SLIP UROLOGY CATHETER

K040519 · Percutaneous Systems, Inc. · EZD · May 20, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040519
• Device Name: SLIP UROLOGY CATHETER
• Applicant: Percutaneous Systems, Inc.
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: May 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SLIP Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder. The device is indicated for providing increased lubricity during the catheter's advancement.

Device Story

The SLIP Urology Catheter is a straight catheter designed for intermittent bladder drainage. It consists of a catheter, sheath, snap ring, and guide ring. The catheter is pre-loaded with a membrane sheath to provide increased lubricity during insertion. The device is used by clinicians to facilitate fluid drainage from the bladder. It functions as a mechanical conduit; no electronic or software components are involved.

Clinical Evidence

No clinical data provided; the device is claimed to be identical to the predicate.

Technological Characteristics

Consists of a catheter, sheath, snap ring, and guide ring. Features a pre-loaded membrane sheath for lubricity. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring intermittent bladder drainage. Provides increased lubricity during catheter advancement.

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

• Memcath Urology Catheter (Memcath Technologies LLC)

Submission Summary (Full Text)

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K040519

Page 1 of 2

# 510(k) SUMMARY

# Percutaneous Systems, Inc.'s SLIP Urology Catheter™

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

SLIP Urology Catheter™

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

> [phone] x201 Phone: Facsimile: [phone]

Robert Behl, President and CEO Contact Person:

February 24, 2004 Date Prepared:

#### Common or Usual Name

Straight Catheter

#### Classification Name

Urological Catheter

#### Predicate Device

Memcath Technologies LLC's Memcath Urology Catheter

# Intended Use/Indications for Use

The SLIP Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder.

The device is indicated for providing increased lubricity during the catheter's advancement.

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*K04051*
Page 2 of 2

### Technological Characteristics

The SLIP Urology Catheter consists of a catheter, a sheath, a snap ring, and a guide ring. The catheter is pre-loaded with a membrane sheath for increased lubricity.

### Performance Data

The SLIP catheter is identical to its predicate, the Memcath Urology Catheter. Thus, no performance data were provided.

#### Substantial Equivalence

The SLIP Urology Catheter is identical to the Memcath Urology Catheter (except for the trade name). The SLIP Urology Catheter has the same intended use, indications for use, technological characteristics, and principles of operation. Thus, the SLIP Urology Catheter is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is a stylized representation, and the text is arranged in a circular pattern around the bird.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 2004

Percutaneous Systems, Inc. c/o Mr. Howard M. Holstein Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, N.W. Washington DC 20004-1109

Rc: K040519

Trade/Device Name: SLIP Urology Catheter™; Models UC2400-06, UC2400-08, UC2400-10, UC2400-12, UC2400-14, UC2400-16, and UC2400-18 Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EZD Dated: April 30, 2004 Received: April 30, 2004

Dear Mr. Holstein:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected wined 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 encroom's the enactment date of the Medical Device Amendments, or to commerce provide to may 20, 1978, as excordance with the provisions of the Federal Food, Drug, de vices that nave been rochers approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general connols provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (sce 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, I'DA 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 least to advised that 1177 brissanted or our device complics with other requirements of the Act that I DA has made a detel meadling administered by other Federal agencies. You must of any Federal statution and including, but not limited to: registration and listing comply with an the 110 110 110 Part 801); good manufacturing practice requirements as set (21 CFR Part 007), acomig (21 CER Part 820); and if applicable, the electronic forth in the quality by of the (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 letter will allow you to begin marketing your antinessur of your device to a legally premarket notification. The FDA miding of substantial equired 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 specific advice for your device on our lasting of a
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions of the promotion and and of the regulation entitled, "Misting and Othce of Compliance at (501) 594-657. Tuss, pear 807.97) you may obtain. Other general by reference to premarket nonitation (21 ccr x x an w be obtained from the Division of Strall
information on your responsibilities under the Act the probles [phone] information on your responsionalities this. In its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-famagain html Manufacturers, International and Colisumior Filsistance and contribution and smamain.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): KOGOSTA

Device Name: SLIP Urology Catheter™

Indications for Use:

The SLIP Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder.

The device is indicated for providing increased lubricity during the catheter's advancement.

Prescription Use _x_ (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use_

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of __

Nancy C. Brogdon
(Division Sign-Off)

ivision of Reproductive, Abdominal. and Radiological Devi ^k) Number