C/T MED-SYSTEMS CASSETTE SYSTEM

K980065 · C/T Med System, Ltd. · KCT · May 11, 1998 · General Hospital

Device Facts

• Record ID: K980065
• Device Name: C/T MED-SYSTEMS CASSETTE SYSTEM
• Applicant: C/T Med System, Ltd.
• Product Code: KCT · General Hospital
• Decision Date: May 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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, Pre-vacuum steam and EO sterilization.

Device Story

The C/T Med-Systems Instrument Cassette System is a reusable metal container made of aluminum and stainless steel, designed to organize and secure dental and medical instruments. The system is used in hospitals, operating rooms, and dental offices to hold instruments throughout the entire cycle of use, cleaning, and sterilization. It supports multiple sterilization methods, including Gravity Steam, Pulsing High Vacuum steam, and Ethylene Oxide (EO). Instruments can also be cleaned via chemical sterilant while inside the cassette. The device provides a structured environment for instrument management, reducing handling and potential injury during the sterilization process. Healthcare providers use the cassettes to maintain instrument organization and sterility from the point of use through the cleaning and sterilization workflow.

Clinical Evidence

No clinical data. Performance was established through bench testing in accordance with AAMI TIR No. 12-1994. Testing validated the cassette system's performance under three sterilization methods: Pulsing High Vacuum steam, Gravity steam, and Ethylene Oxide (EO). Ultrasonic cleaning efficacy was also verified by Indiana University.

Technological Characteristics

Materials: Aluminum and stainless steel. Form factor: Metal containers in various sizes (typically 1.5" x 3.5" x 1" to 8" x 15.5" x 2.5"). Sterilization compatibility: Gravity Steam, Pulsing High Vacuum steam, and Ethylene Oxide (EO). Design features: Internal instrument holding mechanisms, optional latch system.

Indications for Use

Indicated for holding dental and medical instruments and accessories in place during use, cleaning, and sterilization cycles in hospital, operating room, physician, and dental office settings.

Regulatory Classification

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.

Predicate Devices

• Sterilization Cassettes (K962545)
• Hu-Friedy - IMS (K844002)

Submission Summary (Full Text)

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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 - [phone] Fax - [phone]

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:

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".

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 . De<br>ల్లాలు |
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| Use | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-----------|---------------|
| Indicated for holding dental and<br>medical instruments and accessories<br>in place throughout entire instrument<br>use, cleaning and sterilization cycle | Yes | Yes | Assumed |
| Intended to be reused | Yes | Yes | Yes |
| Sterilization by Gravity Steam,<br>Pulsing High Vacuum Steam and<br>Ethylene oxide | Yes | Autoclave | Not specified |
| Design | | | |
| Various sizes offered ranging typically<br>ranging from 2.5" x 8" x 1.5" to<br>8" x 15.5" x 2.5" | Yes | Yes | Yes |
| Utilizes various methods of holding<br>instruments 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 other<br>method used | Not known |
| Validation study performed with half<br>cycles to challenge sterilization<br>method used | Yes | No | Not known |
| AAMI ST 33 -1992 requirements | | | |
| 3.4-3.5 Instructions provided for<br>different cleaning methods of cassette | Yes | Assumed | Assumed |
| 3.6-4.2 Instructions for inspections | Yes | Assumed | Assumed |
| 6.2.2 Sterilization manufacturer<br>documentation 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 listed<br>in 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 hold<br>instruments and accessories in place throughout the entire<br>instrument use, cleaning and sterilization cycle. These cassettes are<br>suitable for Gravity Steam, Pre-vacuum steam and EO sterilization. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per CFR 801.109)

*****************************************************************************************************************************************************************************

or

Over-the-counter use _________________________________________________________________________________________________________________________________________________________

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

510(k) Number _

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