(88 days)
No
The description focuses on piezoelectric technology, pre-set modes, user control, and memory of last settings, none of which indicate AI/ML. There are no mentions of AI, ML, or related concepts like training or test sets.
No.
A therapeutic device is typically one that treats or manages a disease or condition. This device is described as a surgical instrument for cutting bone, which is an interventional tool rather than a therapeutic one itself.
No
The device is described as a "bone cutting instrument" used for surgical procedures like osteotomy and implantology, indicating a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines hardware components such as a bone cutting instrument, handpiece cord connectors, a keyboard, a multi-function footswitch, and a screen, indicating it is not a software-only device.
Based on the provided information, the Piezotome™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "bone cutting instrument intended for use in oral surgery." This describes a surgical tool used directly on a patient's body.
- Device Description: The description details a device that uses piezoelectric ultrasound technology for mechanical bone cutting. This is a physical intervention, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Piezotome™ device performs a surgical procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Piezotome™ device is a bone cutting instrument intended for use in oral surgery.
Product codes
DZI
Device Description
The Piezotome™ is a bone cutting instrument intended for use in oral surgery.
The Piezotome™ device uses piezoelectric ultrasound technology to generate mechanical microvibrations for bone cutting, with minimal trauma to soft tissue, The device is supplied with bone surgery, sinus lift, and ligament cutting tips for use in dental surgery, including osteotomy, osteoplasty, periodontal surgery, and implantology.
This device is fitted with two handpiece cord connectors. Depending on the application, the practitioner may connect two handpieces at the same time.
The Piezotome™ function offers four utilization modes at pre-set ultrasound power settings.
The user regulates the flow rate of the irrigation fluid,
The practitioner controls the device using a keyboard and a multi-function footswitch.
The irrigation fluid flow rate and the ultrasound power are monitored on a screen. For enhanced efficacy, the last settings are memorized by the machine.
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
oral surgery
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
§ 872.4120 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
- 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
MAY 1 2006
Telephone: 011 33 556 34 0607 Fax: 011 33 556 34 9292
| Contact Person: | Steve Salesky
SATELEC
c/o Acteon, Inc.
130 Gaither Drive, Suite 100
Mt. Laurel, NJ 08054
Telephone: 856 222-9988 Ext. 40
Fax: 856 222-4726 | |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| | E-mail: | steve.salesky@us.acteongroup.com |
January 30, 2006 Date Prepared:
B. Device Identification
Bone Cutting Instrument and Accessories Common Usual Name:
Piezotome™ Proprietary Name:
C. Identification of Predicate Device
| Device | Applicant | 510(k) No. | Date Cleared |
|---|---|---|---|
| Piezosurgery® | Piezosurgery Srl | K043408 | June 8, 2005 |
The Satelec Piezotome™ is substantially equivalent to the predicate device by Piezosurgery Srl, the Piezosurgery® (K043408) previously cleared by the FDA and currently marketed.
D. Device Description
The Piezotome™ is a bone cutting instrument intended for use in oral surgery.
The Piezotome™ device uses piezoelectric ultrasound technology to generate mechanical microvibrations for bone cutting, with minimal trauma to soft tissue, The device is supplied with bone surgery, sinus lift, and ligament cutting tips for use in dental surgery, including osteotomy, osteoplasty, periodontal surgery, and implantology.
This device is fitted with two handpiece cord connectors. Depending on the application, the practitioner may connect two handpieces at the same time.
The Piezotome™ function offers four utilization modes at pre-set ultrasound power settings.
74
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1
The user regulates the flow rate of the irrigation fluid,
The practitioner controls the device using a keyboard and a multi-function footswitch.
The irrigation fluid flow rate and the ultrasound power are monitored on a screen. For enhanced efficacy, the last settings are memorized by the machine.
E. Substantial Equivalence
The Piezotome™ and the predicate device, Piezosurgery® (K043408), are both bone cutting instruments for use in oral surgery. 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 Piezotome™
2
Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter of the circle. In the center of the circle is a stylized graphic of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2006
SATELEC C/O Mr. Steve Salesky Regulatory Affairs ACTEON, Incorporated 130 Gaither Drive, Suite 100 Mount Laurel, New Jersey 08054
Re: K060274 Trade/Device Name: Piezotome™ Regulation Number: 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: January 30, 2006 Received: February 2, 2006
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 Ecderal 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,
Svelte y. Michael Om-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
Indications for Use
510(k) Number:
Device Name:
Piezotome™
Indications for Use:
The Piezotome™ device is a bone cutting instrument intended for use in 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)
Susan Runne
f Parasitology, General Hospital;
Control, Dental Devices
. J 4. 1. 1. Miller