MICROVERTER URETERAL ACCESS SHEATH

K042877 · Percutaneous Systems, Inc. · KNY · Nov 16, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K042877
• Device Name: MICROVERTER URETERAL ACCESS SHEATH
• Applicant: Percutaneous Systems, Inc.
• Product Code: KNY · Gastroenterology, Urology
• Decision Date: Nov 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The MICROVERTER Ureteral Access Sheath is intended to facilitate the introduction of endoscopes and other instruments into the urinary tract. The MICROVERTER Ureteral Access Sheath is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract, and as a lubricious barrier between the ureteral tissue and the endoscope or instrument.

Device Story

The MICROVERTER Ureteral Access Sheath is a urological introducer sheath designed to facilitate endoscopic access to the urinary tract. The device consists of an outer tube pre-loaded with a film membrane and a pusher tube that provides a lumen for the introduction of endoscopes and urological instruments. It functions as a conduit for instruments and a lubricious barrier to protect ureteral tissue during passage. Used in clinical settings by urologists during endoscopic procedures, the device simplifies instrument insertion and fluid injection. By providing a stable, lubricated pathway, it reduces friction and potential trauma to the ureteral wall, facilitating safer and more efficient urological interventions.

Clinical Evidence

Bench testing only. Performance data demonstrated no significant difference in the performance of the MICROVERTER Ureteral Access Sheath compared to the predicate devices.

Technological Characteristics

Consists of a film membrane covering an outer tube and a pusher tube providing a lumen for instrument introduction. The outer tube is pre-loaded with the film membrane. No specific materials or standards are disclosed.

Indications for Use

Indicated for patients undergoing endoscopic urological procedures requiring the introduction of endoscopes, instruments, or fluid injection into the urinary tract; serves as a lubricious barrier between ureteral 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 SLIP Urology Introducer Sheath
• Cook Flexor Ureteral Access Sheath
• Boston Scientific Navigator Ureteral Access Sheath

Submission Summary (Full Text)

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NOV 1 6 2004

K042877
Payeldz

### 510(k) SUMMARY

# Percutaneous Systems, Inc.'s MICROVERTER Ureteral Access 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]

Contact Person: Thomas Lawson

September 25, 2004 Date Prepared:

#### Common or Usual Name

Urology Introducer Sheath

#### Classification Name

Accessories, Catheter, G-U

#### Predicate Device

PSI SLIP Urology Introducer Sheath Cook Flexor Ureteral Access Sheath Boston Scientific Navigator Ureteral Access Sheath

#### Intended Use / Indications for Use

The MICROVERTER Ureteral Access Device is intended to facilitate the introduction of endoscopes and other instruments into the urinary tract. The device is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the

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urinary tract, and as a lubricious barrier between the ureteral tissue and the endoscope or instrument.

## Technological Characteristics

The MICROVERTER Ureteral Access Sheath consists of a film membrane covering an outer tube, and a pusher tube that provides a lumen for the introduction of endoscopes and instruments. The outer tube is pre-loaded with the film membrane.

### Performance Data

Performance data demonstrated no significant difference in the performance of the MICROVERTER Ureteral Access Sheath and the predicate device.

## Substantial Equivalence

The MICROVERTER Ureteral Access Sheath has the same intended use, indications for use, and principles of operation and very similar technological characteristics as the predicate devices. Thus, the MICROVERTER Ureteral Access Sheath is substantially equivalent to the cleared predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2004

Thomas Lawson, Ph.D. Director, Clinical Affairs Percutaneous Systems, Inc. 1300 Crittenden Lane, #301 MOUNTAIN VIEW CA 94043-1359

Re: K042877

Trade/Device Name: MICROVERTER Ureteral Access Sheath Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 KNY Dated: September 25, 2004 Received: October 18, 2004

Dear Dr. Lawson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w one 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 the enated of the enactment date of the Medical Device Amendments, or to devices that have been rear 20, 1710, 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 do not require 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 (Premarket Approval), 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 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.

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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.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/cdrh/dsmaldsmamain.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):_ K 042 877

Device Name: MICROVERTER Ureteral Access Sheath

Indications for Use:

The MICROVERTER Ureteral Access Sheath is intended to facilitate the introduction of endoscopes and other instruments into the urinary tract.

The MICROVERTER Ureteral Access Sheath is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract, and as a lubricious barrier between the ureteral tissue and the endoscope 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. Brogdon

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number