(189 days)
Not Found
No
The document describes a dental operative unit using piezoelectric ultrasound technology for bone cutting. There is no mention of AI, ML, image processing, or any data-driven decision-making processes. The performance studies focus on electrical and mechanical parameters, not algorithmic performance.
No
The device is used for dental surgery, including bone cutting and osteoplasty, which are procedures rather than a treatment for a specific condition.
No
The device is described as a dental operative unit for bone cutting and dental surgery. Its function is to generate mechanical micro vibrations for procedures like osteotomy, osteoplasty, and implantology, which are therapeutic actions, not diagnostic ones. The performance studies evaluate its mechanical and electrical characteristics, not its ability to detect or identify a medical condition.
No
The device description clearly states it is a "dental operative unit" that supplies utilities and serves as a base for dental tools, utilizing "Piezoelectric Ultrasound Technology" and including physical accessories like a handpiece and footswitch. This indicates a hardware-based device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to supply utilities to and serve as a base for dental tools for use by qualified dental practitioners for procedures like bone cutting, osteotomy, osteoplasty, and implantology. This describes a surgical or procedural device used directly on a patient, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a dental operative unit that uses piezoelectric ultrasound technology for bone cutting. This is a physical intervention device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a surgical or procedural device used in a clinical setting, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Satelec PIEZOTOME SOLO (or PIEZOTOME SOLO LED available in option) is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.
Product codes (comma separated list FDA assigned to the subject device)
DZI
Device Description
The New Device is a dental operative unit that supplies utilities to and serves as a base for Satelec Bone Cutting Handpiece (K091252, cleared July 22, 2009).
The New Device uses Piezoelectric Ultrasound Technology to generate mechanical micro vibrations for bone cutting, with minimal trauma to soft tissue.
The device is supplied with Dental Bone Surgery Tips for use in dental surgery, including osteotomy, osteoplasty and implantology. Also, the New Device uses accessories such as Piezoelectric Handpiece, Multifunction Footswitch, Bracket and Irrigation Tubing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The aim of the evaluation was to demonstrate the Substantial Equivalence of the Satelec PIEZOTOME SOLO Device and the selected Predicate Device in terms of Performances. The Performances of the New Device have been evaluated on test bench.
The evaluated Performances were:
- The current values provided in the Piezoelectric Handpiece for each mode.
- The modulation frequencies provided in the Piezoelectric Handpiece for each mode.
- The minimum and maximum irrigation flows available for each mode.
- The leakage currents.
After tests, the obtained results have been directly compared to the Predicate Device Performances. The results of the comparison show that the Performances of the New Device and the Predicate Device are similar.
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.
Not Found
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
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
KI12188
Section 05 - 510(k) Summary (SMDA Requirements)
FEB - 3 2012
This Summary of Safety And Effectiveness is submitted in accordance with 21 CFR 807.92.c.
1 - Administrative Information
Date Prepared: 1- a.
July 12, 2011
1-b. 510(k) Submitter
Contact Person:
1-с.
SATELEC 17, Avenue Gustave Eiffel BP 30216 33708 Merignac Cedex France Telephone: 33 (0) 556 34 06 07 Fax: 33 (0) 556 34 92 92
Rick Rosati SATELEC c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Telephone: 800-289-6367 Ext. 39 Fax: 856-222-4726 E-Mail: rick.rosati@us.acteongroup.com
Establishment registration number: 1- e..
8044015
Pre-Market Notification 510(k) Submission for PIEZOTOME SOLO By SATELEC Confidential Document - Version 01
Image /page/0/Picture/13 description: The image shows a logo with the letter G in a stylized font. Below the letter G, the text "ISO 13485" is visible. The logo appears to be a certification mark related to the ISO 13485 standard, which pertains to quality management systems for medical devices.
company of ACTEON Group Eiffel . BP 30216 . 33708 MERIGNAC cedex . FRANCE 33 (0) 556 34 06 07 · Fax + 33 (0) 556 34 92 92 . satelec@acteongroup.com . www.acteongroup.com es Applications des Techniques Electroniques - S A.S. au capital de 1 309 548 € Société pour la 782 016 240 . N' Intracommunautaire FR 39 782 016 240
Image /page/0/Picture/15 description: The image shows the logo for Satelec Acteon. The logo is black and white and includes the text "SATELEC ACTEON" in a stylized font. Above the logo is the number "05 - 1". There is a curved line on the left side of the logo.
1
Section 05 -- 510(k) Summary (SMDA Requirements)
2 - Device Information
| 2-a. | Common Name of device: | Bone Cutting Material and Accessories |
|---|---|---|
| 2-b. | Trade Name of device: | PIEZOTOME SOLO |
| PIEZOTOME SOLO LED (available in option) | ||
| 2-c. | Classification regulation: | 21 CFR 872.4120 |
| 2-e. | Medical Device Class: | II |
| 2-f. | Panel: | Dental |
| 2-g. | Product code: | DZI |
3 - Identification of legally marketed device(s)
The Substantial Equivalence (SE) of the Device is based on the ... Predicate Device identified in the Table 01.
Table 01 - Identification of legally marketed device
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
The Property of Children
42, 18, 1
1
production of the station and the country of
Carles Comments of Children Comments of | Children Children Children Come
1249 Pri
.
Section of the state of the state of the states | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| -----------
WWW.TO TO TO CALLALLA | -
| | CON CONSUL CAR CONSULT CARD COLLECT COLLEGION
AAAAAAAAA |
4 - Description of the Device
The New Device is a dental operative unit that supplies utilities to and serves as a base for Satelec Bone Cutting Handpiece (K091252, cleared July 22, 2009).
The New Device uses Piezoelectric Ultrasound Technology to generate mechanical micro vibrations for bone cutting, with minimal trauma to soft tissue.
The device is supplied with Dental Bone Surgery Tips for use in dental surgery, including osteotomy, osteoplasty and implantology. Also, the New Device uses accessories such as Piezoelectric Handpiece, Multifunction Footswitch, Bracket and Irrigation Tubing.
Pre-Market Notification 510(k) Submission for PIEZOTOME SOLO By SATELEC Confidential Document - Version 01
Image /page/1/Picture/12 description: The image shows a logo with the letter 'G' in a stylized font at the top. Below the 'G', there is some smaller text that is difficult to read due to the image quality. Underneath the smaller text, the text 'ISO 13485' is visible. The logo appears to be a certification mark related to ISO 13485 standards.
SATE FC . A company of ACTEON Group Eiffel · BP 30216 · 33708 MERIGNAC cedex · FRANCE 17 av Gistave Tel + 33 (0) 556 34 06 07 . Fax + 33 (0) 556 34 92 92 E-mail: satelec@acteongroup.com · www.acteongroup.com Société pour la Conceptions des Techniques Electroniques - S.A.S. au captal de 1 309 548 E
R.C. Bordeaux B 732 016 240 · N' Intracommunautaire FR 39 782 016 240
Image /page/1/Picture/14 description: The image shows the logo for ACTEON SATELEC. The logo is in black and white, with the word "ACTEON" in large, bold letters. Above the word "ACTEON" is the word "SATELEC" in smaller letters. To the left of the word "ACTEON" is a curved line.
2
Section 05 - 510(k) Summary (SMDA Requirements)
5 - Intended Use
The intended use of the Satelec PIEZOTOME SOLO (or PIEZOTOME SOLO LED available in option) is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.
6- Technological characteristics of the Device compared to the Predicate Device
Technological characteristics of the Device are the same as the Predicate Device.
Technological perspective:
The Device and the Predicate Device use the same technology (piezoelectricity technology).
Material perspective:
The Device and the Predicate Device are very similar because the casings are made in self-extinguishing material (UL94-V0).
Design perspective:
The Device and the Predicate Device use the same:
- Switching Power Supply. –
- Motherboard.
- Irrigation Board. . -
- Light Board.
- Irrigation Tubing.
- Piezoelectric Handpiece.
- Dental Bone Surgery Tips. -----
- Bracket.
Also, both devices are equipped with a large display and a Multifunction Footswitch.
Energy source perspective:
The Device and the Predicate Device:
- Use the same input energy source (electric power supply). i
- Deliver the same output energy source (ultrasonic micro-vibration).
Material in contact with the patient:
Because of the Device and the Predicate Device use the same Irrigation Tubing, Piezoelectric Handpiece and Dental Bone Surgery Tips, the materials in contact with the patient are exactly the same.
7 - Determination of substantial equivalence
The Satelec PIEZOTOME SOLO (or PIEZOTOME SOLO LED available in option) is a dental operative unit that supplies utilities to and serves as a base for Satelec Bone Cutting Handplece. The Satelec PIEZOTOME SOLO (or PIEZOTOME SOLO LED available in option) Indications for Use are similar to the Satelec IMPLANT CENTER 2.
Pre-Market Notification 510(k) Submission for PIEZOTOME SOLO By SATELEC Confidential Document - Version 01
Image /page/2/Picture/29 description: The image shows a logo with the letters 'GT' stacked on top of each other. Below the letters, the text 'ISO 13485' is visible. The logo appears to be a certification mark, possibly indicating compliance with the ISO 13485 standard, which relates to quality management systems for medical devices.
SATELEC . A company of ACTEON Group . . . . . . BP 30216 · 33708 MERIGNAC cedex · FRANCE 33 (0) 556 34 06 07 . Fax + 33 (0) 556 34 92 92 E-mail: satelec@acteongroup.com · www.acteongroup.com onception des Applications des Techniques - S.A.S. au capital de 1 309 548 €
R.C. Bordeaux 8 782 016 240 • N' intracommunautaire FR 39 782 016 240
Image /page/2/Picture/31 description: The image shows the logo for Satelec Acteon. The logo is black and white and features the word "ACTEON" in large, bold letters. Above the word "ACTEON" is the word "SATELEC" in smaller letters. To the left of the word "ACTEON" is a curved line. The image also contains the number "05 - 3" at the top.
Image /page/2/Picture/32 description: The image shows a black and white speckled pattern. The black specks are scattered randomly across the white background. The specks vary in size and density, with some areas having more specks than others.
3
Section 05 - 510(k) Summary (SMDA Requirements)
The Device is the same as the Satelec IMPLANT CENTER 2 (K091252, date cleared) Predicate Device in terms of functioning principle. Both devices use the PIEZOTOME Topology. Also the Devices use the same Handpiece and the same range of Dental Bone Surgery Tips.
From internal structure perspective, Devices are very similar because the Switching Power Supply, the Motherboard, the Irrigation Board and the Light Board used are the same for the Device and the Predicate Device.
From external structure perspective, the devices are very similar because the casings are made in self-extinguishing material (UL94-V0) and both Devices are equipped with a large display. Also, both Devices use a multi function footswitch.
Moreover, the materials in contact with the patient are exactly the same.
Discussion of the non-dinical Tests:
The aim of the evaluation was to demonstrate the Substantial Equivalence of the Satelec PIEZOTOME SOLO Device and the selected Predicate Device in terms of Performances. The Performances of the New Device have been evaluated on test bench.
The evaluated Performances were:
- The current values provided in the Piezoelectric Handpiece for each mode. -
- The modulation frequencies provided in the Piezoelectric Handpiece for each mode.
- The minimum and maximum irrigation flows available for each mode.
- The leakage currents.
After tests, the obtained results have been directly compared to the Predicate Device Performances. The results of the comparison show that the Performances of the New Device and the Predicate Device are similar.
8 - Conclusion
The Satelec PIEZOTOME SOLO (or the PIEZOTOME SOLO LED available in option) is exactly the same as the identified Predicate Device in terms of Indication For Use. Because of the used technologies, characteristics and performances are similar to the Predicate Device, the characteristics of the Satelec PIEZOTOME SOLO (or the PIEZOTOME SOLO LED available in option) do not affect the Safety of the patients or of the operator. Moreover, the Effectiveness is the same as of the Predicate Device.
There is no doubt that the Satelec PIEZOTOME SOLO (or the PIEZOTOME SOLO LED available in option) is efficient and safe for the intended uses.
The PIEZOTOME SOLO device is substantially equivalent to the IMPLANT CENTER 2 Predicate Device (K091252, cleared July 22, 2009).
End of Section
Pre-Market Notification 510(k) Submission for PIEZOTOME SOLO By SATELEC Confidential Document - Version 01
Image /page/3/Picture/19 description: The image shows a logo with the letter 'G' in a stylized font. Below the 'G', the text 'ISO 13485' is visible, indicating compliance with the ISO 13485 standard for medical devices. The logo and text are in black and white, and the image appears to be a cropped portion of a document or label.
SATE FC . A company of ACTEON Group 17 av. Gustave Eiffet . BP 30216 . 33708 MERIGNAC cedex . FRANCE el + 33 (0) 556 34 06 07 · Fax + 33 (0) 556 34 92 92 E-mail: satelec@acteongroup.com · www.acteongroup.com Société pour la Conception des Techniques Electroniques • S.A.S. au captisé de 1 309 548 €
R.C. Bordeaux 6 782 016 240 • N' intracommunautaire FR 39 782 016 240
Image /page/3/Picture/21 description: The image shows the Acteon Satelec logo. The word "ACTEON" is in large, bold, black letters, with a curved black line extending from the left side of the "A" and underneath the word. Above and to the right of "ACTEON" is the word "SATELEC" in smaller, black letters. At the top of the image are the numbers "05 - 4".
4
THE SEAR
Section 05 – 510(k) Summary (SMDA Requirements)
This page is intentionally left in blank
Pre-Market Notification 510(k) Submission for PIEZOTOME SOLO By SATELEC Confidential Document - Version 01
Image /page/4/Picture/4 description: The image shows a logo with the letter 'G' in a stylized font. Below the 'G', the text 'CERTIFIED' is visible in a smaller font size. Underneath 'CERTIFIED', the text 'ISO 13485' is present, indicating compliance with the ISO 13485 standard, which is related to quality management systems for medical devices.
SATELEC - SATELEC - A company of ACTEDN Group
17 av. Gustave Elifel - BP 30216 - 33708 MERIGHAC cedex - FRANCE
E-mail: satelec@acteongroup.com · www.acteongroup.com
Image /page/4/Picture/6 description: The image shows the logo for Satelec Acteon. The logo is black and white and features the word "ACTEON" in large, bold letters. Above the word "ACTEON" is the word "SATELEC" in smaller letters. To the left of the word "ACTEON" is a curved line. At the top of the image is the number "05 - 5".
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head turned to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Rick Rosati Quality Manager . SATELEC - ACETEON, Incorporated 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054
FEB - 3 2012
Re: K112188
Trade/Device Name: PIEZOTOME SOLO PIEZOTOME SOLO LED (in option) Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: January 27, 2012 Received: January 30, 2012
Dear Mr. Rosati:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
6
Page 2 - Mr. Rosati
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Wh tör.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Section 04 - Indication for Use
Indications for Use
510(k) Number (if known): K112458
Device Name:
PIEZOTOME SOLO PIEZOTOME SOLO LED (in option)
Indications for Use:
The intended use of the Satelec PIEZOTOME SOLO (or PIEZOTOME SOLO LED available in option) is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.
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)
h
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page 1 of 1