(326 days)
This air-powered dental handpiece is intended for removal of carious material, cavities and crow preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures. It is designed for use by a trained professional in the field of general dentistry.
The Maxima PRO 45L air-driven handpieces are air driven dental handpieces for the use by a trained professional in the field of general dentistry. The devices are air-powered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the gravity steam autoclave methods that have been validated. Through the coupling connected to a dental unit, the proposed dental handpiece receive air for functionality of the high speed turbine. They also receive cooling water for cutting through one port and light for illumination through another port. Further one there is a jet needle supplied with the Maxima PRO 45L. By using this part the operator is able to clean the spray port in the head of the product if there is an insufficient amount of cooling water out of the Maxima PRO 45L according to the instructions for use. The mechanism of action for the proposed air driven handpieces is as follows: The dental handpieces is an air-driven handpiece which will be supplied with water, air and light through the tube and the coupling of a dental treatment unit. The handpiece is operated by pneumatic pressure applied on the cartridge, providing a rotation between 380,000 and 420,000 rpm. For proper operation, set air pressure on the dental treatment unit at 40 ± 1.45 psi and check with a pressure gauge Air supply must be dry, clean, and uncontaminated. For the cooling water, a minimum of 50 ml/min (pressure 14.5 ± 1.5 psi (1± 0.1) of water is needed. The Multiflex coupling has a bulb which enables thought existing optical fiber in the handpiece, the lighting at the place of action of the drill. Dental burs (not part of this 510(k)) according to ISO 1797-1 type 3 could be inserted into the chuck system of the turbine. The Maxima PRO 45L interacts with the patient through a rotating bur with the patient teeth according to the intended use. The Maxima PRO 45L is providing with connection MULTIflex system. The connectors carry the air for the high speed turbine, the cooling water for cutting treatment and light for illumination from the dental treatment unit. The coupling is an accessory that permits quick exchange of the work equipment and high costeffectiveness when extending your range of instruments. As a matter of course each dental instrument can be ergonomically rotated 360° on the MULTIflex coupling. The MULTIflex connectors are accessories to the medical device which will not be delivered together with the Maxima PRO 45L.
The provided document describes the 510(k) premarket notification for the "Maxima PRO 45L" dental handpiece. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study in the way one might for a novel diagnostic or therapeutic device.
However, I can extract information related to performance testing and equivalence claims based on the provided text.
Here's an analysis of the provided information regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for a dental handpiece (a Class I device), the "acceptance criteria" are not detailed in terms of specific clinical endpoints or diagnostic metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly met by demonstrating that the device performs as well as or similarly to the predicate devices on specific operational and safety standards.
| Feature / Performance Metric | Acceptance Criteria (Implicitly based on Predicate & Standards) | Reported Device Performance (Maxima PRO 45L) |
|---|---|---|
| Indications for Use | Same as predicate devices for general dentistry roles. | Matches stated Indications for Use. |
| Principle of Operation | Air-driven, receives air, water, light through dental unit. | Matches stated Principle of Operation. |
| Water Ports | Similar to predicates (1 or 3). | One |
| Fiber Optics | Presence/absence similar to predicates. | With built-in light system |
| Dimensions (Head size) | Within acceptable range compared to predicates. | Height: 14.6 mm, Diameter: 12.5 mm |
| Type of Chuck | Same as predicate. | Push Button |
| Power (approx.) | Comparable to predicates. | 19 watts |
| Bur Retention Force | Same as predicate. | Up to 24 Ncm |
| Operating Pressure | Within comparable range of predicates. | 40 ± 1.45 psi recommended |
| Idling Speed | Within comparable range of predicates. | 380,000 - 420,000 rpm |
| Head Angle | Same as predicate. | 45-degree |
| Compliance to Standards | Meets relevant international standards. | ISO 14457 (2012) and ISO 9168 (2009) |
| Biocompatibility | Meets ISO 10993. | Completed and passed. |
| Sterilization Validation | Validated methods. | Completed and passed. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or patient-specific samples. The performance testing was based on non-clinical tests conducted on the device hardware itself. Therefore, a sample size of patient data or data provenance (country of origin, retrospective/prospective) is not applicable here. The "test set" for this type of device refers to the physical units of the device subjected to laboratory performance testing (e.g., a certain number of handpieces tested for durability, speed, bur retention, etc.). However, the exact number of units tested is not specified in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes physical device performance testing against engineering standards and specifications, not interpretation of clinical data where expert ground truth would be required.
4. Adjudication method for the test set
This information is not applicable for the same reasons as point 3.
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
This is not applicable. The device is an air-powered dental handpiece, a mechanical tool, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, AI integration, or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a mechanical dental handpiece, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for this device, in essence, is defined by international engineering and performance standards (ISO 14457:2012 and ISO 9168:2009) and by comparative performance data from legally marketed predicate mechanical devices. The device's performance metrics (e.g., idling speed, bur retention force, operating pressure) are measured against the specifications outlined in these standards and compared to the reported characteristics of predicate devices.
8. The sample size for the training set
This is not applicable as the device is a mechanical tool and does not employ a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
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Image /page/0/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 a human figure, represented by three overlapping profiles, with the head tilted upwards.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 4, 2015
KaVo do Brasil Industria e Comercio Ltda Mr. Marcos Fernandes Nunes RA/QA Manager Rua Chapeco, 86 Joinville, Santa Catarina 89.221-040 BRAZIL
Re: K141576 Trade/Device Name: Maxima PRO 45L Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: March 23, 2015 Received: April 3, 2015
Dear Mr. Nunes:
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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Page 2 - Mr. Marcos Fernandes Nunes
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 device-related 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Section IV - Indications for Use
K141576 510(k) Number (if known):
Device Name: Maxima PRO 45L
Indications for Use:
This air-powered dental handpiece is intended for removal of carious material, cavities and crow preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures.
It is designed for use by a trained professional in the field of general dentistry.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Use (Part 21 CFR 801 Subpart D) C)
AND / OR
Over-The-Counter
(21 CFR 807 Subpart
(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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141576
Device Name
Maxima PRO 45L
Indications for Use (Describe)
This air-powered dental handpiece is intended for removal of carious material, cavities and crow preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures. It is designed for use by a trained professional in the field of general dentistry.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section V - 510(k) Summary
Submitter:
KaVo do Brasil Indústria e Comércio Ltda Rua Chapecó 86 89.221-040 Joinville - Santa Catarina - Brazil Marcos Fernades Nunes - Contact Person 55 (47) 34510246 - Phone number +55 (47) 34510115 - Facsimile
Date of Summary: April 30, 2015
Device Name:
- Trade Name - Maxima PRO 45L
- Common Name - Handpiece, air-powered, dental
- Classification Name Dental Handpiece and accessories, per 21 CFR § 872.4200 ●
- Product Code and Classification EFB, Class I ●
Devices for Which Substantial Equivalence is Claimed:
HIGH SPEED AIR TURBINE HANDPIECES TI Max X 450 (K112024) marketed by ● Nakanishi, Incorporated
HIGH SPEED AIR TURBINE HANDPIECES Karan 45, Dexor 45 (K101717) marketed by ● Aerobine, Incorporated
Device Description:
The Maxima PRO 45L air-driven handpieces are air driven dental handpieces for the use by a trained professional in the field of general dentistry. The devices are air-powered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the gravity steam autoclave methods that have been validated. Through the coupling connected to a dental unit, the proposed dental handpiece receive air for functionality of the high speed turbine. They also receive cooling water for cutting through one port and light for illumination through another port.
Further one there is a jet needle supplied with the Maxima PRO 45L. By using this part the operator is able to clean the spray port in the head of the product if there is an insufficient amount of cooling water out of the Maxima PRO 45L according to the instructions for use.
The mechanism of action for the proposed air driven handpieces is as follows:
The dental handpieces is an air-driven handpiece which will be supplied with water, air and light through the tube and the coupling of a dental treatment unit.
The handpiece is operated by pneumatic pressure applied on the cartridge, providing a rotation between 380,000 and 420,000 rpm.
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For proper operation, set air pressure on the dental treatment unit at 40 ± 1.45 psi and check with a pressure gauge Air supply must be dry, clean, and uncontaminated.
For the cooling water, a minimum of 50 ml/min (pressure 14.5 ± 1.5 psi (1± 0.1) of water is needed.
The Multiflex coupling has a bulb which enables thought existing optical fiber in the handpiece, the lighting at the place of action of the drill.
Dental burs (not part of this 510(k)) according to ISO 1797-1 type 3 could be inserted into the chuck system of the turbine. The Maxima PRO 45L interacts with the patient through a rotating bur with the patient teeth according to the intended use.
The Maxima PRO 45L is providing with connection MULTIflex system. The connectors carry the air for the high speed turbine, the cooling water for cutting treatment and light for illumination from the dental treatment unit.
The coupling is an accessory that permits quick exchange of the work equipment and high costeffectiveness when extending your range of instruments. As a matter of course each dental instrument can be ergonomically rotated 360° on the MULTIflex coupling.
The MULTIflex connectors are accessories to the medical device which will not be delivered together with the Maxima PRO 45L.
Indication for use:
This air-powered dental handpiece is intended for removal of carious material, cavities and crow preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures.
It is designed for use by a trained professional in the field of general dentistry.
Substantial Equivalence:
The proposed air driven handpieces functions in a manner similar to, and are intended for the same use as the TI Max X 450 (K112024) marketed by Nakanishi, Incorporated and to the Karan 45, Dexor 45 (K101717) marketed by Aerobine, Incorporated.
The proposed handpieces are similar to the two predicate devices in that they are dental airdriven handpieces for use by a trained professional in the field of general dentistry. Proposed handpieces are substantially equivalent in design, indication for use and function to the two predicate devices noted above. The proposed handpieces and the predicate devices are reusable (sterilizable) and ergonomically shaped. Both the proposed device and the predicate devices receive air for the high speed turbines to function, and the cooling water for cutting treatment through the tube and the specific coupling of a dental unit.
For proper operation, set air pressure on the dental treatment unit at 40 ± 1.45 psi and check with a pressure gauge Air supply must be dry, clean, and uncontaminated.
For the cooling water, a minimum of 50 ml/min (pressure 14.5 ± 1.5 psi (1± 0.1) of water is needed.
The proposed handpieces differs from the TI Max X 450 (K112024) and to the Karan 45, Dexor 45 (K101717), in the head size dimension and the compliance to standards. The proposed device have been evaluated according to the new standard ISO 14457:2012 - Dentistry Handpieces and Motors, and the predicate devices have been evaluated according to the older version of ISO 7785-1:1997 - Dental Handpieces - Part 1 High -Speed air turbine Handpieces.
The performance test demonstrates that the differences in technological characteristics between the proposed handpiece and the predicate handpiece do not raise additional questions. The testing has been performed using the updated standard that was used in the predicates device.
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Summary of the Technological Characteristics:
| DescriptiveInformation | Maxima PRO 45L | Primary Pred.K112024 | Reference DeviceK101717 |
|---|---|---|---|
| Indicationsfor Use | This air-powered dentalhandpiece is intended forremoval of cariousmaterial, cavities and crowpreparations, removal offilings, processing of tooth,restoration of surfaces andas a surgical tool for thirdmolar removal procedures.It is designed for use by atrained professional in thefield of general dentistry. | The Ti-Max X450 is anair-powered dentalhandpiece with intendeduse of being a Surgicaltool for impacted thirdmolar removal andperiodontal proceduresfor which a conventionalhandpiece would beused. | Karam 45 and Dexor 45are air-powered highspeed dental handpieceswith intended use ofbeing a surgical tool forimpacted third molarremoval andperiodontal proceduresfor whichconventional handpiecewould be used. |
| Principle ofoperation | Through the tube and thecoupling connected to adental unit, the air-powered handpiecereceives the air foroperating the high speedturbine, the cooling waterfor cutting treatmentthrough one port and lightfor illumination theoperation area. | Through the tube and thecoupling connected to adental unit, the air-powered handpiecereceives the air foroperating the high speedturbine, the cooling waterfor cutting treatmentthrough one port andlight for illumination theoperation area. | Through the tube andthe coupling connectedto a dental unit, the air-powered handpiecereceives the air foroperating the highspeed turbine, thecooling water forcutting treatmentthrough one port. |
| Water ports | One | Three | One |
| Fiber optics | With built-in light system | With and without built-inlight system | without built-in lightsystem |
| Dimensions | Head size-Height: 14,6mmHead size-Diameter: 12,5mm | Head size-Height: 13,6mmHead size-Diameter: 11,2mm | Head size-Height: 13,6mmHead size-Diameter:11,2 mm |
| Type of chuck | Push Button | Same | Same |
| Power (approx.) | 19 watts | 21 watts | 16 watts |
| CouplingDimensions | Length with coupling:Approx. 121 mm | Information not available | Information notavailable |
| Chemicalcomposition ofthe patient-contactingportions of thedevice | Round Copper 17,463(2.0375 / CuZn36Pb3) andCr-N/Cr CoatingRound Steel 12,7(1.4305_303 / X8CrNiS18-9) and Cr CoatingEcobrass 40 (C6930/CuZn21Si3P)Round Steel 12,7(1.4305_303 / X8CrNiS18-9) and Cr Coating | Information not available | Stainless steel,aluminum alloy, copperalloy, chrome plating,nickel plating,elastomer |
| 9) and Cr Coating(See details in SectionXVI) | |||
| Chemicalcomposition ofthe water tube | German Silver1,2 (2.0730 /CuNi12Zn24) with Crcoating(See details in SectionXVI) | Stainless steel | Information notavailable |
| Light Intensity | Approx. 25,000 LUX | Same | without light system |
| Bur retentionforce | Up to 24 Ncm | Same | Same |
| OperatingPressure | 40 ± 1.45 psirecommended | 32 to 44 psirecommended | 29 - 36 psirecommended |
| Idling Speed | 380,000 - 420,000 rpm | 380,000 - 450,000 rpm | 380,000 - 450,000 rpm |
| Head angle | 45-degree | Same | Same |
| Compliance toStandards | Complies with ISO 14457and ISO 9168 | Complies with ISO7785-1 and ISO 9168 | Complies with ISO7785-1 and ISO 9168 |
| Lubricant | KaVo SprayHenry Schein Spray &Clean | PANA SPRAY PlusPANA SPRAY | Karam Spray |
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Non-Clinical Test Data:
- . Performance tests according to the international standards ISO 14457 First edition 2012-09-15 - Dentistry - Handpieces and Motors for proposed dental air-driven handpieces has been conducted to determine the conformance to the state of the art. Biocompatibility per ISO 10993 and sterilization validation have been completed which demonstrate that the proposed devices are substantially equivalent to the predicate devices.
- . ISO 9168 Third edition 2009-07-15 - Dentistry - Hose connectors for air driven dental handpieces
Clinical Test Data:
Clinical testing was determined to be not required for this product.
Conclusion:
Based upon the tests according to the international standards listed above for dental air-driven handpieces, the biocompatibility and sterilization studies and the similar technological and performance characteristics as compared to the predicate devices, the performance of the Maxima PRO 45L is deemed perform as well as the predicate devices.
§ 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.