MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER

K050008 · Mentor Corp. · EZD · Jun 3, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050008
• Device Name: MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
• Applicant: Mentor Corp.
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Jun 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter is intended for use in male, female and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode

Device Story

Intermittent urethral urinary catheter for bladder drainage; prelubricated with water-soluble hydrophilic lubricant; features proximal introducer tip to reduce contamination; includes telescoping sleeve with distal drainage port and suction cup for toilet stabilization. Used by patients or caregivers in home or clinical settings. Device facilitates urine voiding for individuals with urinary retention; reduces patient contact during insertion. Available as single unit or kit with accessories (gloves, towel, swabs, towelette).

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO standards: Cytotoxicity (Agar Diffusion), Guinea Pig Maximization (sensitization), Systemic Toxicity (acute injection), Acute Vaginal Irritation, and Genotoxicity (Ames Test). Results demonstrated no sensitization, no mutagenicity, and acceptable reactivity levels.

Technological Characteristics

Intermittent urethral catheter; hydrophilic water-based lubricant; telescoping sleeve; suction cup attachment. Biocompatibility testing conducted per ISO methods. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for male, female, and pediatric patients requiring bladder drainage due to inability to promote natural urine flow or presence of significant residual urine volume.

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

• Mentor Self-Cath Plus Catheter (K003874)
• Mentor Self-Cath Closed System (K003873)

Submission Summary (Full Text)

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Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

The assigned 510(k) number is: K050008

| Contact Person: | Donna A. Crawford<br>Director, Domestic Regulatory Submissions<br>Mentor Corporation<br>201 Mentor Drive<br>Santa Barbara, CA 93111 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | 805-879-6304 |
| FAX: | 805-879-6015 |
| Date Prepared: | December 30, 2004 |

Device Name and Classification

| Trade Name: | Mentor Self-Cath ^® Hydrogel™ Intermittent Urethral Urinary Catheter |
|----------------------|--------------------------------------------------------------------------------|
| Common Name: | Urinary Catheter |
| Classification Name: | Urological Catheter and Accessories |
| Product Code: | 78 EZD |

## Manufacturer

Mentor Minnesota 1601 West River Road North Minneapolis, MN 55411

## Device Description

The Mentor Self-Cath® HydroGel™ catheter (hereafter referred to as SCHG) is an extension of the existing Mentor Self-Cath product line. The device is a modification of the Mentor Self-Cath® Plus catheter and the Mentor Self-Cath Closed System catheter.

The SCHG is intended to be used to drain urine from the bladder. It is provided sterile and is for single-use only. It consists of a prelubricated catheter with an introducer tip on the proximal end which is designed to reduce patient contact and

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potential contamination while advancing the catheter into the urethra. The catheter is prelubricated with a water-soluble hydrophilic water-based lubricant. The catheter is packaged inside a thin flexible telescoping sleeve that is designed to extend from the catheter to the urine collection device or toilet during bladder voiding. The distal end of the sleeve includes a drainage port with a suction cup for attachment to the toilet, thus stabilizing the sleeve during the voiding process. The SCHG also has a reduced package size for ease of transport.

The SCHG is available singly or as a kit with the following accessories included: non-latex gloves, a paper poly towel, PVP swabs, and a BZK towelette.

#### Substantial Equivalence Claim

Mentor Corporation believes the proposed Mentor SCHG is substantially equivalent in form and function to Mentor's Self-Cath Plus Catheter and the Self-Cath Closed System, which were cleared under 510(k)s K003874 and K003873, respectively.

#### Indications for Use

The Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter is intended for use in male, female and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode

#### Summary of Testing

Mentor has performed biocompatibility testing on the SCHG:

Cytotoxicity (Agar Diffusion - ISO Method): The catheter portion of the test article did not induce cytotoxicity. The introducer tip portion did introduce cytotoxicity; however, the reactivity was less that a Grade 2 (mild reactivity). Therefore, the test article does meet the criteria of this test.

Guinea Pig Maximization (Saline and Vegetable Oil Extracts): There were no signs of sensitization observed in guinea pigs treated with the test article. Therefore, the test article is not considered to elicit contact dermal allergenicity.

Systemic Toxicity (Acute Systemic Injection with Saline and Vegetable Oil Extracts: The test article met the requirements of the systemic injection test.

Acute Vaginal Irritation: The test article meets the requirements of the vaginal irritation test.

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Genotoxicity (Ames Test): The results of this test indicated that under the experimental conditions, the extracts of this test article were not mutagenic for any tester strain, with or without any S9 activation.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 - 2005

Ms. Donna A. Crawford Director, Domestic Regulatory Submissions Mentor Corporation 201 Mentor Drive SANTA BARBARA CA 93111

Re: K050008

Trade/Device Name: Mentor Self-Cath® HydroGel™ Intermittent Urinary Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD and FCM Dated: May 19, 2005 Received: May 20, 2005

Dear Ms. Crawford:

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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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

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# Page 2 - Ms. Donna Crawford

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.

In addition, we have determined that your device kit contains 3 Povidone-Iodine (PVP) swabs and a benzalkonium chloride (BZK) towellette, which are subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 [phone]

This letter will allow you to begin marketing your device as described in your Section 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, 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). 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/cdrl/industry/support/index.html.

Sincerely vours.

Rate Phillips

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

Enclosure

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# Indications for Use

510(k) Number (if known): Kog 0008

Device Name: Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter

Indications For Use:

The Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter is intended for use in male, female and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

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

11.188

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ra-C. Phillips

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050008

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