(13 days)
The ASC-12 is an ultrasonic scaler that is intended for the following procedures:
Scaling:
Interdentium treatment
Tooth neck and subgingival treatment
Treatment of large dental calculi
Treatment of coatings and tobacco stains
Treatment of periodontal pockets
Interproximal treatment
Loosening of crowns and posts
Endodontics:
Pulp Chamber Cleaning
Canal filling by ultrasonic gutta-percha condensation
The ASC-12 is an AC mains-powered piezoelectric ultrasonic scaler intended for scaling and endodontic procedures. The device consists of a console, a footswitch and an autoclavable handpiece with interchangeable and autoclavable scaling tips.
The provided document K0708166 describes the Aseptico ASC-12 Piezoelectric Scaler. The submission is a 510(k) for substantial equivalence, not a study presenting novel performance data against acceptance criteria. Therefore, much of the requested information regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets is not applicable to this type of document.
The document primarily focuses on demonstrating substantial equivalence to predicate devices (Satelec Suprasson P5 Booster - K961158 and NSK Varios 350 - K031421) by comparing intended use, design, construction, sterility assurance, and performance specifications.
Here's the breakdown of the information provided in the document concerning "acceptance criteria" which, in this context, are the specified performance characteristics for substantial equivalence validation:
1. Table of "Acceptance Criteria" (Performance Specifications) and Reported Device Performance
The acceptance criteria here are derived from the performance specifications of the predicate devices, which the ASC-12 aims to meet or be equivalent to.
| Acceptance Criteria (Performance Characteristic) | Reported Device Performance (ASC-12) |
|---|---|
| Vibration frequency | Between 27 and 32 kHz |
| Scaler coolant flow at the tip | Between 12 ml and 82 ml |
| Water pressure rating | Between 14.5 to 73 psi (1 to 5 bar) |
| Electrical Safety Specifications | Class II equipment with Type BF applied part |
| Equivalence of scaler tip amplitudes and power settings | Established equivalent scaler tip amplitudes and power settings between ASC-12 and predicate device using prescribed power settings for exact same scaler tips. (See tip movement compatibility data - Table not provided in this extract, but referenced in the document) |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the document is a 510(k) summary for substantial equivalence. It does not describe a clinical study with a "test set" in the traditional sense of evaluating diagnostic or treatment efficacy on patients. The "test" mentioned refers to engineering verification of performance specifications against predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. Ground truth, expert consensus, or clinical outcome data as part of a "test set" is not detailed in this 510(k) summary. The "ground truth" for the engineering performance validation would be the measured physical parameters against the specified ranges.
4. Adjudication Method for the Test Set
This is not applicable. There is no mention of an adjudication method as there's no clinical "test set" with subjective interpretations requiring expert consensus.
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 ultrasonic scaler, a physical medical device, not an AI-powered diagnostic or decision support tool. Therefore, MRMC studies are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical instrument, not an algorithm. Standalone performance as typically described for AI devices does not apply.
7. The Type of Ground Truth Used
The "ground truth" for the claims in this submission is based on:
- Engineering Specifications and Measurements: The physical properties and performance parameters (e.g., vibration frequency, coolant flow, water pressure, electrical safety) are measured and compared against established benchmarks or the predicate devices' specifications.
- Comparison to Predicate Devices: The primary "ground truth" for substantial equivalence is the documented characteristics and performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not a machine learning or AI device that requires training data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. See point 8.
Study Proving Acceptance Criteria (Substantial Equivalence)
The entire 510(k) submission itself serves as the "study" proving the device meets the "acceptance criteria" (i.e., demonstrating substantial equivalence to predicate devices). The document states:
- "The following intended [uses] were validated by establishing equivalent scaler tip amplitudes and power settings between a predicate device using their prescribed power settings for the exact same scaler tips to be used with the ASC-12. See tip movement compatibility data."
This indicates that internal engineering verification and comparison testing was conducted. While the detailed "tip movement compatibility data" is not provided in this excerpt, it would constitute the direct evidence of the device's performance against the predicate. The performance claims (frequency, flow, pressure, electrical safety) are typically verified through bench testing and measurements and compared to industry standards or the predicate device's known specifications. The overall conclusion of the FDA (as shown in the subsequent pages granting 510(k) clearance) is that the device is "substantially equivalent" for its intended uses and performance characteristics.
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K0708166
Telephone: (425) 487-3157
Image /page/0/Picture/1 description: The image shows a logo for "ASEPTICO International". The logo features stylized, bold lettering for the word "ASEPTICO", with the word "International" written in a smaller, elegant font underneath. To the right of the text is a graphic that resembles a globe, adding a global or international dimension to the brand's identity.
Fax: (360) 668-8722 Web: www.aseptico.com E-mail: mwaller@aseptico.com Aseptico Inc. · 8333 216" St SE · Woodinville, WA 98072
APR 1 1 2007
510(k) Summary
Grant Ramaley, Director of Regulatory Affairs Contact:
Date Prepared: January 10, 2007
Trade or Proprietary Name: Model ASC-12 Piezoelectric Scaler
Classification Name: 8872.4850 Ultrasonic scaler
510(k) Number:
Device Description: The ASC-12 is an AC mains-powered piezoelectric ultrasonic scaler The device consists of a console, a intended for scaling and endodontic procedures. footswitch and an autoclavable handpiece with interchangeable and autoclavable scaling tips.
The following intended were validated by establishing equivalent scaler tip amplitudes and power settings between a predicate device using their prescribed power settings for the exact same scaler tips to be used with the ASC-12. See tip movement compatibility data.
Features of Substantial Eguivalence to the Satelec Suprasson P5 Booster - 510(k) #K961158 and the NSK Varios 350 - 510(k) #K031421
| 1) Intended Use: scaling and endodontic procedures, including: | |
|---|---|
| Scaling: | Interdentium treatment |
| Tooth neck and subgingival treatment | |
| Treatment of large dental calculi | |
| Treatment of coatings and tobacco stains | |
| Treatment of periodontal pockets | |
| Interproximal treatment | |
| Loosening of crowns and posts | |
| Endodontics: | Pulp Chamber Cleaning |
| Canal filling by ultrasonic gutta-percha condensation |
-
- Design & Construction: AC mains-powered piezoelectric ultrasonic scaler consisting of a console, a footswitch and a handpiece with interchangeable scaling tips. Coolant may be supplied by connection to an external water source.
- Sterility Assurance: Handpiece and scaling tips are removable and autoclavable 3)
-
- Performance:
- a. The vibration frequency is between 27 and 32 kHz
- b. Scaler coolant flow is between 12 ml and 82 ml at the tip
- c. Water pressure rating is between 14.5 to 73 pso (1 to 5 bar)
-
- Electrical Safety Specifications: Class II equipment with Type BF applied part
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APR 1 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aseptico, Incorporated C/O Ms. Casey Conry Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747
Re: K070866
Trade/Device Name: ASC-12 Piezoelectric Scaler Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: March 26, 2007 Received: March 29, 2007
Dear Ms. Conry:
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 - Ms. Conry
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/industry/support/index.html.
Sincerely yours.
Smythe Y. Michie Davis.
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
K070866 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ASC-12 Piezoelectric Scaler
Indications for Use:
The ASC-12 is an ultrasonic scaler that is intended for the following procedures:
Scaling:
Interdentium treatment Tooth neck and subgingival treatment Treatment of large dental calculi Treatment of coatings and tobacco stains Treatment of periodontal pockets Interproximal treatment Loosening of crowns and posts
Endodontics:
Pulp Chamber Cleaning Canal filling by ultrasonic gutta-percha condensation
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Susan Concurrence of CDRH, Office of Device Evaluation (ODE)
entologic Corporal Hospital 11 11:21: ion Gentrol, Dental Devioes
. (k) Number..
§ 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.