PERFECT TISSUE CONTOURING SYSTEM II

K071632 · Coltene/Whaledent, Inc. · EKZ · Oct 18, 2007 · Dental

Device Facts

• Record ID: K071632
• Device Name: PERFECT TISSUE CONTOURING SYSTEM II
• Applicant: Coltene/Whaledent, Inc.
• Product Code: EKZ · Dental
• Decision Date: Oct 18, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.4920
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PerFect® TCS II is intended only for use by licensed dental practitioners who have received appropriate training in the application of electrosurgery. This device is intended to cut or remove soft tissue or to control bleeding during dental and periodontal surgical procedures in the oral cavity.

Device Story

PerFect® TCS II is an AC-powered electrosurgical dental unit; used by licensed dental practitioners in clinical settings. Device utilizes radio-frequency energy to sever and coagulate soft tissue; energy is focused at a small active electrode while the electrode remains cold. System includes a controlled power source, cutting/coagulating electrodes, and a dispersive electrode placed on the patient's back. Features two output modes: 'Cut' and 'Coag' with adjustable intensity. Provides precision tissue management; aids in bleeding control, caries access, and gingival contouring. Benefits include improved surgical control and enhanced procedural outcomes.

Clinical Evidence

Bench testing only. Performance testing conducted by Underwriters Laboratories (UL) confirmed compliance with IEC 60601-1, IEC 60601-2-2, EN55011, and various CAN/CSA standards. Functional testing verified electrode integrity after twenty sterilization cycles.

Technological Characteristics

AC-powered electrosurgical unit; radio-frequency energy source. Electrodes constructed of stainless steel. Includes dispersive electrode for circuit completion. Operates in 'Cut' and 'Coag' modes. Complies with IEC 60601-1, IEC 60601-2-2, EN55011, and EN60601-1-2 standards. No software or firmware components.

Indications for Use

Indicated for licensed dental practitioners to cut or remove soft tissue or control bleeding during dental and periodontal surgical procedures in the oral cavity.

Regulatory Classification

Identification

A dental electrosurgical unit and accessories is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during surgical procedures in the oral cavity. An electrical current passes through the tip of the electrode into the tissue and, depending upon the operating mode selected, cuts through soft tissue or coagulates the tissue.

Predicate Devices

• Strobex Ultron Electrosurge Unit (K850666)

Submission Summary (Full Text)

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K071632

| Device Owner and Manufacturer: | Coltene/Whaledent, Inc. |
|--------------------------------|---------------------------------|
| | 235 Ascot Parkway |
| | Cuyahoga Falls, Ohio 44223-3701 |
| | Ph. 330-916-8800 |
| | Fax [phone] |
| | Registration Number: 2416455 |
| Contact Person: | Glenn Persello |
| | 235 Ascot Parkway |
| | Cuyahoga Falls, Ohio 44223 |
| | Ph. 330-916-8837 |

OCT 1 8 2007
coltène
whaledent
Summary prepared on June 6, 2007

| Trade name | PerFect® Tissue Contouring System II (PerFect® TCS II) |
|----------------|----------------------------------------------------------|
| Common name | Electrosurgical Dental Unit |
| Panel Part | 872 - Dental Devices |
| Subpart E | Surgical Devices |
| Sec. | 872.4920 - Unit, Electrosurgical and Accessories, Dental |
| Product Code | EKZ |
| Classification | Class II |

| Predicate Device | The Strobex Ultron Electrosurge Unit that is legally marketed under 510(k) K850666. |
|------------------|-------------------------------------------------------------------------------------|
|------------------|-------------------------------------------------------------------------------------|

| Intended Use | The PerFect® TCS II is intended only for use by licensed dental practitioners who have received appropriate training in the application of electrosurgery. This device is intended to cut or remove soft tissue or to control bleeding during dental and periodontal surgical procedures in the oral cavity. |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Characteristic | Strobex Electrosurge | PerFect® TCS II |
|---------------------|----------------------|-----------------|
| Intended Use | Same | Same |
| Indications for use | Same | Same |
| Electrodes | Same | Same |
| Software / Firmware | None | None |

See Section 12. Substantial Equivalence for additional information.
.

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## SECTION E. 510(K) SUMMARY

| General<br>Description | PerFect® TCS II is an electrosurge unit designed to appeal to both the new and experienced user of<br>electrosurgery. PerFect® TCS II can simplify and enhance the results of a variety of everyday<br>procedures performed by virtually every dentist, including the control of bleeding, gaining access to<br>caries and aesthetic contouring of gingiva.<br><br>The PerFect® TCS II is an AC-powered device consisting of a controlled power source and a set of<br>cutting and coagulating electrodes. The radio-frequency energy used by PerFect® TCS II is able to<br>sever and coagulate tissue because it focuses the heat energy at the small, active electrode. While the<br>active electrode remains cold, sufficient heat energy is generated in its path to sever and coagulate<br>effectively.<br><br>The high-frequency energy focused at the active electrode returns to the electrosurge through the large<br>dispersive electrode, which is placed on the back of the dental chair against the patient's back during<br>use. The PerFect® TCS II has two output modes: "Cut" and "Coag." The operator can adjust the<br>intensity of these modes. When the power output is adjusted properly, the electrode cuts without<br>resistance, permitting an extraordinary degree of control and precision.<br><br>The PerFect® TCS II is designed to use the Strobex (predicate) handpiece electrodes. These handpiece<br>electrodes have not changed in biocompatibility materials (stainless steel) or in the manufacturing<br>process. In addition performance testing was conducted by UL that included functional testing of<br>electrodes sterilized twenty times via the recommended cycle. |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Testing | The PerFect® Tissue Contouring System II (PerFect® TCS II) complies with IEC 60601-1:1988 + A1:<br>1991 + A2: 1995, IEC 60601-2-2, EN55011, Group1, EN60601-1-2 and EN60601-2-2 Clause 36. The<br>product was investigated to the following additional standards: EN 60601-1: 1990 + A1:1993 +<br>A2:1995 + A13:1996, CAN/CSA C22.2 No. 601.1-M90 (R1997), CAN/CSA C22.2 No. 601.1S1-94,<br>and CAN/CSA C22.2 No. 601.1B-90.<br><br>The PerFect® TCS II complies with the following National Differences: AT, AU, BE, CA, CH, CZ,<br>DE, DK, FI, FR, GB, GR, HU, IE, IT, NL, NO, PL, PT, SE, SI, SK, TR, US.<br><br>PerFect® TCS II was tested by Underwriters Laboratories Inc. Melville Division 1285 Walt Whitman<br>Road Melville, NY 11747-3081 USA. |
| Performance<br>Testing<br>Conclusions | The PerFect® TCS II has demonstrated that it is equally effective as the predicate device and is in fact a<br>safer device due to the fact it has been certified to comply to the requirements of the recognized<br>standards by performance testing. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 8 2007

Mr. Glenn Persello Compliance Engineer Coltène Whaledent, Incorporated 235 Ascot Parkway Cuyahoga Falls, Ohio 44223-3701

Re: K071632

Trade/Device Name: PerFect® Tissue Contouring System II (PerFect® TCS II) Regulation Number: 872.4920 Regulation Name: Dental Electrosurgical Unit and Accessories Regulatory Class: II Product Code: EKZ Dated: September 12, 2007 Received: September 13, 2007

Dear Mr. Persello:

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.

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Page 2 - Mr. Persello

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Suitte Y. Michino MD.

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

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## Indications for Use

510(k) Number (if known): K071632

Device Name: PerFect® Tissue Contouring System II (PerFect® TCS II)

Indications for Use:

The PerFect® TCS II is intended to cut or remove soft tissue or to control bleeding during dental and periodontal surgical procedures in the oral cavity.

Prescription Use X (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)

Susa Roarr

of Anesthesiology, General Hospital, Control. Dental D

umber: _67130