PIEZOSURGERY MEDICAL

K083284 · Piezosurgery S.R.L. · JDX · Apr 8, 2009 · Orthopedic

Device Facts

• Record ID: K083284
• Device Name: PIEZOSURGERY MEDICAL
• Applicant: Piezosurgery S.R.L.
• Product Code: JDX · Orthopedic
• Decision Date: Apr 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.4580
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Piezosurgery MEDICAL is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It may also be used with endoscopic visual assistance to perform the above listed procedures.

Device Story

Ultrasonic surgical system; central console with two peristaltic irrigation pumps; two detachable handpieces with piezoelectric transducers; footswitch-operated. System uses ultrasonic frequency resonance modulated with low-frequency bursts to create a 'hammering effect' at the insert tip for bone cutting/drilling. Surgeon selects bone-type-specific cutting modalities, power levels (7 settings), and irrigation flow rates (5 levels) via LCD touch-screen. Used in OR/clinical settings by surgeons. Irrigation tubing kits and tips are single-use sterile components. Device provides precise bone cutting while preserving soft tissue; irrigation prevents overheating.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and performance data regarding cutting modalities, power output, and irrigation control.

Technological Characteristics

Ultrasonic surgical system; piezoelectric transducer handpieces; electronic generator with automatic frequency tuning; touch-screen interface; peristaltic irrigation pumps. Operates via ultrasonic resonance modulated by low-frequency bursts. Seven power levels; five irrigation flow levels. Single-use sterile tips and tubing.

Indications for Use

Indicated for patients requiring bone cutting, osteotomy, osteoplasty, or drilling across otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgical procedures. May be used with endoscopic assistance.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Synthes Electric Pen Drive (EPD) System (K043310)
• Linvatec E9000 System (K990524)
• Piezosurgery (oral use) (K043408)

Submission Summary (Full Text)

{0}------------------------------------------------

PIEZOSURGERY®

Piezosurgery s.r.1. Registered Office: Molo Ponte Morosini 41/7 - 16126 Genoa, Italy Headquarter. Via Portobello, 12 - 16039 Sestri Levante, Italy Tel:[phone], Fax:[phone] E-mail: [e-mail]

APR - 8 2009

## 14083284 510(k) Summary in accordance with 21 CFR 807.92(c)

| Device Name: | Piezosurgery Medical | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Type of 510(k) submission: | Traditional | |
| Date of Submission: | 31 October 2008 | |
| Manufacturer: | Mectron Spa<br>Via Loreto, 15, Carasco, GE 16042, Italy | |
| FDA Registration Number: | 3003933619 | |
| 510(k) Owner: | Piezosurgery SRL<br>Registered Office:<br>Molo Ponte Morosini 41/7 -16126 GE Italy<br>Headquarters:<br>Via Portobello, 12 - 16039 Sestri Levante GE Italy | |
| 510(k) Contact: | Roger Gray<br>Director, Global Regulatory Affairs<br>Donawa Consulting<br>Piazza Albania, 10, 00153 Rome, Italy<br>Tel: [phone]<br>Fax: [phone] | |
| Trade Name: | Piezosurgery Medical | |
| Common Name: | Bone cutting instrument and accessories | |
| Classification Regulation: | 888.4580: Sonic surgical instrument and<br>accessories/attachments | |
| Identification: | A sonic surgical instrument is a hand-held device with<br>various accessories or attachments, such as a cutting tip that<br>vibrates at high frequencies, and is intended for medical<br>purposes to cut bone or other materials, such as acrylic. | |
| Class: | Class II | |
| Product Codes: | HWE, DZI, ERL, HBE and JDX | |

{1}------------------------------------------------

# PIEZOSURGERY®

Piezosurgery s.r.l. Registered Office: Molo Ponte Morosini 41/7 - 16126 Genoa, Italy Headquarter. Via Portobello, 12 - 16039 Sestri Levante, Italy Tel:[phone], Fax:[phone] E-mail: [e-mail]

### Predicate Devices:

| Predicate device 1 | Predicate device 2 | Predicate device 3 |
|--------------------------------------------|-----------------------------------------------------|----------------------------------------------|
| Synthes Electric Pen Drive<br>(EPD) System | Linvatec E9000 System | Piezosurgery (oral use) |
| Synthes (USA) | Linvatec Corporation | Mectron SPA |
| 1690 Russell Road<br>Paoli, PA 19301 USA | 11311 Concept Boulevard<br>Largo, FL 33773-4908 USA | Via Loreto, 15/A<br>16042 Carasco (GE) ITALY |
| K043310 | K990524 | K043408 |

### Device Description:

The Piezosurgery® Medical device is an ultrasonic surgical system consisting of a central console with two integral peristaltic irrigation pumps, and two detachable handpieces. Each handpiece is connected to the console electrically, and each is also connected to one of the irrigation pumps via an irrigation tubing kit. The handpieces contain the ultrasonic transducers. A separate electricallyoperated footswitch is provided with the device, which also attaches to the central console. The irrigation tubing kits and insert tips are supplied sterile and are intended for single-use. A range of optionally available handpiece tips provides the surgeon with a wide variety of options for drilling, cutting and sawing.

The console has a touch-screen display and contains general control system circuits and two ultrasonic generators which drive the handpiece functions. The irrigation tubing kit is fed with physiological saline solution during the surgical procedure from saline bags (not supplied) which hang from drip stands that attach to the rear of the central console.

The user may activate either of the two handpieces by the selection from the LCD touch-screen and by pressing the footswitch.

### Intended Use:

The Piezosurgery MEDICAL is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It may also be used with endoscopic visual assistance to perform the above listed procedures.

### Technological Characteristics:

The desired surgical effect is obtained by using an ultrasonic frequency of resonance modulated in amplitude with low frequency bursts according to the bone quality program selected by the operator. The integral Piezosurgery® electronic generator performs automatic tuning of the working frequency. optimizing the efficiency of the piezoelectric transducer in the handpiece.

This feature makes it possible to produce a "hammering effect" of the insert tip, resulting in a cutting action.

{2}------------------------------------------------

## PIEZOSURGERY®

Piezosurgery s.r.l. Registered Office: Molo Ponte Morosini 41/7 - 16126 Genoa, Italy Headquarter. Via Portobello, 12 - 16039 Sestri Levante, Italy Tel:[phone], Fax:[phone] E-mail: [e-mail]

### Performance Data:

Depending on the object bone type, the user can select four cutting modalities. The flow rate of physiological saline irrigation solution is user-adjustable on five levels, and the user may also set the power output from a choice of seven levels.

### Conclusion:

.......

Based on the information contained within this submission, it is concluded that the Piezosurgery Medical device is substantially equivalent to the predicate devices already in interstate commerce within the USA.

{3}------------------------------------------------

Image /page/3/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 an abstract symbol that resembles an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 8 2009

Piezosurgery SRL % Donawa Consulting Mr. Roger Gray Piazza Albania, 10 · 00153 Rome Italy

Re: K083284

Trade/Device Name: Piezosurgery Medical device Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic surgical instrument and accessories/attachments Regulatory Class: II Product Code: JDX, HWE, DZI, ERL, HBE - Dated: Mach 24, 2009 Received: March 31, 2009

Dear Mr. Gray:

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.

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

{4}------------------------------------------------

Page 2 - Mr. Roger Gray

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark M. Mulkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Indications for Use Statement

#### Indications for Use

14083284-510(k) Number (if known): Not known

Device Name: Piezosurgery Medical device

Indications for Use: The Piezosurgery MEDICAL is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It may also be used with endoscopic visual assistance to perform the above listed procedures.

Prescription Use (Part 21 CFR 801 Subpart D)

区

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)

Niel R. Pylke for mxn

(Division Sign-O Division of General, Restorative, and Neurological Devices

510(k) Number K093284

Page 1 of 1