INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT

K013483 · Hollister, Inc. · KOD · Jan 14, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K013483
• Device Name: INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT
• Applicant: Hollister, Inc.
• Product Code: KOD · Gastroenterology, Urology
• Decision Date: Jan 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The InCare Pre lubricated Intermittent Catheters are 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 Pre-lubricated Intermittent Catheters are sterile, non-latex, PVC devices designed for bladder drainage. Features include integral gel reservoir for pre-lubrication, no-touch insertion design, and polished eyes to minimize urethral trauma. Available in various sizes with straight or coude tips. Advance Plus models include an introducer tip to reduce UTI risk and an integrated collection bag. Used by patients or caregivers in clinical or home settings. Facilitates fluid passage to/from the urinary tract; reduces contamination risk via no-touch handling; improves user convenience for those with limited dexterity.

Clinical Evidence

Bench testing only. Biocompatibility assessment conducted per ISO 10993-1, USP, and FDA guidelines.

Technological Characteristics

Materials: PVC. Design: Flexible tubular catheter with integral gel reservoir, no-touch handling features, and polished eyes. Tip options: straight or coude. Sterilization: Sterile. Connectivity: None. Software: None.

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

• Self-Cath Plus by Mentor (K003784)
• InstantCath by MTG (K973120)
• MMG/O'Neil by Rusch (K010420)
• Self Cath CS by Mentor (K003873)

Submission Summary (Full Text)

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Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048-3781 Telephone: [phone] Facsimile: 847.918.3860

KOI 3483
Page 1 of 2

# JAN 1 4 2002

lollister

Pre lubricated Intermittent Catheter

# 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 17, 2001

#### 2. Name of Device:

InCare Pre lubricated Intermittent Catheters

# 3. Name of Predicate Device(s)

| Self-Cath Plus by Mentor | K003784 |
|--------------------------|---------|
| InstantCath by MTG | K973120 |
| MMG/O'Neil by Rusch | K010420 |
| Self Cath CS by Mentor | K003873 |

#### 4. Description of Device

The InCare Advance and Advance Plus Intermittent Catheters are pre-lubricated with gel to promote easy insertion and user convenience. The catheter gel is contained in an integral reservoir, which eliminates gel migration throughout the package. The InCare Advance and Advance Plus catheters are sterile, non-latex, polyvinyl chloride 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. Both catheters incorporate a no-touch design, which enables the user to easily insert the catheter without direct hand contact, thus reducing the possibility of contamination.

The InCare Advance Plus Intermittent Catheter has an introducer tip that is intended to reduce reoccurring UTI and a collection bag to contain urine. The InCare Advance Plus is also available in a kit known as InCare Advance Plus Kit.

The InCare Advance and Advance Plus pre-lubricated intermittent catheters are available in various sizes and with a straight or coude tip to accommodate a wide range of male, female, and pediatric end users.

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# Pre lubricated Intermittent Catheter

KO13483

Image /page/1/Picture/1 description: The image shows the Hollister logo. The logo consists of a stylized cross-like symbol on the left and the word "Hollister" in a serif font on the right. The logo is in black and white.

# 5. Statement of Intended Use

The InCare Pre lubricated Intermittent Catheters are 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.

### 6. Statement of Technological Characteristics of the Device

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

Biocompatibility assessment of the InCare Pre lubricated Intermittent Catheters 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 Evaluation of Medical Devices. Based upon the results of this assessment, the materials used to fabricate the InCare Pre lubricated 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 Pre lubricated Intermittent catheters are substantially equivalent to devices currently in distribution.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville . MD 20850

JAN 1 4 2002

Mr. Joseph S. Tokarz Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048-3781 Re: K013483 Trade/Device Name: Hollister InCare Prelubricated Intermittent Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Codes: 78 KOD and FCM Dated: October 17, 2001 Received: October 18, 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] |

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 Cbrogdon

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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Pre lubricated Intermittent Catheter

013483

b. Statement of Intended Use

| 510(k) Number (if Known): | K013483 |
|---------------------------|---------------------------------------------|
| Device Name: | InCare Pre-lubricated Intermittent Catheter |

Indications For Use:

The InCare Pre-lubricated Intermittent Catheter is indicated for use by male, female and pediative 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR

Over-the-Counter-Use

(Optional Format 1-2-96)

Jevin A. Simpson

510(k) Numb