BACKSTOP CATHETER

K110491 · Pluromed, Inc. · KOD · Mar 16, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K110491
• Device Name: BACKSTOP CATHETER
• Applicant: Pluromed, Inc.
• Product Code: KOD · Gastroenterology, Urology
• Decision Date: Mar 16, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

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.

Device Story

BackStop Catheter is 100cm, 3 French, single lumen catheter with radiopaque tip; features stainless steel braid and proximal female luer lock hub. Used by physicians in clinical settings to access urinary tract; inserted over guidewire or through ureteroscope working channel. Facilitates delivery of gels or fluids to target site. Device provides mechanical access and delivery conduit; aids in urological procedures. Benefits include precise delivery of therapeutic agents or contrast media to urinary tract.

Clinical Evidence

Bench testing only. Performance tests included catheter hub-to-shaft tensile strength, pressure during gel delivery, burst/leak pressure, insertion force, column strength, shaft tensile strength, and hub testing. Samples were accelerated aged at 7, 13, and 37 months.

Technological Characteristics

100cm, 3 French, single lumen catheter; stainless steel braid; radiopaque tip; female luer lock hub. Mechanical device; no energy source or software. Sterilization method modified from predicate.

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

• BackStop Catheter (K103349)

Submission Summary (Full Text)

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# 4110491

MAR 1 6 201

## 510(k) Summary Safety and Effectiveness Data Summary

Prepared By:

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

Telephone Number: Fax Number:

Contact Person:

781.932.0574 419.828.6350

James Wilkie [e-mail]

Date Prepared:

March 7, 2011

BackStop Catheter

Urological Catheter

BackStop Catheter 510(k) Number: K103349

Urological Catheters and Accessories

Proprietary Name: Common Name: Classification Name:

Substantial Equivalence:

Classification: Requlation Number:

876.5130 KOD

Class II

Description of Device:

Product Code:

Intended Use:

Substantial Equivalence:

The BackStop Catheter is a 100cm, 3 French, single lumen catheter with a radiopaque tip that facilitates access to the urinary tract. The catheter is inserted over a guidewire or through the working channel of a ureteroscope and is advanced through the urinary tract to the desired 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.

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.

The modified device is identical to, and has the same technological characteristics as the predicate device, except for some of the materials of construction and the method of sterilization.

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Results of bench testing have established the device as safe and effective for its intended use, which is identical to that of the predicate device.

#### Non-Clinical Data:

Pluromed has conducted the following non-clinical performance tests, with samples accelerated aged at T=7 months, T=13 months and T=37 months, in support of the changes in materials and method of sterilization to the proposed BackStop Catheter.

- . Catheter hub-to-shaft tensile strength
- . Catheter pressure during gel delivery
- . Catheter Burst/Leak Pressure
- . Catheter Insertion Force
- . Catheter Column Strength
- . Shaft Tensile Strength
- . Catheter Hub Testing

Conclusions: The results of the non-clinical performance tests demonstrate the equivalence of the modified BackStop Catheter to the predicate device. The proposed BackStop Catheter is considered safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of an eagle with three lines representing its wings.

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

MAR 1 6 201

Re: K110491

> Trade/Device Name: BackStop Catheter Regulation Number: 21 CFR \$876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KOD Dated: February 16, 2011 Received: February 22, 2011

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 mav 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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## Page 2

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Lemon MD

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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# Indications for Use

510(k) Number (if known):

K110491

Device Name: 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.

Prescription Use V

AND/OR

Over the Counter Use __

(21 CFR 807 Subpart C)

(21 CFR 801 Subpart D)

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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Halet Leum

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110491

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