UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES
Device Facts
| Record ID | K132224 |
|---|---|
| Device Name | UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES |
| Applicant | Unimed Surgical Products, Inc. |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Oct 8, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Cutting of Soft Tissue Coagulation of Soft Tissue
Device Story
Coated electrosurgical electrodes used for cutting and coagulation of soft tissue during surgical procedures. Device connects to electrosurgical pencil; delivers electrical energy to tissue. Performance verified via physical testing (coating adhesion, pull force) and electrical testing (dielectric strength, hipot) per IEC 60601-2-2. Biocompatibility confirmed per ISO 10993-1. Used by surgeons in clinical settings.
Clinical Evidence
Bench testing only. No clinical data provided. Testing included coating adhesion (≥ 3.5 lbs), pull force (≥ 10 lbs), electrical safety (dielectric strength, hipot per IEC 60601-2-2), and biocompatibility (ISO 10993-1). Shelf life validated using Arrhenius model.
Technological Characteristics
Electrosurgical electrodes with specialized coatings. Energy source: electrosurgical generator. Connectivity: connects to electrosurgical pencil. Standards: IEC 60601-2-2 (electrical safety), ISO 10993-1 (biocompatibility). Sterilization: not specified.
Indications for Use
Indicated for cutting and coagulation of soft tissue in surgical procedures. Prescription use only.
Regulatory Classification
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Predicate Devices
- Unimed Surgical Coated Electrosurgical Electronic (K970066)
- Unimed Coated Laparoscopic/ Arthroscopy/ Suction-Irrigation Electrodes (K970066)
- Coated Laparoscopic/ Arthroscopy/ Suction-Irrigation/Coated Ball Electrodes (K962935)
Related Devices
- K061878 — ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC · E Surgical, LLC · Oct 24, 2006
- K962935 — UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE · Unimed Surgical Products, Inc. · Sep 3, 1996
- K962044 — VALLEYLAB COATED ELECTRODES · Valleylab, Inc. · Aug 30, 1996
- K964329 — UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM) · Richard Wolf Medical Instruments Corp. · May 21, 1997
- K093025 — BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES · Bovie Medical Corporation · Dec 22, 2009
Submission Summary (Full Text)
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K132224
510(K) SUMMARY 8.0
1
r
Date Prepared: July 3, 2013
| 8.1 | SUMMARY OF SAFETY AND EFFECTIVENESS |
|---------------|-------------------------------------|
| Submitted By: | Lee Alexander |
| | President |
| | Unimed Surgical Products, Inc |
| 8.2 Trade/Proprietary Name: | Unimed Surgical Coated Electrosurgical Electrodes |
|-------------------------------------|------------------------------------------------------------------------|
| 8.3 Common/Usual Name: | Electrosurgical Electrodes |
| 8.4 Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| 8.5 Manufacturing Facility Address: | Unimed Surgical Products, Inc. 1041 Belcher Road Largo, FL 33777 |
| Establishment Registration Number: | 1058746 |
| 8.6 Sterilization Facility Address: | Food Technology Service, Inc. 502 Prairie Mine Road Mulberry, FL 33860 |
| Establishment Registration Number: | 1054811 |
| 8.7 Classification: | Class: II |
OCT 0 8 2013Classification: 8.1
Panel: General and Plastic Surgery Product Code: GEI Cite: 21 CFR 878.4400
#### Substantial Equivalence 8.8
Unimed Surgical Coated Electrosurgical Electrodes are substantially equivalent to the Unimed Unimed Surgical Coated Electrosungliar Electronic (19770066) and the Unimed
Coated Laparoscopic/ Arthroscopy/ Suction-Imgation Electrodes (K970066) Coated Laparoscopics Anthroscopyr Suction Institute/Coated Ball Electrodes (K962935)
- Technological Characteristics 8.9 Technological Characteristics
Unimed Surgical Coated Electrosurgical Electrodess have the same technological characteristics as the current marketed product.
#### Performance Data 8.10
Penformance Data
Verification testing of the electrodes was performed sufficient to confirm that the products meet their specifications.
### 8.10.1 Physical Testing
- Minimum Coating Adhesion ≥ 3.5 Ibs. 8.10.1.1
- Minimum Coating Adriesion E 0.0 150.
Pull Test Attachment to Pencil compliant with IEC 60601-2-2 -Minimum 8.10.1.2 10-lbs Pull Force
- 8.10.2 Coating Testing
- ling
Performance and integrity of the coatings of aged devices were confirmed at 8.10.2.1 Normal and Extreme use conditions.
- 8.10.3 Electrical Testing per IEC 60601-2-2
- Dielectric Strength 8.10.3.1
- Hipot Testing ' 8.10.3.2
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8.10.4 Biological Specifications
8.10.4.1 Biocompatibility
o. 10.4. I meet the requirements of ISO 10993-1
Color Additives 8.10.4.2
o: 10.4.2 - Solor Additives
Color additives are listed as GRAS and are non-toxic in the Code of Federal Regulations.
8.10.5 Shelf Life
o. 10.5 Shell Life date using the Arrhenius Model.
Conclusion 8.11
Conclusion
Unimed Surgical concludes, based on the information presented, that the US Onlined Ourgical concludes, based on the the trently marketed legally in the US.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
### DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
October 8, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Unimed Surgical Products, Incorporated Ms. Lee Alexander President 1041 Belcher Road Largo, Florida 33777
, Florida 337.
Re: K132224
Trade/Device Name: Coated Electrosurgical Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 30, 2013 Received: October 4, 2013
Dear Ms. Alexander:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 (2 1 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Lee Alexander
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
# Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# INDICATIONS FOR USE
510(k) Number: K132224
Coated Electrosurgical Electrodes Device Name:
The Coated Electrosurgical Electrodes are intended for the following Indications for Use: indications:
- Cutting of Soft Tissue ♥
- Coagulation of Soft Tissue .
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
!:
Over-The-Counter Use (21 CFR 801 Subpart C)
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