VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,

K090960 · Hollister, Inc. · GBM · Aug 20, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090960
• Device Name: VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
• Applicant: Hollister, Inc.
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Aug 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The VaPro 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

VaPro intermittent catheter is a hydrophilic-coated, single-use device for urinary bladder drainage. It features a protective sleeve and introducer tip to shield the catheter from distal urethral bacteria during insertion. The device is pre-lubricated via a vapor strip within the packaging that hydrates the coating, eliminating the need for manual activation. Designed for ease of use by patients with limited dexterity. The device is inserted through the urethra to the bladder to facilitate urine flow. It is intended for use by patients requiring intermittent catheterization.

Clinical Evidence

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

Technological Characteristics

Hydrophilic PVP (polyvinylpyrrolidone) coated catheter; water vapor hydration system; protective sleeve and introducer tip; funnel end design; sterile; single-use; biocompatible materials per ISO 10993.

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

• Astra Tech AB Lofric® Primo™ Single Use Urinary Catheter (K050874)
• SpeediCath Catheter (K023254)
• Incare Advance/Advance Plus Intermittent Catheter (K013483)

Submission Summary (Full Text)

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# 510(k) Summary

| Submitted By: | Chris Stukel<br>Hollister Incorporated<br>2000 Hollister Drive<br>Libertyville, IL 60018<br>847-680-1000 | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Date Summary Prepared: | August 19, 2009 | |
| Device Name: | Classification Name- Urological catheter and accessories<br>Common/Usual Name- Catheter, Urological<br>Proprietary Name- VaPro™ Intermittent Catheter | |
| Predicate Device: | The VaPro intermittent catheter is substantially equivalent<br>to the following products: | |
| | Product | 510(k) |
| | Astra Tech AB Lofric® Primo™<br>Single Use Urinary Catheter | K050874 |
| | SpeediCath Catheter | K023254 |
| | Incare Advance/Advance Plus<br>Intermittent Catheter | K013483 |
| Device Description: | The VaPro intermittent catheter is a hydrophilic coated<br>single use catheter to be used as a means of managing<br>urinary incontinence by draining urine from the bladder.<br>The catheter comes in a protective sleeve and is offered<br>with a protective introducer tip as a way to shield the sterile<br>catheter from bacteria in the distal urethra during insertion.<br>The packaging contains a vapor strip that hydrates the<br>catheter coating which then lubricates the catheter. The<br>outer packaging was designed to facilitate access for those<br>with limited dexterity. | |
| Intended Use: | The VaPro intermittent catheter is a flexible tubular device<br>that is inserted through the urethra by male, female and<br>pediatric patients who need to drain urine from the bladder. | |
| Technological<br>Characteristics: | The table below summarizes the technological<br>characteristics of the device as compared to the predicate<br>devices. | |

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| Characteristics | VaPro<br>Standard<br>with Tip | Astra Tech AB<br>Lofric®<br>Primo™<br>(K050874) | Speedicath<br>(K023254) | Incare<br>Advance/Advance Plus<br>(K013483) |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The VaPro<br>intermittent<br>catheter is a<br>flexible<br>tubular<br>device that<br>is inserted<br>through the<br>urethra by<br>male, female<br>and pediatric<br>patients who<br>need to<br>drain urine<br>from the<br>bladder. | The LoFric<br>Primo Single<br>Use Urinary<br>Catheter is<br>intended for<br>intermittent<br>catheterization<br>of the urethra. | The SpeediCath<br>catheter is<br>indicated for use<br>by patients with<br>chronic urine<br>retention and<br>patients with a<br>post void<br>residual volume<br>(PVR) due to<br>neurogenic and<br>non-neurogenic<br>voiding<br>dysfunction.<br>The catheter is<br>inserted into the<br>urethra to reach<br>the bladder<br>allowing urine to<br>drain. | Indicated for<br>use by male,<br>female and<br>pediatric<br>patients for the<br>purpose of<br>bladder<br>drainage. The<br>Catheter is a<br>flexible tubular<br>device that is<br>inserted<br>through the<br>urethra and<br>used to pass<br>fluids to or<br>from the<br>urinary tract. |
| Condition of<br>Use | Single Use | Single Use | Single Use | Single Use |
| Prelubricated | Yes-by<br>water vapor<br>hydration | Yes- by water<br>hydration | Yes-by saline<br>solution<br>hydration | Yes-by<br>hydrogel |
| Ready to use | Yes | Requires<br>bursting of water<br>sachet prior to<br>use | Yes | Yes |
| End Design | Funnel | Funnel | Funnel | Funnel |
| Sterile | Yes | Yes | Yes | Yes |
| No touch design | Yes-<br>contains<br>sleeve | Yes - by using<br>exterior<br>packaging | No | Yes-contains<br>sleeve |
| Lubricant | PVP Based<br>(polyvinylpyr<br>ollidone)<br>Coating | PVP Based<br>(polyvinylpyrrolid<br>one)<br>Coating | PVP Based<br>(polyvinylpyrrolid<br>one)<br>Coating | Hydrogel |
| Protective Tip | Yes | No | No | Yes |

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Biocompatibility testing was performed based on Performance Testing the United States Food and Drug Administration Office of Conclusions: 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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

### AUG 2 0 2009

Mr. Chris Stukel Senior Global Regulatory Affairs Analyst Hollister, Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048-3781

Re: K090960

Trade/Device Name: VaPro" Intermittent Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: August 13, 2009 Received: August 14, 2009

Dear Mr. 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.

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

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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.

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/cdrl/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Lammy M. Mouk

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

#### 510(k) Number (if known): K090960

Device Name: VaPro™ Intermittent Catheter

Indications for Use:

The VaPro 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 ਮ (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)

Arvark Nha

(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _