The Tuttnauer Mini Container and Standard Case Cassettes are general 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 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 effective sterilization. The Mini Container and Standard Case Cassettes are small to medium-sized trays with silicone mats that are useful in the organization, containment and transport of medical and dental instruments. An array of Mini Container sizes are available to accommodate various instrument sizes. The Mini Container also offers an integrated instrument holder and are designed to hold hand-held instruments 2.5mm to 8mm in diameter.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Tuttnauer Mini Container Cassette and Tuttnauer Standard Case Cassette, based on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Primary Function: Allow effective sterilization of instruments within the cassette.	"Tuttnauer cassettes allow effective steam sterilization of instruments contained within them during normal autoclave operation."
Sterilization Efficacy (Gravity Steam): Achieve successful sterilization in gravity steam cycles.	"Three half-cycle tests were performed on each cassette for [gravity] steam sterilization. Successful sterilization was accomplished with all cassettes in each test."
Sterilization Efficacy (Prevacuum Steam): Achieve successful sterilization in prevacuum steam cycles.	"Three half-cycle tests were performed on each cassette for [prevacuum] steam sterilization. Successful sterilization was accomplished with all cassettes in each test."
Compatibility with Sterilization Types: Perform effectively in steam sterilization cycles.	"The devices are indicated for use in steam sterilization." (Implies effective in both gravity and prevacuum steam given the testing).
Instrument Containment: Hold instruments and accessories in place during the sterilization cycle.	"The Tuttnauer Mini Container and Standard Case Cassettes are designed to hold instruments and accessories in place during the sterilization cycle." (This is part of the intended use and implicitly met by the design). "An array of Mini Container sizes are available to aboundsted instrument holder and are designed to hold hand-held instruments 2.5mm to 8mm in diameter."
Material Durability/Compatibility: Manufactured from a chemical-resistant thermoplastic compatible with all forms of sterilization.	"Tuttnauer cassettes are manufactured from a chemical resistant thermoplastic that has been tested by its manufacturer for capability with all forms of sterilization." (Specific test results not provided, but the manufacturer's claim is presented.)
Substantial Equivalence: Demonstrate substantial equivalence to predicate devices regarding intended use, reusability, sterilization methods (gravity/vacuum steam), available sizes, instrument holding methods, and latch systems.	The comparison table indicates "Yes" for all listed criteria for Tuttnauer Cassettes, matching the predicate devices where applicable (e.g., Intended Use, Reusable, Sterilization by Gravity Steam, Sterilization by Vacuum Steam, Various size cassettes available, Various methods for holding instruments, Latch system to hold lid in place).
Compliance with AAMI TIR 12-1994: Be tested to AAMI TIR 12-1994.	"Tested to AAMI TIR 12-1994: Yes" (for Tuttnauer Cassettes).
Half-Cycle Validation: Undergo half-cycle validation to challenge sterilization.	"Half-cycle validation to challenge sterilization: Yes" (for Tuttnauer Cassettes). Actual test results indicated "Successful sterilization was accomplished with all cassettes in each test" for both gravity and prevacuum steam.

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

Test Set Sample Size: For the efficacy portion of the non-clinical testing, three half-cycle tests were performed on each cassette for each method of sterilization (gravity and prevacuum steam). This implies at least 6 tests per cassette type (3 for gravity, 3 for prevacuum), and likely 12 tests in total since both "Mini Container" and "Standard Case" cassettes were tested. The number of physical cassettes tested isn't explicitly stated beyond "each cassette."
Data Provenance: The document does not specify the country of origin of the data. The study was conducted by Tuttnauer, a U.S. company. The study is prospective as it describes specific validation studies performed by the manufacturer for the purpose of this submission.

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. The type of testing performed (half-cycle sterilization validation) typically involves laboratory-based methods and the use of biological or chemical indicators to assess sterility, rather than expert human interpretation of results in the traditional sense of medical imaging or diagnostic devices. Someone performed the tests and evaluated the indicators for "successful sterilization," but their qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the study describes physical performance testing (sterilization efficacy) rather than human interpretation of data requiring adjudication. The assessment of "successful sterilization" would be based on objective indicators rather than subjective expert 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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a medical instrument cassette, not an AI-powered diagnostic or assistive tool, so such a study would be irrelevant.

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

Not applicable. This device is a physical product (a sterilization cassette), not an algorithm or software. Therefore, standalone algorithm performance testing is not relevant or described.

7. The Type of Ground Truth Used

The ground truth used for the sterilization efficacy tests was likely based on:

Biological Indicators (BIs): These contain highly resistant bacterial spores; their inactivation after a sterilization cycle confirms sterility.
Chemical Indicators (CIs): These change color or form upon exposure to specific sterilization parameters (e.g., steam, temperature, time).
Physical Monitoring: Readings from sterilizer gauges or printouts (temperature, pressure, time).

The combination of these, particularly the BIs, would establish the "successful sterilization" ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve machine learning or AI, so there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Summary

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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: 516-737-0720 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:

	TuttnauerCassettes	Riley Medical	PST Trays	C/T MedicalSystems
Intended Use -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 andStainless 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 (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,

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

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 CassetteTuttnauer Standard Case Cassette
Indications For Use:	The Tuttnauer Mini Container and Standard Case Cassettes are generadental/medical instrument cassettes intended to hold instruments andaccessories in place during the sterilization cycle. The devices areindicated 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)

0031

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).