ACCORDION

K052048 · Percutaneous Systems, Incorporated · FFL · Sep 13, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K052048
• Device Name: ACCORDION
• Applicant: Percutaneous Systems, Incorporated
• Product Code: FFL · Gastroenterology, Urology
• Decision Date: Sep 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ACCORDION Urological Occluding Guidewire is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract.

Device Story

The ACCORDION Urological Occluding Guidewire is a two-part device featuring a removable handle. It is used endoscopically by urologists or trained clinicians within the ureteral tract. The device functions as a mechanical tool to entrap and retrieve urinary calculi or foreign objects and serves as a guide for other urological instrumentation. By facilitating the removal of obstructions and providing a pathway for instruments, the device assists in clearing the urinary tract, potentially relieving patient symptoms associated with stones or foreign bodies.

Clinical Evidence

Bench testing only.

Technological Characteristics

Two-part guidewire system with a removable handle. Mechanical retrieval and guidance functionality. No electronic or software components.

Indications for Use

Indicated for endoscopic entrapment and removal of calculi and foreign objects from the urinary tract and for guiding instrumentation within the ureteral tract 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

• SLIP Urology Introducer Sheath (Percutaneous Systems, Inc.)
• SEIF Orology introducer Should (Boston Scientific Corp.)
• Movable Core Guidewire (CR Bard, Inc.)

Submission Summary (Full Text)

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K052048

### SEP 1 3 2005

### 510(k) SUMMARY

## Percutaneous Systems, Inc.'s ACCORDION Urological Occluding Guidewire

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

Percutaneous Systems, Inc. 1300 Crittenden Lane, Suite 101 Mountain View, CA 94043-1359

| Phone: | [phone] |
|------------|----------------|
| Facsimile: | [phone] |

Thomas Lawson Contact Person:

May 10, 2005 Date Prepared:

## Common or Usual Name

Urology Retrieval Device

## Classification Name

G-U Devices

#### Predicate Devices

SLIP Urology Introducer Sheath, Percutaneous Systems, Inc. SEIF Orology introducer Should, + Stoutentific Corp. Movable Core Guidewire, CR Bard, Inc.

#### Intended Use

The ACCORDION Urological Occluding Guidewire is intended to be used The ACCORDION Offical Occluding Calability Calability of other from the endoscopically to chirap anstrumentation within the ureteral tract.

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# Technological Characteristics

The ACCORDION Urological Occluding Guidewire consists of a film The ACCORDION Orological Other a two-part guidewire with a removable handle.

## Performance Data

Not required.

## Substantial Equivalence

The ACCORDION Urological Occluding Guidewire has the same intended The ACCORDION Orologiour Orologiour Oroclading Coperation and Very similar use, Indications for doe, ans as the predicate devices. Thus, the technological charactenstics as the prodicate about - Includes devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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# SEP 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thomas Lawson, Ph.D. Thomas Lawoon, I'mical & Regulatory Affairs Percutaneous Systems, Inc. 1300 Crittenden Lane, #101 MOUNTAIN VIEW CA 94043-1359

Re: K052048

K052048
Trade/Device Name: ACCORDION Urological Occluding Guidewire, Models AC281205 ACCORDION Orological Goofs annog Canading Co., AC2814510; AC381205
through AC2812010; AC281455 through AC2814510; through AC2812010; and, AC381455 through AC3814510 Regulation Number: 21 CFR §876.4680 Regulation Name: Ureteral stone dislodger Regulatory Class: II Product Code: FFL Dated: May 28, 2005 Received: July 29, 2005

#### Dear Dr. Lawson:

Dodl Dr. Lawson.
We have reviewed your Section 510(k) prematically and set the indication for use stated in We have reviewed your Section 310(R) premation invinced (for the indications for uses stated in
above and have determined the device is substantially equivalent commerce pri above and have delerinned the device is scessaries. Species marketed in interstate commerce prior to the enclosure) to legally marketed predical Device Amendments, or to devices that have been May 28, 1976, the enaculient use of the Frederal Food, Drug, and Cosmetic Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act reclassified in accordance with the provisions of the country (PMA). You may, therefore, market the do not require approval of a prematics approvisions of the Act. The general controls provisions of the Act
device, subject to the general controls provisions of the Act. The device, subject to the gelleral condois provincies of devices, good manufacturing practice, labeling, morado requires against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Prematket If your device is classified (see above) into extrely. Existing major regulations affecting your 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 41, Paris 800 to 8 device can be found in the Code of Federal ing your device 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 issuance of a substance of the requirements of the Act or ally
FDA has made a determination that your device complex with securies. You must comp FDA has made a determination mar your device connect was agencies. You must comply with all the Federal statues and regulations administered by band issung (2) CFR Part 807); labeling Act's requirements, including, but hot mined to reguirements set for t in the quality systems (QS) (2) 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)
The supportunities and consisted and pubscription of your device to a legal This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA Indine if your device and this permits premarket notification. The FDA Inding of substantial equivaliation for your device of the results your dovice to procced to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r and the summer on any and of the following numbers, based on the regula If you desire specific advice for your device on our labeling regaration (10 - 120)
contact the Office of Compliance at one of the following numbers, based on the regulation 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 "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, " Misoration on your responsibilities under the Act from the Act from the 807.97). You may obtain other general information on your responsibility and its toll-free number (800)
Division of Small Manufacturers, International Incon DIVIsion of Small Manator or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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 OS 2 50 4 B

Device Name: ACCORDION Urological Occluding Guidewire

Indications for Use:

The ACCORDION Urolgoical Occluding Guidewire is intended to
rely and on the column in whose colouli and other foreign be used endoscopically to entrap and remove care.
objects from the urinary tract and to guide instrumentation within the ureteral tract.

Prescription Use __X_ (Per 21 C.F.R. 801.109) AND/OR Over-The-Counter Use_________________________________________________________________________________________________________________________________________________

(Please do not WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of __

Nancy Snowdon

and Radiological D 510(k) Number

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