(71 days)
No
The description focuses on piezoelectric ultrasound technology for mechanical bone cutting and does not mention any AI or ML components.
No
The device is used for surgical procedures like cutting, drilling, shaping, and smoothing bones and teeth, which are operative functions rather than therapeutic.
No
The device is an ultrasonic surgical system used for cutting, shaping, and smoothing bones and teeth in various surgical procedures. It is an operative tool, not a diagnostic one.
No
The device description explicitly lists hardware components such as a console, power cord, foot pedal, wrench, and handpiece, indicating it is a physical system, 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 clearly describes a surgical system for cutting bone and teeth in various surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The device description details a surgical unit with handpieces and tips for mechanical cutting using ultrasound technology.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical procedures.
N/A
Intended Use / Indications for Use
The Piezoelectric System distributed by Synthes USA is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone and bone substitutes. The system can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery.
Product codes
JDX, DZi, ERL, HBE, HWE
Device Description
The Satelec PIEZOELECTRIC SYSTEM is an operative unit that consists of a console, a power cord, a foot pedal, a wrench and a handpiece. The PIEZOELECTRIC SYSTEM device uses piezoelectric ultrasound technology to generate mechanical microvibrations for bone cutting, with minimal trauma to soft tissue.
A variety of attachments will be available for the Piezoelectric System for cutting bone, bone substitutes, osteotomy, osteoplasty, decorticating, drilling, shaping and smoothing of bones and teeth in a variety of surgical procedures. These attachments will be available "Sterile" -Single Use only (do not re-use).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones and teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.4580 Sonic surgical instrument and accessories/attachments.
(a)
Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.
0
K100410 16
510(k) Pre-Market Notification for Satelec PIEZOELECTRIC SYSTEM
2 Page 1 of
SMDA Summary of Safety and Effectiveness - "510 (k) Summary"
A. Submitter Information SATELEC - ACTEON Group 17, Avenue Gustave Eiffel BP 30216 33708 Merignac Cedex FRANCE
APR 2 8 2010
011 33 556 34 0607 Telephone: 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
B. Device Identification
Common Usual Name:
Sonic surgical instrument and accessories/attachments
PIEZOELECTRIC SYSTEM
Proprietary Name:
Classification:
Class II device (per 21 CFR § 888.4580)
-* ***
1
510(k) Pre-Market Notification for Satelec PIEZOELECTRIC SYSTEM
Page 2 __ of 2
C. Identification of the Predicate Device
| Predicate 1 | Predicate 2 | Predicate 3 | |
|---|---|---|---|
| Device name | Piezosurgery® | ||
| Medical Device | Electric Pen Drive | IMPLANT CENTER 2 | |
| Sponsor | Mectron Spa | Synthes | SATELEC - ACTEON |
| K number | K083284 | K043310 | K091252 |
D. Device Description
The Satelec PIEZOELECTRIC SYSTEM is an operative unit that consists of a console, a power cord, a foot pedal, a wrench and a handpiece. The PIEZOELECTRIC SYSTEM device uses piezoelectric ultrasound technology to generate mechanical microvibrations for bone cutting, with minimal trauma to soft tissue.
A variety of attachments will be available for the Piezoelectric System for cutting bone, bone substitutes, osteotomy, osteoplasty, decorticating, drilling, shaping and smoothing of bones and teeth in a variety of surgical procedures. These attachments will be available "Sterile" -Single Use only (do not re-use).
E. Indications for Use
The Piezoelectric System distributed by Synthes USA is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone and bone substitutes. The system can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery.
F. Substantial Equivalence
Information presented supports substantial equivalence.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an eagle or a bird in flight, with flowing lines representing its wings and tail feathers. The emblem is rendered in a bold, black color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Satelec % Acteon, Inc. Mr. Rick Rosati 124 Gaither Drive, Suite 140 Mt. Laurel, New Jersey 08054
APR 2 8 2010
Re: K100410
Trade/Device Name: Piezoelectric System Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic surgical instrument and accessories/attachments Regulatory Class: Class II Product Code: JDX, DZi, ERL, HBE, HWE Dated: April 15, 2010 Received: April 16, 2010
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.
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
3
Page 2 - Mr. Rick Rosati
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
cerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K100410
Device Name: Piezoelectric System
Indications for Use:
The Piezoelectric System, distributed by Synthes, is an ultrasonic surgical system consisting of handpieces and associated tips, for cutting bone substitutes and metal. The system can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth, in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical spine, and plastic/reconstructive surgery.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of D vice Evaluation (ODE) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100410