BACKSTOP CATHETER

K103349 · Pluromed, Inc. · KOD · Jan 7, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K103349
• Device Name: BACKSTOP CATHETER
• Applicant: Pluromed, Inc.
• Product Code: KOD · Gastroenterology, Urology
• Decision Date: Jan 7, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Pluromed 3F 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 gels, such as BackStop™, or fluid into the urinary tract.

Device Story

3F BackStop Catheter is a 100 cm, 3F, single lumen, radiopaque catheter; facilitates urinary tract access. Physician-operated; inserted over guidewire or through ureteroscope working channel. Features stainless steel braid and proximal female luer lock hub. Used to deliver fluids or gels (e.g., BackStop) to specific ureteral locations. Enables targeted therapeutic delivery; assists in urological procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

100 cm, 3F, single lumen, radiopaque catheter. Materials include stainless steel braid. Features standard female luer lock hub. Sterilized via radiation per AAMI/ANSI/ISO 11137-1:2006 and 11137-2:2006. Packaging compliant with AAMI/ANSI/ISO 11607-1:2006. Biocompatibility evaluated per AAMI/ANSI/ISO 10993-1:2009(E).

Indications for Use

Indicated for physicians to facilitate urinary tract access via retrograde or antegrade routes; used with guidewires or for injection of gels/fluids into the urinary tract.

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

• Pluromed BackStop™ Catheter (K090270)

Submission Summary (Full Text)

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Section 5. 510(k) Summary

Safety and Effectiveness Data Summary
JAN - 7 2011

| Prepared By: | Pluromed Inc. |
|----------------------|--------------------------------------|
| | 25-H Olympia Avenue |
| | Woburn, MA 01801 |
| Telephone Number: | 781-932-0574 |
| Fax Number: | 419-828-6350 |
| Contact Person: | James Wilkie |
| | [e-mail] |
| Proprietary Name: | 3F BackStop™ Catheter |
| Classification Name: | Urological Catheters and Accessories |
| Common Name: | Urological Catheter |
| Classification: | Class II |
| Regulation Number: | 876.5130 |
| Product Code: | 78 KOD |

Indications for Use The Pluromed 3F 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 gels, such as BackStop™, or fluid into the urinary tract.

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

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K103349

Recognition Number 2-98: AAMI / ANSI / ISO 10993-1:2009(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 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: Pluromed BackStop™ Catheter, K090270.

Description of Device: The Pluromed 3F BackStop™ Catheter is a 100 cm, 3F, single lumen, radiopaque catheter that facilitates access to the urinary tract. The catheter may be inserted over a guidewire or through the working channel of an ureteroscope and is advanced through the urinary tract to the desired location in the ureter. Once in place fluid or gels, such as BackStop™, 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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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

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

JAN - 7 2011

Re: K103349

Trade/Device Name: 3F BackStop Catheter Regulation Number: 21 CFR 8876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KOD Dated: November 12, 2010 Received: November 16. 2010

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see 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, 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); medical device reporting of medical device-related

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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 CFFR 1000-0050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Centers0ffices/CDRHOffices/ucm1727 Cr KT for for for for for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 the [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default:htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Hubert Humphrey

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

## Enclosure

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K103349

JAN - 7 2011

## Section 4. Indications for Use

510(k) Number (if known):

Device Name: 3F BackStop Catheter

Indications for Use:

The 3F 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 gels, such as BackStop™, or fluid into the urinary tract.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

AND/OR

8

Over the Counter Use _

(21 CFR 807 Subpart C)

(21 CFR 801 Subpart D)

Arni Bi-Wiao

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K103349