BACKSTOP CATHETER, MODEL 60-0000-3100

K090270 · Pluromed, Inc. · KOD · May 15, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090270
• Device Name: BACKSTOP CATHETER, MODEL 60-0000-3100
• Applicant: Pluromed, Inc.
• Product Code: KOD · Gastroenterology, Urology
• Decision Date: May 15, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Indications for Use

The BackStop Catheter is indicated for use by physicians for facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the injection of fluid into the urinary tract.

Device Story

BackStop Catheter is 100cm, 3F single lumen radiopaque catheter; facilitates urinary tract access. Physician inserts device over guidewire or through ureteroscope working channel; progresses to target ureter location. Once positioned, device allows fluid injection via standard female luer lock hub. Device features stainless steel braid. Used in clinical settings by physicians to assist urological procedures.

Clinical Evidence

bench testing only

Technological Characteristics

100cm, 3F single lumen radiopaque catheter; stainless steel braid; standard female luer lock hub. Complies with AAMI/ANSI/ISO 11607-1 (packaging), 10993-1 (biocompatibility), and 11137-1/2 (radiation sterilization).

Indications for Use

Indicated for physicians to facilitate urinary tract access via retrograde or antegrade routes; used with guidewires or for fluid injection.

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

• Imager II Urology Torque Catheter (K011965)

Submission Summary (Full Text)

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# 510(k) Summary Safety ad Effectiveness Data Summary

Prepared By:

Telephone Number: Fax Number:

Contact Person:

Proprietary Name: Classification Name: Common Name:

Classification: Regulation Number: Product Code:

Indications for Use:

Pluromed Inc. 25-H Olympia Avenue Woburn, MA 01801

781-932-0574 419-828-6350

James Wilkie [e-mail]

BackStop Catheter Urological Catheters and Accessories Urological Catheter

Class II 876.5130 78 KOD

The BackStop Catheter is indicated for use by physicians for facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the injection of fluid into the urinary tract.

#### Performance Standards:

Recognition Number 14-193: AAMI / ANSI / ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, 3ed.

Recognition Number 2-98: AAMI / ANSI / ISO 10993-1:2003(E), Biological evaluation of medical devices -- Part 1: Evaluation and testing.

Recognition Number 14-224: AAMI / ANSI / ISO 11137-1:2006, Sterilization of health care

MAY 15 2009

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products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices.

Recognition Number 14-225: AAMI / ANSI / ISO 11137-2:2006, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose.

### Substantial Equivalence:

Description of Device:

Imager II Urology Torque Catheter Urological Catheter 510(k) Number: 011965

The BackStop Catheter is a 100cm, 3F single lumen radiopaque catheter to facilitate access to the urinary tract. The catheter is inserted over a guidewire or through the working channel of an ureteroscope and is progressed through the urinary tract to the desired ureter location. Once in place fluid may be injected via the catheter.

The device is a single lumen catheter with a stainless steel braid and a standard female luer lock hub on the proximal end.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is black and white.

MAY 15 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James Wilkie Vice President, Operations Pluromed, Inc. 25-H Olympia Avenue WOBURN MA 01801

Re: K090270

Trade/Device Name: BackStop Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KOD Dated: May 4, 2009 Received: May 6, 2009

Dear Mr. Wilkie:

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 indications for use stated in the enclosure) to legally marketed predicate devices marketed 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 misbranding and adulteration.

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); medical device reporting (reporting of medical device-related adverse, events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 yours,

[signature]

Janine M. Morris 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

#### K090270 510(k) Number (if known):

Device Name: BackStop Catheter

Indications for Use:

The BackStop Catheter is indicated for use by physicians for facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the injection of fluid into the urinary tract.

### PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X : (21 CFR 801 Subpart D)

AND/OR

Over the Counter Use

(21 CFR 807 Subpart C)

hymn Dathan

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.

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