K Number
K043408
Device Name
PIEZOSURGERY DEVICE
Manufacturer
Date Cleared
2005-06-08

(180 days)

Product Code
Regulation Number
872.4120
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Piezosurgery device is a bone cutting instrument intended for use in oral surgery.
Device Description
The Piezosurgery® device uses piezoelectric ultrasonic technology to generate mechanical The riezdsurgery done cutting, with minimal trauma to soft tissue. The device is supplied mith sharp, smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery and surgical orthodontics.
More Information

Not Found

No
The summary describes a device using piezoelectric ultrasonic technology for bone cutting and does not mention any AI or ML components or capabilities.

Yes

The device is intended for use in oral surgery for bone cutting, with a focus on minimizing trauma and promoting healing. This aligns with the definition of a therapeutic device designed to cure, mitigate, treat, or prevent disease, or to affect the structure or any function of the body.

No
The provided text describes the Piezosurgery device as a "bone cutting instrument" used for "oral surgery." Its function is related to mechanical cutting and shaping bone, not diagnosing medical conditions or diseases.

No

The device description explicitly states it is a "bone cutting instrument" that uses "piezoelectric ultrasonic technology to generate mechanical vibrations" and is "supplied with sharp, smoothing and blunt insert tips." This clearly indicates a hardware device with physical components for surgical intervention.

Based on the provided information, the Piezosurgery device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "a bone cutting instrument intended for use in oral surgery." This describes a surgical tool used directly on a patient's body for a surgical procedure.
  • Device Description: The description details a device that uses piezoelectric technology to cut bone with minimal trauma to soft tissue. This is a physical intervention on the patient.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The provided information does not mention any analysis of specimens or diagnostic purposes.

Therefore, the Piezosurgery device is a surgical instrument, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Piezosurgery device is a bone cutting instrument intended for use in oral surgery.

Product codes

DZI

Device Description

The Piezosurgery® device uses piezoelectric ultrasonic technology to generate mechanical The riezdsurgery done cutting, with minimal trauma to soft tissue. The device is supplied mith sharp, smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery and surgical orthodontics.

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

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

Performance and safety evaluations were based on clinical and histologic data on the Piezosurgery device. These pertained to incision characteristics, cutting precision and surgical tactile control, risk of adjacent tissue damage, mineralized tissue heating, integrity of the osteotomized surfaces, and post-operative healing. The evaluations demonstrated the need for limited pressure on the handpiece to achieve the desired cutting action, and the possibility of trauma to soft tissue.

Key Metrics

Not Found

Predicate Device(s)

Micro-motor system MD20 Nouvag (K042434)

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

Piezosurgery 510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92 (c)

K number:K043408
--------------------
  1. Submitter's information:

| | Tomaso Vercellotti, M.D., D.D.S.
Piezosurgery s.r.l.
Molo Ponte Morosini 41/7
16126 Genoa, Italy
Phone: +39 010 254 1934
E-mail: perfler@piezosurgery.com |

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  1. Contact person:

| | Maria E. Donawa, M.D.
Donawa Consulting
P.zza Albania, 10
00153 Rome, Italy
Phone: +39 06 578 2665
E-mail: medonawa@donawa.com |

-------------------------------------------------------------------------------------------------------------------------------------------------
  1. Date summary prepared:
June 6, 2005
----------------
  1. Device name and classification:
a. Trade/device name:Piezosurgery®
b. Classification name:Bone Cutting Instrument and Accessories (per 21 CFR section 872.4120)
c. Classification panel:Dental
d. Regulatory class:Class II
e. Product code:DZI

5. Device description:

  1. Device dessmithom:
    The Piezosurgery® device uses piezoelectric ultrasonic technology to generate mechanical The riezdsurgery done cutting, with minimal trauma to soft tissue. The device is supplied mith sharp, smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery and surgical orthodontics.

6. Intended use:

o. The Piezosurgery device is a bone cutting instrument intended for use in oral surgery.

7. Predicate device:

Micro-motor system MD20 Nouvag (K042434)

8. Substantial equivalence comparison:

o. Technical oquivals.comparisons presented in this submission support a Technical, clinical and niotologic compansent prosurgery and other bone cutting devices muling of oubotantial of the US. In addition, this technology has been shown to allow precise osteotomies with minimal risk of tissue heating and osteonecrosis damage.

1

9. Performance evaluations:

  1. Performance evaluations.
    Performance and safety evaluations were based on clinical and histologic data on the Performance and salely evaluations were bacal on and surgical tactile control, risk of adjacent tissue
    incision characteristics, cutting precision and surgical tactile contro Incision characteristics, cutting probision and ourgious technized surfaces, and postdamage, mineralized tissue heating, integrity of the osted insinces, and postdamage, mineralized tissue neating, megnity of the octosty delineated incisions and the operative nealling. The evaluations domenation pve the desired cutting action,
    need for limited pressure on the handpiece to achieve the desired to ask tigen heed for limited pressure on the nanspioo to dellier sibility of trauma to soft tissue.

10. Conclusion:

  1. Conclusion:
    The performance and safety data presented in this premarket notification support a finding and The performance and salety uata proomed in this promation of the predicate device specified in this submission.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle, and the text "U.S. Department of Health and Human Services, Inc." is written around the circle's perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 8 - 2005

Piezosurgery Srl C/O Ms. Maria E. Donawa President Donawa Consulating Srl Piazza Albania, 10 00153 Rome, Italy

Re: K043408

Trade/Device Name: Piezosurgery® Regulation Number: 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: April 28, 2005 Received: May 2, 2005

Dear Ms. Donawa:

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 - Ms. Donawa

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 Iegally 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,

Jnette G. Michael m.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 Statement

510(k) Number:K043408
Device Name:Piezosurgery®
Indications for Use:The Piezosurgery 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

(Division Sign-Off) Division of Anesthesiology, General Hespita. Infection Control, Dental Devices

Kaus408 510(k) Number __

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