VaPro Pocket

K143594 · Hollister Incorporated · GBM · Jan 9, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K143594
• Device Name: VaPro Pocket
• Applicant: Hollister Incorporated
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Jan 9, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The intermittent catheter is a single use 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 Pocket is a single-use, flexible, intermittent urinary catheter; designed for bladder drainage in patients with urinary incontinence. Device features: hydrophilic-coated, phthalate-free PVC tube; two smooth eyelets; protective sleeve; protective introducer tip to shield against distal urethral bacteria; color-coded funnel. Packaging includes a sealed water compartment; water migrates to catheter compartment to activate hydrophilic coating. Device is ready-to-use; no collection bag utilized. Designed for discreet storage and easy access. Operated by patient or caregiver; used in home or clinical settings. Provides non-invasive bladder management; reduces risk of contamination during insertion via protective tip and sleeve.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included package integrity, transportation, and sterility validation (Gamma Irradiation per ANSI/AAMI/ISO 11137-1:2006 & -2:2013). Biocompatibility previously established in K141642; new packaging biocompatibility testing performed with satisfactory results.

Technological Characteristics

Materials: Phthalate-free PVC catheter, PVP-based hydrophilic coating. Design: Funnel end, protective sleeve, protective introducer tip. Dimensions: 20cm (8 inch) and 40cm (16 inch) lengths; 10-16 Fr sizes. Sterilization: Gamma Irradiation (ANSI/AAMI/ISO 11137). Connectivity: None. Energy source: None.

Indications for Use

Indicated for male, female, and pediatric patients requiring intermittent urinary bladder drainage.

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 (K141642)

Submission Summary (Full Text)

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

January 9, 2015

Hollister Incorporated Jeanne Lee Sr. Manager, Regulatory Affairs 2000 Hollister Drive Libertyville, IL 60048

Re: K143594

> Trade/Device Name: VaPro™ Pocket Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: December 17, 2014 Received: December 18, 2014

Dear Jeanne Lee,

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.

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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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

:

510(k) Number (if known)

## K143594

Device Name VaPro™ Pocket 12.18

Indications for Use (Describe)

VaPro™ Pocket 40cm 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.

VaPro™ Pocket 20cm intermittent catheter is a flexible tubular device that is inserted through the urethra by female patients who need to drain urine from the bladder.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary

| Submitted By: | Jeanne Lee<br>Hollister Incorporated<br>2000 Hollister Drive<br>Libertyville, IL 60018<br>(t) 847-996-6350<br>(f) 847-918-3981 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Summary Prepared: | January 6, 2015 |
| Device Name: | Classification Name- Urological catheter and accessories<br>Common/Usual Name- Catheter, Urethral<br>Proprietary Name- VaPro™ Pocket intermittent catheter |
| Device Class/Product Code: | Urological catheter and accessories are Class II devices per<br>876.5130 (Therapeutic Devices). Product code-GBM. |
| Predicate Device: | VaPro intermittent catheter, K141642 |
| Device Description: | The VaPro Pocket intermittent catheter is a single use catheter to<br>be used as a means of managing urinary incontinence by draining<br>urine from the bladder. The catheter has the following elements:<br>∑ hydrophilic-coated PVC catheter (phthalate free)<br>∑ 2 smooth catheter eyelets<br>∑ protective sleeve<br>∑ protective introducer tip as a way to shield the sterile<br>catheter from bacteria in the distal urethra during insertion<br>∑ color coded funnel<br>The packaging contains a sealed water compartment chamber of<br>which the water migrates to the catheter compartment and<br>lubricates the catheter. The outer packaging was designed to be<br>discreet, easy to store, easy to open and facilitate access to the<br>catheter.<br>This product does not utilize a collection bag. |
| Intended Use: | The intermittent catheter is a single use flexible tubular device that<br>is inserted through the urethra by male, female, and pediatric<br>patients who need to drain urine from the bladder. |

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

| | Modified Device:<br>VaPro Pocket 20cm<br>intermittent catheter | Modified Device:<br>VaPro Pocket 40cm<br>intermittent catheter | Predicate Device:<br>VaPro intermittent<br>catheter (K141642) |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The intermittent<br>catheter is a single use<br>flexible tubular device<br>that is inserted through<br>the urethra by female<br>patients who need to<br>drain urine from the<br>bladder. | The intermittent catheter is a single use flexible<br>tubular device that is inserted through the urethra<br>by male, female, and pediatric patients who need<br>to drain urine from the bladder. | The intermittent catheter is a single use flexible<br>tubular device that is inserted through the urethra<br>by male, female, and pediatric patients who need<br>to drain urine from the bladder. |
| Condition of Use | Single Use | Single Use | Single Use |
| Prelubricated | Yes-by water vapor<br>hydration | Yes-by water vapor<br>hydration | Yes-by water vapor<br>hydration |
| Ready to use | Yes | Yes | Yes |
| End Design | Funnel | Funnel | Funnel |
| Sterile | Yes | Yes | Yes |
| No touch design | Yes-has protective<br>sleeve | Yes-has protective<br>sleeve | Yes-has protective<br>sleeve |
| Catheter Material | PVC ( phthalate free) | PVC ( phthalate free) | PVC (phthalate free) |
| Lubricant | PVP Based<br>(polyvinylpyrollidone)<br>Coating | PVP Based<br>(polyvinylpyrollidone)<br>Coating | PVP Based<br>(polyvinylpyrollidone)<br>Coating |
| Protective Tip | Yes | Yes | Yes |
| Collection Bag | No | No | No |

The following table outlines the sizes/styles of the VaPro intermittent catheter product line:

| Device | Device Type | Size<br>(Fr) | Length<br>(in) | Type<br>Straight/Nelaton or<br>Curved/Coude |
|--------|-------------|--------------|----------------|---------------------------------------------|
| VaPro™ | Predicate | 6 | 8 | Straight |
| VaPro | Predicate | 8 | 8 | Straight |
| VaPro | Predicate | 10 | 8 | Straight |
| VaPro | Predicate | 12 | 8 | Straight |
| VaPro | Predicate | 14 | 8 | Straight |
| VaPro | Predicate | 6 | 16 | Straight |
| VaPro | Predicate | 8 | 16 | Straight |
| VaPro | Predicate | 10 | 16 | Straight |
| VaPro | Predicate | 12 | 16 | Straight |
| VaPro | Predicate | 14 | 16 | Straight |
| VaPro | Predicate | 16 | 16 | Straight |

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| Device | Device Type | Size<br>(Fr) | Length<br>(in) | Type<br>Straight/Nelaton or<br>Curved/Coude |
|--------------|----------------|--------------|----------------|---------------------------------------------|
| VaPro | Predicate | 18 | 16 | Straight |
| VaPro | Predicate | 12 | 16 | Curved |
| VaPro | Predicate | 14 | 16 | Curved |
| VaPro | Predicate | 16 | 16 | Curved |
| VaPro Plus | Predicate | 12 | 8 | Straight |
| VaPro Plus | Predicate | 14 | 8 | Straight |
| VaPro Plus | Predicate | 12 | 16 | Straight |
| VaPro Plus | Predicate | 14 | 16 | Straight |
| VaPro Pocket | Modified, 20cm | 10 | 8 | Straight |
| VaPro Pocket | Modified, 20cm | 12 | 8 | Straight |
| VaPro Pocket | Modified, 20cm | 14 | 8 | Straight |
| VaPro Pocket | Modified, 40cm | 10 | 16 | Straight |
| VaPro Pocket | Modified, 40cm | 12 | 16 | Straight |
| VaPro Pocket | Modified, 40cm | 14 | 16 | Straight |
| VaPro Pocket | Modified, 40cm | 16 | 16 | Straight |

Performance Testing:

There have been no changes to the device, only to the packaging. Therefore, no new biocompatibility testing was performed. For biocompatibility testing on the device in accordance with ISO 10993, please refer to 510(k) K141642.

Biocompatibility testing was performed on the new packaging. This report is available upon request. All results were satisfactory.

Sterility testing was performed using Gamma Irradiation in accordance with Method 1 validation per ANSI/AAMI/ISO 11137-1:2006 & -2:2013. All results were satisfactory.

Package integrity testing was performed to verify the maintenance of the sterile barrier through shelf life. The testing concluded that VaPro Pocket packaging is capable of maintaining a sterile barrier for at least two years.

Transportation testing was performed in order to verify that there is no impact to the safety or efficacy of the catheter performance. The test produced successful results.

Conclusion: Based on the performance testing conducted it is concluded that the modified device, VaPro Pocket, is as safe and effective and performs equivalent to the predicate device.