(126 days)
No
The device description focuses on basic electrosurgery principles and power control, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is also marked as "Not Found".
Yes
The device is used to cut or remove soft tissue and control bleeding during dental and periodontal surgical procedures, which are therapeutic interventions.
No
The device description states its purpose is to "cut or remove soft tissue or to control bleeding during dental and periodontal surgical procedures," and it focuses on "severing and coagulating tissue" using radio-frequency energy. This describes a therapeutic, not a diagnostic, function.
No
The device description clearly states it is an "electrosurge unit" which is an AC-powered hardware device consisting of a power source, electrodes, and a handpiece. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cut or remove soft tissue or to control bleeding during dental and periodontal surgical procedures in the oral cavity." This describes a surgical tool used directly on a patient's tissue, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description details an electrosurge unit that uses radio-frequency energy to sever and coagulate tissue. This is a physical intervention on living tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the PerFect® TCS II is a surgical device, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
EKZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed dental practitioners
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)
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.
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 Whitman Road Melville, NY 11747-3081 USA.
Conclusions: 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.
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
Not Found
§ 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.
0
| 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.
.
1
SECTION E. 510(K) SUMMARY
| General
Description | 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. |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Testing | 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.
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 Whitman
Road Melville, NY 11747-3081 USA. |
| Performance
Testing
Conclusions | 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. |
2
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.
3
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
4
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