HELICA TC

K972267 · Tenerco, Inc. · GEI · Sep 14, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K972267
• Device Name: HELICA TC
• Applicant: Tenerco, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Laparoscopic, Endoscopic, and open surgical procedures where Monopolar electrosurgery is normally used. Not intended for use on patients with right to left cardiac shunting.

Device Story

Helica 'TC' is a microprocessor-controlled helium thermal coagulator for soft tissue surgery. Device uses flexible disposable probes to deliver helium gas (1-5 L/min) and electrical power (2-33 watts) to create a helium plasma between probe and target tissue. Plasma enables controlled coagulation; inert helium gas inhibits combustion and clears surgical site of smoke, vapor, and blood to improve visibility. Operated by surgeon via foot control in OR/endoscopic settings. Lower gas pressure (<1.5 psi) and wattage compared to argon-based systems. Benefits include improved visualization and controlled tissue effect.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by bench testing, adherence to electrical safety standards (IEC 601-1, IEC 601-2-2, ANSI/AAMI HF18), and reference to published studies on gas-enhanced electrosurgery.

Technological Characteristics

Microprocessor-controlled helium thermal coagulator. Operates at 2-33 watts with 1-5 L/min helium flow. Uses flexible disposable probes (2.5-4mm diameter, 60-310mm length). Electrical safety per IEC 601-1 (1988), IEC 601-2-2 (1991), and ANSI/AAMI HF18 (1993). Biocompatible materials.

Indications for Use

Indicated for use in all soft tissue surgery, including laparoscopic, endoscopic, and open procedures, for patients requiring monopolar electrosurgical coagulation. Contraindicated for patients with right to left cardiac shunting.

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

• Valley Lab APEC (K924918, K931028, K942579)
• ERBE APC 300 (K954229, K962690)

Submission Summary (Full Text)

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K472267

# SUMMARY OF EQUIVALENCY OF SAFETY AND EFFECTIVENESS

# HELICA 'TC', VALLEY LAB. APEC AND ERBE APC 300

### HELICA 'TC'

#### VALLEY LAB. APEC

ERBE APC 300

#### INTENDED USE:

Laparoscopic, Endoscopic, and open surgical procedures where Monopolar electrosurgery is normally used. Not intended for use on patients with right to left cardiac shunting.

### PRODUCT DESCRIPTION:

The 'TC' is a microprocessor controlled Helium Thermal Coagulator. Working at 2 to 33 watts of power with Helium gas flows of 1 to 5 liters/minute depending on procedure and probe. The 'TC' automatically works with all of the flexible disposable probes. Models T, C, D, E, R, and S. (Size range 2.5mm to 4mm x 60 mm to 310mm)

In all cases probe is activated (foot control) in the gas-enhanced mode, A Helium plasma is created between the probe and the target tissue. This mode permits the user to coagulate tissue in a more controlled manner than with standard fulguration and the flow of inert gas produces the following additional beneficial effects: (1) The presence of inert gas at surgical site inhibits combustion with other gases (e.g., oxygen, nitrogen, etc.)

Same

Same

Endoscopy

Unknown

Same

Use several generators Ranging from 40 to 120 Watts and Argon gas flows From 0.5 to 16 liters/minute .

Uses a number of hand sets Depending on procedure.

Does the same using Argon gas . Has both hand and foot controls. APC 300 generator Not specified Argon gas flows From 0.1 to 9 liters /minute.

Uses 3 specified Probes depending Type of operation.

Does the same Using Argon gas.

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And the gas jet pushes any residual smoke or water vapor away from the site, thereby improving visibility, and (2) The gas jet pushes blood out of the way which significantly reduces the coagulation of blood on the surface of the tissue and provides the surgeon with improved visibility at surgical site.

## SAFETY and PERFORMANCE

| The Helica 'TC' due to its design<br>and the use of Helium needs only<br>very low gas pressure (does not<br>exceed 1.5 psi at probe tip) and<br>very low wattage to achieve<br>excellent results. | Needs more gas pressure<br>And power due to Argon<br>Being a heavier gas and to<br>Design of the generator<br>Hand set. | Same. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------|
| Published studies show that gas-<br>enhanced electrosurgery is safe<br>effective. | Same. | Same. |
| BIOCOMPATABILITY | | |
| Selection of materials meet all<br>known standards. | Same. | Same. |
| ELECTRICAL | | |
| Meets or exceeds all applicable sections<br>of, IEC 601-1 (1988), Medical Electrical<br>Equipment Part 1: General Requirements<br>for Safety, IEC 601-2-2 (1991), Medical<br>Electrical Equipment Part 2: Particular<br>Requirements for the Safety of High<br>Frequency Surgical Equipment, and ANSI<br>/AAMI HF18 (1993), Electrosurgical Devices. | Same. | Same. |
| SUMMARY NUMBERS | K924918, K931028, K942579 | Unknown |

## K924918. K931028. K942579. K954229, K962690

Unknown

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1999

John B. Webb. Ph.D. CEO Tenerco, Inc. 1020 West Bay Avenue Newport Beach, California 92661

Re: K972267 Trade Name: Helica TC (Thermal Coagulator) Regulatory Class: II Product Code: GEI Dated: August 25, 1999 Received: August 26, 1999

15

Dear Dr. Webb:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - John B. Webb, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address - 4 - 4 - - - -"http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

[signature]

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510 (k) Number: K972267

Device Name:

Helica TC (Thermal Coagulator)

Indications for Use: The device is a helium gas electrosurgical coagulator for use in all soft tissue surgery--laparoscopic, endoscopic, and open.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|----------|
| Division of General Restorative Devices | |
| 510(k) Number | K9-72267 |

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________