(79 days)
To be used by Dental Professionals during dental cleaning and periodontal (gum) therapy to remove calculus, plaque and staining of the tecth by application of an ultrasonic vibrating tip to the teeth.
The Hu-Friedy® brand Symmetry S-Series Piezo Scaling Tip is similar to the Piezo Scaling Tips used with the predicate devices listed above. This device is intended to be used by dental professionals for dental cleaning and periodontal therapy to remove calculus from the teeth. The Symmetry S-Series ultrasonic insert has essentially the same design as the predicate device's ultrasonic inserts. Laboratory tests performed to make this determination include cleaning, sterilization, and mechanical life testing. The key elements of piezoelectric ultrasonic tip compatibility include: correspondence of tip thread to hand-piece specification, tip vibration at resonant frequency established by equipment specification, (27-32 kHz) and a linear tip displacement in a range consistent with the power output setting on the generator.
The provided 510(k) summary focuses on the substantial equivalence of the Symmetry S-Series Piezo Scaling Tips to predicate devices. The "study" mentioned is a field evaluation rather than a rigorous clinical trial with quantified acceptance criteria in the typical sense for a medical device with objective performance metrics.
Here's an attempt to extract and format the information based on the provided text, while acknowledging its limitations for certain categories:
Acceptance Criteria and Device Performance Study
The primary study mentioned is a field evaluation comparing the Symmetry S-Series Piezo Scaling Tips to a predicate device's competitive tip.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Compatibility: | |
| Tip thread correspondence | Compatible with hand-piece specification |
| Tip vibration (resonant) | Consistent with equipment specification (27-32 kHz) |
| Linear tip displacement | In a range consistent with the power output setting on the generator |
| Clinical Performance: | |
| Scaling efficiency | Perceived to be equal to, or slightly better than the predicate device's competitive tip |
| Adaptability to tooth surface | Perceived to be equal to, or slightly better than the predicate device's competitive tip |
| Water delivery | Perceived to be equal to, or slightly better than the predicate device's competitive tip |
| Patient comfort during use | Perceived to be equal to, or slightly better than the predicate device's competitive tip |
| Overall preference | Overall conclusion: perceived to be equal to, or slightly better than the predicate device's competitive tip (This is the overarching "acceptance" for clinical use) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text only mentions "clinicians were asked to evaluate."
- Data Provenance: Not explicitly stated. Likely refers to a prospective evaluation conducted by dental professionals. Country of origin not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated. The text refers to "clinicians" in the plural, but
the exact number is not provided. - Qualifications of Experts: The experts are described as "clinicians," implying dental professionals (e.g., dentists, dental hygienists). No specific years of experience or board certifications are mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The evaluation seems to be based on individual clinician perceptions, summarized as an "overall conclusion." There is no indication of a formal adjudication process (e.g., 2+1 or 3+1 consensus).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The evaluation was a field study assessing subjective perceptions from clinicians, not a formal MRMC study evaluating diagnostic or therapeutic accuracy with quantifiable endpoints.
- Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as this device is a physical dental scaling tip and not an AI-assisted diagnostic or therapeutic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable, as this device is a physical dental scaling tip and not an algorithm. The "mechanical compatibility" tests (resonant frequency, tip displacement) can be considered standalone performance for the physical device characteristics, confirming it operates within specified parameters before human use.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the mechanical aspects, the ground truth was engineering specifications and measurements (e.g., resonant frequency range, consistent linear tip displacement). For the clinical performance, the "ground truth" was essentially expert subjective opinion/perception (clinician evaluations of scaling efficiency, adaptability, water delivery, patient comfort, and overall preference) in comparison to a predicate device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI. The design and validation of the device were based on engineering principles and compatibility with existing equipment.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device. The design was established based on existing knowledge of piezoelectric ultrasonic technology and the characteristics of predicate devices, with lab tests verifying mechanical characteristics.
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FEB 1 2006
510(k) SUMMARY
| Submitter | Keith DunnHu-Friedy Mfg. Co., Inc.3232 N. Rockwell St.Chicago, IL 60618Tel. 773-975-6100 Fax 773-868-3558 |
|---|---|
| ----------- | --------------------------------------------------------------------------------------------------------------------------- |
Date Prepared
11/01/05
Device Name
Trade name Common name Classification name
Symmetry S-Series Piezo Scaling Tips Dental Ultrasonic Scaler Ultrasonic Scaler
Legally marketed Devices to which equivalence is claimed:
| Satelec Suprasson P-Max | K942139 |
|---|---|
| Satelec Suprasson P5 Booster | K961158 |
Description of the device
The Hu-Friedy® brand Symmetry S-Series Piezo Scaling Tip is similar to the Piezo Scaling Tips used with the predicate devices listed above.
This device is intended to be used by dental professionals for dental cleaning and periodontal therapy to remove calculus from the teeth.
The Symmetry S-Series ultrasonic insert has essentially the same design as the predicate device's ultrasonic inserts. Laboratory tests performed to make this determination include cleaning, sterilization, and mechanical life testing. The key elements of piezoelectric ultrasonic tip compatibility include: correspondence of tip thread to hand-piece specification, tip vibration at resonant frequency established by equipment specification,
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(27-32 kHz) and a linear tip displacement in a range consistent with the power output setting on the generator. At the conclusion of engineering design control testing, it was found that critical clements of design, resonant frequency and tip displacement are compatible with the predicate device's tips.
To determine if the Symmetry S-Series ultrasonic insert performed similar to or better than the predicate device, a field evaluation was undertaken. For the field study, clinicians were asked to evaluate the inserts as related to scaling efficiency, adaptability to the tooth surface, water delivery, patient comfort during use and overall preference. The overall conclusion of this evaluation was that the Symmetry S-Series tips were perceived to be equal to, or slightly better than the predicate device's competitive tip.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three stripes representing the department's mission to promote health, well-being, and human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 FEB I
Mr. Keith Dunn Regulatory Affairs Hu-Friedy Manufacturing Company, Incorporated 3232 North Rockwell Street Chicago, Illinois 60618
Re: K053178
Trade/Device Name: Symmetry S-Series Piezoclectric Scaling Tips Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: October 17, 2005 Received: November 17, 2005
Dear Mr. Dunn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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. Dunn
Please be advised that FDA's issuance of a substantial equivalence determination documot 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) gegulation (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 £21), 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-firee number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Sviette y. N. Mclian Omd.
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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Indications for Use
510(k) Number (if known): ..........................................................................
Device Name: Symmetry S-Scries Piczoclectric Scaling Tips
Indications for Use:
To be used by Dental Professionals during dental cleaning and periodontal (gum) therapy to remove calculus, plaque and staining of the tecth by application of an ultrasonic vibrating tip to the teeth.
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
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KC53178
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.