Onli Intermittent Catheter

K163179 · Hollister Incorporated · GBM · Jan 26, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K163179
• Device Name: Onli Intermittent Catheter
• Applicant: Hollister Incorporated
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Jan 26, 2017
• 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

Onli intermittent catheter is a single-use, hydrophilic-coated, phthalate-free PVC catheter designed for urinary incontinence management. It features two smooth eyelets, a color-coded funnel, and a movable gripper (on 16-inch models) to assist insertion. The device is pre-lubricated via an integrated water compartment that hydrates the coating upon opening. It is used by patients for self-catheterization or by caregivers to drain urine from the bladder. The device is supplied sterile and is intended for single use.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 and FDA G95-1. Sterility validated per ANSI/AAMI/ISO 11137-1:2006 & 2:2013. Packaging integrity testing confirmed a two-year shelf life. Transportation testing verified safety and efficacy under environmental hazards.

Technological Characteristics

Materials: Phthalate-free PVC catheter, PVP-based hydrophilic coating. Dimensions: 16-inch length available. Features: Movable gripper, two eyelets, color-coded funnel. Sterilization: Gamma irradiation (ANSI/AAMI/ISO 11137-1:2006 & 2:2013). Hydration: Integrated water compartment for vapor hydration.

Indications for Use

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

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 26, 2017

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

Re: K163179 Trade/Device Name: Onli Intermittent Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: Class II Product Code: GBM Dated: December 27, 2016 Received: December 29, 2016

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,

Charles Viviano -S

For 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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## 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: | November 9, 2016 | |
| Device Name: | Proprietary Name - OnliTM intermittent catheter | |
| | Common/Usual Name - Catheter, Urethral | |
| | Classification Name - Urological catheter and accessories | |
| Device Class: | Class II per 21 CFR 876.5130 | |
| Product Code: | GBM | |
| Predicate Device: | VaPro intermittent catheter, K141642 | |
| Device Description: | The Onli intermittent catheter is a single use catheter to be used as<br>a means of managing urinary incontinence by draining urine from<br>the bladder. The catheter has the following elements:<br>Σ Ready to use, single use intermittent catheter<br>Σ Hydrophilic-coated, phthalate free catheter<br>Σ Two smooth catheter eyelets<br>Σ Color coded funnel<br>Σ Not made with natural rubber latex<br>Σ Gripper on the16-in. catheter to aid with insertion<br><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>easy to open and facilitate access to the catheter. | |
| Intended Use: | The intermittent catheter is a flexible tubular device that is inserted<br>through the urethra by male, female and pediatric patients who<br>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>Onli<br>intermittent catheter | Predicate Device:<br>VaPro<br>intermittent catheter<br>(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 hydration | Yes-by water vapor hydration |
| Ready to use | Yes | Yes |
| No touch design | No | Yes-has protective sleeve |
| Protective Tip | No | Yes |
| Movable Gripper<br>(16-in. catheter only) | Yes | No |
| Catheter Material | PVC (phthalate free) | PVC (phthalate free) |
| Lubricant | PVP Based Coating<br>(polyvinylpyrollidone) | PVP Based Coating<br>(polyvinylpyrollidone) |
| End Design | Funnel | Funnel |
| Sterilization | Gamma Irradiation | Gamma Irradiation |

Performance Testing:

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.

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 Onli 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 due to the hazards associated with the transportation environment. The test produced successful results.

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