STERILE SUREFLEX® FILES AND INSTRUMENTS are precision instruments cut from a nickel titanium shaft for increased flexibility over stainless steel instruments. They conform better to the curved surface of most root canals. They reduce the chance of apical transportation and breakage from binding in the canal. They feature non-slip plastic handles for a firmer grip, as well as ISO color coding for easy identification.

After sterilization, these files and instruments presented the same resistance in torsion and shear stress as non-sterilized instruments. No significant change in color or mechanical behavior of the plastic handles was evident following gamma irradiation.

The device package is a compartmentalized container with six (6) individually separated cells. The package includes a heat-sealed non-tearing perforated thermal adhesive strip. This strip allows for a single cell to be opened per file as required by the dentist, while all other file cells remain sealed and sterile.

AI/ML Overview

This document is a 510(k) summary for DENTSPLY's STERILE SUREFLEX® FILES AND INSTRUMENTS. It primarily focuses on demonstrating substantial equivalence to a previously marketed non-sterile version of the same product, rather than providing the kind of detailed performance study typically associated with AI/software-as-a-medical-device (SaMD) clearances. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable as the submission is not about an AI/ML device or a device requiring complex performance validation.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance
Identity to Predicate Device (Composition, Manufacturing Process, Sterilization Process)	"identical to the Presterilized SureFlex® files and instruments now marketed" (K951607)
Sterility (Proof of effective sterilization)	"subjected to sterilization by gamma irradiation from a Cobalt 60 source." Validation method: "AAMI Method 1."
Mechanical Properties after Sterilization (Torsion, Shear Stress, Plastic Handle Behavior)	"presented the same resistance in torsion and shear stress as non-sterilized instruments.""No significant change in color or mechanical behavior of the plastic handles was evident following gamma irradiation."
Intended Use	"Used to file and shape root canals and to remove necrotic tissue as a means to create a funnel-shaped cavity."
Packaging Integrity	"compartmentalized container with six (6) individually separated cells.""heat-sealed non-tearing perforated thermal adhesive strip." (Allows single cell opening while others remain sterile)

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

Sample Size for Test Set: Not explicitly stated as a separate "test set" for performance evaluation in the way a clinical trial for software would. The "test" involved comparing the properties of sterilized versus non-sterilized instruments. The number of instruments tested for torsion, shear stress, and handle behavior is not specified.
Data Provenance: The study was conducted by DENTSPLY, likely internal testing. The country of origin of the data is not specified but is implicitly associated with DENTSPLY's manufacturing and testing facilities (York, PA, USA). It is a prospective evaluation of the new, sterilized devices.

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

Not applicable. This submission is for a physical medical device (dental files), not an AI/ML-based diagnostic or imaging device requiring expert ground truth for classification. The "ground truth" for mechanical properties would be measured values, and for sterility, it would be the results of standard sterility tests.

4. Adjudication Method for the Test Set

Not applicable. There was no human interpretation or adjudication in the sense of a diagnostic classification. The measurements were objective (e.g., resistance in torsion, presence/absence of microbial growth post-sterilization).

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

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used

Objective Measurements/Standards:
- Sterility: Adherence to "AAMI Method 1" for sterilization validation. This method typically involves biological indicators and direct testing for microbial growth.
- Mechanical Integrity: Measured resistance in torsion and shear stress, and visual/physical assessment of plastic handle behavior (color, mechanical properties). The "ground truth" is that these values should be "the same" as the non-sterilized predicate device.
- Composition/Manufacturing: Direct comparison to the predicate device to confirm identical nature.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. (See point 8)

Summary

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510(k) SUMMARY

K971603

DENTSPLY

NAME & ADDRESS:

DENTSPLY International

570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 ax (717) 854-2343-

P. J. Lehn Telefax (717) 849-4343

CONTACT: P. Jeffery Lehn

4 1997 II IN

DATE PREPARED: April 29, 1977

TRADE OR PROPRIETARY NAME: STERILE SUREFLEX® FILES AND INSTRUMENTS

COMMON OR USUAL NAME: Files and Instruments

CLASSIFICATION NAME: Dental hand instruments 872.4565

K951607 LEGALLY MARKETED DEVICE: Presterilized SureFlex® Files

DEVICE DESCRIPTION: STERILE SUREFLEX® FILES AND INSTRUMENTS are manufactured for DENTSPL.Y Caulk by DENTSPLY Maillefer®. They are identical to the Presterilized SureFlex® files and instruments now marketed (K951607). However, DENTSPLY Caulk plans to market these devices as sterile and to revise the labeling to reflect this change. There are no changes to the composition, manufacturing process, or sterilization process.

INTENDED USE: STERILE SUREFLEX® FILES AND INSTRUMENTS are used to file and shape root canals and to remove necrotic tissue as a means to create a funnel-shaped cavity.

TECHNOLOGICAL CHARACTERISTICS: As noted above, there are no changes in the composition, manufacturing or sterilization of these files and instruments.

These files and instruments were subjected to sterilization by gamma irradiation from a Cobalt 60 source. The validation method used was AAMI Method 1.

We believe that the fact that the new device is identical to the predicate device, along with the sterilization data presented, supports the safety and effectiveness of STERILE SUREFLEX® FILES AND INSTRUMENTS for the intended uses.

000010

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Image /page/1/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 1997

Mr. P. Jeffrey Lehn ·Director, Corporate Compliance and Regulatory Affairs Baxter Healthcare Corporation DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872 :44

K971603 Re : Sterile Sureflex® Files and Instruments Trade Name: Requlatory Class: I Product Code: EFA Dated: April 29, 1997 Received: May 01, 1997

Dear Mr. Lehn:

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 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) requlation (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 requlation 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. Lehn

11 2017 11:40

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) 594-4618. 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 at (301). 443-6597.

Sincerely yours

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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PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 801.109) .....

510(K) Number:

Device Name:

STERILE SUREFLEX® FILES AND INSTRUMENTS

Indications for Use:

Used to file and shape root canals and to remove necrotic tissue as a means to create a funnel-shaped cavity.

Susan Plassman

Concurrence of CDRH, Office of Device Evaluation (ODE) (Divisio 510k) ાર

Over-The-Counter Use __

000007

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.