General dental / medical instrument cassettes intended to hold instruments and accessories in place throughout the entire instrument use, cleaning and sterilization cycle. These cassettes are suitable for Gravity Steam, Pulsing High Vacuum steam and EO sterilization. Instruments may be cleaned by chemical sterilant.

Device Description

A cassette system and accessories designed to hold various dental and medical instrument to be cleaned and sterilized. The design is a metal, aluminum and stainless steel container which has various methods of holding the instruments in place. Available in various sizes ranging which have a typical size of 1.5" x 3.5" x 1" to 8" x 15.5" x 2.5".

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the C/T Med-Systems Cassette System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on demonstrating equivalence to predicate devices and compliance with relevant AAMI (Association for the Advancement of Medical Instrumentation) standards and specifications for sterilization, cleaning, and material compatibility.

Acceptance Criteria (Performance Standards / Specifications)	Reported Device Performance (C/T Med-System Cassette System)
AAMI TIR No. 12-1994 compliance	Yes (Independently tested according to AAMI TIR No. 12-1994)
Validation study performed with half-cycles to challenge sterilization method used	Yes
AAMI ST 33 -1992 requirements
3.4-3.5 Instructions provided for different cleaning methods of cassette	Yes
3.6-4.2 Instructions for inspections	Yes
6.2.2 Sterilization manufacturer documentation available	Yes
6.2.3 Drying time in labeling	Yes
6.2.4 EO residual removal in labeling	Yes
6.3 User (basic) responsibilities listed in labeling	Yes
7.3.1 Routine inspection in labeling	Yes
Materials: Aluminum and stainless steel	Yes (Device design uses metal, aluminum, and stainless steel)
Intended Use: Holding dental and medical instruments and accessories in place throughout entire instrument use, cleaning and sterilization cycle	Yes (Stated as intended use)
Intended to be reused	Yes
Sterilization by Gravity Steam, Pulsing High Vacuum Steam and Ethylene Oxide (EO)	Yes (Tested for Pulsing High Vacuum and Gravity Steam and Ethylene Oxide (EO))
Design: Various sizes offered ranging typically from 1.5" x 3.5" x 1" to 8" x 15.5" x 2.5"	Yes (Stated as typical sizes)
Utilizes various methods of holding instruments in place	Yes
May incorporate latch system to hold	(Implied through "various methods of holding instruments")
Ultrasonic cleaning compatibility	Tested for ultrasonic cleaning by Indiana University

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical "sample size" for the performance testing in terms of number of cassettes or specific sterilization cycles beyond stating that the system "was independently tested."

Data Provenance: The testing was "independently tested" according to AAMI TIR No. 12-1994 and "tested for ultrasonic cleaning by Indiana University." This suggests external, objective testing. The document does not specify the country of origin of the data beyond "Indiana University" for ultrasonic cleaning. It is a prospective study, as the device was subjected to specific performance tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document for the performance testing of the sterilization cassettes. The assessment is against established industry standards (AAMI TIR No. 12-1994, AAMI ST 33 -1992) rather than expert consensus on individual outcomes.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the context of expert review for clinical outcomes. The performance testing appears to be based on objective measurements against scientific standards and methods outlined in AAMI documents.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or clinical interpretation where human readers are involved. This document describes a medical device for sterilization, not diagnostic interpretation.

6. If a Standalone Study Was Done

Yes, a standalone study was done. The document states: "The C/T Med-System Cassette system was independently tested according to AAMI TIR No. 12-1994 for its performance under three (3) sterilization methods - Pulsing High Vacuum and Gravity steam and Ethylene Oxide (EO). It was also tested for ultrasonic cleaning by Indiana University." This refers to the algorithm/device (cassette system) performing in isolation to meet the established performance standards.

7. The Type of Ground Truth Used

The ground truth used for this device's performance assessment is established industry standards and scientific methods for sterilization efficacy and material compatibility, specifically:

AAMI TIR No. 12-1994 (Technical Information Report for designing a sterilization process)
AAMI ST 33 -1992 (Guidelines for the safe and effective use of steam sterilization)
Standardized tests for ultrasonic cleaning.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as this is not an AI or machine learning device. The document describes performance testing for a physical medical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for CT Med-Systems LTD., INC. The logo features the letters "CT" in a bold, sans-serif font, with a caduceus symbol placed between them. Below the logo, the text "MED-SYSTEMS LTD., INC." is printed. The date "MAY 11 1998" is printed at the bottom of the image.

K980065

Non-Confidential Summary of Safety and Effectiveness

page 1 of 3 January 6, 1998

C/T Med- Systems Ltd., Inc. 3755 N. Arlington Ave. Indianapolis, IN 46218

Tel - (317) 543-4250 Fax - (317) 543-4203

Alan Booker - Operations Manager Official Contact: C/T Med-Systems Cassette System Proprietary or Trade Name: Sterilization Cassettes Common/Usual Name: Sterilization Wrapper Pack, Bag and Accessories Classification Name: C/T Med-Systems Cassette system Device: Sterilization Cassettes - K962545 Predicate Devices: Hu-Friedy - IMS - K844002

Device Description:

Indicated Use --General dental / medical instrument cassettes intended to hold instruments and accessories in place throughout the entire instrument use, cleaning and sterilization cycle. These cassettes are suitable for Gravity Steam, Pulsing High Vacuum steam and EO sterilization. Instruments may be cleaned by chemical sterilant.

Environment of Use -- Hospital, Operating Room (OR), physician and dental office or places where instruments are sterilized. Page 3 of 75

Industry Member of Safety and Effectiveness Non-Confidential Sur

Office Sterilization & Asepsis Procedures Research Foundation

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Non-Confidential Summary of Safety and Effectiveness

page 2 of 3 January 6, 1998

Summary of Performance testing --

The C/T Med-System Cassette system was independently tested according to AAMI TIR No. 12-1994 for its performance under three (3) sterilization methods - Pulsing High Vacuum and Gravity steam and Ethylene Oxide (EO). It was also tested for ultrasonic cleaning by Indiana University.

Comparison to Predicate Devices: ﺭﻳﺎﺿﻴﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮ

	CALL CARDER STATE	Sterilization . Din Teixilen . Deల్లాలు



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11-51-2017.112	中心数据
Carlos Comments11652

Use
Indicated for holding dental andmedical instruments and accessoriesin place throughout entire instrumentuse, cleaning and sterilization cycle	Yes	Yes	Assumed
Intended to be reused	Yes	Yes	Yes
Sterilization by Gravity Steam,Pulsing High Vacuum Steam andEthylene oxide	Yes	Autoclave	Not specified
Design
Various sizes offered ranging typicallyranging from 2.5" x 8" x 1.5" to8" x 15.5" x 2.5"	Yes	Yes	Yes
Utilizes various methods of holdinginstruments in place	Yes	Yes	Yes
May incorporate latch system to hold

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Non-Confidential Summary of Safety and Effectiveness

. . .

page 3 of 3

January 6, 1998

Performance Standards / Specifications
Tested in accordance to AAMI
TIR No. 12-1994	Yes	No but othermethod used	Not known
Validation study performed with halfcycles to challenge sterilizationmethod used	Yes	No	Not known
AAMI ST 33 -1992 requirements
3.4-3.5 Instructions provided fordifferent cleaning methods of cassette	Yes	Assumed	Assumed
3.6-4.2 Instructions for inspections	Yes	Assumed	Assumed
6.2.2 Sterilization manufacturerdocumentation available	Yes	Yes	Not known
6.2.3 Drying time in labeling	Yes	Not known	Not known
6.2.4 EO residual removal in labeling	Yes	Not known	Not known
6.3 User (basic) responsibilities listedin labeling	Yes	Not known	Not known
7.3.1 Routine inspection in labeling	Yes	Not known	Not known
Materials
Aluminum and stainless steel	Yes	Yes	Yes

Differences between Other Legally Marketed Predicate Devices

There are no significant differences between the intended device and the predicates - Sterilization Cassette - K962545 and Hu-Friedy - IMS - K844002.

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Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one above the other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY | | 1998

Mr. Alan Booker ·Operations Manager C/t Med Systems, Ltd., Incorporated 3755 North Arlington Avenue Indianapolis, Indiana 46218

Re : K980065 C/T Med-Systems - Sterilization Cassette Trade Name: System Regulatory Class: II Product Code: KCT Dated: April 22, 1998 Received: April 23, 1998

Dear Mr. Booker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Booker

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timot Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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TIONSTORUSET INDICA

510(k) Number:	(to be assigned)
Device Name:	C/T Med-Systems Instrument Cassette System
Intended Use :	General dental / medical instrument cassettes intended to holdinstruments and accessories in place throughout the entireinstrument use, cleaning and sterilization cycle. These cassettes aresuitable for Gravity Steam, Pre-vacuum steam and EO sterilization.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per CFR 801.109)

Over-the-counter use _________________________________________________________________________________________________________________________________________________________

(Division Sign-Off) Stearce ) Division of Dental, Infection Control, PhD and General Hospital Devices

510(k) Number _

Page 10 of 75

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).