SURX RF SYSTEM

K020952 · Surx, Inc. · MUK · May 30, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020952
• Device Name: SURX RF SYSTEM
• Applicant: Surx, Inc.
• Product Code: MUK · General, Plastic Surgery
• Decision Date: May 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SURx RF System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence due to hypermobility.

Device Story

SURx RF System comprises RF generator and single-use, sterile bipolar applicator; available in laparoscopic (LP) and transvaginal (TV) configurations. Applicator tip includes integrated thermistor for temperature monitoring at target tissue. Device used by physicians in clinical settings to perform tissue shrinkage and stabilization. System delivers radiofrequency energy to pelvic tissue; thermal feedback loop enables controlled treatment. Optional TV Sizer accessory confirms adequate treatment area; blunt dissection required prior to application. Output provides thermal energy for tissue modification; clinical benefit includes stabilization of pelvic structures to address stress urinary incontinence.

Clinical Evidence

Clinical analysis conducted to support indications for use statement. Data gathered from clinical studies and literature review of devices cleared for female urinary incontinence treatment. Evidence supports that the system performs as intended and maintains safety and effectiveness profiles.

Technological Characteristics

Bipolar electrosurgical system; RF generator; sterile single-use applicators (LP and TV); integrated thermistor for temperature monitoring; no return pad required.

Indications for Use

Indicated for female patients with stress urinary incontinence due to hypermobility requiring shrinkage and stabilization of pelvic 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

• SURx LP System (K011190)
• SURx TV System (K020126)

Submission Summary (Full Text)

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MAY 3 0 2002

SURx Women's Health First 1/2 Premarket Notification: SURx RF System, Labeling Change

#### SECTION 1.3

Ko20952

# 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 RF 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)
- SURx TV System (K020126) ●

# DEVICE DESCRIPTION

The SURx RF System consists of two components: the SURx Radiofrequency (RF) Generator and the SURx Applicator. The SURx Applicator connects to the Generator. The SURx Applicator is supplied sterile and intended for single use. The Applicator uses a bipolar design, such that no return pad is required for operation. The tip of the Applicator contains a thermistor to monitor temperature at the targeted area. Two applicators are available: one for use when performing this procedure using a laparoscopic approach (LP Applicator), the other applicator is used during a transvaginal approach (TV Applicator).

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The SURx Transvaginal (TV) Sizer is an optional accessory for use with the SURx TV I ho Botor The SURx TV Sizer confirms the exposed area for treatment is adequate to Applicator. The SON blunt dissection is required prior to applying the SURx TV Applicator tip on the tissue to treated.

# INDICATION FOR USE STATEMENT

The SURx RF System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence due to hypermobility.

# SUBSTANTIAL EQUIVALENCE COMPARISON

## Technological Characteristics

There has been no change to the generator or applicators. The system is identical to that cleared in the referenced 510(k)s.

## Indications for Use

Substantial equivalence for the SURx RF System is supported by the predicate devices, which has an identical indication statement.

## Clinical Performance Data

The SURx RF System has been cleared for the treatment of female stress urinary incontinence. Clinical analysis was conducted to support the change in the language in the indications for use statement. Sufficient data have been gathered from clinical studies to determine that the SURx RF System performs as clinically intended and that no new issues of safety and effectiveness are introduced.

## Literature Review

Published literature was reviewed on devices cleared for the treatment of female urinary incontinence as additional supporting documentation to support the modified indication for use.

## CONCLUSION

Based on the design, materials, function, intended use, and clinical evaluation, the SURx RF System is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. Safety and effectiveness are reasonably assured, justifying 510(k) clearance.

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a flowing, abstract design connecting them.

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

NOV 4 2010

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

Re: K020952

Trade/Device Name: SURx RF System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: MUK Dated: March 22, 2002 Received: March 25, 2002

Dear Mr. Curtis:

This letter corrects our substantially equivalent letter of May 30, 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,**

[signature]

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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#### SECTION 1.2

# INDICATIONS FOR USE STATEMENT

510(k) Number:

K020952

SURx RF System Device Name:

Indications for Use:

The SURx RF System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence due to hypermobility.

(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

OL

on of General. Restorative and Neurological Devices

510(k) Number K020952

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