCO, S.L.
• Product Code: KCT · General Hospital
• Decision Date: Oct 2, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Klockner Surgical Box is a set of sterilization cassettes (thirteen different models between injection molding and machining sterilization cassettes). They all are designed to hold various dental surgical drills, instruments and/or tools in order to orqanize, steam sterilize and transport the instruments between uses. Their use and handling are intended for physicians and dental professionals in health care or equivalent facilities. The sterilization cassettes have to be enclosed in an FDAcleared steam sterilizable wrap and sterilized in an FDA-cleared sterilizer according to the following cycle: - o Pre-vacuum Steam at 134℃ for 4 minutes with 15 minutes drying time. The trays are intended for sterilization of metal and thermoplastic loads.

Device Story

Klockner Surgical Box consists of reusable rigid sterilization cassettes/trays designed to hold dental surgical drills, instruments, and tools. The device is used by physicians and dental professionals in healthcare facilities to organize, steam sterilize, and transport instruments. The cassettes are placed inside an FDA-cleared steam sterilizable wrap and processed in an FDA-cleared sterilizer using a pre-vacuum steam cycle (134°C for 4 minutes, 15 minutes drying). The system protects instruments during sterilization and transport. The device is available in injection-molded and machined configurations, utilizing PPSU polymers, medical-grade silicone, and stainless steel. The output is a sterilized, organized set of instruments ready for clinical use. The device benefits patients by ensuring instruments are properly sterilized and maintained in a sterile state until use.

Clinical Evidence

No clinical data. Bench testing only. Validation included cleaning validation (AAMI TIR30:2011, ISO 11737-1), steam sterilization validation (ISO 17665-1, half-cycle method), and reuse limit testing (101 cycles). Worst-case loads were confirmed to be clean, sterile, and dry after the specified sterilization cycle.

Technological Characteristics

Reusable rigid sterilization cassettes. Injection-molded models: Radel R-5100/R-5800 PPSU, medical-grade silicone, 304 stainless steel latches. Machined models: Radel R PPSU, PROPYLUX HS2 heat-stabilized plastic, TECASON P VF PPSU. Dimensions vary by model. Connectivity: None. Energy source: None (passive). Sterilization: Pre-vacuum steam (134°C).

Indications for Use

Indicated for physicians and dental professionals in health care or equivalent facilities to hold, organize, steam sterilize, and transport dental surgical drills, instruments, and tools. Intended for use with metal and thermoplastic loads.

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)

Reference Devices

• PolyVac Surgical Instruments Delivery System (K012105)
• Steri-Cassette and Steri-Cage Sterilization Packaging Systems (K162063)
• THS sterilization Tray (K120947)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue.

October 2, 2018

Soadco, S.L. Maria Mitjaneta Quality Manager Avgda. Fiter I Rossell, 4 Bis- Local 2 Escaldes-Engordany, AD700 Ad

Re: K173642

Trade/Device Name: Klockner Surgical Box Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: July 30, 2018 Received: September 5, 2018

# Dear Maria Mitjaneta:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Clarence W. Murray lii III -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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Image /page/2/Picture/0 description: The image shows the logo for SOAD for KLOCKNER. The logo is in black and white, with the letters "SOAD" in a bold, sans-serif font. The "O" in SOAD is replaced by a globe. Below the logo, the words "for KLOCKNER" are written in a smaller font. The logo is simple and modern, and it is likely used to represent a company or organization.

# INDICATIONS FOR USE

K173642 510(k) Number (if known):

Device Name: Klockner Surgical Box

#### Indications for Use:

Klockner Surgical Box is a set of sterilization cassettes (thirteen different models between injection molding and machining sterilization cassettes). They all are designed to hold various dental surgical drills, instruments and/or tools in order to orqanize, steam sterilize and transport the instruments between uses. Their use and handling are intended for physicians and dental professionals in health care or equivalent facilities. The sterilization cassettes have to be enclosed in an FDAcleared steam sterilizable wrap and sterilized in an FDA-cleared sterilizer according to the following cycle:

- o Pre-vacuum Steam at 134℃ for 4 minutes with 15 minutes drying time.
The trays are intended for sterilization of metal and thermoplastic loads.

Klockner Surgical Box includes the following variations of each type of cassette:

| Type of<br>cassette | Reference (Ref.) | Device Model Name | Maximum number of<br>instruments / Weight<br>of each container* |
|----------------------|------------------|--------------------------------|-----------------------------------------------------------------|
| Injection<br>molding | KIT KLOCKNER | Surgical Box Kit Klockner | 80 / 1200 gr. |
| | KIT INTERNA | Surgical Box Kit Internal® | 60 / 1160 gr. |
| | KIT VEGA | Surgical Box Kit Vega | 53 / 1160 gr. |
| | KIT ESSENTIAL | Surgical Box Kit Essential® | 38 / 1120 gr. |
| | KIT EXTERNA | Surgical Box Kit External® | 35/ 1120 gr. |
| | KIT 20 06 00 ESS | Essential® Guide System Kit | 62 / 1180 gr. |
| Machined | KIT 10 00 02 | Drill Stop Box Kit | 35 / 180 gr. |
| | KIT 10 00 03 | Expansion Box Kit | 8 / 200 gr. |
| | KIT 10 00 04 | Regeneration Box Kit | 26 / 180 gr. |
| | KIT 10 00 05 | Bone Space Maintainers Box Kit | 7 / 180 gr. |
| | KIT 10 00 06 | Pterigomaxilar Box Kit | 14 / 216 gr. |
| | KIT 10 00 07 | MedLocate Box Kit | 31 / 181 gr. |
| | KIT 10 00 08 | Prosthetic Box Kit | 19 / 256 gr. |

*Weight of the final product of the Klockner Surgical Box. Full container with all the possible instruments included, wrapped in plastic and included in a corporate carton box which is also wrapped in plastic.

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Image /page/3/Picture/1 description: The image shows a logo with the text "SOADC" in bold, black letters. The letters are stylized and interconnected. The logo also includes a globe graphic, and the text "for KLOCKNER" is written in a smaller font below the globe. The entire logo is set against a gray background.

Prescription Use (Part 21 CFR 801 Subpart D) AND / OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# 510(k) SUMMARY

| Date of Preparation: | 9-28-2018 |
|----------------------|------------------------------------------------------------------------------------|
| Submitter name: | SOADCO, S.L. |
| Submitter address: | Avgda. Fiter i Rossell, 4bis - Local 2<br>ESCALDES - ENGORDANY<br>AD-700 (ANDORRA) |
| Contact person: | Maria Mitjaneta |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Device Trade Name: | KlocknerSurgical box |
| Common Name: | Instrument Sterilization Tray |
| Classification Name: | Sterilization Wrap |
| Regulation Number: | 21 CFR 880.6850 |
| Class: | Class II |
| Product code: | KCT |

Legally Marketed (Predicate) Device:

| Primary Predicate<br>device<br>510(k) Number | Device Trade Name | Manufacturer | |
|----------------------------------------------|------------------------------------|--------------------------------------------|--------------|
| K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron<br>Manufacturing LLC | |
| Reference<br>devices | 510(k)<br>Number | Device Trade Name | Manufacturer |

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| 1 | K012105 | PolyVac Surgical Instruments Delivery<br>System | Symmetry Medical Inc. |
|---|---------|------------------------------------------------------------------|-----------------------------------|
| 2 | K162063 | Steri-Cassette and Steri-Cage<br>Sterilization Packaging Systems | Sybron Dental Specialties<br>Inc. |
| 3 | K120947 | THS sterilization Tray | Hologic, Inc. |

#### Device Description:

Klockner Surgical Box is a reusable rigid sterilization cassette or organizing tray intended for the purpose of containing reusable (and in some cases, non-reusable) devices for sterliization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization.

Under the device trade name "Klockner Surgical Box", two different sets of sterliization surgical boxes are presented: (Both sets differ in the way the plastic is molded).

- Injection molding sterilization cassettes ●
- Machined sterilization cassettes ●

Injection molding Klockner Surgical Box: Dimensions: 11.3 in x 6.93 in x 2.2 in

Each box consists of three components, a boking lid and an internal individualized insert tray. The internal insert tray has the ability to hold individualized pieces and accessories which include dental tools, drills and ratchet. A single box design is available with a size of approximately 11.3 in x 6.93 in x 2.2 inches and it will be marketed in six different kits:

| Reference (Ref.) | Device Model Name | | |
|---------------------|---------------------------|--------------|-----------------|
| <b>KIT KLOCKNER</b> | Surgical Box Kit Klockner | - containing | 80 instruments* |

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| KIT INTERNA | Surgical Box Kit Internal® | - containing | 60 | instruments* |
|------------------|-----------------------------|--------------|----|--------------|
| KIT VEGA | Surgical Box Kit Vega | - containing | 53 | instruments* |
| KIT ESSENTIAL | Surgical Box Kit Essential® | - containing | 38 | instruments* |
| KIT EXTERNA | Surgical Box Kit External® | - containing | 35 | instruments* |
| KIT 20 06 00 ESS | Essential® Guide System Kit | - containing | 62 | instruments* |

*Maximum number of instruments each kit can contain

The id, base and insert tray are made of Radel® R PPSU (polyphenylsulfone), Radel® R-5800 (violet color) is used® R-5100 GY1037 (gray color) is used for the insert tray in two out of the six possible configurations of the surgical box, and Rade® R-5100 BK937 (black color) is used for the base of all configurations and for the surgical box variations. the instruments contained in the injection molding Klockner Surgical Box (dental tools, drills and ratchet), are placed in small circular brackets (grommets) located throughout the insert tray. Brackets and holders, are made of medical The lid is locked to the trays with 304 stainless steel latches and both the lid and the trays are silkscreened in white ink with the trade name to to facilitate the user's use.

The instruments to be sterilized in the injection cassettes are all non-porous devices and include dental surgical drills and tools.

#### Machined Klockner Surgical Box:

#### Dimensions: 4.72 in x 2.95 in x 1.79 in and 1.02 in

Each container consists of two parts, a base and a linsert tray in this type of surgical box. Depending on the dental tools and instruments comprised in each kit/variation, there are seven different box designs intended to be commercialized:

| Reference (Ref.) | Device Model Name | | | |
|------------------|-------------------------------------------------|--------------|----|----------------|
| KIT 10 00 02 | Drill Stop Box Kit | — containing | | 35 instruments |
| KIT 10 00 03 | Expansion Box Kit | - containing | oc | instruments |
| KIT 10 00 04 | Regeneration Box Kit | - containing | | 26 instruments |
| KIT 10 00 05 | Bone Space Maintainers Box Kit - containing | | 7 | instruments |

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| KIT 10 00 06 | Pterigomaxilar Box Kit | - containing | 14 | instruments |
|--------------|------------------------|--------------|----|-------------|
| KIT 10 00 07 | MedLocate Box Kit | - containing | 31 | instruments |
| KIT 10 00 08 | Prosthetic Box Kit | - containing | 19 | instruments |

These seven machined sterlization boxes are available in two sizes depending on the Plengomaxilar Box Kit and the Prosthetic Box Kit which are marketed in a size of 4.72 in the five remaining marketed kits measure 4.72 in x 2.95 in x 1.02 in.

The base is made of PROPYLUX® HS2 heat-stabilized plastic, and the lid is manufactured using TECASON® P VF polyphenylsulfone (PPSU) Smoke. Bases of all seven boxes are laser silkscreened with the trademark and useful information for the user. The system that enables to lock the lid to the box is based on the ability of the lid to slip through two guides that have a burr.

The instruments and dental tools to be sterilized in the machined sterilization cassettes are all non-porous devices.

All the cassettes of Klockner Surgical Box are reusable and the materials allow repeated sterliization wrap must be used for sterilization purposes to maintain the sterility contents.

# Intended Use / Indications for Use:

Klockner Surgical Box is a set of sterlization cassettes (thitteent models between injection molding and machining sterlization cassettes). They all are designed to hold surgical drills, instruments and/or tools in order to organize, steam sterilize and transport the instruments between uses. Their use and handling are intended for physicians in health care or equivalent facilities. The sterilization cassettes must be enclosed in an FDA- cleared sterlized wap and sterlized in an FDA-cleared sterilizer according to the following cycle:

Pre-vacuum Steam at 134ºC for 4 minutes drying time. The trays are intended for sterlization of metal and ● thermoplastic loads.

Klockner Surgical Box includes the following variations of each type of cassette:

| Type of<br>cassette | Reference (Ref.) | Device Model Name | Maximum number of<br>instruments / Weight<br>of each container* |
|----------------------|------------------|----------------------------|-----------------------------------------------------------------|
| Injection<br>molding | KIT KLOCKNER | Surgical Box Kit Klockner | 80 / 1200 gr. |
| Injection<br>molding | KIT INTERNA | Surgical Box Kit Internal® | 60 / 1160 gr. |
| Injection<br>molding | KIT VEGA | Surgical Box Kit Vega | 53 / 1160 gr. |

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| Type of<br>cassette | Reference (Ref.) | Device Model Name | Maximum number of<br>instruments / Weight<br>of each container* |
|---------------------|------------------|--------------------------------|-----------------------------------------------------------------|
| | KIT ESSENTIAL | Surgical Box Kit Essential® | 38 / 1120 gr. |
| | KIT EXTERNA | Surgical Box Kit External® | 35 / 1120 gr. |
| | KIT 20 06 00 ESS | Essential® Guide System Kit | 62 / 1180 gr. |
| Machined | KIT 10 00 02 | Drill Stop Box Kit | 35 / 180 gr. |
| | KIT 10 00 03 | Expansion Box Kit | 8 / 200 gr. |
| | KIT 10 00 04 | Regeneration Box Kit | 26 / 180 gr. |
| | KIT 10 00 05 | Bone Space Maintainers Box Kit | 7 / 180 gr. |
| | KIT 10 00 06 | Pterigomaxilar Box Kit | 14 / 216 gr. |
| | KIT 10 00 07 | MedLocate Box Kit | 31 / 181 gr. |

*Weight of the final product of the Klockner Surgical Box. Full container with all the possible instruments included, wrapped in plastic and included in a corporate carton box which is also wrapped in plastic.

# Summary of Technological Characterics:

Proposed device intended use, indications for use and technological characteristics have been compared with those of the predicates devices (see next pages).

| ELEMENT | NEW DEVICE | PRIMARY<br>PREDICATE | REFERENCE<br>DEVICE 1 | REFERENCE<br>DEVICE 2 | REFERENCE<br>DEVICE 3 | Comparison: |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Klockner Surgical Box | InterActive Complete<br>Surgical Tray | PolyVac Surgical<br>Instruments Delivery<br>System | Steri-Cassette and Steri-<br>Cage Sterilization<br>Packaging System | THS sterilization Tray | Subject device<br>vs. |
| Manufacturer | SOADCO,S.L. | Implant Direct Sybron<br>Manufacturing LLC | Poly Vac Inc./ Symmetry<br>Medical Inc. | Sybron Dental Specialties<br>Inc. | Hologic, Inc. | Predicate<br>device /<br>Reference<br>devices |
| 510 (K) | | K142519 | K012105 | K162063 | K120947 | |
| Indications for<br>Use: | Klockner Surgical Box<br>is a set of sterilization | The InterActive<br>Complete Surgical | PolyVac's delivery<br>systems consist of | The Steri-Cassettes<br>and Steri-Cages are | The THS<br>Sterilization Tray is | Similiar |
| | | | | | | |
| Intended use | cassettes (thirteen<br>different models<br>between injection<br>molding and machining<br>sterilization cassettes).<br>They all are designed to<br>hold various dental<br>surgical drills,<br>instruments and/or tools<br>to organize, steam<br>sterilize and transport<br>the instruments<br>between uses. Their<br>use and handling are<br>intended for physicians<br>and dental professionals<br>in health care or<br>equivalent facilities.<br>The sterilization<br>cassettes have to be<br>enclosed in an FDA-<br>cleared steam<br>sterilizable wrap and<br>sterilized in an FDA-<br>cleared sterilizer<br>according to the<br>following cycle:<br>Pre-vacuum Steam at<br>134°C for 4 minutes with<br>15 minutes drying time.<br>The trays are intended<br>for sterilization of metal<br>and thermoplastic loads.<br>• and<br>thermoplastic loads. | Tray is designed to<br>hold various dental<br>surgical drills and<br>tools in order to<br>organize, steam<br>sterilize, and transport<br>the instruments<br>between uses. The tray<br>is to be enclosed in an<br>FDA cleared steam<br>sterilizable wrap and<br>sterilized in an FDA<br>cleared sterilizer for<br>one of the following<br>cycles:<br>(1) Prevaccum Steam<br>– At 132 °C for 4<br>minutes with a 20<br>minutes dry time.<br>(2) Gravity Steam - At<br>132 °C for 15 minutes<br>with a 30 minutes dry<br>time. | perforated trays with<br>lids, which are intended<br>to enclose and protect<br>medical device<br>instrumentation, and to<br>facilitate the<br>sterilization process by<br>allowing steam<br>penetration and air<br>removal. When used in<br>conjunction with an<br>approved sterilization<br>wrap, sterility of the<br>enclosed medical device<br>is maintained until used.<br>PolyVac's delivery<br>systems are to be<br>sterilized in one of the<br>following cycles:<br>Prevacuum Steam :<br>132°C - 4 min<br>Gravity Steam: 132°C -<br>30 min<br>Gravity Steam: 121°C<br>- 55 minutes | intended to contain<br>dental intruments for<br>cleaning sterilization,<br>organization storage<br>and handling. The<br>Steri-Cassettes and<br>Steri-Cages are<br>suitable for prevacuum<br>and gravity<br>displacement steam<br>sterilization methods.<br>The cassettes and<br>cages are not intended<br>to maintain sterility;<br>they are intended to be<br>used in conjunction<br>with validated, FDA<br>cleared sterilization<br>wrap in order to<br>maintain sterility of<br>the enclosed devices. | used to enclose,<br>protect, and organize<br>the THS scopes,<br>diagnostic sheath,<br>and associated<br>accessory<br>components, and to<br>facilitate the<br>sterilization process<br>by allowing sterilant<br>penetration and air<br>removal when used<br>in conjunction with<br>an approved<br>sterilization wrap.<br>The THS Instrument<br>tray is not designed<br>to maintain sterility<br>by itself, but.when<br>used in conjunction<br>with an approved<br>sterilization wrap<br>sterility of the<br>enclosed medical<br>device is maintained<br>based on the specific<br>time that the<br>maintenance of<br>sterility for that<br>specific wrap as<br>cleared by the FDA. | |
| | Perforated instrument<br>cassette system to hold | Perforated<br>cassette system to hold | instrument Perforated trays with lids,<br>which are intended to | Perforated trays with lids, to hold | trays with<br>surgical lids, used to enclose, | Same |
| | dental instruments in place<br>during transport, steam<br>sterilization, and storage<br>when used in conjunction<br>with an approved<br>sterilization wrap. | dental instruments in<br>place during transport,<br>steam sterilization, and<br>storage. | enclose and protect medical<br>device instrumentation, and<br>to facilitate the sterilization<br>process by allowing steam<br>penetration and air removal.<br>When used in conjunction<br>with an approved<br>sterilization wrap, sterility<br>of the enclosed medical<br>device is maintained until<br>used. | instruments in<br>place during transport, steam<br>sterilization, and storage. | protect, and organize the<br>THS scopes, diagnostic<br>sheath, and associated<br>accessory components,<br>and to facilitate the<br>sterilization process by<br>allowing sterilant<br>penetration and air<br>removal when used in<br>conjunction with an<br>approved sterilization<br>wrap. | |
| Material<br>Composition | Injection molding surgical<br>box:<br>- Radel® R-5100 and<br>- Radel® R-5800 polymer<br>resin (PPSU<br>Polyphenylsulfone)<br>- Medical grade silicone<br>- 300 series stainless steel<br><br>Machined surgical box:<br>- Radel® R PPSU<br>polymer resin<br>- Polypropylene heat-<br>stabilized plastic | - Radel® R-5000 and<br>- Radel® R-5100<br>(polyphenylsulfone -<br>PPSU)<br>- Medical grade silicone | - Radel® R-5000 plastic<br>- Medical grade silicone<br>- Aluminum<br>- 300 series stainless steel | Cassettes - High Heat: High-<br>Resistant Plastic - Ultem<br>Resin 1000 (proprietary<br>mixture with pigments)<br>(thermoplastic).<br><br>Cassettes - Standard<br>Heat and cages:<br>polypropylene with color<br>(proprietary mixture with<br>pigments)<br>(thermoplastic). | - Radel® R-5000<br>plastic grade<br>- Medical grade<br>silicone<br>- 300 series stainless<br>steel | For injection<br>molding boxes<br>K142519 has<br>the same<br>material<br>composition.<br><br>For machined<br>boxes,<br>K162063 has<br>the same<br>material<br>composition. |
| Reusable | Yes | Yes | Yes | Yes | Yes | Same |
| Material<br>compatibility<br>with<br>sterilization<br>process | Yes | Yes | Yes | Yes | Yes | Same |

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Image /page/11/Picture/0 description: The image shows the logo for SOAD for KLOCKNER. The logo is in black and white, and the letters are large and bold. The letters are arranged in a slightly curved line, and the word "for KLOCKNER" is written in smaller letters below the letters SOAD. The logo is simple and easy to read.

#### Summary discussion of non-clinical data:

Validation test for steam sterilization, validation of manual cleaning and limit of reuse test for the Klockner Surgical Box (Surgical Box Kit Klockner and Bone Space Maintainers Box Kit are the containers that represent worst cases) have been carried out as the results are shown by test reports. All tests demonstrated compliance with both safety and effectiveness requirements that apply to the device, in terms of sterilization performance, maintenance of sterility and reusability.

In the following table, Table 5.1, a summary of the different performance test carried out and the corresponding standards and results are described.

| Performance Test | Standard(s) used | Results |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cleaning validation | AAMI TIR30:2011<br>ISO/DIS 19277 / AFNOR-NF S94-<br>091<br>ISO 11737-1:2006<br>ISO 9377-2:2000<br>European Pharmacopoeia<br>("Method D" from 2.6.14 chapter) | Cleaning instructions were<br>validated and demonstrated that<br>the subject device could be<br>visually and quantifiably cleaned |
| Steam sterilization<br>validation (Half cycle<br>validation: 2' at 134°C) | ISO 17665-1:2006<br>ISO 17665-2:2009<br>AAMI TIR12:2010<br>ISO 11737-2:2009 | No growth at half cycle |
| Limits of reuse<br>(Biocompatibility included) | FDA Guideline: Reprocessing<br>Medical Devices in Health Care<br>Settings: Validation Methods and<br>Labeling (2011)<br>AAMI TIR12:2010<br>AAMI TIR30:2011<br>ISO 10993 | the kits were challenged with<br>101 reprocessing cycles. Both<br>types of sterilization boxes<br>met inspection and<br>performance criteria after 101<br>reuses. |
| Drying Time | Validated in Drying Time Validation<br>Report (ISO 17665; AAMI TIR12) | Worst-case loads were<br>determined to be visually and<br>quantifiably dry after exposure<br>to the sterilization cycle and<br>claimed dry time. |

### Table 5.1 Brief description of non-clinical performance testing

Summary Discussion of Clinical Data:

Not applicable.

## Conclusions:

Based on the performed nonclinical tests, the device is as safe, as effective, and performs as well as the legally marketed predicate device, K142519.