COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015

K082803 · Percutaneous Systems, Inc. · FFL · Nov 13, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K082803
• Device Name: COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015
• Applicant: Percutaneous Systems, Inc.
• Product Code: FFL · Gastroenterology, Urology
• Decision Date: Nov 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Coaxial Accordion Stone Management Device Urological is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and facilitate drainage and retrograde pyelogram.

Device Story

The Coaxial Accordion Stone Management Device is a urological retrieval tool used endoscopically by clinicians. It consists of a film membrane attached to a cannula with a removable handle. The device is inserted into the urinary tract to entrap calculi or foreign objects for removal; it also facilitates drainage and retrograde pyelogram procedures. By providing a mechanical means to capture and extract stones, the device assists in clearing urinary obstructions, potentially reducing patient discomfort and complications associated with calculi.

Clinical Evidence

No clinical data provided; performance data not required.

Technological Characteristics

Device consists of a film membrane attached to a cannula with a removable handle. Mechanical retrieval system; no electronic or software components.

Indications for Use

Indicated for endoscopic entrapment and removal of calculi and foreign objects from the urinary tract, and to facilitate drainage and retrograde pyelogram in patients requiring urological intervention.

Regulatory Classification

Identification

A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• Accordion Urological Occluding Guidewire (Percutaneous Systems, Inc.)
• Open-end Ureteral Catheter (Cook Urologic)

Submission Summary (Full Text)

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K 082803
Pg 1 of 2

# 510(k) Summary

NOV 1 3 2008

## Percutaneous Systems, Inc.'s Coaxial Accordion Stone Management Device

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

Percutaneous Systems, Inc. 3260 Hillview Avenue Suite 100 Palo Alto, CA 94304

| Phone:<br>Facsimile: | (650) 493 - 4200<br>(650) 493 - 4201 |
|----------------------|--------------------------------------|
| Contact Person: | Thomas Lawson |
| Date Prepared: | September 16, 2008 |

## Common or Usual Name

Urology Retrieval Device

### Classification Name

G-U Devices

## Predicate Devices

Accordion Urological Occluding Guidewire, Percutaneous Systems, Inc. Open-end Ureteral Catheter, Cook Urologic.

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### Intended Use

The Coaxial Accordion Stone Management Device Urological is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and facilitate drainage and retrograde pyelogram.

#### Technological Characteristics

The Coaxial Accordion Stone Management Device consists of a film membrane attached onto a cannula with a removable handle.

### Performance Data

Not required.

## Substantial Equivalence

The Coaxial Accordion Stone Management Device has the same intended use, indications for use, and principles of and very similar technological characteristics as the predicate devices. Thus, the Coaxial Accordion device is substantially equivalent to the cleared predicated . Aoost

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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 eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### NOV 1 8 2008

Thomas Lawson, Ph.D. Vice President, Clinical & Regulatory Affairs Percutancous Systems, Inc. 3260 Hillview Avenue, Suite 100 PALO ALTO CA 94304

Rc: K082803

Trade/Device Name: Coaxial Accordion Stone Management Device Regulation Number: 21 CFR 876.4680 Regulation Namc: Ureteral Stone Dislodger Regulatory Class: II Product Code: FFL Dated: September 18, 2008 Received: September 24, 2008

Dear Dr. Lawson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indicitions for use stated in the enclosure) to legally marketed predicate devices market in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, in and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 FFA may publish further announcements concerning your device in the Federal Period.

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#### 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 (Scctions 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

loque M. Whang

Joyce M. Whang, Ph.D. Acting 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

510(k) Number (if known): K C 8280 3

Device Name: Coaxial Accordion Stone Management Device

Indications for Use:

The Coaxial Accordion Stone Management Device is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and facilitate drainage and retrograde pyelogram.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hestleleusa

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Dev 510(k) Number

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