MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES

K101653 · Miltex, Inc. · KCT · Aug 2, 2010 · General Hospital

Device Facts

• Record ID: K101653
• Device Name: MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES
• Applicant: Miltex, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Aug 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

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 Story

Miltex® Thompson™ Cassettes are surgical-grade passivated stainless steel containers designed to organize, store, and protect dental/surgical instruments. Used in dental, surgical, or veterinary settings by clinicians/staff. Instruments are manually placed into internal racks/grooves; cassette lid is closed and secured. The loaded cassette is wrapped in FDA-cleared sterilization wrap and processed in a gravity or pre-vacuum steam autoclave. The device facilitates organized instrument handling, protects instruments from damage, and maintains sterility post-processing when used with appropriate wraps. Benefits include improved workflow efficiency and instrument protection during sterilization and storage.

Clinical Evidence

Bench testing only. Validation performed for gravity steam (250°F/121°C, 30 min exposure, 20 min dry) and pre-vacuum steam (270°F/132°C, 4 min exposure, 20 min dry). Testing confirmed no adverse effects and structural integrity for up to 50 sterilization cycles.

Technological Characteristics

Materials: Surgical-grade passivated stainless steel. Form factor: Various configurations (racks, utility, bur holders) designed for standard autoclaves. Energy source: None (passive). Sterilization: Compatible with gravity and pre-vacuum steam. Connectivity: None. Software: None.

Indications for Use

Indicated for use in dental, surgical, or veterinary procedures to hold instruments and accessories during storage and sterilization cycles. No specific patient population or contraindications identified.

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.

Submission Summary (Full Text)

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

Miltex.

# AUG 0 2 2010

#### Miltex® Thompson™ Cassettes

#### 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.

#### 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.
- 2. Cassettes may be cleaned in an ultrasonic cleaner with an enzymatic solution, such as Miltex EZ-Zyme All Purpose Enzyme Cleaner.
- 3. 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.
- 5. 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.
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K101653 p2.13

- 2. Remove visible debris from each reusable instrument by scrubbing instrument manually with an instrument brush and surfactant or detergent and water.
- 3. Rinse with water to remove chemical or detergent residue.
- 4. 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.
- 5. Close cassette lid tightly after placing instruments in cassette.

#### Sterilization

- 1. Wrap cassette in FDA-cleared sterilization wrap; seal wrap with autoclave tape.
- 2. Date and code cassette on autoclave tape or label on outside of wrapped cassette.
- 3. 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

- 4. 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

3

# 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.

1

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

©2010 Miltex, Inc. All rights reserved.

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 [phone] or [phone] 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:

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.

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