MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM)

K020126 · Surx, Inc. · MUK · Mar 15, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020126
• Device Name: MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM)
• Applicant: Surx, Inc.
• Product Code: MUK · General, Plastic Surgery
• Decision Date: Mar 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SURx TV System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence due to hypermobility in women not eligible for major corrective surgery.

Device Story

The SURx TV System is an electrosurgical device used for the shrinkage and stabilization of female pelvic tissue. It consists of a radiofrequency (RF) generator and a single-use, sterile bipolar applicator. The applicator delivers RF energy to the target tissue and provides irrigation to the treatment site. A thermistor integrated into the applicator tip monitors tissue temperature during the procedure. The system is operated by a clinician. By applying controlled RF energy, the device induces tissue shrinkage, which is intended to treat stress urinary incontinence in patients ineligible for major surgery. The bipolar design eliminates the need for a return electrode pad.

Clinical Evidence

Clinical evaluations were conducted to demonstrate that the SURx TV System functions as intended. Data gathered from these studies supported the determination that the device performs as expected and introduces no new safety or effectiveness issues.

Technological Characteristics

Electrosurgical system utilizing radiofrequency (RF) energy. Bipolar applicator design with integrated thermistor for temperature monitoring. Includes irrigation functionality. Software-controlled generator. Single-use sterile applicator.

Indications for Use

Indicated for women with Type II stress urinary incontinence due to hypermobility who are not eligible for major corrective surgery.

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

• SURx LP System (K011190)

Submission Summary (Full Text)

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SURx Women's Health First

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MAR 1 5 2002

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

# REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

# COMPANY NAME/CONTACT

Alan Curtis SURX 2675 Collier Canyon Road Livermore, CA 94550 [phone] (phone) [phone] (facsimile) [e-mail]

#### NAME OF DEVICE

| Trade Name: | SURx TV System |
|------------------------|-------------------------------------------------------------------------------------|
| Common Name: | Electrosurgical System |
| Device Product Code: | GEI |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and<br>Accessories (21 CFR 878.4400) |
| Device Panel: | General Surgery/Restorative Devices |
| Device Classification: | Class II |

#### PREDICATE DEVICES

- . SURx LP System (K011190)
#### DEVICE DESCRIPTION

The SURx TV System consists of two components: the SURx TV Generator and the SURx TV Applicator. The SURx TV Applicator connects to the Generator. The Applicator also provides irrigation to the treatment site. The SURx TV Applicator is supplied sterile and intended for single use. The Applicator uses a bipolar design, which means that a return pad is not required for operation. The tip of the Applicator contains a thermistor to monitor temperature at the targeted area.

The SURx TV Generator is a radiofrequency (RF) electronic instrument.

Software is utilized in the operation of the SURx TV Generator.

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# INDICATION FOR USE STATEMENT

The SURx TV System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence due to hypermobility in women not eligible for major corrective surgery.

# SUBSTANTIAL EQUIVALENCE COMPARISON

#### Technological Characteristics

The technological characteristics of the SURx TV System are identical to those of the cited predicate electrosurgical device. This device is equivalent in terms of design, materials, principal of operation, and product specifications. The minor modification between the SURx TV System and the predicate device does not raise new issues regarding safety or effectiveness.

#### Indications for Use

Substantial equivalence is also supported for the SURx LP System by the predicate devices cleared for the treatment of female stress urinary incontinence.

#### Clinical Performance Data

Results of clinical evaluations were used to demonstrate that the SURx TV System functioned as clinically intended. Sufficient data have been gathered from clinical studies to determine that the SURx TV System performs as clinically intended and that no new issues of safety and effectiveness are introduced.

## CONCLUSION

Based on the design, materials, function, intended use, and clinical evaluation, the SURx TV System is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. In addition, the SURx TV System raises no new safety or effectiveness issues. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance.

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4 2010 NUV

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Mr. Alan Curtis Vice President, Regulatory and Clinical Affairs SURx, Inc. 2675 Collier Canyon Road LIVERMORE CA 94550

Re: K020126

Trade/Device Name: SURx TV System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: MUK Dated: January 14, 2002 Received: January 15, 2002

Dear Mr. Curtis:

This letter corrects our substantially equivalent letter of March 15, 2002.

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 (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 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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## Page 2 - Mr. Alan Curtis

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Hubert Lewis

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

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SURX Women's Health First Special 510(k): Device Modifications SURx TV System

#### SECTION 1.2

#### INDICATIONS FOR USE STATEMENT

510(k) Number:

KO20126

SURx TV System Device Name:

Indications for Use:

The SURx TV System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence due to hypermobility in women not eligible for major corrective surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Muriam C. Provost

or

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

020126 510(k) Number -