UPDATED SLIP UROLOGY INTRODUCER SHEATH

K042531 · Percutaneous Systems, Incorporated · KNY · Feb 1, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K042531
• Device Name: UPDATED SLIP UROLOGY INTRODUCER SHEATH
• Applicant: Percutaneous Systems, Incorporated
• Product Code: KNY · Gastroenterology, Urology
• Decision Date: Feb 1, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The UPDATED SLIP Urology Introducer Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The UPDATED SLIP Urology 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

Urology introducer sheath designed to facilitate insertion of catheters or instruments into urethra. Device acts as guide and lubricious barrier between urethral tissue and inserted instrument. Components include membrane sheath, outer tube, stabilizing ring, and obturator. Used in clinical urological procedures to minimize friction during catheterization.

Clinical Evidence

Bench testing only; performance data demonstrated no significant difference in performance compared to the predicate device.

Technological Characteristics

Consists of membrane sheath, outer tube, stabilizing ring, and obturator. Outer tube pre-loaded with membrane sheath. Mechanical device; no energy source or software.

Indications for Use

Indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between urethral tissue and the catheter or instrument.

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 SLIP Urology Introducer Sheath

Submission Summary (Full Text)

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K042531
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FEB - 1 2005

#### 510(k) SUMMARY

# Percutaneous Systems, Inc.'s UPDATED SLIP Urology Introducer Sheath

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

Percutaneous Systems, Inc. 1300 Crittenden Lane, #301 Mountain View, CA 94043-1359

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

Thomas Lawson Contact Person:

July 30, 2004 Date Prepared:

#### Common or Usual Name

Urology Introducer Sheath

### Classification Name

Accessories, Catheter, G-U

#### Predicate Device

PSI SLIP Urology Introducer Sheath

### Intended Use / Indications for Use

The UPDATED SLIP Urology Introducer Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The UPDATED SLIP Urology 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.

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K042531
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### Technological Characteristics

The UPDATED SLIP Urology Introducer Sheath consists of a membrane sheath, outer tube, stabilizing ring, and an obturator. The outer tube is pre-loaded with the membrane sheath.

## Performance Data

Performance data demonstrated no significant difference in the r crosmance of the UPDATED SLIP Urology Sheath and the predicate device.

### Substantial Equivalence

The UPDATED SLIP Urology Introducer Sheath has the same intended use, indications for use, and principles of operation and very similar technological characteristics as the predicate device. The minor technological differences between the UPDATED SLIP Urology Introducer Sheath and its predicate, namely, the UPDATED SLIP sheath's obturator, luminal seal, and stabilizing ring, do not raise any new questions of safety or effectiveness. Thus, the UPDATED SLIP II'm gay Introducer Sheath is substantially equivalent to the cleared SLIP Urology Introducer Sheath.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

FEB - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thomas Lawson, Ph.D. Director, Clinical Affairs Percutaneous Systems, Inc. 1300 Crittenden Lane, Suite 301 MOUNTAIN VIEW CA 94043

Re: K042531

Trade/Device Name: UPDATED SLIP Urology Introducer Sheath Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 KNY Dated: January 12, 2005 Received: January 13, 2005

Dear Dr. Lawson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases) 70 ttg enactment date of the Medical Device Amendments, or to conninored processified 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 r ou may, ateres 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 i toals be active a a determination that your device complies with other requirements of the Act that I Dr Hab Intel and regulations administered by other Federal agencies. You must of any Featurers and 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 (21 Cr re rare out your ens (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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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and by of substantial equivalence of your device of your device to a legally premaince notification - rivesults 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 If you desire uponne at one of the following numbers, based on the regulation number at 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 premarket notification" (21 CFR 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/cdrb/dsmadsmamain.html

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

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## Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: UPDATED SLIP Urology Introducer Sheath

Indications for Use:

The UPDATED SLIP Urology Introducer Sheath is intended to facilitate the introduction of catheters and instruments into the urethra.

The UPDATED SLIP Urology Introducer Sheath is indicated for use as a guide for urological catheters or instruments inserted into the a guide for aronogical consisted between the urethral tissue and the catheter or instrument.

Prescription Use _x___________________________________________________________________________________________________________________________________________________________ Use (Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Nancy C Hodgson
(Division Sign-Off)

Division of Reproductive and Radiological Devices 510(k) Number