(115 days)
Not Found
No
The device description and performance studies focus on the mechanical and fluid delivery aspects of the kit, with no mention of AI or ML technologies.
No
This device is an accessory (kit) for an ultrasonic scaler, designed to provide sterile fluid delivery during dental procedures. It does not directly provide therapeutic treatment itself but facilitates the sterile operation of a therapeutic device.
No
The device is an accessory for an ultrasonic scaler, indicated for the removal of calculus, plaque, and stain from teeth, with a focus on sterile fluid delivery during these procedures. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components: a pressurized infuser bag and a Steri-Mate Handpiece Adapter. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "supragingival and subgingival removal of calculus, plaque and stain from teeth with sterile fluid delivery." This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is an accessory for an ultrasonic scaler used in dental procedures. It facilitates the delivery of sterile fluid during these procedures. This aligns with a therapeutic/procedural function.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / 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.
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.
Product codes
ELC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician, operative dentistry
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The word is horizontally oriented and appears to be a logo or brand name.
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:
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
DENTSPLY International
00012
1
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 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
2
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.
3
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:
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.
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