(174 days)
The ASI 'Advanced Endodontic System - Designer Series (Models 2133E, 2134E, 2115E, 2125E)' is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.
The device is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law
The ASI 'Advanced Endodontic System - Designer Series (Models 2133E, 2134E, 2115E, 2125E)' is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.
I'm sorry, but this document does not contain the information required to fulfill your request. This appears to be an FDA 510(k) clearance letter for a dental treatment unit, not a study report or a document detailing acceptance criteria and device performance evaluation. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes, data provenance, or details about test sets.
- The number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Details about the type of ground truth used (pathology, outcomes data, etc.).
- Sample size for a training set or how ground truth for a training set was established.
This document is a formal notification of market clearance based on substantial equivalence, not a detailed technical report of device validation.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2013
Mr. John McPeek President ASI Medical, Incorporated 14550 East Easter Avenue, Suite 700 CENTENNIAL CO 80112
Re: K123139
Trade/Device Name: Advanced Endodontic System - Designer Series (Models 2133E, 2134E, 2115E, 2125E) Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC, EIA, DZI, EBZ, EFA, EKR, EKX, LQY Dated: March 4, 2013 Received: March 5, 2013
Dear Mr. McPeek:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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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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 devicerelated 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer -S for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Sect. 4 - Indications for Use
510(k) Number (if known): K123139
Device Name: Advanced Endodontic System - Designer Series (Models 2133E, 2134E, 2115E, 2125E)
Indications for Use:
The ASI 'Advanced Endodontic System - Designer Series (Models 2133E, 2134E, 2115E, 2125E)' is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.
The device is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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| 2013.03.27 12:37:43 -04'00' |
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(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Division of Alton, Dental Devices
510(k) Number: K123137
§ 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.