The Cavitron Steri-Mate Handpiece Sterile Lavage Kit is indicated for use with the DENTSPLY Cavitron Ultrasonic Scaler in general prophylaxis and periodontal treatments, and other areas of operative dentistry for the supragingival and subgingival removal of calculus, plaque and stain from teeth with sterile fluid delivery.

Device Description

The Cavitron® Steri-Mate® Handpiece Sterile Lavage Kit is an accessory for Cavitron® Ultrasonic Scalers that use the 30K Steri-Mate® Sterilizable Handpiece. This kit is intended to provide the clinician with a method to use sterile lavage with a Cavitron® Ultrasonic Scaler. The kit consists of a pressurized infuser bag and a Steri-Mate Handpiece Adapter. The Pressurized Infuser bag can be hung from a standard IV pole or similar device. The Steri-Mate Handpiece Adapter is easily installed between the handpiece cable and the Steri-Mate Handpiece. The adapter does not affect the operation of the Cavitron® Unit or the Steri-Mate Handpiece.

AI/ML Overview

The provided document is a 510(k) summary for the Cavitron Steri-Mate Handpiece Sterile Lavage Kit, which is an accessory for ultrasonic scalers used in dentistry. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and quantitative results for a specific performance characteristic (like diagnostic accuracy).

Therefore, many of the requested elements for describing a study proving acceptance criteria cannot be extracted directly from this document. However, I can provide the available information based on the text.

Here's a breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence: Device functions with the Steri-Mate Handpiece for Cavitron Jet.	"The Adapter has been verified to function with the Steri-Mate Handpiece for Cavitron Jet."
Performance Equivalence: Maintains same performance for ultrasonic removal of material from dental surfaces as the predicate device.	"Additionally, comparative operations demonstrate that the Steri-Mate Handpiece Sterile Lavage Kit maintains the same performance to ultrasonically remove material from dental surfaces with the currently marketed device."
Sterile Fluid Delivery Capability: Capable of delivering sterile solutions.	"Validation of the ability of the Sterile Lavage Handpiece Adapter Kit to deliver sterile lavage was tested to the procedures described in the United States Pharmacopeia (31), National Formulary (26), 2008, Chapter <71> Sterility Test. Results have documented that the system is capable of delivering sterile solutions when assembled as directed in the Directions for Use."
Electrical Safety: No active electronic components (implying no need for IEC 60601-1 testing).	"The Steri-Mate Handpiece Sterile Lavage Kit contains no active electronic components. The Steri-Mate Handpiece Adapter allows the use of an external sterile water source. The source is not supplied with the product. Therefore, testing to IEC 60601-1 was considered not necessary based on engineering considerations."
Safety and Effectiveness Equivalence: The use of sterile fluid as a source of lavage is as safe, effective, and performs as well as the predicate device.	"The results of testing demonstrate that the use of sterile fluid as a source of lavage is as safe, effective and performs as well to the currently-marketed predicate device." (This is a summary conclusion based on the noted functional and performance comparisons and sterile delivery validation.)

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

Sample Size: Not explicitly stated. The document refers to "comparative operations" and "testing to the procedures described in the United States Pharmacopeia (31), National Formulary (26), 2008, Chapter <71> Sterility Test." These typically involve controlled laboratory tests rather than human subject test sets with "samples."
Data Provenance: The sterility testing refers to the United States Pharmacopeia, implying performance was validated according to US standards. The nature of the "comparative operations" data provenance (e.g., in-house testing, external lab) is not specified. It is likely retrospective in the sense that the device was developed and then tested.

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

Not applicable. The tests performed are engineering/performance validations (e.g., functionality, sterility), not diagnostic accuracy studies requiring expert-established ground truth on a test set (e.g., imaging review).

4. Adjudication Method for the Test Set

Not applicable, as this was not a study requiring adjudication of expert opinions (e.g., 2+1, 3+1). The testing involved objective measurements and procedures (e.g., sterility test, functional verification).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This sort of study is not relevant to this device, which is an accessory for an ultrasonic scaler and not a diagnostic or AI-based image interpretation tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is an accessory to a human-operated medical device. There is no algorithm, and therefore no a standalone algorithm performance measurement.

7. The Type of Ground Truth Used

For the sterile fluid delivery capability, the ground truth was established by following the procedures and standards outlined in the United States Pharmacopeia (31), National Formulary (26), 2008, Chapter <71> Sterility Test. This is a laboratory-based, objective standard for sterility.
For functional and performance equivalence, the ground truth was established by direct comparison to the performance of the predicate device. This would involve quantifiable measures of operation (e.g., ultrasonic vibration, fluid flow) relative to the predicate device.

8. The Sample Size for the Training Set

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

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

Not applicable. No training set was used.

Summary

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K082973

JAN 2 9 2009

Cavitron Steri-Mate Handpiece Sterile Lavage Kit

DENTSPLY International

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 (717) 845-7511 (voice) 717) 849-4343 (fax) www.dentsply.com

510(k) SUMMARY

for

Cavitron Steri-Mate Handpiece Sterile Lavage Kit

Submitter Information: 1.
DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

Contact Person:	Helen Lewis
Telephone Number:	717-849-4229
Fax Number:	717-849-4343

Date Prepared:

October 2, 2008

Ultrasonic Scaler

§ 872.4850

Class II

ELC

2. Device Name:

Proprietary Name: �
Classification Name: ●
CFR Number: .
Device Class: .
Product Code: .

3. Predicate Device:

DENTSPLY International Company: Steri-Mate Handpiece for Cavitron Jet Device: 510(k) No .: K941392 Date Cleared: 05/23/1994

4. Description of Device:

DENTSPLY International

00012

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with a Cavitron® Ultrasonic Scaler. The kit consists of a pressurized infuser bag and a Steri-Mate Handpiece Adapter. The Pressurized Infuser bag can be hung from a standard IV pole or similar device. The Steri-Mate Handpiece Adapter is easily installed between the handpiece cable and the Steri-Mate Handpiece. The adapter does not affect the operation of the Cavitron® Unit or the Steri-Mate Handpiece.

ર. Indications for Use:

The Steri-Mate Handpiece Sterile Lavage Kit is intended for use with a Cavitron Ultrasonic Scaler in general prophylaxis and periodontal treatments, and other areas of operative dentistry for the supragingival and subgingival removal of calculus, plaque and stain from teeth with sterile fluid delivery.

6. Description of Safety and Substantial Equivalence:

Technological Characteristics

The Steri-Mate Handpiece Adapter is an accessory for the currently marketed Steri-Mate Handpiece for Cavitron Jet (K941392). The Adapter has been verified to function with the Steri-Mate Handpiece for Cavitron Jet. Additionally, comparative operations demonstrate that the Steri-Mate Handpiece Sterile Lavage Kit maintains the same performance to ultrasonically remove material from dental surfaces with the currently marketed device.

Non-Clinical Performance Data.

The Steri-Mate Handpiece Sterile Lavage Kit contains no active electronic . components. The Steri-Mate Handpiece Adapter allows the use of an external sterile water source. The source is not supplied with the product. Therefore, testing to IEC 60601-1 was considered not necessary based on engineering considerations.
. Validation of the ability of the Sterile Lavage Handpiece Adapter Kit to deliver sterile lavage was tested to the procedures described in the United States Pharmacopeia (31), National Formulary (26), 2008, Chapter <71> Sterility Test. Results have documented that the system is capable of delivering sterile solutions when assembled as directed in the Directions for Use.

Conclusion as to Substantial Equivalence

The results of testing demonstrate that the use of sterile fluid as a source of lavage is as safe, effective and performs as well to the currently-marketed predicate device.

DENTSPLY International

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol. The logo is black and white.

Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Helen Lewis · Director, Corporation Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street Suite 60 York, Pennsylvania 17405-0872

JAN 2 9 2009

Re: K082973

Trade/Device Name: Steri-Mate Handpiece Sterile Layage Kit Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: January 22, 2009 Received: January 23, 2009

Dear Ms. Lewis:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Anthony D. Watson for

Ginette Y. Michaud, M.D Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Steri-Mate Handpiece Sterile Lavage Kit

Indications for Use:

1082973

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

000011

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Renne

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082973

DENTSPLY International

Cavitron Steri-Mate Handpiece Sterile Lavage Kit

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.