ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION

K052104 · Conmed Corporation · GEI · Oct 21, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052104
• Device Name: ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION
• Applicant: Conmed Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Single-use electrosurgical accessory used to provide coagulation therapeutic energy to tissue and suction to aspirate blood, coagulum and small bits of tissue debris from the surgical site. The coagulation effect is achieved by the passage of high frequency current through the tissue of interest.

Device Story

Electrosurgical accessory for general surgery; provides simultaneous or independent coagulation and suction. Input: high-frequency (HF) electrosurgical current from external generator. Operation: user activates HF current via handpiece buttons or footswitch; current travels through cannula to tissue to achieve coagulation; suction vent on handle allows aspiration of blood/debris. Device features non-stick silicone (UltraClean™) coating on cannula tip. Used in surgical settings by clinicians. Benefits: provides hemostasis and clears surgical site of debris/fluids. Single-use device.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993, including cytotoxicity, hemolysis, pyrogen, intracutaneous reactivity, sensitization, and acute systemic injection. Compliance with ANSI/AAMI HF-18 and IEC 60601-2-2 standards verified.

Technological Characteristics

Materials: ABS plastic handpiece, copper/PVC cable, brass contacts, aluminum cannula, polyolefin insulator, silicone (UltraClean™) tip. Energy: HF electrosurgical current. Connectivity: Wired connection to electrosurgical generator. Sterilization: Radiation (ISO 11137). Standards: ANSI/AAMI HF-18, IEC 60601-2-2, ISO 14971, ISO 10993.

Indications for Use

Indicated for use in general surgical procedures requiring electrosurgical coagulation and suction of blood, coagulum, and tissue debris. Not indicated for prolonged direct contact with patient tissue.

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

• Suction Coagulator (K033003)

Submission Summary (Full Text)

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OCT 2 1 2005 Traditional 510(k) CONMED UltraClean™ Suction Coaguiator

## 52104

## Summary of Safety and Effectiveness

| Submitted by: | CONMED Electrosurgery Division<br>14603 East Fremont Avenue<br>Centennial, CO 80112 USA<br>Telephone: [phone]<br>Facsimile: 303-699-9854 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Pamela L. Vetter |
| Date Prepared: | August 1, 2005 |
| Proprietary Name: | UltraClean™ Hand Controlled Suction Coagulator and Foot Controlled<br>Suction Coagulator or other trade names as established |
| Common Name: | Suction Coagulator |
| Classification Name: | Electrode, Flexible Suction Coagulator<br>(21 CFR 878.4400)<br>79 GEI |
| Predicate Device: | Suction Coagulator<br>510(k) # K033003 |

Device Description: This suction coagulator has applications in general surgical procedures to provide a means of coagulation using electrosurgical current and also provide a means of suction using the vent on the handle. Suction and coagulation can be performed independently or simultaneously. The device consists of a cable for connection to the output of an electrosurgical generator unit, to carry high-frequency (HF) electrosurgical current to the distal end of the handpiece. gonerater and as either a hand-switching or foot-switching conduit in delivering the HF energy from the electrosurgical generator unit through the cannula tube to produce the therapeutic affect. Current is activated by the coagulation switching element buttons on the handpiece or by using the footswitch. The devices contain a non-stick (UltraClean™) coating on the cannula tip. The devices will be distributed sterile and non-sterile for single-use applications.

Intended Use of Device: Single-use electrosurgical accessory used to provide coagulation therapeutic energy to tissue and suction to aspirate blood, coagulum and small bits of tissue debris from the surgical site. The coagulation effect is achieved by the passage of high frequency current through the tissue of interest.

Technological Characteristics: The proposed device is equivalent to the identified predicate device with respect to technological characteristics and function. The device has been designed to comply with the applicable sections of ANSI/AAMI American National Standard for Electrosurgical Devices HF-18, the International Electrotechnical Commission Standard for Electrosurgical Devices, IEC 60601-2-2, Sterilization of health care products - Requirements for validation and routine control -Radiation Sterilization, ISO 11137, Medical Devices Risk Management, ISO 14971 and Biocompatibility, ISO 10993.

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<052104

## BIOCOMPATIBILITY:

510(k) Premarket Notification

Page 2 of 2

CONMED ELECTROSURGERY

The materials and processes used in the construction of the CONMED UltraClean Suction Coagulator are identical to those of the predicate device with the addition of a silicone-coat (Ultraclean™) on the cannula tip. The original materials have been tested in accordance with accepted biocompatibility test methods and guidance such as ISO 10993 and the General Program Memorandum #G95-1, dated May 1, 1995 and were found to be compatible with the human body. The silicone coating added by ConMed Electrosurgery meets these same requirements and has successfully completed the following biocompatibility testing: Cytotoxicity, Hemolysis, Pyrogen, Intracutaneous Reactivity. Sensitization and Acute Systemic Injection testing (see attached biocompatibility reports).

Table M.1 provides a list of materials used in the construction of the CONMED UltraClean™ Suction Coagulator and identifies the devices and applications where those materials are now in use. Please note that this device is not indicated for prolonged direct contact with patient tissue. The distance between the cannula and tissue undergoing coagulation is normally maintained at 1 cm or less and only in temporary contact with tissue undergoing suction.

| Component/Material | Tissue Contact | Preamendment or 510(k)<br>Reference where cleared |
|---------------------------------------------|----------------|---------------------------------------------------|
| Handpiece<br>ABS Plastic | No | Predicate Device: K033003<br>Suction Coagulator |
| Cable Wire/Jacket<br>Copper wire/PVC jacket | No | Predicate Device: K033003<br>Suction Coagulator |
| Cable Contacts<br>Brass | No | Predicate Device: K033003<br>Suction Coagulator |
| Cannula<br>Aluminum | Yes | Predicate Device: K033003<br>Suction Coagulator |
| Cannula Insulator<br>Polyolefin | Yes | Predicate Device: K033003<br>Suction Coagulator |
| Tip<br>Silicone (UltracleanTM) | Yes | Biocompatibility test reports<br>attached |

Table M.1: Material Biocompatibility Summary

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1 2005

Pamela Vetter Manager of Regulatory Affairs ConMed Electrosurgery 14603 East Fremont Avenue Centennial, Colorado 80112

Re: K052104/S1

Trade/Device Name: Ultraclean Suction Coagulator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 27, 2005 Received: September 28, 2005

Dear Ms. Vetter:

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 forchered above and may sure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prior to rialy 20, 2018 11:11 accordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). and Cosmeter For (110) that 30 nevice, subject to the general controls provisions of the Act. The r ou may, ateres, mains 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 If your device is enabilitional controls. Existing major regulations affecting your device can may or subject to back as 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 f that FDA has made a determination that your device complies with other requirements of the Act that I Dr heal statutes and regulations administered by other Federal agencies. You must or any I carated and 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 Of K Fat 6077; labeling (21 CFR Part 820); and if applicable, the electronic form in the quality byeving (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Vetter

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manteeing your antial equivalence of your device to a legally premits that includion. The PDF micing of cassification 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 If you ucare specific acrite ior your accel [phone]. Also, please note the regulation entitled, Colliable of Comptance to premarket notification" (21CFR Part 807.97). You may obtain Misolanding of reference to premailonsibilities under the Act from the Division of Small other general miorination on your response 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,

Barbara Bouieund
for

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

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K059.104

Device Name:

Indications for Use:

Single-use electrosurgical accessory used to provide coagulation therapeutic energy to tissue and suction to aspirate blood, coagulum and small bits of tissue debris from the surgical site. The coaqulation effect is achieved by the passage of high frequency current through the tissue of interest.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter____

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Breen for mayor

(Division Signral. Restorative, Division of Gen and Neurological Devices

510(k) Number K052104