I-SURGE by SATELEC | FDA 510(k) Summary

The Satelec i-Surge is intended to be used by qualified dental practitioners as an electric micro-motor handpiece with a straight, right or contra-angle attachment for oral dental surgical procedures including implantology, endodontia, periodontology, and dental maintenance.

Device Description

The Satelec i-Surge is intended to be used by qualified dental practitioners as an electric micro-motor handpiece with straight, right or contra-angle attachment for oral dental surgical procedures including implantology, endodontia, periodontology, and dental maintenance.

Functions and settings are selected and adjusted by the footswitch and / or the front panel keyboard on the control unit.

AI/ML Overview

This document is a 510(k) summary for the Satelec i-Surge dental handpiece. It primarily establishes substantial equivalence to a predicate device and does not contain information about a study proving the device meets specific acceptance criteria in the manner of an AI/software performance study.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the given document:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The 510(k) summary focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance criteria and test results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. The document does not describe a clinical or performance study with a test set of data in the context of an AI or diagnostic device. It's about a physical dental handpiece.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable, as no such study is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no such study is described.

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, as this is a dental handpiece, not an AI or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable, as this is a dental handpiece, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable, as no such study generating a quantifiable ground truth is described.

8. The sample size for the training set:

Not applicable, as this is a dental handpiece, not an AI device that undergoes training.

9. How the ground truth for the training set was established:

Not applicable, as this is a dental handpiece, not an AI device that undergoes training.

Summary of what the document does provide regarding device acceptance:

The primary "acceptance criterion" for this device, as detailed in the 510(k) process, is Substantial Equivalence to a legally marketed predicate device.

Acceptance Criterion: The Satelec i-Surge is substantially equivalent to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
Study/Proof: The entire 510(k) submission serves as the "study" and "proof." It compares the i-Surge to its predicate, the Satelec Suni Max (K000049).
Reported Device Performance (in relation to substantial equivalence):
- Intended Use: Both devices are "intended to be used by qualified dental practitioners as an electric micro-motor handpiece with straight, right or contra-angle attachment for oral dental surgical procedures including implantology, endodontia, periodontology, and dental maintenance."
- Technological Characteristics/Safety & Effectiveness: The document states, "Differences that exist between the devices relating to technical specifications, performances, and intended use are minor and do not affect the safety and effectiveness of the i-Surge."

In essence, the "acceptance criteria" here are that the new device is as safe and effective as the predicate device by having similar intended uses and minor, non-impactful differences in technical specifications. The "study" is the comparison made within the 510(k) submission itself.

Summary

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K071965

SEP 1 0 2007

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

A. Submitter Information
SATELEC Z.I. du Phare, BP 30216 17, Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE

Telephone: 011 33 556 34 0607 Fax: 011 33 556 34 9292

Contact Person: Steve Salesky SATELEC c/o Acteon, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel. NJ 08054 Telephone: 800 289-6367 Ext. 40 Fax: 856 222-4726 E-mail: steve.salesky@us.acteongroup.com
Date Prepared: July 12, 2007

B. Device Identification

Common Usual Name: Dental Handpiece

Proprietary Name: i-Surge

C. Identification of Predicate Device

Device	Applicant	510(k) No.	Date Cleared
Suni Max	Satelec	K000049	April 4, 2000

The Satelec i-Surge is substantially equivalent to the predicate device by Satelec, Suni Max (K000049) previously cleared by the FDA and currently marketed.

D. Device Description

Functions and settings are selected and adjusted by the footswitch and / or the front panel keyboard on the control unit.

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K071965 16
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E. Substantial Equivalence

Both the Satelec i-Surge and the predicate device, Satelec Suni Max (K000049) are intended to be used by qualified dental practitioners as an electric micromotor handpiece with straight, right or contra-angle for oral dental surgical procedures including implantology, endodontia, periodontology, and dental maintenance. Differences that exist between the devices relating to technical specifications, performances, and intended use are minor and do not affect the safety and effectiveness of the i-Surge.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the branches of government.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SFP 1 0 2007

SATELEC C/O Mr. Steve Salesky Quality Manager ACTEON, Incorporated 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054

Re: K071965

Trade/Device Name: i-Surge Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: July 12, 2007 Received: July 16, 2007

Dear Mr. Salesky:

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 - Mr. Salesky

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.

Chiu Lin, Ph.D.

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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071

Indications for Use

K071965

510(k) Number:

Device Name: i-Surge

Indications for Use:

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 (ODE)

Suver Punse
(Division Sign-Off)

Division of Anesthesiology, General Hospital. Infection Control, Dental Devi

510(k) Number: K071965

Regulation Number and Section

§ 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.