(126 days)
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.
PerFect® TCS II is an electrosurge unit designed to appeal to both the new and experienced user of electrosurgery. PerFect® TCS II can simplify and enhance the results of a variety of everyday procedures performed by virtually every dentist, including the control of bleeding, gaining access to caries and aesthetic contouring of gingiva.
The PerFect® TCS II is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The radio-frequency energy used by PerFect® TCS II is able to sever and coagulate tissue because it focuses the heat energy at the small, active electrode. While the active electrode remains cold, sufficient heat energy is generated in its path to sever and coagulate effectively.
The high-frequency energy focused at the active electrode returns to the electrosurge through the large dispersive electrode, which is placed on the back of the dental chair against the patient's back during use. The PerFect® TCS II has two output modes: "Cut" and "Coag." The operator can adjust the intensity of these modes. When the power output is adjusted properly, the electrode cuts without resistance, permitting an extraordinary degree of control and precision.
The PerFect® TCS II is designed to use the Strobex (predicate) handpiece electrodes. These handpiece electrodes have not changed in biocompatibility materials (stainless steel) or in the manufacturing process. In addition performance testing was conducted by UL that included functional testing of electrodes sterilized twenty times via the recommended cycle.
Here's an analysis of the acceptance criteria and supporting study for the PerFect® Tissue Contouring System II, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence to Predicate Device | "The PerFect® TCS II has demonstrated that it is equally effective as the predicate device and is in fact a safer device due to the fact it has been certified to comply to the requirements of the recognized standards by performance testing." |
| Compliance with Recognized Electrical Safety Standards | "The PerFect® Tissue Contouring System II (PerFect® TCS II) complies with IEC 60601-1:1988 + A1: 1991 + A2: 1995, IEC 60601-2-2, EN55011, Group1, EN60601-1-2 and EN60601-2-2 Clause 36." "The product was investigated to the following additional standards: EN 60601-1: 1990 + A1:1993 + A2:1995 + A13:1996, CAN/CSA C22.2 No. 601.1-M90 (R1997), CAN/CSA C22.2 No. 601.1S1-94, and CAN/CSA C22.2 No. 601.1B-90." |
| Functional Integrity of Re-sterilized Electrodes | "performance testing was conducted by UL that included functional testing of electrodes sterilized twenty times via the recommended cycle." |
| Biocompatibility Material Equivalence of Electrodes | "These handpiece electrodes have not changed in biocompatibility materials (stainless steel) or in the manufacturing process." |
| Intended Use Equivalence to Predicate Device | "Same" as predicate device. |
| Indications for Use Equivalence to Predicate Device | "Same" as predicate device. |
| Electrode Equivalence to Predicate Device | "Same" as predicate device (in form/function, as the device uses the predicate's electrodes). |
| Absence of Software/Firmware (if predicate device also lacked) | "None" (matching predicate device). |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation does not specify a discrete "test set" sample size for a clinical or in-vitro study involving patient data or images. The performance testing primarily focused on engineering and electrical safety standards compliance rather than a typical clinical evaluation with a test set of cases.
The provenance of data is therefore not applicable in the usual sense of clinical trial data. The compliance testing was performed by Underwriters Laboratories Inc. Melville Division in the USA.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the study described is primarily an engineering and electrical safety compliance assessment, not a clinical study requiring expert labeling or adjudication of medical cases.
4. Adjudication Method
This information is not applicable for the same reason as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not conducted. The submission focuses on demonstrating substantial equivalence through technical and safety performance, not on comparing reader performance with and without AI assistance. The device is an electrosurgical unit, not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not conducted. The device is a physical electrosurgical unit, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation was primarily defined by:
- Recognized International and National Electrical Safety Standards: Such as IEC 60601-1, IEC 60601-2-2, EN55011, EN60601-1-2, CAN/CSA C22.2 series. Compliance with these standards served as the basis for safety and performance "truth."
- Predicate Device Performance: The functional capabilities and safety profile of the Strobex Ultron Electrosurge Unit (K850666) served as the benchmark for demonstrating "equally effective" performance.
- Functional Testing Results: The ability of electrodes to maintain function after repeated sterilization cycles.
8. The Sample Size for the Training Set
This information is not applicable. The PerFect® TCS II is an electrosurgical unit, not a machine learning model, so there is no concept of a "training set" in this submission.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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| Device Owner and Manufacturer: | Coltene/Whaledent, Inc. |
|---|---|
| 235 Ascot Parkway | |
| Cuyahoga Falls, Ohio 44223-3701 | |
| Ph. 330-916-8800 | |
| Fax 330-916-7089 | |
| 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
| GeneralDescription | PerFect® TCS II is an electrosurge unit designed to appeal to both the new and experienced user ofelectrosurgery. PerFect® TCS II can simplify and enhance the results of a variety of everydayprocedures performed by virtually every dentist, including the control of bleeding, gaining access tocaries and aesthetic contouring of gingiva.The PerFect® TCS II is an AC-powered device consisting of a controlled power source and a set ofcutting and coagulating electrodes. The radio-frequency energy used by PerFect® TCS II is able tosever and coagulate tissue because it focuses the heat energy at the small, active electrode. While theactive electrode remains cold, sufficient heat energy is generated in its path to sever and coagulateeffectively.The high-frequency energy focused at the active electrode returns to the electrosurge through the largedispersive electrode, which is placed on the back of the dental chair against the patient's back duringuse. The PerFect® TCS II has two output modes: "Cut" and "Coag." The operator can adjust theintensity of these modes. When the power output is adjusted properly, the electrode cuts withoutresistance, permitting an extraordinary degree of control and precision.The PerFect® TCS II is designed to use the Strobex (predicate) handpiece electrodes. These handpieceelectrodes have not changed in biocompatibility materials (stainless steel) or in the manufacturingprocess. In addition performance testing was conducted by UL that included functional testing ofelectrodes sterilized twenty times via the recommended cycle. |
|---|---|
| PerformanceTesting | The PerFect® Tissue Contouring System II (PerFect® TCS II) complies with IEC 60601-1:1988 + A1:1991 + A2: 1995, IEC 60601-2-2, EN55011, Group1, EN60601-1-2 and EN60601-2-2 Clause 36. Theproduct was investigated to the following additional standards: EN 60601-1: 1990 + A1:1993 +A2:1995 + A13:1996, CAN/CSA C22.2 No. 601.1-M90 (R1997), CAN/CSA C22.2 No. 601.1S1-94,and CAN/CSA C22.2 No. 601.1B-90.The PerFect® TCS II complies with the following National Differences: AT, AU, BE, CA, CH, CZ,DE, DK, FI, FR, GB, GR, HU, IE, IT, NL, NO, PL, PT, SE, SI, SK, TR, US.PerFect® TCS II was tested by Underwriters Laboratories Inc. Melville Division 1285 Walt WhitmanRoad Melville, NY 11747-3081 USA. |
| PerformanceTestingConclusions | The PerFect® TCS II has demonstrated that it is equally effective as the predicate device and is in fact asafer device due to the fact it has been certified to comply to the requirements of the recognizedstandards 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 (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.
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
§ 872.4920 Dental electrosurgical unit and accessories.
(a)
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.(b)
Classification. Class II.