(79 days)
The device is a plastic disposable attachment for use in conjunction with a slow speed handpiece, used during the professional prophylaxis treatment of patient's teeth by a dentist or hygienist.
Our disposable prophylaxis angle is intended as a single use device used by a Dental Professional, either a Dentist or a Dental Hygienist to assist in the cleaning process of patient's teeth. It is intended for a single patient and should be discarded after each patient.
Plastic disposable item comprising a housing (body) that holds two plastic shafts aligned at 90 degrees (right angle) to each other that rotate a cup or brush.
Plastic one-piece housing (outer body) holding 2 internal shafts aligned at 90 degree (right angle) to each other. Tip fitted with a rubber cup or brush to clean teeth.
This document describes the St. George Technology, Inc. Perfection Plus Disposable Prophy Angles and their substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (St. George Technology Perfection Plus DPA) |
|---|---|---|
| Indications for Use | For single use by Dental Professional in cleaning patient's teeth. | Same (Intended as a single-use device during professional prophylaxis treatment of patient's teeth by a dentist or hygienist.) |
| Target Population | Dentists and Hygienists | Same |
| Design | Plastic one-piece housing (outer body) holding 2 internal shafts aligned at 90 degree (right angle) to each other. Tip fitted with a rubber cup or brush to clean teeth. | Same |
| Materials | Two types of plastic with either a rubber cup or brush fitted at the cleaning tip. | Same (Non-latex material used on all cups - Improvement over predicate) |
| Performance | To be able to perform a full cleaning procedure. | Satisfactorily performed when compared to the predicate device in all criteria (fit, wear, duration of performance, strength, and durability). |
| Sterility | Non Sterile | Same |
| Biocompatibility | Have caused concern with latex allergies due to cup material. | Non latex material used on all cups - Improvement |
| Mechanical Safety | Robust construction to withstand forces involved in a cleaning. | Same |
| Energy Used/Delivered | Rotation of the cleaning device cup/brush tip provided by a slow speed hand piece | Same |
| Compatibility with other devices | Designed to fit securely onto most available ISO fitting standard slow speed hand pieces | Same |
| Where Used | Dental Office/Operatory | Same |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the way it would for AI/ML performance. Instead, the testing described appears to be for mechanical and functional evaluation of the device.
- Sample Size: Not explicitly stated. The document mentions "extensively tested in in-vitro environments."
- Data Provenance: The tests were conducted in "in-vitro environments," meaning in a laboratory setting, rather than on human subjects or with clinical data. The country of origin for the data is not specified beyond St. George Technology, Inc. being a US-based company. The data is retrospective in the sense that it evaluates the manufactured device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The study is a non-clinical performance evaluation of a medical device, not an AI/ML study requiring expert ground truth for classification or diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable for this type of non-clinical device performance study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes a non-clinical performance study of a physical medical device (disposable prophy angles), not an AI/ML system. Therefore, an MRMC study and the concept of human readers improving with AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This document pertains to a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this study is the observed performance characteristics of the predicate device and the St. George Technology device under defined in-vitro testing conditions. This includes measurements of fit, wear, duration of performance, strength, and durability. It is based on objective, quantifiable physical properties rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This information is not applicable. This is a medical device performance study, not an AI/ML study that uses a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, there is no "training set" in the context of this device performance study.
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Koz3953
11:40:00
ST. GEORGE TECHNOLOGY, INC.
FEB 1 4 2003
1
I'remarket Notification [510(k)] Summary
| Submitted by: | St. George Technology, Inc. |
|---|---|
| Contact Person: | Vernon Watkins |
| Address: | P.O. Box 2849Wilmington, NC 28402USA |
| Telephone: | (910) 397-0781 |
| Fax: | (910) 397-0791 |
| E-mail: | Vwatkins@byegeorge.com |
| Date Prepared: | November 2002 |
| Trade Name: | St. George Technology, Inc. Perfection Plus DisposableProphy Angles |
| Common Name: | Disposable Prophy Angles (DPA's) |
| Classification Name: | Dental Contra and Right-Angle Handpiece Attachment |
| Predicate Device: | Young Dental Manufacturing Disposable Prophy Angle |
| Description Of Device: | Plastic disposable item comprising a housing (body) thatholds two plastic shafts aligned at 90 degrees (right angle)to each other that rotate a cup or brush. |
| Intended Use: | The device is a plastic disposable attachment for use inconjunction with a slow speed handpiece, used during theprofessional prophylaxis treatment of patient's teeth by adentist or hygienist. |
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ST. GEORGE TECHNOLOGY, INC.
´ `echnological Characteristics Compared With Predicate Device:
| Device 1 | St. George Technology | |
|---|---|---|
| Young Manufacturing DPA | Perfection Plus DPA | |
| 510(k) 790722 | ||
| Indications for Use | For single use by Dental Professional incleaning patient's teeth. | Same |
| Target Population | Dentists and Hygienists | Same |
| Design | Plastic one-piece housing (outer body)holding 2 internal shafts aligned at 90degree (right angle) to each other. Tipfitted with a rubber cup or brush to cleanteeth. | Same |
| Materials | Two types of plastic with either a rubbercup or brush fitted at the cleaning tip. | Same |
| Performance | To be able to perform a full cleaningprocedure. | Same |
| Sterility | Non Sterile | Same |
| Biocompatibility | Have caused concern with latex allergiesdue to cup material. | Non latex material used on allcups - Improvement |
| Mechanical Safety | Robust construction to withstand forcesinvolved in a cleaning. | Same |
| EnergyUsed/Delivered | Rotation of the cleaning device cup/brushtip provided by a slow speed hand piece | Same |
| Compatibility withother devices | Designed to fit securely onto mostavailable ISO fitting standard slow speedhand pieces | Same |
| Where Used | Dental Office/Operatory | Same |
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ST. GEORGE TECHNOLOGY, INC.
↑ Ion-Clinical Performance:
The St. George Technology, Inc. Perfection Plus Disposable Prophy Angles have been extensively tested in in-vitro environments for fit, wear, duration of performance, strength, and durability.
Conclusion From l Non Clinical Test:
In all criteria the St. George Technology, Inc. Perfection Plus Disposable Prophy Angle performed satisfactorily when compared to the predicate device.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2003
Mr. Vernon Watkins President St. George Technology, Incorporated P.O. Box 2849 Wilmington, North Carolina 28402-2849
Re: K023953
Trade/Device Name: St. George Technology, Inc. Perfection Plus Disposable Prophy Angles Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: November 26, 2002 Received: November 27, 2002
Dear Mr. Watkins:
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. Watkins
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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Susan Kunner
Susan Runner, DDS, MA Interim 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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ST. GEORGE TECHNOLOGY, INC.
Statement of Indications for Use
()ur disposable prophylaxis angle is intended as a single use device used by : Dental Professional, either a Dentist or a Dental Hygienist to assist in the cleaning process of patient's teeth. It is intended for a single patient and :hould be discarded after each patient.
Ken Muly for nsn
(Division Sign-C v. General Hospital. Division of Anesthesiology Infection Control, Dental I
510(k) Number. K023953
§ 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.