The SP 4055 and SP 4055 LUX modules are sub-assemblies of the SUPPRASON P5 Booster Piezoelectric Ultrasonic Scaling Generator which received 510(k) clearance for dental applications (K961158) on May 23, 1996. The SP 4055 and SP 4055 LUX Modules maintain all the functions and the main components of the SUPRASSON P5 Booster, but are stand-alone sub-assemblies manufactured by SATELEC, all with the same components and materials used in the manufacture of the original SUPRASSON P5 Booster product, which can be used in standard dental units. The intended use, technical performance, and clinical indications are identical to those of their predicate device, the SUPRASSON P5 Booster (K961158).

The SP 4055 and SP 4055 LUX modules are multi-purpose ultrasonic generators to be marketed as modular sub-assemblies to manufacturers of dental units. Each module is shipped with three standard tips, 1, 2, and 10P. The SP 4055 and SP 4055 LUX are comprised of 3 setting ranges:

scaling, prosthesis removal, amalgam plugging,
ultrasonic endodontic treatment, and
ultrasonic periodontal treatment.

As the ultrasonic waves are produced by piezoelectricity, the SP 4055 and SP 4055 LUX module handpieces give off very little heat, making it possible for surgeons to perform both periodontal work (subgingival work at low power, where the absence of overheating is vital), as well as loosening (requiring high power, but without the unpleasant side-effect of a hot handpiece).

With the activation of a simple spray, the system ensures efficient cavitation and maximum operating power.

The electronics automatic control system has the capability to adjust power instantaneously in function of the resistance encountered by the insert, and varies handpiece and tips frequency so as to optimize power output.

The SP 4055 and SP 4055 LUX Modules, similar to their predicate device, SUPRASSON P5 Booster (K961158), operate from the action of cavitation, following the propagation of ultrasounds in a frequency spectrum comprised between 27 and 35 kHz.

AI/ML Overview

The provided document is a 510(k) summary for the SATELEC SP 4055 and SP 4055 LUX Modules, which are piezoelectric ultrasonic scaling generators. These modules are largely identical to their predicate device, the SUPRASSON P5 Booster (K961158).

The acceptance criteria for this device are based on demonstrating substantial equivalence to the predicate device. The study proving the device meets these criteria is a substantial equivalence comparison. This type of submission relies on showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness as a legally marketed predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Substantial Equivalence)	Reported Device Performance
Intended Use: Prophylaxis, preservation of soft and hard tissue during dental treatments (scaling, periodontics, endodontics).	Identical to predicate device (SUPPRASON P5 Booster, K961158).
Technical Performance: Production of ultrasonic waves via piezoelectricity, operating in a frequency spectrum between 27 and 35 kHz, automatic power adjustment, low heat generation.	Technical characteristics are "almost identical" to the predicate (Satelec SUPRASSON P-5 Booster). Operates from cavitation following ultrasound propagation in 27-35 kHz range. Low heat, efficient cavitation, maximum power, automatic electronic control for instantaneous power adjustment.
Safety and Effectiveness: Should not raise new questions of safety or effectiveness compared to the predicate device.	Differences in technical specifications, materials, physical appearance, and control systems "do not affect the relative safety or effectiveness" compared to the predicate.
Materials: Same components and materials as the predicate device.	Manufactured with "the same components and materials used in the manufacture of the original SUPPRASON P5 Booster product."
Clinical Indications: Identical to the predicate device.	Identical to the predicate device. Explicitly lists: Scaling (interdental junction, tooth neck, subgingival, large deposits, coatings/tobacco stains, periodontal pockets, interproximal, retro surgery, amalgam plugging, prosthesis loosening, inlay/onlay condensation); Endodontia (canal preparation, cleaning, filling, treatment resumption, prosthesis, micro retro surgery, gutta condensation); Periodontia (root planing, initial therapy, periodontal pockets, furcations, maintenance therapy).

2. Sample Size Used for the Test Set and Data Provenance

This is not a clinical study in the traditional sense with a "test set" of patients. Instead, it's a device comparison and review of technical specifications. The "test" set essentially refers to the detailed comparison of the new device's specifications and performance against the predicate device's established specifications and performance.

Sample Size: Not applicable in the context of a patient-based test set. The "sample" here would be the physical devices themselves (SP 4055 and SP 4055 LUX Modules) and their technical documentation, compared against the predicate device's documentation and specifications.
Data Provenance: The information is derived from internal design documents, technical specifications, and potentially bench testing data from SATELEC (based in France: Z.I. du Phare, BP 216 Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE). This would be prospective in the sense that the new device was designed and evaluated against existing predicate device data to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified. For a 510(k) submission of this type, the "experts" are typically the manufacturing engineers, quality control personnel, and regulatory affairs specialists at SATELEC who compiled the technical specifications and conducted any necessary bench testing. The FDA review team (Office of Device Evaluation, Division of Dental, Infection Control and General Hospital Devices) acts as the ultimate "expert" body in determining substantial equivalence.
Qualifications: For SATELEC, these would be engineers and regulatory professionals. For the FDA, it would be medical device reviewers and scientific staff with expertise in dental devices, as indicated by the "Director Division of Dental, Infection Control and General Hospital Devices" signature.

4. Adjudication Method for the Test Set

Not applicable. There is no independent adjudication of a "test set" in the way one would for clinical image interpretation. The substantial equivalence determination is made by the FDA based on the provided data and comparison to the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of clinical data (e.g., radiologists reading images), not for a device like an ultrasonic scaler where direct performance metrics and physical characteristics are compared.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Yes, a form of "standalone" evaluation was done implicitly. The device (algorithm/machine) performance is based on its physical and functional characteristics (frequency range, power output control, heat generation, cavitation) as an independent unit, without requiring human-in-the-loop performance for its core function or for the substantial equivalence claim. The device itself is a standalone unit (though as a sub-assembly for dental units).

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence determination is the established safety and effectiveness of the legally marketed predicate device (SUPRASSON P5 Booster, K961158). The new devices (SP 4055 and SP 4055 LUX Modules) are compared against the known characteristics and performance of this predicate.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

Summary

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K972026

SMDA Summary of Safety and Effectiveness - "510(k) Summary" 8.

JUL - 9 1997

A. Submitter Information
SATELEC Z.I. du Phare, BP 216 Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE

011-33-5-56-34-06-07 Telephone:

Contact Person:

Pascal Dupeyron Requlatory Affairs

May 28, 1997 Date Prepared:

B. Device Identification

Common/Usual Name Proprietary Name:

Piezoelectric Ultrasonic Scaling Generator SP 4055 and SP 4055 LUX Modules

C. Identification of Predicate Device(s)
The SP 4055 and SP 4055 LUX Modules are substantially equivalent to its predicate device, SUPRASSON P5 Booster (K961158) previously cleared and currently marketed.

D. Device Description

and SP 4055 LUX modules are sub-assemblies of the The SP 4055 SUPPRASON P5 Booster Piezoelectric Ultrasonic Scaling Generator which received 510(k) clearance for dental applications (K961158) on May 23, 1996. The SP 4055 and SP 4055 LUX Modules maintain all the functions and the main components of the SUPRASSON P5 Booster, but are stand-alone sub-assemblies manufactured by SATELEC, all with the same components and materials used in the manufacture of the original SUPRASSON P5 Booster product, which can be used in standard dental units. The intended use, technical performance, and clinical indications are identical to those of their predicate device, the SUPRASSON P5 Booster (K961158).

· scaling, prosthesis removal, amalgam plugging,
· ultrasonic endodontic treatment, and
· ultrasonic periodontal treatment.

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With the activation of a simple spray, the system ensures efficient cavitation and maximum operating power.

E. Substantial Equivalence

The technical characteristics of the SP 4055 and SP 4055 LUX Modules are almost identical to those of the Satelec SUPRASSON P-5 Booster. Differences that exist between these devices relating to technical specifications, materials, physical appearance, and control systems do not affect the relative safety or effectiveness of the SP 4055 and SP 4055 LUX Modules relative to its predicate.

The SP 4055 and SP 4055 LUX Modules are intended to provide overall prophylaxis and preservation of soft and hard tissue during the 3 standard dental treatments; Scaling, Periodontics, and Endodontics.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its wing and tail. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUM SERVICES USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jacqueline E. Masse ·Sr. Consultant Satelec C/O Interactive Consulting, Incorporated 70 Walnut Street Wellesley, Massachusetts 02181

JUL - 9 1997

Rė : K972026 SP4044 & SP4055 Lux Modules Trade Name: Regulatory Class: II Product Code: ELC Dated: May 28, 1997 Received: June 2, 1997

Dear Ms. Masse:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as sec forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Masse in i

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 2

510(k) Number (if known):

Device Name: . . . . . . . ..

SP 4055 and SP 4055 LUX Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Indications For Use:

ﻤﺴﺘﺸﻔﺖ

Scaling Endodontics Periodontics

Please refer to the attached listing for a complete description.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number .

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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Page 2 of 2

INDICATIONS FOR USE SATELEC SP 4055 AND SP 4055 LUX MODULES

Scaling:

Interdental junction treatment .
Tooth neck and subgingival treatment .
Treatment of large deposits .

.. .

Treatment of coatings and tobacco stains .
· Treatment of periodontal pockets
· Interproximal treatment
· Retro Surgery
· Plugging
- Amalgam plugging .
Loosening
- Prosthesis Loosening (crown, pivot locsening) .
· Inlay/Onlay Condensation:
- Finish of inlay/onlay restorations .

Endodontia:

Canal preparation .
Canal cleaning .
Canal filling .
Treatment resumption .
. Prosthesis:
- Preparing in luted denture .
- Surface smoothing after burring .
Micro Retro Surgery .
. Gutta Condensation:
- Treatment resumption on gutta percha .
- Post loosening .
- Silver cone loosening .
- Gutta percha condensation .

Periodontia:

Root planing な
. Initial therapy
Treatment of periodontal pockets .
Treatment of furcations .
Maintenance therapy .

Regulation Number and Section

§ 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.