(56 days)
No
The summary describes a standard electric micro-motor handpiece with manual controls and does not mention any AI or ML capabilities.
No
The device is described as an electric micro-motor handpiece used for oral dental surgical procedures and dental maintenance, which are not inherently therapeutic actions but rather tools for performing them.
No
Explanation: The device is described as an electric micro-motor handpiece used for oral dental surgical procedures, not for diagnosing conditions. Its functions involve performing physical procedures like implantology, endodontia, and periodontology.
No
The device description explicitly states it is an "electric micro-motor handpiece" with physical attachments and a control unit with a keyboard and footswitch, indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, the Satelec i-Surge is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "oral dental surgical procedures" and describes it as an "electric micro-motor handpiece." This indicates a device used on the patient for surgical intervention, not for testing samples from the patient in a lab setting.
- Device Description: The description reinforces its function as a surgical tool with a handpiece and control unit, used for procedures like implantology and endodontia.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Satelec i-Surge does not fit this description.
N/A
Intended Use / Indications for Use
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.
Product codes
EFB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified dental practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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.
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K071965 16
2 of 2
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.
2
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.
3
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
4
,
071
Indications for Use
510(k) Number:
Device Name: i-Surge
Indications for Use:
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.
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