(36 days)
The KaVo RONDOflex® plus 360 Handpiece is intended for the: preparation for fissure sealing by cleaning, opening, and extending the fissures; creation of micro-mechanical retention for adhesive restorations on enamel and dentine with subsequent acid etch technique; preparation-of small carious defects; removal of deep discolorations in the enamel; cleaning and removal of adhesive residues from bridges, crowns, etc.; and, preparation of adhesive surfaces of brackets.
This submission is for a modification of a device system cleared under K002708, KaVo Corund Handpiece 2013. The modification is in the form of adding dental water to the stream.
The RONDOflex plus 360 is an air abrasion system in which alumina particles are accelerated to high speed in an air jet in order to remove material from the tooth surface.
The provided text describes a 510(k) summary for the KaVo RONDOflex® plus 360 Handpiece, which is a modification of an existing device. The device is being submitted for substantial equivalence to predicate devices, and as such, the "acceptance criteria" discussed are largely related to demonstrating that the modified device performs as safely and effectively as the predicate devices, with no new questions of safety or effectiveness.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for a modified device seeking substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device shares the same indications for use and has comparable technical characteristics (e.g., abrasive material, sterilization methods) to the predicate devices. The "reported device performance" is essentially that it operates within the specified technical data and its indications for use are the same as the primary predicate.
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (KaVo RONDOflex® plus 360 Handpiece) |
|---|---|
| Indications for Use: Same as predicate device. | SAME as KaVo Corund Handpiece 2013 |
| Abrasive Material: Comparable to predicate devices. | 27 and 50 μ corundum powder and water |
| Sterilization: Same method as predicate device. | Autoclave |
| Technical Data: Operates within specified parameters. | Drive pressure: 3.2 - 6.0 bar |
| Water pressure: 1.5 ± 1.0 bar | |
| Air consumption: 5 - 11 1(S.T.P.)/min | |
| Water flow rate: approx. 40 cm3/min |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of clinical trials or specific performance testing against ground truth. The submission is based on comparison to predicate devices and internal validation studies. There is no information provided about the sample size for these internal validation studies or their data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices through technical comparisons and internal validation. There is no mention of a ground truth established by experts for a specific test set.
4. Adjudication Method for the Test Set
Not applicable. As there is no mention of an external test set requiring expert ground truth, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is an air abrasion handpiece for dental procedures, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would typically be conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (handpiece), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The term "ground truth" as typically used in the context of AI or diagnostic device evaluation is not directly applicable here. The device's safety and effectiveness are established by:
- Comparison to legally marketed predicate devices: The "ground truth" implicitly relies on the established safety and effectiveness of the predicate devices cleared by the FDA.
- Internal validation studies: These studies would typically verify that the device meets its design specifications and performs as intended, likely using engineering and performance metrics relevant to an air abrasion device (e.g., consistency of abrasive flow, pressure, sterilization efficacy). The specific nature of these "internal validation studies" (what they tested and how performance was measured) is not detailed in the provided text.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, no ground truth establishment for a training set is relevant.
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2872
NOV 2 3 2004
EXHIBIT 2
510(k) Summary KaVo America Corporation 340 East Main Street Lake Zurich, Illinois 60047 Toll Free: 800 323 8029 Tel: 847 / 550 - 6800 Fax: 847 / 550 - 6825 e-mail: info@kavousa.com Contact: John Franz, President August 30, 2004
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- Identification of the Device: Proprietary-Trade Name: KaVo RONDOflex® plus 360 Handpiece Classification Name: Airbrush Product Codes KOJ Common/Usual Name: Airbrush
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- Indications for Use (intended use): The KaVo RONDOflex® plus 360 Handpiece is intended for the: preparation for fissure sealing by cleaning, opening, and extending the fissures; creation of micro-mechanical retention for adhesive restorations on enamel and dentine with subsequent acid etch technique; preparation-of small carious defects; removal of deep discolorations in the enamel; cleaning and removal of adhesive residues from bridges, crowns, etc.; and, preparation of adhesive surfaces of brackets.
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- Description of the Device: This submission is for a modification of a device system cleared under K002708, KaVo Corund Handpiece 2013. The modification is in the form of adding dental water to the stream.
The RONDOflex plus 360 is an air abrasion system in which alumina particles are accelerated to high speed in an air jet in order to remove material from the tooth surface.
Technical data: RONDOflex plus 360
Drive pressure: 3.2 - 6.0 bar
Water pressure: 1.5 ± 1.0 bar Air consumption 5 - 11 1(S.T.P.)/min depending on cannula type The pressure set on the turbine drive is automatically increased by 20%, e.g. from 2.8 to 3.2 bar
Water flow rate: approx. 40 cm3/min
Have the pressures of your unit which have been set by the manufacturer checked regularly by a service engineer in order to ensure satisfactory operation of the instrument. Connection: Can be mounted on all MULTIflex couplings.
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5. Safety and Effectiveness, comparison to predicate device:
| ComparisonAreas | KaVo CorundHandpiece 2013(K002708) | Velopex AquacutFluid AbrasionUnit (K024105) | Sirona ProsmileAir Polisher andProphylaxisPowder(K033675) | RONDOflex®plus 360Handpiece(Modified device) |
|---|---|---|---|---|
| Indicationsfor use | Preparation forfissure sealing bycleaning, opening,and extending thefissures; creation ofmicro-mechanicalretention foradhesiverestorations onenamel and dentinewith subsequentacid etch technique;preparation-of smallcarious defects;removal of deepdiscolorations in theenamel; cleaningand removal ofadhesive residuesfrom bridges,crowns, etc.; and,preparation ofadhesive surfaces ofbrackets. | Preparation for pitand fissuresealants. Removaland restoration ofcomposits (sic)Cavitypreparation.Cleaning,polishing, andstain removal | Intended forremoving deposits,plaque, andstaining on allvisible toothsurfaces as well asin fissures andinterdental areas.The ProSmile isalsointended for thefollowingprophylacticapplications:cleaning teethprior to sealingcleaning teethprior tofluoridationcleaning teethprior to bleachingcleaning teethprior to usingbonding materials | SAME as KaVoCorund. |
| AbrasiveMaterial | 27 or 50 μcorundum powder(Aluminum oxide) | 29 μ or 53 μcorundum powder(Aluminum oxide)and water | Sirona prophylaxepowder and water | 27 and 50 μcorundum powderand water |
| Sterilization | Autoclave | SAME | SAME | SAME |
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- Conclusion: In all important respects, the RONDOflex® plus 360 Handpiece is substantially equivalent to the KaVo Corund Handpiece 2013 (K002708), the Velopex Aquacut Fluid Abrasion Unit (K024105)and the Sirona Dental Systems Prosmile Air Polisher and Prophylaxis Powder (K033675). This conclusion is based on indications for use and internal validation studies.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2004
KAVO America Corporation C/O Mr. Daniel Kamm Regulatory Engineer Kamm & Associates PO Box 7007 Deerfield. Illinois 60015
Re: K042872
Trade/Device Name: RONDOflex® plus 360 Handpiece Regulation Number: 872.6080 Regulation Name: Airbrush Regulatory Class: II Product Code: KOJ Dated: October 14, 2004 Received: October 26, 2004
Dear Mr. Kamm:
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. Kamm
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 (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/dsma/dsmamain.html
Sincerely yours,
Chiu-Liang, Ph.D.
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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042872
Indications for Use
510(k) Number (if known):
RONDOflex® plus 360 Handpiece Device Name:_______________
Indications For Use:
The KaVo RONDOflex® plus 360 Handpiece is intended for the: preparation for fissure sealing by cleaning, opening, and extending the fissures; creation of micro-mechanical retention for adhesive restorations on enamel and dentine with subsequent acid etch technique; preparation-of small carious defects; removal of deep discolorations in the enamel; cleaning and removal of adhesive residues from bridges, crowns, etc .; and, preparation of adhesive surfaces of brackets.
Labeling contains the following statement: CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Burns
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Page 1 of 1
§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”