(141 days)
An ultrasonic scaling system is used by dental professionals as 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. This device is contraindicated for children and adults with synthetic teeth. This device should not be used on patients or by users who have a pacemaker.
XP TECHNOLOGY Ultrasonic Scaler
This document is a 510(k) premarket notification letter from the FDA for an ultrasonic scaler, not a study report. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria.
The letter explicitly states: "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... to legally marketed predicate devices." This means the FDA found the device to be similar enough to existing, legally marketed devices to allow its sale, rather than requiring a new, independent study to prove specific performance criteria were met.
The document includes:
- Trade/Device Name: XP TECHNOLOGY Ultrasonic Scaler
- Indications For Use: "An ultrasonic scaling system is used by dental professionals as 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." It also lists contraindications for children and adults with synthetic teeth, and for patients/users with pacemakers.
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number or qualifications of experts used to establish ground truth.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
- Information about a standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
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MAR 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tom Thompson American Eagle Instruments, Incorporated 6575 Butler Creek Road Missoula, Montana 59808
Re: K042972
Trade/Device Name: XP TECHNOLOGY Ultrasonic Scaler Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: February 21, 2005 Received: February 25, 2005
Dear Mr. Thompson:
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 Amerate ents, 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 cither 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 Eederal Register.
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Page 2 - Mr. Thompson
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 (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.
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 vour 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suyate Michael Durd.
Chiu Lin, Ph.D. 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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D. INDICATIONS FOR USE
510(k) Number : K042972
Device Name: XP TECHNOLOGY Ultrasonic Scaler
Indications For Use: ¡ An ultrasonic scaling system is used by dental professionals as 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 This device is contraindicated for children and adults with synthetic teeth teeth.
This device should not be used on patients or by users who have a pacemaker
Swor Runre
on Sien-Off) on of Anesthesiology, General Hospital, Josen Control, Dental Devices
... . . . . Number: __________________________________________________________________________________________________________________________________________________________
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
§ 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.