Miltex Sterilization Cassettes (Miltex®, Thompson™) are general dental/surgical instrument cassettes indicated to hold instruments and accessories in place during storage and the sterilization cycle. Suitable for Gravity Steam and Pre-Vacuum Steam, the cassettes are intended to be used in conjunction with sterilization wrap in order to maintain sterility.

Device Description

Miltex® Thompson™ Cassettes are sterilization cassettes made of surgical-grade passivated stainless steel to provide protection, storage and organization for all types of instruments. Miltex® Thompson™ Cassettes may be used in dental, surgical or veterinary procedures. Cassettes are available in a variety of configurations and are designed to fit standard autoclaves.

AI/ML Overview

The provided text describes Miltex® Thompson™ Cassettes, which are sterilization cassettes used for dental/surgical instruments. The document focuses on their indications for use, contraindications, warnings, precautions, instructions for use (cleaning and sterilization), and validated sterilization parameters. It also includes information about the product's 510(k) clearance (K101653) with the FDA.

Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

Acceptance Criteria / Performance Metric	Reported Device Performance (Miltex® Thompson™ Cassettes)
Sterilization Efficacy (Gravity Steam)	Achieves sterilization at:
- Temperature	250°F (121°C)
- Exposure Time	30 minutes
- Dry Time	20 minutes
Sterilization Efficacy (Pre-Vacuum Steam)	Achieves sterilization at:
- Temperature	270°F (132°C)
- Exposure Time	4 minutes
- Dry Time	20 minutes
Durability (Sterilization Cycles)	Validated to withstand up to 50 sterilization cycles with no evidence of deterioration.
Material	Surgical-grade passivated stainless steel
Weight for Sterilization	Weight of wrapped cassette and contents does not exceed 4.4 lbs (per validated sterilization study).
Maintenance of Sterility	Cassettes wrapped in FDA-cleared sterilization wrap maintain sterility of enclosed instruments for 30 days (as long as sterile barrier is not compromised).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "Miltex® Thompson™ cassettes have been tested with no adverse effects under the following sterilization parameters." and "Miltex® Thompson™ cassettes have been validated to withstand up to 50 sterilization cycles with no evidence of deterioration."

Sample Size: The document does not explicitly state the numerical sample size (number of cassettes or tests) used for the sterilization and durability testing. It indicates that testing and validation were performed, but not the specific quantity of units involved.
Data Provenance: The document does not specify the country of origin where the testing was conducted. Given the manufacturer's address (York, PA, USA) and FDA 510(k) clearance, it is highly likely the testing was conducted in the US or by a facility adhering to US regulatory standards. The data would be considered prospective as it involves controlled testing to validate device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is generally not applicable to a medical device like a sterilization cassette, which undergoes performance testing (e.g., sterilization efficacy, material durability, functional design). The "ground truth" for such a device is established through scientific and engineering standards and validated laboratory testing, not expert consensus on interpretations of images or clinical outcomes. Therefore, no experts in the sense of medical specialists interpreting data are explicitly mentioned as establishing a "ground truth" here. The validation would be performed by qualified engineers, microbiologists, and technicians.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies where human interpretation of ambiguous data requires consensus. For the performance testing of a sterilization cassette, the "adjudication" is based on objective measurements and established pass/fail criteria according to validated protocols and standards (e.g., microbial kill, material integrity, functional checks). There is no mention of an adjudication method involving multiple human readers for consensus.

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

An MRMC comparative effectiveness study is not applicable as this device is a physical instrument for sterilization, not an AI-powered diagnostic tool requiring human interpretation improvement.

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

This refers to AI algorithm performance and is not applicable to a physical sterilization cassette.

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

The ground truth for this device is established by:

Sterilization Efficacy: Meeting established sterility assurance levels (SAL) for steam sterilization, likely demonstrated through biological indicator studies (e.g., killing of specified microorganisms like Geobacillus stearothermophilus) and physical parameters (temperature, pressure, time). This would fall under microbiological testing/standards compliance.
Durability: Physical integrity and functionality of the cassette after a specified number of sterilization cycles, assessed through visual inspection and functional testing, falling under engineering and material performance standards.
Functional Design: The ability to hold instruments, fit standard autoclaves, and be used with sterilization wrap, as per the device description and indications.

8. The sample size for the training set

The concept of a "training set" is relevant for machine learning algorithms. This device is a physical medical device, not an algorithm. Therefore, there is no training set in the AI sense. The design and manufacturing process would involve extensive engineering, material testing, and quality control, but this is distinct from "training data."

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

As there is no training set for an AI algorithm, this question is not applicable. The "ground truth" for the device's design and manufacturing is derived from engineering specifications, industry standards for medical device materials, sterilization guidelines (e.g., AAMI, ISO), and regulatory requirements for instrument sterilization.

Summary

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c S&E K101653$\rho^\prime$

Miltex.

AUG 0 2 2010

Miltex® Thompson™ Cassettes

DEVICE DESCRIPTION

INDICATIONS FOR USE

Miltex® Thompson™ Cassettes are general dental/surgical instrument cassettes indicated to hold instruments and accessories in place during storage and the sterilization cycle. Suitable for gravity steam and pre-vacuum steam, the cassettes are intended to be used in conjunction with sterilization wrap in order to maintain sterility.

CONTRAINDICATIONS

None .

WARNINGS

Do not stack or overfill instruments in cassette; ensure that each instrument is correctly placed into . slots provided.
Close cassette lid to avoid injury caused by instruments protruding from cassette. .
Do not stack cassettes in sterilization unit. .
Do not use any unused instruments in the cassette once soiled instruments have been placed back into . the cassette.

PRECAUTIONS

Wrap instrument cassette only with legally marketed FDA-cleared sterilization wrap. .
Use of nonabsorbent tray liners, such as plastic/silicone-fingered organizing mats, can cause . condensate to pool inside cassette.
. Small baskets, trays, and other types of accessories, especially those with covers or lids, should be used with cassettes only if cassettes have been specifically designed and tested for such purpose.
Complex instruments should be prepared and sterilized according to instrument manufacturer's . instructions.
For effective sterilization and drying, the weight of the wrapped surgical cassette and its contents . should not exceed 4.4 lbs per the validated sterilization study. .

INSTRUCTIONS FOR USE

Cassette Cleaning

1. Cassettes should be cleaned with an instrument brush and surfactant or detergent and water to remove visible debris from all crevices prior to use.
1. Cassettes may be cleaned in an ultrasonic cleaner with an enzymatic solution, such as Miltex EZ-Zyme All Purpose Enzyme Cleaner.
1. Submerge cassette fully into ultrasonic unit and place lid on unit.
Process single layer cassettes for 15 minutes and double layer cassettes for 30 minutes in ultrasonic 4. unit.
1. Following ultrasonic cleaning procedure, remove cassettes and thoroughly rinse with warm water to remove cleaning solution; allow cassette to dry before placing instruments in cassettes for processing.

Manual Cleaning - Instruments

1. Open instrument cassette by pressing push button to release lid. Fold lid under cassette or lay lid flat on a table or work station.
  1

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K101653 p2.13

1. Remove visible debris from each reusable instrument by scrubbing instrument manually with an instrument brush and surfactant or detergent and water.
1. Rinse with water to remove chemical or detergent residue.
1. Dry instruments and place them into cassette. Hand instruments fit into grooves on racks inside cassette; additional instruments can be placed in accessory area of cassette.
1. Close cassette lid tightly after placing instruments in cassette.

Sterilization

1. Wrap cassette in FDA-cleared sterilization wrap; seal wrap with autoclave tape.
1. Date and code cassette on autoclave tape or label on outside of wrapped cassette.
1. Place wrapped cassette into sterilization unit and follow sterilizer's recommended sterilization procedures and an approved National/International Standard.

Miltex® Thompson™ cassettes have been tested with no adverse effects under the following sterilization parameters:

Gravity Steam: Temperature: 250ºF (121ºC) Exposure Time: 30 minutes Dry Time: 20 minutes

Pre-Vacuum Steam: Temperature: 270°F (132°C) Exposure Time: 4 minutes Dry Time: 20 minutes

1. After sterilization, remove cassette from sterilization unit and place in a storage location. Cassettes wrapped in FDA-cleared sterilization wrap maintain sterility of enclosed instruments for 30 days as long as sterile barrier is not compromised.

MAINTENANCE OF CASSETTE

Miltex® Thompson™ cassettes have been validated to withstand up to 50 sterilization cycles with no . evidence of deterioration.
For best and lengthy service life, instrument cassettes should be allowed to properly dry before the . sterilization procedure.
Use Miltex® Instrument Stain Remover to remove water marks or stains if they appear on cassette. .

HOW SUPPLIED

Miltex® Thompson™ Cassettes are supplied one per package in a variety of configurations.

Part #	Model	Part #	Model
3-083005	Thompson™ 5 Utility	STDORTHO	Thompson™ Orthodontic Cassette
3-083105	Thompson™ 5 Single Rack	STDORTHOS	Thompson™ Orthodontic Cassette - Small
3-083210	Thompson™ 5 Double Rack	STDBOS	Thompson™ Surgical Cassette - Small
3-084007	Thompson™ 7 Utility	STDBOM	Thompson™ Surgical Cassette - Medium
3-084107	Thompson™ 7 Single Rack	STDBOL	Thompson™ Surgical Cassette - Large
3-084214	Thompson™ 7 Double Rack	3-080205	Handpiece/Accessory Cassette
3-085009	Thompson™ 9 Utility	4-6835	Universal Surgical Cassette, Small
3-085109	Thompson™ 9 Single Rack	4-083000	Universal Surgical Cassette #5
3-085218	Thompson™ 9 Double Rack	4-084000	Universal Surgical Cassette #7
3-089110	Thompson™ 10	4-085000	Universal Surgical Cassette #9
3-118114	Thompson™ 14	4-089100	Universal Surgical Cassette #10
3-118116	Thompson™ 16	4-008122	Universal Surgical Cassette #22
3-118122	Thompson™ 22	4-008115	Universal Surgical Cassette
3-139126	Thompson™ 26	4-009126	Universal Surgical Cassette #26
3-072007	Thompson™ Slimline 7	4-6815	Universal Surgical Cassette, X-Long
3-082008	Thompson™ Slimline 7 Extended	STDBH	Bur Holder - 12-Hole
STDSL27	Thompson™ Slimline 7 Deep	STDBH6	Bur Holder - 6-Hole
3-072014	Thompson™ Slimline 14	STDBHS	Surgical Bur Holder - 6-Hole
STD222	Standard Cassette - Oral Surgical Double	STDBB2	Bur Box #2 - 40-Hole
STD209	Standard Cassette - Double Nine	STDPB	Small Parts Box
STDSTAT	Standard Cassette	STDES48	Endo File Stand - 48-Hole
STDSTAT8	Standard Cassette 8	STDES60	Endo File Stand - 60-Hole
STDSTAT814	Standard Cassette 814	STDES72	Endo File Stand - 72-Hole

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K101653 p343

SYMBOLS USED ON LABELING

Manufacturer

Authorized Representative in European Community EC REP

Image /page/2/Picture/4 description: The image shows two boxes stacked on top of each other. The top box contains the text 'REF', and the bottom box contains the text 'LOT'. Below the boxes is a triangle shape.

Lot number

Catalog number

CAUTION: See warnings or precautions

Consult instructions for use

Complies with EU Directive 93/42/EEC

ECREP

Miltex, Inc. 589 Davies Drive York, PA 17402 800-645-8000 www.miltex.com

Miltex GmbH 78604 Rietheim-Weilheim Germany

L76-xxxxxx Rev1 7/10

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three wing-like shapes, representing the department's mission of promoting health and well-being. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The logo is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Jennifer Bosley, MBA, RAC Regulatory Affairs Manager Miltex, Incorporated 589 Davies Drive York, Pennsylvania 17402

AUG 0 2 2010

Re: K101653

Trade/Device Name: Miltex® Sterilization Cassettes Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: June 10, 2010 Received: June 11, 2010

Dear Ms. Bosley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Ms. Bosley

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Luone

Anthony D. Watson, B.S., M.S., M.B.A.
Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Indications For Use

510(k) Number (if known):

1101653

AUG 0 2 2010

Device Name:

Miltex® Sterilization Cassettes

Indications for Use:

Validated Sterilization Parameters:

Method	Temperature	Exposure Time	Drying Time
Gravity Steam	250°F (121°C)	30 minutes	20 minutes
Pre-Vacuum Steam	270°F (132°C)	4 minutes	20 minutes

Miltex Part #	Model	Miltex Part #	Model
3-083005	Thompson™ 5 Utility	STDORTHO	Thompson™ Orthodontic Cassette
3-083105	Thompson™ 5 Single Rack	STDORTHOS	Thompson™ Orthodontic Cassette - Small
3-083210	Thompson™ 5 Double Rack	STDBOS	Thompson™ Surgical Cassette - Small
3-084007	Thompson™ 7 Utility	STDBOM	Thompson™ Surgical Cassette - Medium
3-084107	Thompson™ 7 Single Rack	STDBOL	Thompson™ Surgical Cassette - Large
3-084214	Thompson™ 7 Double Rack	3-080205	Handpiece/Accessory Cassette
3-085009	Thompson™ 9 Utility	4-6835	Universal Surgical Cassette, Small
3-085109	Thompson™ 9 Single Rack	4-083000	Universal Surgical Cassette #5
3-085218	Thompson™ 9 Double Rack	4-084000	Universal Surgical Cassette #7
3-089110	Thompson™ 10	4-085000	Universal Surgical Cassette #9
3-118114	Thompson™ 14	4-089100	Universal Surgical Cassette #10
3-118116	Thompson™ 16	4-008122	Universal Surgical Cassette #22
3-118122	Thompson™ 22	4-008115	Universal Surgical Cassette
3-139126	Thompson™ 26	4-009126	Universal Surgical Cassette #26
3-072007	Thompson™ Slimline 7	4-6815	Universal Surgical Cassette, X-Long
3-082008	Thompson™ Slimline 7 Extended	STDBH	Bur Holder - 12-Hole
STDSL27	Thompson™ Slimline 7 Deep	STDBH6	Bur Holder - 6-Hole
3-072014	Thompson™ Slimline 14	STDBHS	Surgical Bur Holder - 6-Hole
STD222	Standard Cassette - Oral Surgical Double	STDBB2	Bur Box #2 - 40-Hole
STD209	Standard Cassette - Double Nine	STDPB	Small Parts Box
STDSTAT	Standard Cassette	STDES48	Endo File Stand - 48-Hole
STDSTAT8	Standard Cassette 8	STDES60	Endo File Stand - 60-Hole
STDSTAT814	Standard Cassette 814	STDES72	Endo File Stand - 72-Hole

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

Over-The-Counter-Use_ (Part 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)

Elizabeth F. (Laurie-Wall)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K101653

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).