Guided DAS Surgical Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Guided DAS Surgical Kit is intended to allow sterilization of the enclosed medical devices.

Guided DAS Surgical Kit requires the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kit is to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: dynamic air removal steam sterilization- Exposure at 132 °C for 4 minutes and 30 minutes dry time.

Guided DAS Surgical Kit is intended for sterilization of non-porous loads.

Guided DAS Surgical Kit is recommended not to be stacked during sterilization.

The combined weight of the Guided DAS Surgical Kit and the associated instruments is 760 grams.

The weight of the empty Guided DAS Surgical Kit is 600 grams.

Device Description

This tray is designed to hold various dental surgical drills and tools to organize and protect the instruments that are sterilized in the trays by the healthcare provider.

AI/ML Overview

The provided text is a 510(k) clearance letter and summary for the "Guided DAS Surgical Kit," which is a sterilization wrap/container. It outlines the device's indications for use, classification, and a comparison to a predicate device.

However, the provided document does not contain information relevant to AI/ML device performance, such as:

A table of acceptance criteria and reported device performance for an AI/ML model.
Sample sizes for AI/ML test sets or training sets.
Data provenance (country of origin, retrospective/prospective).
Number of experts for ground truth establishment or their qualifications.
Adjudication methods.
Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect sizes of AI assistance on human readers.
Standalone (algorithm-only) performance metrics.
Type of ground truth used (expert consensus, pathology, outcome data).

The "Summary of Nonclinical Testing Table" on page 8 focuses on validation tests typical for medical devices related to cleaning, sterilization, dry time, life cycle, and biocompatibility, which are hardware-related and not AI/ML performance metrics. The conclusion explicitly states, "No clinical data were included in this submission."

Therefore, based solely on the provided text, it's impossible to describe the acceptance criteria and the study that proves an AI/ML device meets them, as the document is about a physical medical device (sterilization kit) and not an AI/ML algorithm.

If the request assumes this document should or would contain information about an AI/ML component, then the answer is that the document explicitly does not provide such information.

To answer your request within the confines of the provided text, I must state that the document does not contain the information needed to describe the acceptance criteria and study for an AI/ML device.

The document describes the testing performed for a physical medical device (sterilization kit). The listed tests are for material and functional validation, not for an AI/ML algorithm's analytical or clinical performance.

Summary

FDA 510(k) Clearance Letter - Guided DAS Surgical Kit

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 22, 2025

Talladium España, SL
℅ Rebecca Kattan
Regulatory Specialist
PaxMed International, LLC
12264 El Camino Real
Suite 400
San Diego, California 92130

Re: K243425
Trade/Device Name: Guided DAS Surgical Kit
Regulation Number: 21 CFR 880.6850
Regulation Name: Sterilization Wrap
Regulatory Class: Class II
Product Code: KCT
Dated: June 3, 2025
Received: June 3, 2025

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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K243425 - Rebecca Kattan Page 2

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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K243425 - Rebecca Kattan Page 3

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,

Stephen A. Anisko -S (Digitally signed by Stephen A. Anisko -S Date: 2025.07.22 16:53:22 -04'00')

Stephen Anisko
Acting 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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K243425

Device Name
Guided DAS Surgical Kit

Indications for Use (Describe)

Guided DAS Surgical Kit requires the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

Guided DAS Surgical Kit is intended for sterilization of non-porous loads.

Guided DAS Surgical Kit is recommended not to be stacked during sterilization.

The combined weight of the Guided DAS Surgical Kit and the associated instruments is 760 grams.

The weight of the empty Guided DAS Surgical Kit is 600 grams.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(k) Summary Guided DAS Surgical Kit

510(k) Summary
K243425
Talladium España, SL
Guided DAS Surgical Kit
July 22, 2025

In accordance with 21 CFR 807.92 the following summary of information is provided:

1. ADMINISTRATIVE INFORMATION

Manufacturer Name: Talladium España, SL
Virginia Woolf, 17
Lleida, Lleida, ES 25005
Telephone +34 973-289-580

Official Contact: Xavier Soca Filella, General Manager

Representative/Consultant: Rebecca E. Kattan, PhD
Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone: +1 858-792-1235
Fax: +1 858-792-1236
Email: rkattan@paxmed.com
kthomas@paxmed.com
flarson@paxmed.com

2. DEVICE NAME AND CLASSIFICATION

Trade/Device Name: Guided DAS Surgical Kit
Common Name: Instrument sterilization trays
Regulation Number: 21 CFR 880.6850
Regulation Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Regulatory Class: Class II
Product Code: KCT
Classification Panel: General Hospital
Reviewing Office: Office of Health Technology 4 (OHT 4: Surgical and Infection Control Devices)
Reviewing Division: Division of Health Technology 4 C (Infection Control Devices)

3. PREDICATE DEVICE INFORMATION

Primary predicate device is:
K201878, ST-Z5, Z-Systems AG.

Page 1 of 4 K243425

Page 6

510(k) Summary

K243425
Talladium España, SL
Guided DAS Surgical Kit
July 22, 2025

In accordance with 21 CFR 807.92 the following summary of information is provided:

1. ADMINISTRATIVE INFORMATION

Manufacturer Name: Talladium España, SL
Virginia Woolf, 17
Lleida, Lleida, ES 25005
Telephone +34 973-289-580

Official Contact: Xavier Soca Filella, General Manager

2. DEVICE NAME AND CLASSIFICATION

3. PREDICATE DEVICE INFORMATION

Primary predicate device is:
K201878, ST-Z5, Z-Systems AG.

Page 1 of 4 K243425

Page 7

510(k) Summary

Table of Technological Characteristics Comparison

Attribute	Subject Device K243425 Guided DAS Surgical Kit Talladium España, SL	Primary Predicate Device K201878 ST-Z5 Z-Systems AG
Indications for Use Statement	Guided DAS Surgical Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Guided DAS Surgical Kit is intended to allow sterilization of the enclosed medical devices. Guided DAS Surgical Kit requires the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kit is to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: dynamic air removal steam sterilization- Exposure at 132 °C for 4 minutes and 30 minutes dry time. Guided DAS Surgical Kit is intended for sterilization of non-porous loads. Guided DAS Surgical Kit is recommended not to be stacked during sterilization. The combined weight of the Guided DAS Surgical Kit and the associated instruments is 760 grams. The weight of the empty Guided DAS Surgical Kit is 600 grams.	ST-Z5 surgical trays are health care provider. ST-devices. ST-Z5 surgical trays requdevices. The trays are to be enclosheat (steam) sterilized usPre-vacuum steam: 132 °ST-Z5 surgical trays are ST-Z5 surgical trays are rThe combined weight of weight of the empty ST-ZThe combined weight of the empty Z5-BL/TL tray
Intended Use	This tray is designed to hold various dental surgical drills and tools to organize and protect the instruments that are sterilized in the trays by the healthcare provider.	This tray is designed to hinstruments that are steri
Product Code	KCT	KCT
Design	Rigid polymer base, lid, and removable inner tray	Rigid polymer base, lid, a
Materials	Polyphenylsulfone (Radel®) [lid, base, tray] Medical grade silicone [grommets/holders]	Polyphenylsulfone (Rade
Materials compatible with Sterilization Method	Yes	Yes
Perforated	Yes; allows moist heat (steam) penetration to achieve sterilization	Yes; allows moist heat (s
Reusable	Yes	Yes
Number of Overall Sizes	1	1
Number of Configurations	1	2
Number of uses	50	101
Overall Dimensions	264.67 mm Length x 145.85 mm Width x 61.02 mm Height	185.1 mm Length x 133.6
Vent to Volume Ratio	0.01233 cm²/cm³ (0.001233 mm²/mm³)	0.01596 cm²/cm³
Reusable	Yes	Yes
Use Life Testing	Reusable up to 50 cycles Assembled, sterilized Visual inspection Component dimensional fit verification Functional closure (lid-base latch) verification	Reusable up to 101 cycles Assembled, sterilized Visual inspection Component dimensional
Sterilization Method
Sterilant	Moist heat (steam)	Moist heat (steam)
Cycles	Fractionated vacuum (pre-vacuum) Exposure at 132 °C (270 °F) for 4 minutes with 30 minutes drying time.	Fractionated vacuum (pre Exposure at 132 °C (270
Sterile Barrier	Sterilization wrap, FDA cleared for indicated method and cycle	Sterilization wrap, FDA c

Page 3 of 4

Page 8

510(k) Summary Guided DAS Surgical Kit

7.0 SUMMARY OF NONCLINICAL TESTING

Provided below are the nonclinical test methodologies performed to demonstrate that the subject device meets the acceptance criteria of the standard.

Summary of Nonclinical Testing Table

Test Methodology	Purpose	Results
Manual Cleaning Validation FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (issued March 2015)	The purpose of this test is 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.	Pass
Sterilization Validation including sterilant penetration and dry time validation ANSI/AAMI/ISO 17665-1 ANSI/AAMI/ISO 17665-2	The purpose of this test is to validate that the sterilization instructions listed in the Instructions for Use appropriately sterilize the tray and contents.	Pass
Dry time	The purpose of this test is to validate that the sterilization instructions listed in the Instructions for Use appropriately dry the wrapped tray for storage.	Pass
Life Cycle / Simulated Use-life Validation FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (issued March 2015)	The purpose of this test is to validate the service life of the trays as stated in the Instructions for Use.	Pass
Biocompatibility of Subject Device Cytotoxicity testing ANSI/AAMI/ISO 10993-5 ANSI/AAMI/ISO 10993-12	The purpose of this test is to evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay.	Pass

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.

8.0 CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that the subject device in this 510(k) submission, Guided DAS Surgical Kit, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K201878.

Page 4 of 4 K243425

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).