(72 days)
No
The description focuses on mechanical and electrical specifications (speed, torque, compatibility) and mentions "automatic servo control" which is a standard control system technology, not necessarily AI/ML. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development.
No.
The device is a micromotor used in general dentistry for mechanical procedures such as cutting, shaping, drilling, cleaning, prophylaxis, and polishing of teeth, which are not considered therapeutic interventions based on the provided information.
No
The device description indicates its use for cutting, shaping, drilling, cleaning, prophylaxis, and polishing of teeth, which are all treatment-oriented actions, not diagnostic ones.
No
The device description clearly describes a physical micromotor with specific hardware components (E-type connection, internal spray, motor, etc.) and performance specifications (speed, torque). It is not solely software.
Based on the provided information, the IS40 Micromotor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "cutting, shaping, drilling, cleaning, prophylaxis and polishing of teeth by dental professionals." This describes a physical intervention on the patient's teeth, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a motor used with dental handpieces for mechanical procedures. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of diagnostic testing or providing information about a patient's health status based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The IS40 Micromotor's function is purely mechanical and procedural within the mouth.
N/A
Intended Use / Indications for Use
The intended use of the IS40 Micromotor is in general dentistry for cutting, shaping, drilling, cleaning, prophylaxis and polishing of teeth by dental professionals.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
The IS 40 Micromotor with internal spray is compatible with all types of contra-angles that have an E-type connection and internal spray. The IS 40 Micromotor is used with Satelec Cocoon® Hygienist (K040529) which incorporates the M6 module with automatic servo control for motor power and speed control. IS 40 Micromotor operates at a speed from 1,600 to 40,000 rpm and provides a torque of 1.6 Newton/cm at 3 A.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals / general dentistry
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEC 17 2004
8. SMDA Summary of Safety and Effectiveness - "510(k) Summary"
A. Submitter Information
SATELEC Z.I. du Phare, BP 216 Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE
Telephone: 011 33 556 34 0607 Fax: 011 33 556 34 9292
- Steve Salesky Contact Person: SATELEC c/o Acteon, Inc. 130 Gaither Drive, Suite 100 Mt. Laurel, NJ 08054 Telephone: 856 222-9988 Fax: 856 222-4726
October 4, 2004 Date Prepared:
B. Device Identification
| Common Usual Name: | Micromotor |
|---|---|
| Proprietary Name: | IS 40 Micromotor |
C. Identification of predicate Device
The Satelec IS 40 Micromotor is substantially equivalent to the predicate device by Dentsply International, the eStylus™ Electric Motor System (K031145) previously cleared by the FDA and currently marketed.
D. Device Description
The IS 40 Micromotor with internal spray is compatible with all types of contra-angles that have an E-type connection and internal spray. The IS 40 Micromotor is used with Satelec Cocoon® Hygienist (K040529) which incorporates the M6 module with automatic servo control for motor power and speed control. IS 40 Micromotor operates at a speed from 1,600 to 40,000 rpm and provides a torque of 1.6 Newton/cm at 3 A.
The intended use is in general dentistry for cutting, shaping, drilling, cleaning, prophylaxis and polishing of teeth by dental professionals.
1
E. Substantial Equivalence
The IS 40 Micromotor and the predicate device, eStylus™ Electric Motor System, are both electric motor driven dental handpieces for use with various attachments intended for use in general dentistry. 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 IS 40 Micromotor.
2
Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2004
SATELEC C/O Mr. Steve Salesky Acteon, Incorporated 130 Gaither Drive, Suite 100 Mt. Laurel, New Jersey 08054
Re: K042787
Trade/Device Name: IS 40 Micromotor Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: October 4, 2004 Received: October 6, 2004
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/dsma/dsmamain.html
Sincerely yours.
Susan Ruane
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
Indications for Use
510(k) Number (if known): K042787
Device Name: IS 40 Micromotor
Indications for Use:
The intended use of the IS40 Micromotor is in general dentistry for cutting, shaping, drilling, cleaning, prophylaxis and polishing of teeth by dental professionals.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Suza Quare
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthol. Dental Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number. K042787