(220 days)
The intended use of the Satelec PIEZOTOME 2 is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.
The Satelec PIEZOTOME 2 is a dental operative unit that supplies utilities to and serves as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.
This 510(k) premarket notification is for the Satelec PIEZOTOME 2, a dental operative unit. This submission is a declaration of substantial equivalence to a predicate device, the Satelec PIEZOTOME (K060274). As such, it relies on the safety and effectiveness established for the predicate device rather than presenting new clinical study data to meet acceptance criteria.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. Substantial equivalence claims do not typically involve setting new acceptance criteria or reporting new performance data. Instead, the claim is that the new device performs as safely and effectively as the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. There is no new test set or clinical study for this 510(k) submission. The device is claimed to be substantially equivalent based on similarities to a previously cleared device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No new ground truth establishment was conducted for this submission.
4. Adjudication Method for the Test Set
Not applicable. No test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a comparative effectiveness study. It's a substantial equivalence submission for a new version of an existing device.
6. Standalone Performance (Algorithm only without human-in-the-loop performance)
Not applicable. This device is a physical dental operative unit, not an AI algorithm.
7. Type of Ground Truth Used
Not applicable. No new ground truth was established for this submission. The "ground truth" for the device's safety and effectiveness relies on the predicate device's clearance.
8. Sample Size for the Training Set
Not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
Summary of the 510(k) Document:
- Device: Satelec PIEZOTOME 2
- Predicate Device: Satelec PIEZOTOME (K060274)
- Claim: Substantial Equivalence
- Differences: "Differences that exist between the devices relating to technical specification, performances and intended use are minor and do not affect the safety and effectiveness of the PIEZOTOME 2."
- Indications for Use: To supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.
In essence, the "study" proving the device meets acceptance criteria in this context is the FDA's review and determination that the PIEZOTOME 2 is substantially equivalent to the previously cleared PIEZOTOME. This implies that the new device meets the same safety and effectiveness standards that were established for the predicate device, without requiring a new clinical study or the specific metrics you've requested for AI/algorithm-based devices.
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Ko9133
510(k) Pre-Market Notification for Satelec PIEZOTOME 2
DEC 1 1 2009
SMDA Summary of Safety and Effectiveness – "510 (k) Summary" ത
- A. Submitter Information SATELEC - ACTEON Group 17, Avenue Gustave Eiffel BP 30216 33708 Merignac Cedex FRANCE
- S
Telephone: 011 33 556 34 0607 Fax: 011 33 556 34 9292
Contact Person:
Rick Rosati SATELEC c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Tel: 800 289-6367 Ext. 39 Fax: 856 222-4726 Email: rick rosati@us acteongroup.com
May 1st, 2009 Date Prepared:
- B. Device Identification
Common Usual Name: Bone cutting instrument and accessories
Proprietary Name: PIEZOTOME 2
C. Identification of the Predicate Device
| Device | Applicant | 510(k) No. | Date Cleared |
|---|---|---|---|
| PIEZOTOME | Satelec | K060274 | May 1, 2006 |
The Satelec PIEZOTOME 2 is substantially equivalent to the predicate device by Satelec, the PIEZOTOME (K060274) previously cleared by the FDA and currently marketed.
Indications for Use: The intended use of the Satelec PIEZOTOME 2 is to D. supply utilities to and serve as a base for dental tools such as ultrasonic scaler,
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510(k) Pre-Market Notification for Satelec PIEZOTOME 2
bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.
E. Device Description
The Satelec PIEZOTOME 2 is a dental operative unit that supplies utilities to and serves as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.
F Substantial Equivalence
The PIEZOTOME 2 and the predicate device, PIEZOTOME (K060274) are both dental operative units that supplies utilities to and serves as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery. Differences that exist between the devices relating to technical specification, performances and intended use are minor and do not affect the safety and effectiveness of the PIEZOTOME 2.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
DEC 1 1 2009
SATELEC C/O Mr. Rick Rosati Quality Manager ACTEON. Incorporated 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054
Re: K091331
Trade/Device Name: Piezotome 2 Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: November 23, 2009 Received: November 24, 2009
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.
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.
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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,
Rh for
Ánthony 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
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Indications for Use
1691231 510(k) Number:
PIEZOTOME 2 Device Name:
Indications for Use:
The intended use of the Satelec PIEZOTOME 2 is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.
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)
Kei Marley for MSP
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091331
§ 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.