(113 days)
The Self Adjusting file (SAF) is a mechanically operated endodontic file to be used for cleaning and shaping of root canals, as part of the procedure of root canal treatment.
The ReDent SAF is an endodontic file that is indicated for use in root canal treatment for cleaning and shaping of the root canal. The file portion of the SAF consists of a metal lattice hollow cylinder and is constructed from medical grade nickel-titanium-alloy. The file's cylindrical lattice structure permits compression when inserted into the root canal followed by gradual radial expansion to fill the root canal profile. The file is surface treated by sandblasting, enabling it to file dentin from the canal's interior surface.
The SAF is available in 3 standard lengths, 21mm and 25mm and 31 mm.
The SAF should be mounted on a vertical-motion vibration contra-angle handpiece with a 0.4mm amplitude and vertical vibration of 3000 - 5000 OPM (oscillations per minute). The file is attached to the handpiece via a polypropylene shank.
The provided 510(k) summary for the REDENT NOVA's SAF (Self Adjusting File) does not contain the detailed information requested regarding specific acceptance criteria, a quantitative study proving the device meets those criteria, or details about ground truth establishment, sample sizes for test and training sets, or expert involvement.
The summary states: "Performance tests were carried out to evaluate the properties of the SAF. In all instances the SAF functioned as intended and results observed were as expected." However, it does not provide the specifics of these tests.
Therefore, many of the requested fields cannot be filled. Based on the provided text, here is what can be extracted and what is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Functioned as intended | In all instances the SAF functioned as intended. |
| Results observed were as expected | Results observed were as expected. |
| Specific quantitative criteria (e.g., shaping efficacy, canal deviation, fracture resistance, etc.) | Not provided in the document. |
Note: The document broadly states the device "functioned as intended" and "results observed were as expected." This is a general statement and lacks quantitative or specific performance metrics that would typically define acceptance criteria for a medical device.
Study Information
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document only mentions "Performance tests were carried out," but no details about the sample size or type of study (in vitro, in vivo, etc.) are given.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. The summary does not describe a study involving "ground truth" established by experts in the context of diagnostic or interpretive performance. The performance tests mentioned appear to be mechanical or functional evaluations of the device itself.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No information on adjudication is present as this type of study was not described.
-
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:
- No. This device is an endodontic file, a mechanical tool, not an AI-assisted diagnostic or interpretive system. Therefore, an MRMC study related to interpretation would not be applicable.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. The document describes performance tests for a mechanical device. The "ground truth" would likely be defined by engineering specifications or established dental standards for root canal preparation, but the specifics are not detailed.
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The sample size for the training set:
- Not applicable. This device is a mechanical tool and does not involve a "training set" in the context of machine learning.
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How the ground truth for the training set was established:
- Not applicable. This device is a mechanical tool and does not involve a "training set" or "ground truth for a training set" in the context of machine learning.
Summary of what is known:
The REDENT NOVA's SAF (Self Adjusting File) is a mechanically operated endodontic file for cleaning and shaping root canals. Performance tests were conducted, and the manufacturer reported that the device "functioned as intended" and "results observed were as expected." The device was found substantially equivalent to predicate devices (Quantec Series 2000, ProFile Series 29, and ProTaper) based on similar intended use, indications, technological characteristics, principles of operation, and these performance data.
Key Missing Information:
The document lacks any specific, quantifiable acceptance criteria. It also does not provide details about the methodology, sample sizes, specific measurements, or results of the "performance tests" that were conducted. Without these details, a comprehensive description of how the device demonstrably meets quantitative acceptance criteria cannot be provided.
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Ko92933
510(k) SUMMARY
REDENT NOVA's SAF (Self Adjusting File)
JAN 1 4 2010
Submitter's Name, Address, Telephone Number, Contact Person: and Date Prepared
Hogan & Hartson
Phone: 202 637 5600 Facsimile: 202 637 5910
Contact Person: Jonathan S. Kahan
Date Prepared: December 14, 2009
Name of Device and Name/Address of Sponsor:
SAF (Self Adjusting File)
Redent Nova Ltd.
15 Hataasia street
P.O.B 4159
Ra'anana
.
43000, Israel
Common or Usual Name
SAF (Self Adjusting File)
Classification Name
| Name: | Dental Handpiece and accesories |
|---|---|
| Product code: | EFB |
| Classification regulation: | 872.4200 |
| Class: | I |
| Panel: | Dental |
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Predicate Devices
ProTaper - Dentsply Tulsa Dental (510(k) exempt)
Quantec Series 2000 - Tyco Dental (K962031)
Profile 29 - Dentsply Tulsa Dental (K933582)
Intended Use / Indications for Use
The Self Adjusting file (SAF) is a mechanically operated endodontic file to be used for cleaning and shaping of root canals, as part of the procedure of root canal treatment.
Technological Characteristics
The ReDent SAF is an endodontic file that is indicated for use in root canal treatment for cleaning and shaping of the root canal. The file portion of the SAF consists of a metal lattice hollow cylinder and is constructed from medical grade nickel-titanium-alloy. The file's cylindrical lattice structure permits compression when inserted into the root canal followed by gradual radial expansion to fill the root canal profile. The file is surface treated by sandblasting, enabling it to file dentin from the canal's interior surface.
The SAF is available in 3 standard lengths, 21mm and 25mm and 31 mm.
The SAF should be mounted on a vertical-motion vibration contra-angle handpiece with a 0.4mm amplitude and vertical vibration of 3000 - 5000 OPM (oscillations per minute). The file is attached to the handpiece via a polypropylene shank.
Performance Data
Performance tests were carried out to evaluate the properties of the SAF. In all instances the SAF functioned as intended and results observed were as expected.
Substantial Equivalence
The SAF is substantially equivalent to the Quantec Series 2000 (manufactured by Tycom Dental), ProFile Series 29 (manufactured by Dentsply Tulsa Dental) and ProTaper (manufactured by Dentsply Tulsa Dental). The SAF has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the SAF and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrates that the SAF is as safe and effective as the Quantec Series 2000, ProFile Series 29 and the ProTaper. Thus, the SAF is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-6609 Silver Spring, MD 20993-0002
Redent Nova Limited C/O Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. Columbia Square 555 13th Street, Northwest Washington, DC 20004
JAN 1 4 2010
Re: K092933
Trade/Device Name: Self Adjusting File (SAF) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: December 31, 2009 Received: December 31, 2009
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.
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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
for
Anthony D. Watson, BS, MS, MBA 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): K092933
Device Name:
The Self Adjusting File (SAF)
Indications for Use:
The Self Adjusting file (SAF) is a mechanically operated endodontic file to be used for cleaning and shaping of root canals, as part of the procedure of root canal treatment.
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)
RSBez DOS/or Dr.K.P.Mury (Acting)
(Division Sign-Off)
Page 1 of
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092933.
§ 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.