VAPRO PLUS POCKET Intermittent Catheter

K152268 · Hollister Incorporated · GBM · Sep 9, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K152268
• Device Name: VAPRO PLUS POCKET Intermittent Catheter
• Applicant: Hollister Incorporated
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Sep 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 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 Plus Pocket intermittent catheter is a single-use, sterile, flexible PVC (phthalate-free) device for urinary incontinence management. It features a hydrophilic PVP-based coating, two smooth eyelets, a protective sleeve, and an introducer tip to minimize bacterial contamination during insertion. The device includes an integrated collection bag for use when external receptacles are unavailable. It is pre-lubricated via an internal water compartment that hydrates the coating upon activation. The device is designed for discreet storage and ease of use. It is intended for use by patients or caregivers to drain urine from the bladder, facilitating bladder management and reducing the risk of urinary retention.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included packaging integrity (sterile barrier maintenance for at least two years) and transportation testing to verify safety and efficacy. Sterility was validated via Gamma Irradiation per ANSI/AAMI/ISO 11137-1:2006 & 2:2013.

Technological Characteristics

Materials: Phthalate-free PVC catheter, PVP-based hydrophilic coating. Design: Funnel end, protective sleeve, protective introducer tip, integrated collection bag. Sterilization: Gamma Irradiation (ANSI/AAMI/ISO 11137-1:2006 & 2:2013). Connectivity: None. Energy source: None (manual operation).

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 Plus 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

September 9, 2015

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

Re: K152268

> Trade/Device Name: VaPro Plus Pocket Intermittent Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: August 7, 2015 Received: August 11, 2015

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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Benjamin R. Fisher -S

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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### Indications for Use

510(k) Number (if known)

K152268

Device Name VaPro Plus Pocket

Indications for Use (Describe)

VaPro Plus Pocket 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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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: | Aug 7, 2015 |
| Device Name: | Classification Name- Urological catheter and accessories |
| | Common/Usual Name- Catheter, Urethral |
| | Proprietary Name- VaPro Plus Pocket ^TM intermittent catheter |
| Device Class/Product Code: | Urological catheter and accessories are Class II devices per 21 CFR 876.5130. Product code GBM. |
| Predicate Device: | VaPro Plus intermittent catheter, K141642 |
| Device Description: | The VaPro Plus Pocket intermittent catheter is a single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter has the following elements:<br>∑ hydrophilic-coated PVC catheter (phthalate free)<br>∑ Two smooth catheter eyelets<br>∑ protective sleeve<br>∑ protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion<br>∑ color coded funnel<br>The packaging contains a sealed water compartment chamber of which the water migrates to the catheter compartment and lubricates the catheter. The outer packaging was designed to be discreet, easy to store, easy to open and facilitate access to the catheter. The catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical. |
| Intended Use: | The 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. |

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

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

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 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 I validation per ANSI/AAMI/ISO 11137-1:2006 & 2:2013. All results were satisfactory.

Packaging integrity testing was performed to verify the maintenance of the sterile barrier through shelf life. The testing concluded that VaPro Plus 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 Plus Pocket, is as safe and effective and performs equivalent to the predicate device.