INCARE INTERMITTENT CATHETER

K013345 · Hollister, Inc. · KOD · Jan 7, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K013345
• Device Name: INCARE INTERMITTENT CATHETER
• Applicant: Hollister, Inc.
• Product Code: KOD · Gastroenterology, Urology
• Decision Date: Jan 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The InCare Intermittent Catheter is indicated for use by male, female and pediatric patients for the purpose of bladder drainage. The catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.

Device Story

InCare Intermittent Catheter is a sterile, non-latex, PVC tubular device for bladder drainage; inserted through urethra to pass fluids to/from urinary tract. Features polished, smooth eyes to minimize urethral trauma and hematuria; packaging designed for users with limited dexterity. Available in various sizes for male, female, and pediatric populations. Used in clinical or home settings for incontinence management.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and biocompatibility assessment per ISO 10993-1 and USP standards.

Technological Characteristics

PVC material; sterile; non-latex; flexible tubular form factor; polished eye design. Biocompatibility verified per ISO 10993-1 and USP 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

• Conveen Intermittent Catheters
• Mentor Self Cath
• Rusch FloCath (K000070)

Submission Summary (Full Text)

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Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048-3781

JAN 0 7 2002

InCare Intermittent Catheter

Telephone: 847,680,1000 Facsimile: 847.918.3860

. 013345
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# Hollister

## 510(k) Summary

## 1. Sponsor's name, Address and Contact Person

Sponsor Hollister Incorporated 2000 Hollister Drive Libertyville IL. 60048 Contact Person Joseph S. Tokarz Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 [phone] Ph: [phone] Fax:

Date Summary Prepared - October 5, 2001

#### 2. Name of Device:

InCare Intermittent Catheter

#### 3. Name of Predicate Device(s)

Conveen Intermittent Catheters Mentor Self Cath Rusch FloCath (K000070)

#### 4. Description of Device

The InCare Intermittent Catheters are intended to be used as a means of managing urinary incontinence by draining urine from the bladder. The InCare Intermittent Catheters are sterile, non-latex, PVC catheters. A unique manufacturing process ensures that the eyes of the intermittent catheters are polished and smooth to help eliminate trauma to the urethra, reducing the possibility of hematuria.

The catheter packaging has been designed to facilitate easy opening for those users with limited dexterity.

The InCare Intermittent catheters are available in various sizes to accommodate a wide range of male, female, and pediatric end users.

#### 5. Statement of Intended Use

The InCare Intermittent Catheter is indicated for use by male, female and pediatric patients for the purpose of bladder drainage. The catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.

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K013345
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### InCare Intermittent Catheter

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# 6. Statement of Technological Characteristics of the Device

The InCare Intermittent catheter is substantially equivalent to the predicate devices in design, materials used, and intended use. The InCare Intermittent Catheters are made of a PVC material that is substantially equivalent to the predicate devices.

Biocompatibility assessment of the InCare Intermittent Catheter has been conducted based on the principles and guidelines established by various governmental regulatory agencies and standard setting organizations. Among these are the following: United States Pharmacopoeia, General program memorandum #G95-1, United States Food and Drug Administration Office of Device Evaluation and The International Standards Organization ISO 10993-1 Biological Dovice Linatation of Medical Devices. Based upon the results of this assessment, the materials used to Evariate in of incere Intermittent Catheters are considered biocompatible and appropriate for their intended use.

#### 7. Conclusion

Based on information presented above and in the body of this premarket notification the InCare Intermittent Catheter is substantially equivalent to devices currently in distribution.

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Food and Drug Administration 9200 Corporate Boulevard Rockville . MD 20850

# JAN 0 7 2002

Mr. Joseph S. Tokarz Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048-3781 Re: K013345

Trade/Device Name: InCare Intermittent Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 KOD Dated: October 5, 2001

Received: October 9, 2001

Dear Mr. Tokarz:

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); 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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

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Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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InCare Intermittent Catheter

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b. Statement of Intended Use

510(k) Number (if Known): Device Name:

K 013345
InCare Intermittent Catheter

Indications For Use:

The InCare Intermittent Catheter is indicated for use by male, female and pediatric patients for the purpose of bladder drainage. The Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Prescription Use | <div style="display:inline-block;"> <span style="float: left;"></span> <span style="float: left;">OR</span> </div> |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| (Per 21 CFR 801.109) | |

*Nancy C broaden*

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K013345 |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-the-Counter-Use

(Optional Format 1-2-96)

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