CYSTOGLIDE DILATING INTRODUCER SHEATH

K052134 · Percutaneous Systems, Inc. · KNY · Sep 22, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K052134
• Device Name: CYSTOGLIDE DILATING INTRODUCER SHEATH
• Applicant: Percutaneous Systems, Inc.
• Product Code: KNY · Gastroenterology, Urology
• Decision Date: Sep 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The CystoGlide Dilating Introducer Sheath is a urological device used to facilitate urethral stricture dilation and the introduction of catheters or instruments. The device consists of a sheath and a stabilizing hub, designed to be tracked over a urological guidewire. It acts as a lubricious barrier between the urethral tissue and the inserted instrument, reducing friction during the procedure. It is intended for use by clinicians in a urological setting. By providing a guided, lubricious pathway, the device assists in the safe and efficient placement of urological instruments, potentially reducing trauma to the urethral tissue during catheterization or dilation procedures.

Clinical Evidence

Bench testing only. Performance data demonstrated no significant difference in the performance of the CystoGlide Dilating Introducer Sheath compared to the predicate devices.

Technological Characteristics

The device consists of a sheath and a stabilizing hub. It is designed for tracking over a urological guidewire. The device functions as a mechanical dilator and guide. No specific materials, energy sources, or software algorithms are described.

Indications for Use

Indicated for patients requiring urethral dilation and the introduction of urological catheters or instruments into the urethra. Functions as a dilator, guide, and lubricious barrier between urethral tissue and instruments.

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

• PSI's UPDATED SLIP Urology Introducer Sheath
• Cook Urological's Urethral Dilator Set

Submission Summary (Full Text)

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K052134
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# SEP 2 2 2005

### 510(k) SUMMARY

# Percutaneous Systems, Inc.'s CYSTOGLIDE DILATING INTRODUCER
STORE Systems, Inc.'s CHEATH SHEATH

# 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]

Thomas Lawson Contact Person:

July 25, 2005 Date Prepared:

# Common or Usual Name

Urology Dilating Introducer Sheath

#### Classification Name

Accessories, Catheter, G-U

#### Predicate Device

PSI's UPDATED SLIP Urology Introducer Sheath Cook Urological's Urethral Dilator Set

### Intended Use / Indications for Use

The CYSTOGLIDE DILATING INTRODUCER SHEATH is intended to The CTSTOOLIDE DiEATING Istrictures and the introduction of catheters
facilitate the dilation of urethral strictures and the RUATING facilitate the dilation of arethra. The CYSTOGLIDE DILATING or instruments into the arething. can a urethral dilator and as a INTRODUCEN SHEATT is indicated for attailed into the urethra and guide for urological catricters of increatival tissue and the catheter or instrument.

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K052134
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# Technological Characteristics

The CYSTOGLIDE DILATING INTRODUCER SHEATH consists of a film,
The CYSTOGLIDE DILATING INTRODUCER - The dovice can be front-The CYSTOGLIDE DILATING INTROTRY (Notector. The device can be fronta sheath, a stablizing high and over a urological guidewire.

### Performance Data

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

### Substantial Equivalence

The CYSTOGLIDE DILATING INTRODUCER SHEATH has similar The CYSTOGLIDE Dications for use, principles of operation and technological intended use, indications for docted devices. The CYSTOGLIDE DILATING
characteristics as the predicate devices. The CYST is substantially charactenstics as the predicate advanced on Sheath is substantially INTRODUCER SHEATH Orology Introducer Sheath and the Urethral Dilator Set.

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SEP 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thomas Lawson, Ph.D. VP, Clinical & Regulatory Affairs Percutaneous Systems, Inc. 1300 Crittenden Lane, Suite 101 MOUNTAIN VIEW CA 94043-1359

K052134 Re:

K052134
Trade/Device Name: CYSTOGLIDE DILATING INTRODUCER SHEATH CYSTOGEIDE DIDATHING IN CD2117, CD1915 and CD1713 Regulation Number: 21 CFR §876.5520 Regulation Name: Urethral dilator Product Code: FAH and KOE Froduct Countion Number: 21 CFR §876.5130 Regulation Number: 21 Gr St St St St St eter and accessories Product Code: KNY Regulatory Class: II Dated: July 25, 2005 ﺎﺭ ﻳﺮﺗﺒ Received: August 5, 2005

Dear Dr. Lawson:

We have reviewed your Section 510(k) prematicet notification of intent to market the device referenced We have reviewed your Section 510(K) picitialse indications for the indications for use stated in
above and have determined the device is substant in indications commerce pr above and have delemined the cevices is stedios in interstate comments prior to
the enclosure) to legally marketed predicated in interses or to devices that have the enclosure) to legally marketed predical Device Amendments, or to devices that have been
May 28, 1976, the enactment date of the Medical Device Amendments, or to devices t May 28, 1976, the enactment and of the Medical Doug, and Cosmetic Act (Act) that reclassified in accordance with the provisions of and issues (PMA). You may, therefore, market the do not require approval of a prematics approval approvation of the general controls provisions of the Act
device, subject to the general controls provisions of the Act menufa device, subject to the general controls of the really as and manufacturing practice, labeling, merado requires against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Precuations affecting vour If your device is classified (see above) into claim and creations affecting your and Approval), it may be subject to such additions. Title 21, Parts 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations: Title 21, Paris 800 to 8 device can be found in the Code of Federal Register. In the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA's issualice of a substance of the requirements of the Act of any
FDA has made a determination that your device complex with other comply with all FDA has made a determination that your devices. You must concess. You must comply with all the Federal statutes and regulations administered by registration and listing (21 CFR Part 807), labeling
Act's requirements, including, but not limited to registration as set fo Act 's requirements, including, but to million is reguirements as set forth in the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set for (21 CFR Part 801); good manufacturing practice the electronic product radiation control provisions
regulation (21 CFR Part 820); and if applicable, the electronic product rad (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
This and the supportunity Black of substantial equivalence of your device to a This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA in a location for your device and thus, premarket notification. The FDA finding of substantial equivalence of your device of your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our labeling regulation (1) - 11 crail on 1977)
contact the Office of Compliance at one of the following numbers, based on th the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to prematic notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general intermation on your responsible of the manner (800)
Division of Small Manufacturers, International and Consumer Assistance at its toll-Division of Small Manalastar at its Internet address.
638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

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# Indications for Use Statement

K652134 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: CYSTOGLIDE DILATING INTRODUCER SHEATH

Indications for Use:

The CYSTOGLIDE DILATING INTRODUCER SHEATH Urology is The CTSTOCEIDE DIEXTRYS: and to facilitate the introduction of catheters and instruments into the urethra.

The CYSTOGLIDE DILATING INTRODUCER SHEATH is indicated for rne OTOTOOElDHilator and as a guide for urological catheters or use as a dreinfal and as a lubricious barrier between the urethral tissue and the catheter or instrument.

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)

Page 1 of __

David h. lyons

(Division Sign-Off) Division of Reproductiv and Radiological Devices 510(k) Number

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