VAPRO PLUS INTERMITTENT CATHETER

K110862 · Hollister Incorporated · GBM · Apr 26, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K110862
• Device Name: VAPRO PLUS INTERMITTENT CATHETER
• Applicant: Hollister Incorporated
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Apr 26, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The VaPro Plus intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.

Device Story

Hydrophilic-coated, single-use intermittent catheter; manages urinary incontinence by draining bladder. Features protective sleeve and introducer tip to shield catheter from distal urethral bacteria during insertion. Vapor strip in packaging hydrates coating for lubrication. Integrated with collection bag for drainage when external receptacle is unavailable. Designed for users with limited dexterity. Used in clinical or home settings; operated by patient or caregiver. Output is urine drainage; facilitates bladder management and reduces infection risk.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 and FDA G95-1. Product evaluation confirmed device functionality.

Technological Characteristics

Flexible tubular catheter; PVP-based hydrophilic coating; water vapor hydration; protective sleeve; introducer tip; integrated collection bag. Single-use; sterile. Materials comply with ISO 10993 biocompatibility standards.

Indications for Use

Indicated for male, female, and pediatric patients requiring bladder drainage via urethral catheterization.

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

• VaPro™ Intermittent Catheter (K090960)
• Incare Advance/Advance Plus Intermittent Catheter (K013483)

Submission Summary (Full Text)

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K110862

## 510(k) Summary

## APR 2 6 2011

| Submitted By: | Chris Stukel<br>Hollister Incorporated<br>2000 Hollister Drive<br>Libertyville, IL 60018<br>847-680-1000 | | | | | | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Date Summary Prepared: | March 24, 2011 | | | | | | |
| Device Name: | Classification Name- Urological catheter and accessories | | | | | | |
| | Common/Usual Name- Catheter, Urethral | | | | | | |
| | Proprietary Name- VaPro™ Plus Intermittent Catheter | | | | | | |
| Predicate Device: | The VaPro Plus intermittent catheter is substantially equivalent to<br>the following products: | | | | | | |
| | Product 510(k) VaPro™ Intermittent Catheter K090960 Incare Advance/Advance Plus<br>Intermittent Catheter K013483 | | | | | | |
| Device Description: | The VaPro Plus intermittent catheter is a hydrophilic coated<br>single use catheter to be used as a means of managing urinary<br>incontinence by draining urine from the bladder. The catheter<br>comes in a protective sleeve and is offered with a protective<br>introducer tip as a way to shield the sterile catheter from bacteria<br>in the distal urethra during insertion. The packaging contains a<br>vapor strip that hydrates the catheter coating which then<br>lubricates the catheter. The outer packaging was designed to<br>facilitate access for those with limited dexterity. The catheter is<br>connected to a collection bag for use when drainage into a<br>suitable receptacle is not feasible or practical. | | | | | | |
| Intended Use: | The VaPro Plus intermittent catheter is a flexible tubular device<br>that is inserted through the urethra by male, female and pediatric<br>patients who need to drain urine from the bladder. | | | | | | |

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K110862

Technological Characteristics: The table below summarizes the technological characteristics of the device as compared to the predicate devices.

| Characteristics | VaPro Plus | VaPro Intermittent | Incare Advance/ |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intermittent Catheter | Catheter | Advance Plus |
| | | (K090960) | (K013483) |
| Intended Use | The VaPro Plus<br>intermittent catheter is a<br>flexible tubular device that<br>is inserted through the<br>urethra by male, female<br>and pediatric patients who<br>need to drain urine from<br>the bladder. | The VaPro intermittent<br>catheter is a flexible<br>tubular device that is<br>inserted through the<br>urethra by male, female<br>and pediatric patients<br>who need to drain urine<br>from the bladder. | Indicated for use by male,<br>female and pediatric<br>patients for the purpose of<br>bladder drainage. The<br>Catheter is a flexible<br>tubular device that is<br>inserted through the urethra<br>and used to pass fluids to or<br>from the urinary tract. |
| Condition of<br>Use | Single Use | Single Use | Single Use |
| Prelubricated | Yes-by water vapor<br>hydration | Yes-by water vapor<br>hydration | Yes-by hydrogel |
| Ready to use | Yes | Yes | Yes |
| End Design | Catheter funnel attached to<br>collection bag | Funnel | Advance - Funnel<br>Advance Plus - Catheter<br>funnel inserted into<br>collection bag |
| Sterile | Yes | Yes | Yes |
| No touch<br>design | Yes-contains sleeve | Yes-contains sleeve | Yes-contains sleeve |
| Lubricant | PVP Based<br>(polyvinylpyrollidone)<br>Coating | PVP Based<br>(polyvinylpyrollidone)<br>Coating | Hydrogel |
| Protective Tip | Yes | Yes | Yes |
| Collection Bag | Yes | No | No- Advance<br>Yes- Advance Plus |

Performance Testing Conclusions:

Biocompatibility testing was performed based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1 and ISO 10993 biocompatibility testing standards. Results indicate compliance to the standard.

Product evaluation also supports device functionality.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Christine Stukel Sr. Global Regulatory Affairs Analyst Hollister, Inc. 2000 Hollister Drive LIBERTYVILLE IL 60048-3781

APR 2 6 2011

Re: K110862

Trade/Device Name: VaPro™ Plus Intermittent Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: March 24, 2011 Received: March 29, 2011

Dear Ms. Stukel:

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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## 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 Remmer 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

K110862

510(k) Number (if known): _ K |10 86 Z

Device Name: VaPro™ Plus Intermittent Catheter

Indications for Use:

The VaPro Plus intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.

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)

ductive. Gastro-Renal, and 510(k) Numb

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VaPro™ Plus Special 510(k) Submission