(312 days)
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 organize, 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 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 ●
The provided text describes the Klockner Surgical Box, a set of sterilization cassettes, and its regulatory clearance (K173642). It focuses on non-clinical data to demonstrate substantial equivalence to predicate devices, rather than clinical data or AI algorithm performance.
Therefore, the requested information regarding AI algorithm performance metrics (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, effect size of human readers with AI assistance) is not applicable to this document. This document pertains to the physical and functional performance of a medical device (sterilization cassettes) and not an AI-powered diagnostic or assistive tool.
However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria, based on the provided non-clinical performance testing.
1. Table of acceptance criteria and the reported device performance:
The document describes performance tests in "Table 5.1 Brief description of non-clinical performance testing" on page 11. The "Results" column essentially serves as the reported device performance, and the context of the "Standard(s) used" implies the acceptance criteria defined by those standards.
| Acceptance Criteria (Implied by Standard/Test) | Reported Device Performance (Results) |
|---|---|
| Cleaning Validation | Cleaning instructions were validated and demonstrated that the subject device could be visually and quantifiably cleaned. |
| Standards: AAMI TIR30:2011, ISO/DIS 19277 / AFNOR-NF S94-091, ISO 11737-1:2006, ISO 9377-2:2000, European Pharmacopoeia ("Method D" from 2.6.14 chapter) | |
| Steam Sterilization Validation | No growth at half cycle (Half cycle validation: 2' at 134°C). |
| Standards: ISO 17665-1:2006, ISO 17665-2:2009, AAMI TIR12:2010, ISO 11737-2:2009 | |
| Limits of Reuse | The kits were challenged with 101 reprocessing cycles. Both types of sterilization boxes met inspection and performance criteria after 101 reuses. (Biocompatibility included). |
| Standards: FDA Guideline: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (2011), AAMI TIR12:2010, AAMI TIR30:2011, ISO 10993 | |
| Drying Time | Worst-case loads were determined to be visually and quantifiably dry after exposure to the sterilization cycle and claimed dry time. |
| Standards: Validated in Drying Time Validation Report (ISO 17665; AAMI TIR12) |
2. Sample sized used for the test set and the data provenance:
The document states that "Surgical Box Kit Klockner and Bone Space Maintainers Box Kit are the containers that represent worst cases" for the validation tests. This implies that these specific models were used as representatives for the entire Klockner Surgical Box line. The exact number of units of these "worst-case" models used for testing is not explicitly stated, but it refers to "the kits" for the limits of reuse test.
- Test Set Sample Size: Represented by "Surgical Box Kit Klockner" and "Bone Space Maintainers Box Kit" as worst-case containers. The precise number of these kits tested is not provided, other than "the kits" for reuse.
- Data Provenance: The tests were carried out to demonstrate compliance for the device manufactured by Soadco, S.L. in Andorra, implying the tests were conducted for this device and potentially at their facility or a contracted lab. The document does not specify if the data is retrospective or prospective, but given it's for premarket notification, it would be data collected specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The study is a non-clinical performance evaluation of a physical sterilization device, not an AI model that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests would be defined by the rigorous standardized methods of the cited regulatory standards (e.g., absence of microbial growth, visual cleanliness, material integrity after cycles).
4. Adjudication method for the test set:
Not applicable, as it pertains to expert consensus for AI model evaluation, which is not relevant here. The evaluation methods for the device performance tests would follow the protocols of the cited standards.
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 non-clinical study for a physical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a non-clinical study for a physical device, not an AI algorithm.
7. The type of ground truth used:
The "ground truth" for the non-clinical tests is based on objective, quantifiable measures and methodologies prescribed by recognized international and national standards:
- Cleaning validation: Visual inspection and quantifiable cleaning measures (e.g., residual soil detection).
- Steam sterilization validation: Absence of microbial growth in biological indicators after sterilization.
- Limits of reuse: Meeting inspection and performance criteria (e.g., material integrity, functionality) after a specified number of reprocessing cycles.
- Drying time: Visual and quantifiable dryness.
8. The sample size for the training set:
Not applicable. There is no AI model or training set involved.
9. How the ground truth for the training set was established:
Not applicable. There is no AI model or training set involved.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 ofcassette | Reference (Ref.) | Device Model Name | Maximum number ofinstruments / Weightof each container* |
|---|---|---|---|
| Injectionmolding | 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 2ESCALDES - ENGORDANYAD-700 (ANDORRA) |
| Contact person: | Maria Mitjaneta |
| Phone: | +376 800 590 |
| Fax: | +376 800 594 |
| E-mail: | calidad@soadco.com |
| 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 Predicatedevice510(k) Number | Device Trade Name | Manufacturer | |
|---|---|---|---|
| K142519 | InterActive Complete Surgical Tray | Implant Direct SybronManufacturing LLC | |
| Referencedevices | 510(k)Number | Device Trade Name | Manufacturer |
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| 1 | K012105 | PolyVac Surgical Instruments DeliverySystem | Symmetry Medical Inc. |
|---|---|---|---|
| 2 | K162063 | Steri-Cassette and Steri-CageSterilization Packaging Systems | Sybron Dental SpecialtiesInc. |
| 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 | ||
|---|---|---|---|
| KIT KLOCKNER | 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 ofcassette | Reference (Ref.) | Device Model Name | Maximum number ofinstruments / Weightof each container* |
|---|---|---|---|
| Injectionmolding | KIT KLOCKNER | Surgical Box Kit Klockner | 80 / 1200 gr. |
| Injectionmolding | KIT INTERNA | Surgical Box Kit Internal® | 60 / 1160 gr. |
| Injectionmolding | KIT VEGA | Surgical Box Kit Vega | 53 / 1160 gr. |
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| Type ofcassette | Reference (Ref.) | Device Model Name | Maximum number ofinstruments / Weightof 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 | PRIMARYPREDICATE | REFERENCEDEVICE 1 | REFERENCEDEVICE 2 | REFERENCEDEVICE 3 | Comparison: |
|---|---|---|---|---|---|---|
| Trade Name | Klockner Surgical Box | InterActive CompleteSurgical Tray | PolyVac SurgicalInstruments DeliverySystem | Steri-Cassette and Steri-Cage SterilizationPackaging System | THS sterilization Tray | Subject devicevs. |
| Manufacturer | SOADCO,S.L. | Implant Direct SybronManufacturing LLC | Poly Vac Inc./ SymmetryMedical Inc. | Sybron Dental SpecialtiesInc. | Hologic, Inc. | Predicatedevice /Referencedevices |
| 510 (K) | K142519 | K012105 | K162063 | K120947 | ||
| Indications forUse: | Klockner Surgical Boxis a set of sterilization | The InterActiveComplete Surgical | PolyVac's deliverysystems consist of | The Steri-Cassettesand Steri-Cages are | The THSSterilization Tray is | Similiar |
| Intended use | cassettes (thirteendifferent modelsbetween injectionmolding and machiningsterilization cassettes).They all are designed tohold various dentalsurgical drills,instruments and/or toolsto organize, steamsterilize and transportthe instrumentsbetween uses. Theiruse and handling areintended for physiciansand dental professionalsin health care orequivalent facilities.The sterilizationcassettes have to beenclosed in an FDA-cleared steamsterilizable wrap andsterilized in an FDA-cleared sterilizeraccording to thefollowing cycle:Pre-vacuum Steam at134°C for 4 minutes with15 minutes drying time.The trays are intendedfor sterilization of metaland thermoplastic loads.• andthermoplastic loads. | Tray is designed tohold various dentalsurgical drills andtools in order toorganize, steamsterilize, and transportthe instrumentsbetween uses. The trayis to be enclosed in anFDA cleared steamsterilizable wrap andsterilized in an FDAcleared sterilizer forone of the followingcycles:(1) Prevaccum Steam– At 132 °C for 4minutes with a 20minutes dry time.(2) Gravity Steam - At132 °C for 15 minuteswith a 30 minutes drytime. | perforated trays withlids, which are intendedto enclose and protectmedical deviceinstrumentation, and tofacilitate thesterilization process byallowing steampenetration and airremoval. When used inconjunction with anapproved sterilizationwrap, sterility of theenclosed medical deviceis maintained until used.PolyVac's deliverysystems are to besterilized in one of thefollowing cycles:Prevacuum Steam :132°C - 4 minGravity Steam: 132°C -30 minGravity Steam: 121°C- 55 minutes | intended to containdental intruments forcleaning sterilization,organization storageand handling. TheSteri-Cassettes andSteri-Cages aresuitable for prevacuumand gravitydisplacement steamsterilization methods.The cassettes andcages are not intendedto maintain sterility;they are intended to beused in conjunctionwith validated, FDAcleared sterilizationwrap in order tomaintain sterility ofthe enclosed devices. | used to enclose,protect, and organizethe THS scopes,diagnostic sheath,and associatedaccessorycomponents, and tofacilitate thesterilization processby allowing sterilantpenetration and airremoval when usedin conjunction withan approvedsterilization wrap.The THS Instrumenttray is not designedto maintain sterilityby itself, but.whenused in conjunctionwith an approvedsterilization wrapsterility of theenclosed medicaldevice is maintainedbased on the specifictime that themaintenance ofsterility for thatspecific wrap ascleared by the FDA. | |
| Perforated instrumentcassette system to hold | Perforatedcassette system to hold | instrument Perforated trays with lids,which are intended to | Perforated trays with lids, to hold | trays withsurgical lids, used to enclose, | Same | |
| dental instruments in placeduring transport, steamsterilization, and storagewhen used in conjunctionwith an approvedsterilization wrap. | dental instruments inplace during transport,steam sterilization, andstorage. | enclose and protect medicaldevice instrumentation, andto facilitate the sterilizationprocess by allowing steampenetration and air removal.When used in conjunctionwith an approvedsterilization wrap, sterilityof the enclosed medicaldevice is maintained untilused. | instruments inplace during transport, steamsterilization, and storage. | protect, and organize theTHS scopes, diagnosticsheath, and associatedaccessory components,and to facilitate thesterilization process byallowing sterilantpenetration and airremoval when used inconjunction with anapproved sterilizationwrap. | ||
| MaterialComposition | Injection molding surgicalbox:- Radel® R-5100 and- Radel® R-5800 polymerresin (PPSUPolyphenylsulfone)- Medical grade silicone- 300 series stainless steelMachined surgical box:- Radel® R PPSUpolymer resin- Polypropylene heat-stabilized plastic | - Radel® R-5000 and- Radel® R-5100(polyphenylsulfone -PPSU)- Medical grade silicone | - Radel® R-5000 plastic- Medical grade silicone- Aluminum- 300 series stainless steel | Cassettes - High Heat: High-Resistant Plastic - UltemResin 1000 (proprietarymixture with pigments)(thermoplastic).Cassettes - StandardHeat and cages:polypropylene with color(proprietary mixture withpigments)(thermoplastic). | - Radel® R-5000plastic grade- Medical gradesilicone- 300 series stainlesssteel | For injectionmolding boxesK142519 hasthe samematerialcomposition.For machinedboxes,K162063 hasthe samematerialcomposition. |
| Reusable | Yes | Yes | Yes | Yes | Yes | Same |
| Materialcompatibilitywithsterilizationprocess | 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 TIR30:2011ISO/DIS 19277 / AFNOR-NF S94-091ISO 11737-1:2006ISO 9377-2:2000European Pharmacopoeia("Method D" from 2.6.14 chapter) | Cleaning instructions werevalidated and demonstrated thatthe subject device could bevisually and quantifiably cleaned |
| Steam sterilizationvalidation (Half cyclevalidation: 2' at 134°C) | ISO 17665-1:2006ISO 17665-2:2009AAMI TIR12:2010ISO 11737-2:2009 | No growth at half cycle |
| Limits of reuse(Biocompatibility included) | FDA Guideline: ReprocessingMedical Devices in Health CareSettings: Validation Methods andLabeling (2011)AAMI TIR12:2010AAMI TIR30:2011ISO 10993 | the kits were challenged with101 reprocessing cycles. Bothtypes of sterilization boxesmet inspection andperformance criteria after 101reuses. |
| Drying Time | Validated in Drying Time ValidationReport (ISO 17665; AAMI TIR12) | Worst-case loads weredetermined to be visually andquantifiably dry after exposureto the sterilization cycle andclaimed 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.
§ 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).