KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.

KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT WT SNIPER and the associated instruments is 820 grams.

The weight of the empty KIT WT SNIPER is 620 grams.

The KIT WT SNIPER is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers.

Indications for Use for the KIT WT SNIPER JSI

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT WT SNIPER JSI and the associated instruments is 920 grams.

The weight of the empty KIT WT SNIPER JSI is 620 grams.

The KIT WT SNIPER JSI is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers.

Indications for Use for the KIT WT INTERNA

KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT WT INTERNA and the associated instruments is 840 grams.

The KIT WT INTERNA is exclusively indicated to assist in the installation of implants of both the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers.

Indications for Use for the KIT WT VEGA

KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT WT VEGA and the associated instruments is 820 grams.

The weight of the empty KIT WT VEGA is 620 grams.

The KIT WT VEGA is exclusively indicated to assist in the installation of the VEGA® family and is not compatible with other lines and systems of other manufacturers.

Indications for Use for the KIT WT ESSENTIAL

KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterlization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 ℃ for 4 minutes and 16 minutes dry time.

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT WT ESSENTIAL and the associated instruments is 800 grams.

The weight of the empty KIT WT ESSENTIAL is 620 grams.

The KIT WT ESSENTIAL is exclusively indicated to assist in the installation of implants of the ESSENTIAL® CONE family and is not compatible with other lines and systems of other manufacturers.

Indications for Use for the KIT MEDGUIDE®

KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT MEDGUIDE® and the associated instruments is 240 grams.

The weight of the empty KIT MEDGUIDE® is 160 grams.

The KIT MEDGUIDE® is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers.

Device Description

The subject device trays are designed to hold various dental surgical drills and tools to organize and protect the instruments that are sterilized in the tray by the healthcare provider . The base, inner trav, and lid components are designed to be integrated into a single unit (the complete trav) which contains and protects the interior components during sterilization. The lid latches to the base to secure the tray into a single unit. The base, inner tray, and lid components are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam) sterilization and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polysulfone and AISI 316L stainless steel. Holders of various geometries to position instruments in the kits are manufactured from silicone. The subject device trays are summarized in the following table Summary of Tray Dimensions and Contents.

AI/ML Overview

The provided text is a 510(k) summary for the KLOCKNER KITS, a medical device intended to enclose other medical devices for sterilization. The information provided focuses on the non-clinical testing performed to demonstrate the device meets acceptance criteria and is substantially equivalent to predicate devices. It does not contain information about a study proving a device (like AI/ML software) meets acceptance criteria for a diagnostic aid, which would involve concepts like sensitivity, specificity, human reader performance, expert ground truth, and training data.

Therefore, many of the requested elements for describing the acceptance criteria and a study proving device performance (especially those related to AI/ML or diagnostic performance) cannot be extracted from this document. This document describes a physical medical device (sterilization kits) and its validation through standard engineering and sterility testing, not an AI/ML diagnostic software.

However, I can extract the available information as best as possible, interpreting "device performance" in the context of this specific regulatory submission for the KLOCKNER KITS.

Device: KLOCKNER KITS (Sterilization Trays)

Purpose of the Study: To demonstrate that the KLOCKNER KITS are safe, effective, and perform as well as or better than legally marketed predicate devices, specifically regarding their ability to be cleaned, sterilized, and maintain integrity over multiple uses. This is a non-clinical validation study, not a clinical trial or a diagnostic AI performance study.

1. A table of acceptance criteria and the reported device performance

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance/Results
Manual Cleaning Validation	To validate that the cleaning instructions provided in the Instructions for Use appropriately clean the tray, and to ensure the sterilization cycle will be effective.	Cleaning instructions were validated and demonstrated that the subject devices could be visually and quantifiably cleaned.	Pass
Sterilization Validation (incl. sterilant penetration & dry time validation)	To validate that the sterilization instructions listed in the Instructions for Use appropriately sterilize the tray and contents.	3 consecutive half-cycles performed for each of 4 configurations of trays demonstrate complete inactivation of all biologic indicators; A minimum SAL (Sterility Assurance Level) of 10-6 is achieved if the Instructions for Use are followed.	Pass
Dry time Validation	To validate that the sterilization instructions listed in the Instructions for Use appropriately dry the wrapped tray for storage.	Using pre-cycle and post-cycle weights, the weight gain after drying will be < 3%.	Pass
Life Cycle / Simulated Use-life	To validate the service life of the trays as stated in the Instructions for Use.	Subject kits were challenged with at least 40 reprocessing cycles. All kits met inspection and performance criteria after 40 uses. (For a safety factor of 2X, a maximum of 20 uses is recommended in labeling).	Pass
Biocompatibility (Cytotoxicity)	To evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay.	The in vitro assay performed on the test article showed no reactivity.	Pass

2. Sample size(s) used for the test set and the data provenance:

Cleaning Validation: Not explicitly stated, but implies multiple units or repeats to demonstrate "visually and quantifiably cleaned."
Sterilization Validation: "3 consecutive half-cycles performed for each of 4 configurations of trays."
Dry Time Validation: Not explicitly stated, likely performed alongside sterilization validation.
Life Cycle / Simulated Use-life: "Subject kits were challenged with at least 40 reprocessing cycles." The number of individual kits tested is not specified but would be a subset of the configurations.
Biocompatibility: Not explicitly stated, but standard practice involves testing material samples.

The data provenance is from non-clinical laboratory testing and validation studies conducted by the manufacturer, SOADCO, S.L., as part of their 510(k) submission. No geographic origin of the test data is provided beyond the manufacturer's address in Andorra. The studies are by nature prospective tests performed to validate the device's design and performance.

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 and not provided in this document. The ground truth for these non-clinical tests (sterility, cleanliness, physical integrity) is established through standardized laboratory methods (e.g., biological indicators for sterility, gravimetric analysis for dryness, visual/quantitative assays for cleanliness, physical inspection for life cycle), not through expert consensus or interpretation by human clinicians/radiologists.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, such as evaluating medical images. Here, the tests are objective, laboratory-based validations.

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:

This information is not applicable and not provided. An MRMC study is relevant for evaluating the performance of diagnostic AI (Artificial Intelligence) systems, often in radiology. This document concerns a physical medical device (sterilization trays) and its non-clinical performance characteristics, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable and not provided. This concept relates to the performance of an AI algorithm, which is not the device described in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for these tests is based on:

Sterility: Absence of microbial growth (biological indicators achieving SAL of 10-6).
Cleanliness: Absence of visible or quantifiable biological/chemical residues.
Dryness: Minimal weight gain (less than 3%).
Life Cycle: Retention of physical and functional integrity after repeated cycles (visual inspection, functional closure).
Biocompatibility: No cytotoxic response in cell culture.

These are established scientific and engineering standards, not clinical "outcomes data" or "expert consensus" in the diagnostic sense.

8. The sample size for the training set:

This information is not applicable and not provided. The KLOCKNER KITS are a physical sterilization device, not an AI/ML model, and therefore do not have a "training set."

9. How the ground truth for the training set was established:

This information is not applicable and not provided for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows 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 logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."

December 18, 2024

Soadco, S.L. % Rebecca Kattan Regulatory Specialist PaxMed International, LLC 12264 El Camino Real Suite 400 San Diego, California 92130

Re: K243128

Trade/Device Name: Klockner Kits Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 29, 2024 Received: September 30, 2024

Dear Rebecca Kattan:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/2/Picture/3 description: The image shows the name "Stephen A. Anisko -S" in bold black font on the left side of the image. On the right side of the image, there is a digital signature by Stephen A. Anisko -S. The date of the signature is 2024.12.18 17:36:15-05'00'.

for: Christopher K. Dugard Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K243128

Device Name KLOCKNER KITS

Indications for Use (Describe)

Indications for Use for the KIT WT SNIPER

KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKER KITS are intended to allow sterilization of the enclosed medical devices.

KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterlity of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT WT SNIPER and the associated instruments is 820 grams.

The weight of the empty KIT WT SNIPER is 620 grams.

Indications for Use for the KIT WT SNIPER JSI

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT WT SNIPER JSI and the associated instruments is 920 grams.

The weight of the empty KIT WT SNIPER JSI is 620 grams.

Indications for Use for the KIT WT INTERNA

KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT WT INTERNA and the associated instruments is 840 grams.

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Indications for Use for the KIT WT VEGA

KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT WT VEGA and the associated instruments is 820 grams.

The weight of the empty KIT WT VEGA is 620 grams.

The KIT WT VEGA is exclusively indicated to assist in the installation of the VEGA® family and is not compatible with other lines and systems of other manufacturers.

Indications for Use for the KIT WT ESSENTIAL

KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT WT ESSENTIAL and the associated instruments is 800 grams.

The weight of the empty KIT WT ESSENTIAL is 620 grams.

The KIT WT ESSENTIAL is exclusively indicated to assist in the installation of implants of the ESSENTIAL® CONE family and is not compatible with other lines and systems of other manufacturers.

Indications for Use for the KIT MEDGUIDE®

KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT MEDGUIDE® and the associated instruments is 240 grams.

The weight of the empty KIT MEDGUIDE® is 160 grams.

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 K243128 SOADCO, S.L. KLOCKNER KITS

December 12, 2024

ADMINISTRATIVE INFORMATION

Manufacturer Name	SOADCO, S.L.Av. Pessebre, 76-82, BaixosAD700 Escaldes-Engordany, Andorra [AD]Telephone: +37 (6) 800-590
Official Contact	Mercedes Roldan, General Manager
Representative/Consultant	Rebecca E. Kattan, PhDKevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone: +1 858-792-1235Email: rkattan@paxmed.com kthomas@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Device Name	KLOCKNER KITS
Common Name	Instrument sterilization trays
Regulation Number	21 CFR 880.6850
Regulation Name	Sterilization Wrap
Regulatory Class	Class II
Product Code	KCT
Classification Panel	General Hospital
Reviewing Office	Office of Health Technology 4(OHT 4: Office of Surgical and Infection Control Devices)
Reviewing Division	Division of Health Technology 4C(Infection Control Devices)

PREDICATE DEVICE INFORMATION

K173642, KLOCKNER Surgical Box, SOADCO, S.L. K212068, Biotech Dental Kits, Biotech Dental SAS

The primary predicate device is K173642. The reference device is K212068.

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SUBJECT DEVICE INDICATIONS FOR USE STATEMENT

Indications for Use for the KIT WT SNIPER

KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization -Exposure at 134 °C for 4 minutes and 16 minutes dry time.

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT WT SNIPER and the associated instruments is 820 grams. The weight of the empty KIT WT SNIPER is 620 grams.

Indications for Use for the KIT WT SNIPER JSI

KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT WT SNIPER JSI and the associated instruments is 920 grams. The weight of the empty KIT WT SNIPER JSI is 620 grams.

Indications for Use for the KIT WT INTERNA

KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT WT INTERNA and the associated instruments is 840 grams. The weight of the empty KIT WT INTERNA is 620 grams.

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Indications for Use for the KIT WT VEGA

KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cvcles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization -Exposure at 134 ℃ for 4 minutes and 16 minutes dry time.

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT WT VEGA and the associated instruments is 820 grams. The weight of the empty KIT WT VEGA is 620 grams.

The KIT WT VEGA is exclusively indicated to assist in the installation of implants of the VEGA® family and is not compatible with other lines and systems of other manufacturers.

Indications for Use for the KIT WT ESSENTIAL

KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

The combined weight of the KIT WT ESSENTIAL and the associated instruments is 800 grams. The weight of the empty KIT WT ESSENTIAL is 620 grams.

The KIT WT ESSENTIAL is exclusively indicated to assist in the installation of implants of the ESSENTIAL® CONE family and is not compatible with other lines and systems of other manufacturers.

Indications for Use for the KIT MEDGUIDE®

KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

KLOCKNER KITS are intended for sterilization of non-porous loads.

KLOCKNER KITS are recommended not to be stacked during sterilization.

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The combined weight of the KIT MEDGUIDE® and the associated instruments is 240 grams. The weight of the empty KIT MEDGUIDE® is 160 grams.

SUBJECT DEVICE DESCRIPTION

[Tray Part Number]/[Kit Part Number]	Number ofitems (in Kit)	EnclosedVolume	Total VentArea	Vent to volumeratio
[20 06 32]/ [KIT WTSNIPER]	69	185.239 in3	93.41 in2	0.504 in2/ in3
[20 06 33]/ [KIT WTSNIPER JSI]	104	185.239 in3	93.41 in2	0.504 in2/ in3
[10 06 23]/ [KIT WTINTERNA]	36	185.239 in3	93.41 in2	0.504 in2/ in3
[10 06 23]/ [KIT WTVEGA]	31	185.239 in3	93.41 in2	0.504 in2/ in3
[10 06 23]/ [KIT WTESSENTIAL]	22	185.239 in3	93.41 in2	0.504 in2/ in3
[10 00 09]/ [KITMEDGUIDE®]	16	14.280 in3	2.656 in2	0.181 in2/ in3

Summary of Tray Dimensions and Contents

TECHNOLOGICAL CHARACTERISTICS COMPARISION DISCUSSION

The subject device and the predicate device K173642 have the same intended use, the same product classification and product code (KCT) and have similar Indications for Use statements. The subject device and the predicate device K173642 are reusable rigid containers used to organize and protect the instruments that are sterilized by the healthcare provider. The subject device and the predicate device K173642 are to be sterilized by moist heat (steam) and require the use of an FDA cleared wrap to maintain sterility. The Indications for Use Statement (IFUs) for the subject device is similar to that of the predicate device K173642 and reference device K212068; slight differences in language of the IFUs do not affect the intended use.

The subject device is provided in 2 sizes and 6 configurations; the predicate device K173642 is provided in 1 size and 1 configuration. The subject device and the predicate device have

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similar overall dimensions, enclose similar volumes, and have similar vent to volume ratios. Differences in the dimensions and vent to volume ratios between the subject device and the predicate device are mitigated by the sterilization validation performed.

The reference device, K212068, is provided in 10 sizes and 11 configurations. The subject device and the reference device have very similar overall dimensions, enclose very similar volumes, and have very similar vent to volume ratios. Differences in the dimensions and vent to volume ratios between the subject device and the predicate device are mitigated by the sterilization validation performed.

The basis for the belief of SOADCO, S.L. that the subject device is similar to the predicate device and reference device is summarized in the following Table of Technological Characteristics Comparison.

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Table of Technological Characteristics Comparison

	Subject Device	Primary Predicate Device	Refence Predicate Device	Similarity
	K243128KLOCKNER KITSSOADCO, S.L.	K173642KLOCKNER Surgical BoxSOADCO, S.L.	K212068Biotech Dental KitsBiotech Dental
Product Code	KCT	KCT	KCT	Same
Intended Use	organize and protect the devices, instruments, and accessories that aresterilized by health care provider	organize and protect the devices, instruments, and accessories that are sterilized by healthcare provider	organize and protect the devices, instruments, and accessories that aresterilized by health care provider	Same
Design	2-piece plastic trays- Rigid polymer base and lid3-piece plastic trays- Rigid polymer base, lid, and removable inner tray	3-piece plastic trays- Rigid polymer base, lid, and removable inner tray	2-piece plastic trays- Rigid polymer base and lid3-piece plastic trays- Rigid polymer base, lid, and removable inner tray2-piece metal trays- Rigid metal base, lid, and inner tray.	Similar
Materials	2-piece plastic traysPolyphenylsulfone (PPSU) [lid/base]3-piece plastic traysPolyphenylsulfone (PPSU) [lid, base]Polyphenylsulfone (PPSU) + Silicone SE-PX [inner tray]	Injection molding surgical box: - Radel® R-5100 and Radel® R-5800 polymer resin(PPSU – Polyphenylsulfone) - Medical grade silicone - 300 series stainless steelMachined surgical box: - Radel® R PPSU polymer resin - Polypropylene heat stabilizedplastic	2-piece plastic traysPolyphenylsulfone (PPSU) (Radel R5000) [lid]Polypropylene (PPHS) [base]3-piece plastic traysPolyphenylsulfone (Radel R5000) [lid, base, insert]Medical grade silicone [grommets]2-piece metal traysStainless Steel AISI 304LMedical grade silicone [grommets]	Same
Materials Compatible withSterilization Method	Yes	Yes	Yes	Same
Perforated	Yes, allows moist heat (steam) penetration to achieve sterilization	Yes, allows moist heat (steam) penetration to achieve sterilization	Yes; allows moist heat (steam) penetration to achieve sterilization	Same
Number of Overall Sizes	2	1	10	Similar
Number of Configurations	6	1	11	Similar
	Length x Width x Height	Length x Width x Height	Length x Width x Height
	Vent to Volume Ratio	Vent to Volume Ratio	Vent to Volume Ratio
Overall Dimensions andVent to Volume Ratio	251mm x 156mm x 60.7mm0.1984 cm²/cm³ (0.504 in²/ in³)	287.02 mm x 176.02 mm x 55.8 mm (11.3 in x 6.93 in x 2.2 in)(0.181 in²/ in³)	150 mm x 65 mm x 25 mm0.2260 cm²/cm³	Similar
	251mm x 156mm x 60.7mm0.1984 cm²/cm³ (0.504 in²/ in³)		150 mm x 65 mm x 25 mm0.1472 cm²/cm³	Similar
	251mm x 156mm x 60.7mm0.1984 cm²/cm³ (0.504 in²/ in³)		150 mm x 65 mm x 25 mm0.3694 cm²/cm³	Similar
	251mm x 156mm x 60.7mm0.1984 cm²/cm³ (0.504 in²/ in³)		150 mm x 65 mm x 25 mm0.3932 cm²/cm³	Similar
	251mm x 156mm x 60.7mm0.1984 cm²/cm³ (0.504 in²/ in³)		125 mm x 127 mm x 24.5 mm0.1224 cm²/cm³	Similar
	120mm x 75mm x 26mm0.0713 cm²/cm³ (0.181 in²/ in³)		125 mm x 127 mm x 36.5 mm0.0346 cm²/cm³	Similar
			125 mm x 127 mm x 32.5 mm0.0567 cm²/cm³	Similar
			162.2 mm x 170 mm x 55 mm0.0049 cm²/cm³	Similar
	Subject Device	Primary Predicate Device	Refence Predicate Device	Similarity
	K243128KLOCKNER KITSSOADCO, S.L.	K173642KLOCKNER Surgical BoxSOADCO, S.L.	K212068Biotech Dental KitsBiotech Dental
			162.2 mm x 170 mm x 55 mm0.0049 cm²/cm³
			162.2 mm x 170 mm x 65 mm0.0041 cm²/cm³
			40 mm x 50 mm x 20 mm0.9500 cm²/cm³
Reusable	Yes	Yes	Yes	Same
Use Life Testing	Reusable up to 20 cyclesAssembled, sterilizedVisual inspectionFunctional closure (lid-base latch) verification	Reusable up to 101 cycles.Assembled, sterilizedVisual inspection	Reusable up to 100 cyclesAssembled, sterilizedVisual inspectionComponent dimensional fit verificationFunctional closure (lid-base latch) verification	Similar
Sterilant	Moist heat (steam)	Moist heat (steam)	Moist heat (steam)	Same
Cycles	Pre-vacuum Steam at 134°C for 4 minutes with 16 minutes drying time.	Pre-vacuum Steam at 134°C for 4 minutes with 15 minutes drying time.	Fractionated vacuum (pre-vacuum)Exposure at 132 °C (270 °F) for 4 minutes with 20 minutes drying time.	Similar
Sterile Barrier	Sterilization wrap or pouch, FDA cleared for indicated method and cycle	Sterilization wrap or pouch, FDA cleared for indicated method and cycle	Sterilization wrap or pouch, FDA cleared for indicated method andcycle	Same

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SUMMARY OF NONCLINICAL TESTING

Provided below are the nonclinical test methodologies performed to demonstrate the subject devices met the acceptance criteria of the standard.

Test Methodology	Purpose	Acceptance Criteria	Results
Manual Cleaning ValidationFDA GuidanceReprocessing Medical Devices inHealth Care Settings: ValidationMethods and Labeling (issuedMarch 2015)ANSI AAMI ST8:2013/(R)2018	The purpose of this test is tovalidate that the cleaninginstructions provided in theInstructions for Useappropriately clean the tray, andto ensure the sterilization cyclewill be effective.	Cleaning instructions werevalidated and demonstrated thatthe subject devices could bevisually and quantifiably cleaned.	Pass
Sterilization Validationincluding sterilant penetrationand dry time validationANSI/AAMI/ISO 17665-1:2006/(R)2013ANSI/AAMI/ISO 17665-2:2009	The purpose of this test is tovalidate that the sterilizationinstructions listed in theInstructions for Useappropriately sterilize the trayand contents.	3 consecutive half-cyclesperformed for each of 4configurations of traysdemonstrate complete inactivationof all biologic indicators; Aminimum SAL of 10-6 is achievedif the Instructions for Use arefollowed.	Pass
Dry timeValidated in Drying TimeValidation ReportAAMI TIR12: 2020ANSI/AAMI/ISO 17665-2:2009	The purpose of this test is tovalidate that the sterilizationinstructions listed in theInstructions for Useappropriately dry the wrappedtray for storage.	Using pre-cycle and post-cycleweights, the weight gain afterdrying will be< 3%.	Pass
Life Cycle / Simulated Use-lifeper Validation FDA GuidanceReprocessing Medical Devices inHealth Care Settings: ValidationMethods and Labeling (issuedMarch 2015)AAMI TIR12:2020/(R)2023	The purpose of this test is tovalidate the service life of thetrays as stated in the Instructionsfor Use.	Subject kits were challenged withat least 40 reprocessing cycles. Allkits met inspection andperformance criteria after 40 uses.For a safety factor of 2X, amaximum of 20 uses isrecommended in labeling	Pass
Biocompatibility of SubjectDeviceCytotoxicity testingANSI/AAMI/ISO 10993-5:2009/(R)2014ANSI/AAMI/ISO 10993-12:2012	The purpose of this test is toevaluate the cytotoxicitypotential of the test article usingan in vitro cell culture assay.	The in vitro assay performed onthe test article showed noreactivity.	Pass

	Summary of Nonclinical Testing Table
--	--------------------------------------	--	--	--	--

In summary, the nonclinical testing provided for these devices met the acceptance criteria for each standard and test methodology used to evaluate the devices as shown in the table above.

No clinical data were included in this submission.

CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that the subject device in this 510(k) submission, KLOCKNER KIT, is as safe, as effective, and perform as well as or better than the legally marketed predicate devices cleared under K173642.

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).