NOVASYS TRANSURETHRAL RF SYSTEM

K042132 · Novasys Medical, Inc. · NVJ · Dec 21, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042132
• Device Name: NOVASYS TRANSURETHRAL RF SYSTEM
• Applicant: Novasys Medical, Inc.
• Product Code: NVJ · General, Plastic Surgery
• Decision Date: Dec 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Novasys Transurethral RF System is indicated for the transurethral treatment of female stress urinary incontinence due to hypermobility in women who have failed conservative treatment and who are not candidates for surgical therapy.

Device Story

System delivers controlled, low-level radiofrequency (RF) energy to treat female stress urinary incontinence (SUI) due to hypermobility. Device consists of RF generator and transurethral probe. Principle of operation involves localized collagen denaturation via RF energy to address tissue laxity. Procedure is non-surgical, performed in outpatient setting without general anesthesia. Physician operates system to deliver energy transurethrally. Clinical benefit includes improved quality of life, reduced daily incontinence episodes, decreased pad usage, and improved Valsalva leak point pressure. System serves as alternative for patients seeking non-surgical intervention with minimal recovery requirements.

Clinical Evidence

Evidence includes a pilot clinical trial and a 12-month U.S. multicenter clinical trial. Results demonstrated safety with no serious adverse events and limited anticipated adverse events. Efficacy endpoints at 12 months included improved quality of life, reduced daily incontinence episodes, reduced daily pad use, and improved Valsalva leak point pressure.

Technological Characteristics

Electrosurgical system utilizing radiofrequency (RF) energy for localized collagen denaturation. Comprises an RF generator and transurethral probe. Operates as an electrosurgical cutting and coagulation device (21 CFR 878.4400).

Indications for Use

Indicated for female patients with stress urinary incontinence due to hypermobility who have failed conservative treatment and are not candidates for surgical therapy.

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

• Novasys Electrosurgical Electrode Family (K001150)
• Novasys 'Ariel' RF Electrosurgical Control Module and Accessories (K013730)
• SURx RF System (K020952)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Debra Reisenthel President and Chief Executive Officer Novasys Medical, Inc. 39684 Eureka Drive Newark, California 94560

JUL 2 2 2005

Re: k042132

Trade/Device Name: Novasys Medical's Transurethral RF System Regulation Number: 21 CFR 878.4400 Regulation Name: Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women Regulatory Class: Class II Product Code: NVJ Dated: July 14, 2005 Received: July 14, 2005

Dear Ms. Reisenthel:

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 Parl 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality

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#### Page 2 - Ms. Debra Reisenthel

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.

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,
N. Cartel

Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

f

Enclosure

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# Indications for Use

510(k) Number (if known): K042132

Device Name: Novasys Transurethral RF System

Indications For Use: .

The Novasys Transurethral RF System is indicated for the transurethral treatment of female stress urinary incontinence due to hypermobility in women who have failed conservative treatment and who are not candidates for surgical therapy.

Prescription Use × (Part 21 CFR 801 Subpart D)

:

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation

Hacem
7/22/05

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510(k) Premarket Notification Novasys Transurethral RF System

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442

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K042132

16 SUMMARY

.

#### 510(k) SUMMARY (AS REQUIRED BY 21 CFR 807.92) 16.1

CONCLUSION 16.2

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#### 16.1 510(k) SUMMARY (AS REQUIRED BY 21 CFR 807.92)

Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Novasys Medical. Inc., is providing a summary of the safety and effectiveness information available for the Novasys Transurethral RF System, as well as the substantial equivalence decision-making process used for the Novasys Transurethral RF System.

#### SPONSOR/APPLICANT NAME AND ADDRESS

Novasys Medical, Inc. 39684 Eureka Drive Newark. CA 94560 [phone] (telephone) [phone] (facsimile)

## SPONSOR/APPLICANT CONTACT INFORMATION

Debra Reisenthel President & Chief Executive Officer Novasys Medical, Inc. 39684 Eureka Drive Newark, CA 94560 [phone] (telephone) [phone] (cell phone) [phone] (facsimile)

#### DATE OF PREPARATION OF 510(k) SUMMARY

August 6, 2004

## DEVICE TRADE OR PROPRIETARY NAME

Novasys Transurethral RF System

#### DEVICE COMMON NAME

Electrosurgical System

#### DEVICE CLASSIFICATION NAME

Electrosurgical Cutting and Coagulation Device and Accessories (per 21 CFR 878.4400)

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510(k) Premarket Notification Novasys Transurethral RF System

#### DEVICE PRODUCT CODE

GEI

#### DEVICE PANEL

General and Plastic Surgery

# IDENTIFICATION OF THE LEGALLY MARKETED DEVICES AGAINST WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED

#### 1. Technological Characteristics Predicate Devices

- Novasys Electrosurgical Electrode Family . Novasys Medical, Inc. K001150
- · Novasys "Ariel" RF Electrosurgical Control Module and Accessories Novasys Medical, Inc. K013730

#### 2. Indication for Use Statement Predicate Device

- . SURx RF System SURx, Inc. K020952
#### DEVICE DESCRIPTION

The Novasys Transurethral RF Generator delivers controlled, low-level radiofrequency energy through the Novasys Transurethral RF Probe for localized collagen denaturation.

#### INDICATION FOR USE STATEMENT

The Novasys Transurethral RF System is indicated for the transurethral treatment of female stress urinary incontinence due to hypermobility.

## SUBSTANTIAL EQUIVALENCE

#### 1. Technological Characteristics Predicate Devices

The technological characteristics of the Novasys Transurethral RF System are equivalent to those of the cited predicate electrosurgical devices and are similar to other legally

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marketed RF devices distributed by other manufacturers. The predicate devices are equivalent in terms of design, materials, principle of operation, and product specifications. Any differences between the Novasys Transurethral RF System and the predicate devices do not raise new issues regarding safety or effectiveness.

#### 2. Indication for Use Statement Predicate Device

Substantial equivalence for the Novasys Transurethral RF System Indication for Use Statement is supported by the cited predicate device with a Indication for Use Statement that is identical in terms of medical disorder (stress urinary incontinence), pathophysiological etiology (hypermobility), and patient population (female). The Indication for Use Statement for the Novasys Transurethral RF System is supported by the results of the clinical trials.

### SUMMARY OF NON-CLINICAL AND PRE-CLINICAL DATA

Results of bench testing and pre-clinical (animal) studies demonstrated that the Novasys Transurethral RF System met its performance specifications, was technologically substantially equivalent to its predicate devices, and that no new issues of safety or effectiveness were introduced.

## SUMMARY OF CLINICAL DATA

Results of clinical trials (both the Pilot Clinical Trial and the subsequent U.S. Multicenter Clinical Trial) demonstrated that the Novasys Transurethral RF System functioned as clinically designed and intended. Sufficient data has been gathered from clinical investigations to determine that the Novasys Transurethral RF System performs as clinically designed and intended, and that no new issues of safety or effectiveness were introduced.

# SUBSTANTIAL EQUIVALENCE DECISION-MAKING PROCESS

The guidance document titled, "Premarket Notification 510(k): Regulatory Requirements for Medical Devices, Substantial Equivalence Decision-making Process (Detailed),"

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revised August 1992 by the Center for Devices and Radiological Health, was used to determine the substantial equivalence for the Novasys Transurethral RF System.

#### CONCLUSION 16.2

Stress urinary incontinence (SUI), the most common form of urinary incontinence disorder, affects an estimated 17 million Americans, adversely impacting their quality of life. Numerous and varied therapeutic approaches are currently offered to treat this lifealtering disorder, ranging from non-invasive pelvic floor muscle exercises and minimally-invasive pelvic floor muscle electrical stimulation to invasive surgical bladder suspensions and slings.

The overwhelming majority of women suffering from SUI do not select a definitive treatment from the available options. Research has demonstrated that the majority of these women are seeking a treatment which is safe, rapid, non-surgical, associated with minimal recovery requirements, and does not require frequent repeat administration. The treatment effectiveness expected by female SUI patients in return for these treatment characteristics is improvement in their quality of life.

The least invasive currently available SUI treatment options suffer from issues relating to treatment efficacy, durability, chronicity, and patient compliance. The more invasive SUI treatment modalities are plagued by concerns regarding treatment safety and burdensome recovery requirements.

This submission presents evidence that the Novasys Transurethral RF System fulfills the wishes and expectations of women suffering from this disorder. As desired by patients, the Novasys Transurethral RF System treatment has demonstrated safety, with no Serious Adverse Events and only limited Anticipated Adverse Events occurring during the 12 month U.S. Clinical Trial. The non-surgical, outpatient procedure is rapidly performed without the need for general anesthesia and is associated with minimal recovery requirements. Patients have demonstrated improvement in quality of life, reduction in

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number of daily incontinence episodes, reduction in daily incontinence pad use, and improvement in Valsalva leak point pressure 12 months following treatment.

Along with the demonstration of Novasys Transurethral RF System safety and effectiveness, this submission has presented evidence of substantial equivalence to legally marketed predicate devices for both technological characteristics and Indication for Use Statement.

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