SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM)

K011190 · Surx, Inc. · MUK · Jan 8, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K011190
• Device Name: SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM)
• Applicant: Surx, Inc.
• Product Code: MUK · General, Plastic Surgery
• Decision Date: Jan 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SURx Laparoscopic Probe (LP) Radio Frequency (RF) 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

SURx LP System comprises radiofrequency (RF) generator and single-use, sterile laparoscopic applicator; applicator features bipolar design, eliminating need for return pad, and includes integrated thermistor for temperature monitoring at treatment site; system provides irrigation to target tissue; physician operates device during laparoscopic procedure to deliver RF energy for tissue shrinkage and stabilization; output allows clinician to treat pelvic tissue; clinical benefit includes stabilization of pelvic structures to address stress urinary incontinence in patients ineligible for major surgery.

Clinical Evidence

Clinical evaluations were conducted to demonstrate that the SURx LP System functions as intended. Data gathered from clinical studies confirmed the device performs as clinically intended and introduces no new safety or effectiveness issues.

Technological Characteristics

Radiofrequency (RF) electrosurgical system; bipolar applicator design; integrated thermistor for temperature monitoring; includes irrigation capability; single-use sterile applicator; RF generator instrument; software-controlled operation.

Indications for Use

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

• Vidamed TUNA® (Transurethral Needle Ablation) System (K960918, K965199, K002583)
• ArthroCare Urologic Multi-Electrode Electrosurgery System (K961069)
• Oratec Interventions Model ORA 40 Electrothermal Generator (K973159, K964071, K971532)
• Louisville Laboratories, Laparoscopic Bladder Neck Suspension Kit (K971797)
• Empi, Inc. Innova® ComfortPulse® Vaginal Electrode (K964577)

Submission Summary (Full Text)

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SURx Women's Health First

..

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### REGULATORY AUTHORITY

# JAN 0 8 2002

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 LP 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

### Predicate Radiofrequency Electrosurgical Generator Systems

- · Vidamed TUNA® (Transurethral Needle Ablation) System (K960918, K965199, K002583)
- · ArthroCare Urologic Multi-Electrode Electrosurgery System (K961069)
- · Oratec Interventions Model ORA 40 Electrothermal Generator (K973159, K964071, K971532)

#### Predicate Indications for Use Devices

- · Louisville Laboratories, Laparoscopic Bladder Neck Suspension Kit (K971797)
- · Empi, Inc. Innova® ComfortPulse® Vaginal Electrode (K964577)

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2/3 Ko 11190 510(k) Premarket Notification SURx Women's Health First SURx LP System

### DEVICE DESCRIPTION

The SURx LP System consists of two components: the SURx LP Generator and the SURx LP Applicator. The SURx LP Applicator connects to the Generator. The Applicator also provides irrigation to the treatment site. The SURx LP 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 LP Generator is a radiofrequency (RF) electronic instrument.

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

#### INDICATION FOR USE STATEMENT

The SURx Laparoscopic Probe (LP) Radio Frequency (RF) 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 LP System are identical to those of the cited predicate electrosurgical devices, as well as the devices distributed by other manufacturers. These devices are equivalent in terms of design, materials, principal of operation, and product specifications. Any differences between the SURx LP System and the predicate devices do not raise new issues regarding safety or effectiveness.

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### 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 LP System functioned as clinically intended. Sufficient data have been gathered from clinical studies to determine that the SURx LP 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 LP System is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. In addition, the SURx LP System raises no new safety or effectiveness issues. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 8 2002

Mr. Alan Curtis Vice President, Regulatory and Clinical Affairs SURx 2675 Collier Canyon Road Livermore, California 94550

Re: K011190

Trade/Device Name: SURx LP System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 30, 2001 Received: October 31, 2001

Dear Mr. Curtis:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.

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Page 2 - Mr. Alan Curtis

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Stipt Pluches

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

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number: K011190

Device Name: SURx RF System

Indications for Use:

The SURx Laparoscopic Probe (LP) Radio Frequency (RF) 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | or | Over-The-Counter Use |
|----------------------|---|----|----------------------|
| (Per 21 CFR 801.109) | | | |

(Division of Restorative)

A . Be at, Restorative and Neu beground bevices

KOIII90 510(k) N -