(92 days)
RDT3 Handpiece Head is a reciprocating dental handpiece attachment intended for use in root canal preparations using the Self Adjusting File, SAF (K092933) (ReDent Nova LTD., Ra'anana Israel).
RDT3 is a reciprocating vertical vibrating handpiece attachment and is capable of providing the SAF with an impact movement of approximately 0.4 mm and up to 5,000 rpm drive speed required for conducting endodontic treatment. Low torque (max 9.5 ar cm) rotation motion is integrated in order to ease insertion of the file into the root canal. The file is attached to the RDT3 head via friction grip.
The provided document describes a 510(k) premarket notification for the REDENT NOVA's RDT3 Handpiece Head. It focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and performance testing. However, it does not include information about a clinical study involving human or even simulated patients, nor does it involve AI, expert consensus for ground truth, or statistical measures like sensitivity, specificity, or AUC typically associated with device performance in diagnostic or prognostic applications.
The acceptance criteria and "study" described are engineering and material performance tests.
Here is the information based on the provided text, recognizing the limitations of its scope regarding "acceptance criteria" in a clinical sense:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for each test with pass/fail values. Instead, it states that tests were carried out in accordance with ISO 7785-2 and an in-house test, and for all of them, the device "functioned as intended" and "results observed were as expected." This implies that the RDT3 met the implied performance standards of the ISO standard and the internal test.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to ISO 7785-2 for Handpiece Head Chuck Friction Grip | "In all instances the RDT3 functioned as intended and results observed were as expected." |
| Conformance to ISO 7785-2 for Handpiece Head Resistance to Sterilizing Procedure | "In all instances the RDT3 functioned as intended and results observed were as expected." |
| Conformance to ISO 7785-2 for Handpiece Head Temperature Rise | "In all instances the RDT3 functioned as intended and results observed were as expected." |
| Conformance to ISO 7785-2 for Handpiece Head Resistance to Corrosion | "In all instances the RDT3 functioned as intended and results observed were as expected." |
| In-house test for Handpiece Head Sodium Hypochlorite Exposure | "In all instances the RDT3 functioned as intended and results observed were as expected." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the performance tests (e.g., how many handpieces were tested for chuck friction grip or corrosion). The tests are described as in vitro engineering and material tests, not tests on clinical data. No information on data provenance (country of origin, retrospective/prospective) is provided, as it's not applicable to these types of tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for these engineering tests would be derived from the objective measurements and standards set forth in ISO 7785-2, not from expert consensus or clinical evaluation.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
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 a dental handpiece head, a mechanical device. The submission does not involve AI or human readers, and therefore no MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical handpiece head, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is based on the standards and methodologies outlined in ISO 7785-2 and presumably a documented internal specification for the in-house Sodium Hypochlorite Exposure test.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not an AI or machine learning model, so there is no training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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K 101172
510(k) SUMMARY REDENT NOVA's RDT3 Handpiece Head
Submitter's Name, Address, Telephone Number, Contact Person: and Date Prepared
Hogan Lovells US LLP Phone: (202) 637-5600 Facsimile: (202) 637-5910
Contact Person: Jonathan S. Kahan
Date Prepared: July 21, 2010
Name of Device and Name/Address of Sponsor:
RDT3 Handpiece Head
Redent Nova Ltd. 15 Hataasia street P.O.B 4159 Ra'anana 43000, Israel
Common or Usual Name
Handpiece head attachment
Classification Name
| Name: | Dental Handpiece and Accessories |
|---|---|
| Product code: | EFA |
| Classification regulation: | 872.4200 |
| Class: | I |
| Panel: | Dental |
Predicate Devices
Intra Lux Head 3LDSY (K092446)
Intended Use / Indications for Use
RDT3 Handpiece Head is a reciprocating dental handpiece attachment intended for use in root canal preparations using the Self Adjusting File, SAF (ReDent Nova LTD., Ra'anana lsrael).
Technological Characteristics
RDT3 handpiece attachment is compatible with the KaVo GENTLE power low-speed handbiece. The RDT3 is able to operate the SAF during root canal treatment procedures, while working with continuous sodium hypochlorite irrigation.
JUL 2 7 2010
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RDT3 is a reciprocating vertical vibrating handpiece attachment and is capable of providing the SAF with an impact movement of approximately 0.4 mm and up to 5,000 rpm drive speed required for conducting endodontic treatment. Low torque (max 9.5 ar cm) rotation motion is integrated in order to ease insertion of the file into the root canal.
The file is attached to the RDT3 head via friction grip.
Performance Data
Performance tests were carried out to evaluate the properties of the RDT3.
The tests were carried in accordance with ISO 7785-2 Dental Handpieces Part 2: Straight and Geared Angle Handpieces:
- � Handpiece head Chuck Friction Grip
- Handpiece Head Resistance to Sterilizing Procedure .
- . Handpiece Head Temperature Rise
- . Handpiece Head Resistance to Corrosion
In addition Redent performed an In-house test:
- Handpiece Head Sodium Hypochlorite Exposure ●
In all instances the RDT3 functioned as intended and results observed were as expected.
Substantial Equivalence
The RDT3 is substantially equivalent to the Intra Lux Head 3LDSY (manufactured by KaVo GmbH & Co (Sybron Dental Specialties Inc)). The RDT3 has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the RDT3 and its predicate device identified below raises no new issues of safety or effectiveness.
The technological and operational differences between the RDT3 and its predicate are:
- . Higher maximal drive speed.
- . RDT3 has a low torque 360° rotation motion whereas the 3LDSY has a free 360° rotation.
- . Different means of attaching the file to the handpiece head.
- . Different materials used for internal components.
These differences do not raise new questions of safety or efficacy. Additionally, performance testing in compliance with ISO 7785-2 demonstrates that the RDT3 is comparable to the Intra Lux Head 3LDSY. Accordingly, the RDT3 is substantially equivalent.
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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 stylized eagle with its wings spread, and three wavy lines extending from the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Redent Nova Limited C/O Mr. Jonathan S. Kahan Hogan Lovells US LLP Columbia Square, 555 13th Street, NW Washington, District of Columbia 20004
. The 8 2010
Re: K101172
Trade/Device Name: RDT3 Handpiece Head Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFA Dated: July 21, 2010 Received: July 21, 2010
Dear Mr. Kahan:
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. Kahan
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Quinn
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use Statement
510(k) Number (if known): _
Device Name:
JUL 27 2010
RDT3 Handpiece Head
Indications for Use:
RDT3 Handpiece Head is a reciprocating dental handpiece attachment intended for use in root canal preparations using the Self Adjusting File, SAF (K092933) (ReDent Nova LTD., Ra'anana Israel).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ren Muhy
(Division Sign-Off) Page __ of ___________________________________________________________________________________________________________________________________________________________________ Division of Anestnesiology, General Hospital Infection Control, Dental Devices
Number: K101172
§ 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.