(2 days)
Designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry for the supragingival and subgingival removal of calculus, plaque and stains from teeth.
The Jet-Mate™ Sterilizable Handpiece is a detachable dental handpiece. It is designed to be detached from the cable assembly for the purpose of autoclave sterilization. This modified handpiece is used with the Cavitron® dental units.
The provided text describes a 510(k) premarket notification for a dental device, the "Jet-Mate™ Sterilizable Handpiece." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies with detailed performance metrics against acceptance criteria.
Therefore, the document does not contain the information requested in points 1-9 regarding specific acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
Here's why and what the document does indicate:
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Substantial Equivalence: The core of a 510(k) submission is to show that the new device is "substantially equivalent" to a predicate device. This often means demonstrating similar technological characteristics, intended use, and safety/effectiveness without necessarily conducting new clinical trials that establish performance against novel acceptance criteria.
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Predicate Device: The Jet-Mate™ Sterilizable Handpiece is found to be substantially equivalent to the "Steri-Mate™ Handpiece (K941392)."
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Rationale for Equivalence: The document states: "The Jet-Mate™ Sterilizable Handpiece has the same principles of operation and is very similar in design characteristics to the marketed device." It also mentions, "Because of the nearly equivalent material composition of JET-MATE™ STERILIZABLE HANDPIECE to the predicate device, no additional toxicity testing was necessary."
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Intended Use: The intended use of the Jet-Mate™ is "for general prophylaxis treatments to remove calculus, plaque and stains from teeth," which is stated to be the "same intended use as previously cleared for K941392, Steri-Mate™ Handpiece."
In summary, for a 510(k) submission like this, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a device that has already established its safety and effectiveness. There is no new study described in this document that would provide the detailed information requested in your prompt.
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6 2002 NOV
DENTSPLY
NAME & ADDRESS:
DENTSPLY International
570 West College Avenue ) Box 877 rk, PA 17405-0872 71 845-7511 ax (717) 849-4762
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
October 30, 2002 DATE PREPARED:
JET-MATE™ STERILIZABLE HANDPIECE TRADE OR PROPRIETARY NAME:
Accessory to dental units (872.4850 and 872.6080) CLASSIFICATION NAME:
PREDICATE DEVICES: Steri-Mate™ Handpiece K941392
DESCRIPTION OF DEVICE: The Jet-Mate™ Sterilizable Handpiece is a detachable dental handpiece. It is designed to be detached from the cable assembly for the purpose of autoclave sterilization. This modified handpiece is used with the Cavitron® dental units.
INTENDED USE: The Jet-Mate™ Sterilizable Handpiece is designed for general prophylaxis treatments to remove calculus, plaque and stains from teeth
TECHNOLOGICAL CHARACTERISTICS: The Jet-Mate™ Sterilizable Handpiece has the same principles of operation and is very similar in design characteristics to the marketed device. Therefore, we believe that the Jet-Mate™ Sterilizable Handpiece is substantially equivalent to the Steri-Mate® Handpiece (K941392).
Because of the nearly equivalent material composition of JET-MATE™ STERILIZABLE HANDPIECE to the predicate device, no additional toxicity testing was necessary.
We believe that the prior use of the components of JET-MATE™ STERILIZABLE HANDPIECE in legally marketed devices and the data provided support the safety and effectiveness of JET-MATE™ STERILIZABLE HANDPIECE for the intended uses.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line. The text appears to be part of a document or sign.
NOV
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. P. Jeffery Lehn Director, Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re: K023697
Trade/Device Name: Jet-Mate™ Sterilizable Handpiece Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: 76 ELC Dated: October 30, 2002 Received: November 4, 2002
Dear Mr. Lehn:
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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Page 2 - Mr. Lehn
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 your device to proceed to the market.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy Ulatowski
Timothy latowski 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
(As Required by 21 CFR 807.87(e)
510(K) Number (if known):
Device Name: Jet-Mate™ Sterilizable Handpiece
Designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry for the supragingival and subgingival removal of calculus, plaque and stains from teeth.
This is the same intended use as previously cleared for K941392, Steri-Mate™ Handpiece.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Suxir Rumney
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number ...
§ 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.