CYSTOGLIDE INTRODUCER SHEATH

K052298 · Percutaneous Systems, Incorporated · KNY · Dec 12, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K052298
• Device Name: CYSTOGLIDE INTRODUCER SHEATH
• Applicant: Percutaneous Systems, Incorporated
• Product Code: KNY · Gastroenterology, Urology
• Decision Date: Dec 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The CYSTOGLIDE INTRODUCER SHEATH is intended to facilitate the introduction of catheters or instruments into the urethra. The CYSTOGLIDE INTRODUCER SHEATH is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.

Device Story

The CystoGlide Introducer Sheath is a urological accessory designed to facilitate the insertion of catheters or instruments into the urethra. The device consists of a film, a sheath, a stabilizing ring, and an obturator. It incorporates a ViaShield film membrane to isolate the sheath from skin microflora. By acting as a lubricious barrier, the device reduces friction between the urethral tissue and the inserted catheter or instrument, potentially improving patient comfort and reducing trauma during the procedure. It is intended for use by healthcare professionals in clinical settings. The device functions as a mechanical guide and protective interface during standard urological catheterization procedures.

Clinical Evidence

Bench testing only. Performance data demonstrated no significant difference in the performance of the CYSTOGLIDE INTRODUCER SHEATH compared to the predicate devices.

Technological Characteristics

Components include a film, sheath, stabilizing ring, and obturator. Features a ViaShield film membrane for isolation from skin microflora. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring urethral catheterization or instrumentation; serves as a guide and lubricious barrier between urethral tissue and the inserted device.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• UPDATED SLIP Urology Introducer Sheath
• LoFric catheter (Astra Tech)
• MMG/O'Neil catheter (Rusch)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) SUMMARY

# DEC 1 2 2006

# Percutaneous Systems, Inc.'s CYSTOGLIDE INTRODUCER SHEATH Advertising Claims

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Percutaneous Systems, Inc. 1300 Crittenden Lane, #101 Mountain View, CA 94043-1359

> [phone] x 204 Phone: Facsimile: [phone]

Contact Person: Thomas Lawson

Date Prepared: August 15, 2005

#### Common or Usual Name

Urology Introducer Sheath

#### Classification Name

Accessories, Catheter, G-U

#### Predicate Device

PSI's UPDATED SLIP Urology Introducer Sheath Astra Tech's LoFric catheter Rusch's MMG/O'Neil catheter

#### Intended Use / Indications for Use

The CYSTOGLIDE INTRODUCER SHEATH is intended to facilitate the introduction of catheters or instruments into the urethra. The CYSTOGLIDE INTRODUCER SHEATH is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.

Image /page/0/Picture/17 description: The image shows an oval shape with three diagonal lines inside. The oval is slightly tilted to the right. The three diagonal lines are parallel to each other and are also tilted to the right.

{1}------------------------------------------------

## Technological Characteristics

The CYSTOGLIDE INTRODUCER SHEATH consists of a film, a sheath, a stabilizing ring, and an obturator. The sheath is isolated from the skin microflora by the ViaShield film membrane.

## Performance Data

Performance data demonstrated no significant difference in the performance of the CYSTOGLIDE INTRODUCER SHEATH and the predicate devices.

## Substantial Equivalence

The CYSTOGLIDE INTRODUCER SHEATH has similar intended use, indications for use, principles of operation and technological characteristics as the predicate devices. The CYSTOGLIDE INTRODUCER SHEATH is substantially equivalent to the cleared UPDATED SLIP Urology Introducer Sheath, the LoFric Intermittent Catheter and the MMG/O'Neil catheter.

Image /page/1/Picture/6 description: The image contains a hand-drawn oval shape with the number 112 written inside. The number is written in a simple, slightly slanted style. The oval shape is not perfectly symmetrical, giving it a casual, hand-drawn appearance.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

DEC 1 2 2006

Thomas Lawson, Ph.D. VP, Clinical and Regulatory Affairs Percutaneous Systems, Inc. 1300 Crittenden Lane Suite 101 MOUNTAIN VIEW CA 94043

Re: K052298

> Trade/Device Name: CYSTOGLIDE INTRODUCER SHEATH Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KNY Dated: October 11, 2006 Received: October 12, 2006

Dear Dr. Lawson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave ro rolled your concerning the device is substantially equivalent (for the indications for referenced about and harv to legally marketed predicate devices marketed in interstate commerce ass mated in the enactment date of the Medical Device Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic nave occh roomsbirred in accerantoval 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 (sec above) into either class II (Special Controls) or class III (Premarket If your devise is elasting (500 work) ditional controls. Existing major regulations affecting your Apploval), it they be saylor to out.Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906 - 2006". The logo features the letters "FDA" in a stylized font. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.

*Protecting and Promoting Public Health*

{3}------------------------------------------------

Page 2 -

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.

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 one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

#### Indications for Use Statement

510(k) Number (if known):

Device Name: CYSTOGLIDE INTRODUCER SHEATH

Indications for Use:

The CYSTOGLIDE INTRODUCER SHEATH Urology is intended to facilitate the introduction of catheters and instruments into the urethra.

The CYSTOGLIDE INTRODUCER SHEATH is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.

_ X _ _ AND/OR Over-The-Counter Use_ Prescription Use

(Per 21 C.F.R. 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Leperm

Page 1 of _/

(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K052298

11e