(89 days)
The StarCare Handpiece Maintenance Unit is intended for the internal cleaning, i.e purging of old lubricant, and the lubrication of air-driven high speed handpieces, electric micromotor attachments and turbines used in dentistry.
StarCare Handpiece Maintenance Unit should be used only after the handpieces have been externally cleaned and prior to sterilization.
The StarCare Handpiece Maintenance Unit is used for the cleaning, i.e. purging of old lubricant, and lubrication of lubricated high speed handpieces, electric micromotor attachments and handpiece turbines. The unit consists of two connections for high speed handpieces, one connection for electric micromotor attachments and one connection for handpiece turbine cleaning. The unit supplies cleaner and lubricant to the connection only when a high speed handpiece or electric micromotor attachment is present. The handpiece turbine cleaning function is independent of the high speed handpiece and electric micromotor attachment cleaning and lubrication function.
Two reservoirs within the unit supply the cleaner and lubricant to the individual stations. These reservoirs are clearly marked regarding the contents of the reservoir. The cleaner and lubricant are delivered to the high speed handpiece and electric micromotor attachment connection via tubes controlled by the activation of magnetic valves. The liquid is dispensed by pressurized air to the high speed handpiece and electric micromotor attachment.
The StarCare Handpiece Maintenance Unit is a device used for the cleaning and lubrication of dental handpieces. The provided text is a 510(k) summary, which outlines the device's characteristics and its equivalence to predicate devices, rather than a study report detailing performance against acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria, study design, and performance metrics for the StarCare Handpiece Maintenance Unit is not directly available within this document.
However, based on the information provided, we can infer some aspects and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from 510(k) context) | Reported Device Performance (as stated or implied) |
|---|---|
| Cleaning (Purging Old Lubricant) | "used for the cleaning, i.e. purging of old lubricant" |
| Lubrication | "and lubrication of lubricated high speed handpieces, electric micromotor attachments and handpiece turbines" |
| Compatibility with handpiece types | Compatible with "high speed handpieces, electric micromotor attachments and handpiece turbines" |
| Independent operation of turbine cleaning | "handpiece turbine cleaning function is independent of the high speed handpiece and electric micromotor attachment cleaning and lubrication function." |
| Detection of connected handpiece/attachment | "The unit detects if a high speed handpiece or electric micromotor attachment is connected and delivers cleaner and lubricant only to the occupied stations." |
| Purging excess cleaner/lubricant | "After cleaning and lubrication cycle a burst of compressed air is forced into the high speed handpiece or electric micromotor attachment to purge the instrument of excess cleaner, lubricant and debris." |
| Electrical Safety | Similar to predicate devices (IMPLIES meeting safety standards, but no specific performance stated) |
| Mechanical Safety | Identical to predicate devices (IMPLIES meeting safety standards, but no specific performance stated) |
| Biocompatibility | Identical to predicate devices (IMPLIES meeting relevant standards, but no specific performance stated) |
| Chemical Safety | Identical to predicate devices (IMPLIES meeting relevant standards, but no specific performance stated) |
Missing Information: The document does not provide quantifiable acceptance criteria (e.g., "removes X% of old lubricant," "lubricates sufficiently to extend handpiece life by Y%," or specific technical performance metrics for cleaning/lubrication efficacy). Performance is generally described in terms of its intended function and similarity to predicate devices, not through specific test results against defined criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. This 510(k) summary does not describe a clinical or performance study with a defined test set of units or handpieces.
- Data Provenance: Not applicable, as no specific performance data from a "test set" is presented. The document focuses on technological comparison to predicate devices, not primary performance data.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts
- Not applicable. This is not a study involving expert-established ground truth. The demonstration of safety and effectiveness relies on substantial equivalence to existing predicate devices, rather than a new clinical or performance study requiring expert adjudication of outcomes.
4. Adjudication Method for the Test Set
- Not applicable. There is no described test set or adjudication process in this document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in this 510(k) summary. This type of study is typical for diagnostic imaging devices involving human readers, which is not the nature of the StarCare Handpiece Maintenance Unit.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a mechanical unit, not an algorithm. Therefore, no standalone algorithm performance study would be relevant or discussed. The device's performance is intrinsically linked to its physical operation and interaction with the dental handpieces.
7. Type of Ground Truth Used
- Not applicable. For this type of device and submission, "ground truth" in the sense of expert consensus, pathology, or outcomes data is not utilized to demonstrate equivalence. The "ground truth" for a 510(k) submission generally refers to the established safety and effectiveness of the predicate devices to which the new device is compared. The claim is that the new device is "substantially equivalent" in its performance, intended use, and technological characteristics to devices already cleared for market.
8. Sample Size for the Training Set
- Not applicable. There is no "training set" for this device, as it is a mechanical unit, not an AI/ML algorithm or a diagnostic tool that learns from data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, for the same reasons as point 8.
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DEC 2 8 2009
510(k) Premarket Notification StarCare Handpiece Maintenance Unit Section 5
510(k) Summary
Section 5: 510(k) Summary
Company:
DentalEZ Inc., StarDental Division Owner/operator number 2520265
Contact Person:
Dale Braas, Engineering/Quality Manager Kay Engle, Regulatory Affairs Supervisor DentalEZ Inc., StarDental Division 1816 Colonial Village Lane Lancaster, PA 17601 Phone: (717) 291-1161 Fax: (717) 391-2757
Proprietary/Trade Name:
StarCare Handpiece Maintenance Unit
Classification:
Handpiece, Air-powered, Dental (21 C.F.R. § 872.4200, Product code EFB)
Predicate Device:
Statmatic, manufactured by SciCan LTD. Ontario, Canada (K073319) Lubrina, manufactured by J. Morita USA, Inc., Irvine, CA. (K070074) Assistina, manufactured by A-Dec Incorporated, Newburg, OR (K010127)
StarCare Handpiece Maintenance Unit has similar intended uses, similar methods of operation and similar technology to the previously cleared predicate devices. Although minor differences exist between the StarCare Handpiece Maintenance Unit and predicate devices, they do not present any new questions of safety or effectiveness.
Device Description:
The StarCare Handpiece Maintenance Unit is used for the cleaning, i.e. purging of old lubricant, and lubrication of lubricated high speed handpieces, electric micromotor attachments and handpiece turbines. The unit consists of two connections for high speed handpieces, one connection for electric micromotor
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attachments and one connection for handpiece turbine cleaning. The unit supplies cleaner and lubricant to the connection only when a high speed handpiece or electric micromotor attachment is present. The handpiece turbine cleaning function is independent of the high speed handpiece and electric micromotor attachment cleaning and lubrication function.
Two reservoirs within the unit supply the cleaner and lubricant to the individual stations. These reservoirs are clearly marked regarding the contents of the reservoir. The cleaner and lubricant are delivered to the high speed handpiece and electric micromotor attachment connection via tubes controlled by the activation of magnetic valves. The liquid is dispensed by pressurized air to the high speed handpiece and electric micromotor attachment.
Intended Use:
The StarCare Handpiece Maintenance Unit is intended for the internal cleaning. i.e. purging of old lubricant, and the lubrication of air-driven high speed handpieces, electric micromotor attachments and turbines used in dentistry.
StarCare Handpiece Maintenance Unit should be used only after the handpieces have been externally cleaned and prior to sterilization.
Technological Characteristics:
The StarCare Handpiece Maintenance Unit is a self-contained cleaning and lubrication system that can clean and lubricate up to two high speed handpieces and one electric micromotor attachment at the same time. Indicator lights on the front panel of the unit, show which handpiece station is currently being serviced. The cleaner and lubricant are pumped from separate reservoirs located within the unit. The unit detects if a high speed handpiece or electric micormotor attachment is connected and delivers cleaner and lubricant only to the occupied stations. After cleaning and lubrication cycle a burst of compressed air is forced into the high speed handpiece or electric micromotor attachment to purge the instrument of excess cleaner, lubricant and debris.
The handpiece turbine cleaning function of the StarCare Handpiece Maintenance Unit is independent of the high speed handpiece and electric micromotor attachment cleaning and lubrication. With the front door of the unit oven, the operator holds the handpiece in place during the handpiece turbine cleaning process. After the cleaning and lubrication cycle a burst of compressed air is forced into the chuck to purge the excess cleaner, lubricant and debris. An indicator light on the front panel illuminates during the cleaning process.
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The following table summarizes the comparison of the StarCare Handpiece Maintenance Unit to the predicate devices for various technological characteristics.
| Technological Characteristics | Predicate Device Comparisonconclusion |
|---|---|
| Indication for use | Similar |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Identical |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environmentand other devices | Identical |
| Where used | Identical |
| Standards met | Similar |
| Electrical Safety | Similar |
Substantial Equivalence:
The determination of substantial equivalence is based on the premise that the proposed device and the predicate devices have the same intended use, similar technology and design.
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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ms. Kay Engle Regulatory Affairs Supervisor DentalEZ Incorporated StarDental Division 1816 Colonial Village Lane Lancaster, Pennsylvania 17601
JAN 2 1 2010
Re: K093072
Trade/Device Name: StarCare Handpiece Maintenance Unit Regulation Number: 21CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: September 29, 2009 Received: September 30, 2009
Dear Ms. Engle:
This letter corrects our substantially equivalent letter of December 28, 2009.
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 (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 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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Page 2 - Ms. Engle
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: StarCare Handpiece Maintenance Unit
Indications for Use:
The StarCare Handpiece Maintenance Unit is intended for the internal cleaning, i.e purging of old lubricant, and the lubrication of air-driven high speed handpieces, electric micromotor attachments and turbines used in dentistry.
StarCare Handpiece Maintenance Unit should be used only after the handpieces have been externally cleaned and prior to sterilization.
CAUTION: Federal law restricts this device to sale by or on the order of a dentist.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RSBER DDS for Dr. K.P. Mulry (Acting)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K093072
§ 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.