TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE

K990761 · Tuttnauer U.S.A Co, Ltd. · FRG · Jul 9, 1999 · General Hospital

Device Facts

• Record ID: K990761
• Device Name: TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE
• Applicant: Tuttnauer U.S.A Co, Ltd.
• Product Code: FRG · General Hospital
• Decision Date: Jul 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Tuttnauer Mini Container and Standard Case Cassettes are genera dental/medical instrument cassettes intended to hold instruments and accessories in place during the sterilization cycle. The devices are indicated for use in both gravity and pre-vacuum steam sterilization.

Device Story

Tuttnauer Mini Container and Standard Case Cassettes are reusable sterilization trays designed to organize and secure medical/dental instruments during autoclave cycles. Cassettes consist of chemical-resistant thermoplastic bodies with biomedical-grade silicone inserts to stabilize instruments (2.5mm to 8mm diameter). Devices feature a latching lid system to maintain instrument position. Used in clinical settings by healthcare staff to facilitate steam sterilization; cassettes allow steam penetration to ensure effective processing. Benefit includes organized instrument transport and protection during sterilization.

Clinical Evidence

Bench testing only. Validation studies performed for both gravity and pre-vacuum steam sterilization methods. Three half-cycle tests conducted per cassette type for each sterilization method. Successful sterilization achieved in all tests.

Technological Characteristics

Materials: Chemical-resistant thermoplastic body, biomedical-grade silicone instrument inserts. Design: Cassette form factor with latching lid. Sterilization: Gravity and pre-vacuum steam. Standards: Tested to AAMI TIR 12-1994.

Indications for Use

Indicated for use as a container to hold dental and medical instruments and accessories in place during gravity and pre-vacuum steam sterilization cycles.

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

• Surgical Instrument Tray (K944025)
• PST Trays (Unknown)
• C/T Med-Systems Cassette System (K980065)

Submission Summary (Full Text)

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JUL 12 1999

## 510(k) Summary

K930761

Tuttnauer USA Co. Ltd. Submitter: 33 Comac Loop, Equi-Park Ronkonkoma, NY 11779

> 800-624-5836 Phone: [phone] Fax:

Robert R. Basile Contact Name:

March 8, 1999 Date Prepared:

Common Name: Sterilizer Cassette

- Tuttnauer Mini Container Cassette Trade Name: Tuttnauer Standard Case Cassette
- Accessory to Sterilization Wrap Classification Name: Class II Device - 21 C.F.R. § 880.6850

# Substantial Equivalence:

The Tuttnauer Mini Container and Standard Case Cassettes are substantially equivalent to the following currently marketed sterilization cassettes:

| Company | Product Name | 510(k) Clearance Number |
|--------------------------------|---------------------------------|-------------------------|
| Riley Medical, Inc. | Surgical Instrument Tray | K944025 |
| Plastic Sterilizing Tray Corp. | PST Trays | Unknown |
| C/T Med-Systems Ltd., Inc | C/T Med-Systems Cassette System | K980065 |

## General Description:

The Tuttnauer Mini Container Cassette and Tuttnauer Standard Case Cassette are sterilization cassettes that are designed to allow steam to pass through the device to ensure Sterlization Cassettes that are designed to anothers are small to medium-sized trays with silicone mats effective sterifization: "The Mini: Committed on and transport of medical and dental instruments. that are useral in the organization, ce available to accommodate various instrument An array of Milli Container sizes are available to aboundsted instrument holder and are designed to hold hand-held instruments 2.5mm to 8mm in diameter.

## Design and Materials:

Tuttnauer cassettes are manufactured from a chemical resistant thermoplastic that has been tested by its manufacturer for capability with all forms of sterilization. Cassette inserts used to stabilize the instruments are manufactured from biomedical grade silicone.

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#### Intended Use:

The Tuttnauer Mini Container and Standard Case Cassettes are general dental/medical instrument cassettes intended instruments and accessories in place during the sterlization cycle. The devices are indicated for use in steam sterilization.

## Technology Considerations:

The following is a chart showing the similarities and difference between the Tuttnauer Mini Container and Tuttnauer Standard Case cassettes and their predicate devices:

| | Tuttnauer<br>Cassettes | Riley Medical | PST Trays | C/T Medical<br>Systems |
|------------------------------------------------------------|------------------------|-----------------|-----------------|---------------------------------|
| Intended Use -<br>To hold instruments during sterilization | Yes | Yes | Yes | Yes |
| Reusable | Yes | Yes | Yes | Yes |
| Sterilization by Gravity Steam | Yes | Yes | Yes | Yes |
| Sterilization by Vacuum Steam | Yes | Yes | Yes | Yes |
| Sterilization by Ethylene Oxide | Not Requested | Yes | Yes | Yes |
| Tested to AAMI TIR 12-1994 | Yes | No | Unknown | Yes |
| Half-cycle validation to challenge sterilization | Yes | No | Unknown | Yes |
| Various size cassettes available | Yes | Yes | Yes | Yes |
| Various methods for holding instruments | Yes | Yes | Yes | Yes |
| Latch system to hold lid in place | Yes | Yes | Yes | Yes |
| Material | Plastic Polymer | Plastic Polymer | Plastic Polymer | Aluminum and<br>Stainless Steel |

#### Non-Clinical Testing:

Tuttnauer conducted validation studies on the Mini Container and Standard Case cassettes for gravity and prevacuum steam sterilization. Three half-cycle tests were performed on each cassette for each method of sterilization. Successful sterilization was accomplished with all cassettes in each test.

#### Conclusion:

It is Tuttnauer USA Co. Ltd.'s conclusion that the Tuttnauer Mini Container Cassette and Tuttnauer Standard Case Cassette are substantially equivalent to their predicate devices. Based upon test data submitted, Tuttnauer cassettes allow effective steam sterilization of instruments contained within them during normal autoclave operation.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1.2 1999

Tuttnauer USA Company, LTD. c/o Mark M. Yacura, Esquire Akin, Gump, Strauss, Hauer & Feld, L.L.P. 1333 New Hampshire Avenue, N.W. Suite 400 Washington, DC 20036

Re : K990761 Trade Name: Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette Regulatory Class: II Product Code: FRG Dated: June 7, 1999 Received: June 7, 1999

Dear Mark M. Yacura, Esquire:

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 of the Act. The general controls provisions of the Provis 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 Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Mcdical 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.

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Page 2 - Mark M. Yacura, Esquire

Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of 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 leqally 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 regulation (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,

and the many of the starting to the starting the first of the first of the first of the first of the first of the first of the first and the first and the first and the first

Short a

Ti

Timothy A. Ulatowski 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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| 510(k) Number: | K990761 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Tuttnauer Mini Container Cassette<br>Tuttnauer Standard Case Cassette |
| Indications For Use: | The Tuttnauer Mini Container and Standard Case Cassettes are genera<br>dental/medical instrument cassettes intended to hold instruments and<br>accessories in place during the sterilization cycle. The devices are<br>indicated for use in both gravity and pre-vacuum steam sterilization. |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

(FLEASE DO NOT MICTE BEDO MINIS BEDO F - 12 - 40 - 40 - 40 - 40 - - - --------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|-------------------------|---|
| OR Over-The-Counter Use | X |

(Per 21 C.F.R. § 801.109)

| (Division Sign-Off) | |
|---------------------------------------------------------------------|---------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K990761 |

(Optional Format 1-2-96)

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