HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT

K033477 · Rochester Medical Corp. · MJC · Jun 10, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K033477
• Device Name: HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
• Applicant: Rochester Medical Corp.
• Product Code: MJC · Gastroenterology, Urology
• Decision Date: Jun 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hydrophilic-Antibacterial Intermittent Catheter: Urethral catheter for urological use only. The Rochester Medical Corporation Hydrophilic-Antibacterial Intermittent Catheter is intended for urinary bladder drainage in the management of incontinence, in adult males and females requiring catheterization for bladder dysfunction, and surgical procedures. Efficacy of the Hydrophilic-Antibacterial Intermittent Catheter in preventing urinary tract infection during intermittent use has not been shown. It is not intended as a treatment for active urinary tract infection. Intermittent Catheter Closed System Kit: For urological use only. The Intermittent Catheter Closed System Kit is intended for use by patients for the purpose of bladder drainage.

Device Story

Device consists of single-lumen urethral catheter with hydrophilic and antibacterial coating; available as standalone catheter or within closed system kit (catheter-in-a-bag configuration with introducer tip and insertion supplies). Used for intermittent bladder drainage in clinical or home settings. Operated by patients or healthcare providers. Catheter inserted into urethra to facilitate urine drainage. Antibacterial coating intended to provide local effect. Benefits include management of incontinence and bladder dysfunction. Output is physical drainage of bladder. No electronic or software components.

Clinical Evidence

Bench testing only. Biocompatibility studies performed: ISO Elution Method (cytotoxicity), ISO Intracutaneous Study (irritation), USP/ISO Systemic Toxicity, ISO Sensitization (maximization method), Urinary Bladder Irritation with histopathology, and ISO Muscle Implantation (4-week). Results showed no significant systemic toxicity, sensitization, or bladder irritation. Cytotoxic effect observed in elution testing was deemed acceptable for local, intermittent mucosal application.

Technological Characteristics

Single-lumen urethral catheter; hydrophilic and antibacterial coating; 12 to 18 French sizes; male and female lengths. Constructed from elastomers identical to predicate devices. Supplied sterile for single use. No energy source, connectivity, or software.

Indications for Use

Indicated for adult males and females requiring urinary bladder drainage due to incontinence or bladder dysfunction, and for use during surgical procedures. Not indicated for treatment of active urinary tract infections.

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

• Rochester Medical Antibacterial Personal® Catheter (K001143)
• Rochester Medical Antibacterial Personal® Catheter (K000722)
• Rochester Medical Hydrophilic Personal® Catheter (K000723)
• Mentor Self-Cath Closed System (K003873)
• Hollister InCare Advance Plus Kit (K013483)
• Rusch MMG/O'Neil Catheter (K010420)

Submission Summary (Full Text)

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JUN 1 0 2004

Image /page/0/Picture/1 description: The image shows the logo for Rochester Medical. The logo features a stylized checkmark above the word "Rochester" in a bold, italicized font. Below "Rochester" is the word "MEDICAL" in smaller, block letters. The logo is black and white.

# 14.0 510(k) SUMMARY

This summary of safety and effectiveness information is being submitted in accordance with the f
or and effective and as a CDP 907 02 I ills summary of carses of SMDA 1990 and 21 CFR 807.92.

| Submitter and Contact Person: | Robert Anglin<br>Rochester Medical Corporation |
|-------------------------------|------------------------------------------------|
| Name of the Device: | Urological Catheter and Accessories |
| Classification Name: | Hydrophilic-Antibacterial Intermittent Cathete |
| Proprietary Name: | Intermittent Catheter Closed System Kit |

### Predicate Devices:

Predicate Devices.
Rochester Medical Antibacterial Personal®Catheter K001143
143 Rochester Medical Antibacterial Personal® Catheter K000722 Rochester Medical Hydrophilic Personal® Catheter K000723 Mentor Self-Cath Closed System K003873 Hollister InCare Advance Plus Kit K013483 Rusch MMG/O'Neil Catheter K010420

## Intended Use of the Device

# Hydrophilic-Antibacterial Intermittent Catheter

Hydrophilic-Antibacterial Intermittent Catheter is internittent Catheter is intended for actual For urological use only. The Hydrophility of increations and increating overlung dysfunction males and temales requiring cannelerization for maining militarerial Intermittent Catheter in and surgical procedures. Efficacy of the Trydropinne Printent use has not been shown. It is not intended as a treatment for active urinary tract infection.

Intermittent Catheter Closed System Kit

Intermittent Closed System Kit is intended for use by patients for use by patients for the purpose of bladder drainage.

#### Device Description

The Hydrophilic-Antibacterial Intermittent Catheter consists of a hydrophilic and antibacterial I he Hydrophilic-Antibacterial internities canfour drainage eyes on the proximal tip. It is
coated single lumen catheter with either two or four drainers of 8 coated single fumen cathers.

The Intermittent Catheter Closed System Kit consists of a single lumen urethral catheter I he intermittent Catherer Closed Dystem ren contral® Catheter K000723, Hydrophilic
(Hydrophilic-Antibacterial Intermittent catheter, Personal)® Catheter K001142) in a closed (Hydrophilic-Antibacterial internation catherer (1 Catheter K001 143) in a closed system Personal® Catheter K000723, of Antibacterial Fersonal - Gatherer-in-a-bag configuration with an introducer tip and insertion supplies.

Rochester Medical Corporation Rochester Medical Corporation
Hydrophilic-Antibacterial Intermittent Catheter and Intermittent Catheter Closed System Kit 510 (k) Notification

Page 11 of 12

Rochester Medical Drive

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Image /page/1/Picture/0 description: The image shows the logo for Rochester Medical. The logo is black and white and features the word "Rochester" in a bold, sans-serif font. Below the word "Rochester" is the word "MEDICAL" in a smaller, sans-serif font. Above the word "Rochester" is a curved line.

The catheters described in the 510(k) have similar technological and performance characteristics to
ries of the many of the collection (Artibostorial Personal) Catheter K0011 The cathers described in the STORT have simmal teesonal" Catheter K001143 and the Rochester Medical orand devices are need in the catheres are manufactured using similar.
Hydrophilic Personal® Catheter K000723). All of the catatomers and have a hydrop Hydrophilic Personal " Catheter K00072-3). An other elastomers and have a hydrophilie and processes. The cathere's are constructed from smeene same materials as the predicate antibacterial coating. The device are thanhactures as the Antibaterial Personal® Catheter, 12 to
devices. The catheters are supplied in the same sizes as the Antibation of Ca devices. The catheters are supplied in the same in the Prosed System Kit is substantially
18 French male and female lengths. The International Closed System Kit 18 French male and female lengths. The Intentified Costem, Hollister InCare Advance Plus Kit,
equivalent to the predicate Mentor Self-Cli-Characa are appliae sterile for sing equivalent to the predicate Mentor Sell-Cather, Second, Section, Section of Single use.
and the Rusch MMG/O'Neil Catheter. All of the devices are supplied sterile for single

# Testing and Results

The following is a summary of biocompatibility testing that Rochester Medical Corporation has The following is a summary of blocompatibility testing that seems on the Intermittent Catheter Closed System Kit:

| Test | Conclusion |
|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity Study using the ISO Elution<br>Method | *Test extracts showed a cytotoxic effect. The<br>antibacterial agent is a known mutagen and is<br>known to be cytotoxic. |
| ISO Intracutaneous Study (Saline and Sesame<br>Oil Extracts) | No evidence of significant irritation. |
| USP and ISO Systemic Toxicity Study (Saline<br>and Sesame Oil Extracts) | No mortality or evidence of systemic toxicity. |
| ISO Sensitization Test in Fifteen Guinea Pigs –<br>Maximization Method (Saline and Sesame Oil<br>Extract) | No evidence of delayed dermal contact<br>sensitization. |
| Urinary Bladder Irritation Study with<br>Histopathology | Considered to be a non irritant to the urinary<br>bladder. |
| ISO Muscle Implantation Study -4 Week with<br>Histopathology | The macroscopic reaction was not significant<br>as compared to the negative control material.<br>Microscopically classified as a slight irritant as<br>compared to the negative control article. |

* We conclude that this result is acceptable in the intended clinical application because the drug
e *We conclude that this result is acceptable in the meet o intract upply an in small doses (total of
substance is topically applied and acts local complements be grown of the substance is topically applied and acts locally, is exposed to mast and and and and through the mucous membrane of the urethra.

Rochester Medical Corporation Rochester Medical Corporation
Hydrophilic-Antibacterial Intermittent Catheter and Intermittent Catheter Closed System Kit 510 (k) Notification

Page 12 of 12

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JUN 1 0 2004

Mr. Richard Fryar VP, Research & Development Rochester® Medical One Rochester Medical Drive STEWARTVILLE MN 55976

Re: K033477

Rosser /
Trade/Device Name: Hydrophilic-Antibacterial Intermittent Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 MJC Dated: May 20, 2004 Received: May 24, 2004

Dear Mr. Fryar:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) the acted predicate devices marketed in interstate for use stated in the encrosule, to regally manated problem to the Medical Device Ameralments, or to commerce prior to May 28, 1976, and enacting with the provisions of the Federal Food, Drug, devices that have been recassince in accordance what a premarket approval application (PMA).).). and Cosment Act (Act) that to not require sppro the general controls provisions of the Act. The You may, therefore, market me devices, saojeen to the more of registration, listing of general controls provisions of the free here and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classifica (sec above) into etime major regulations affecting your device can be it may be subject to adultional controls. Entraling may of the 21, Parts 800 to 898. In addition, FDA may found in the Code of reactar regularing your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuates of a subscribes with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has made a decemmanon and Journer Federal agencies. You must of any Federal Statues and regulations amminents, but not limited to: registration and listing comply with an the Act STequilements, metading on manufacturing practice requirements as set (21 CFR Part 807), fabening (21 CFR Part 820); and 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 81 CFR 1980 1960 forth in the quality systems (QS) regulation (ST-542 of the Act); 21 CFR 1000-1050.
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 Section 510(k) This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA inding of substantial oquivalence and th premarket notification. The FDA inding of substantial of the more of this, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (2) CFR Part 801), please
r in the regulation of the following suggest of a following suggless, based If you desire specific advice for your device on our labouring organized on the regulation number at the top of the 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 Additionally, for questions on the promotion and and the regulation entitled, "Misbranding
Office of Compliance at [phone]. Also, please note obtain. Other general Office of Compliance at [phone]. Associated on any obtain. Other general
by reference to premarket notification" (21CFR Part 807.97) you may obtain of Sma by reference to premarket notification (21C) 1 Friend 60 mg good from the Division of Small
information on your responsibilities under the Act its toll from the United (800) information on your responsibilities much as its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-free number (800). Manufacturers, International and Collsumer Assistance a to too.
[phone] or at its Internet address http://www.fda.gov/odch/dsmaldsmamain.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

Enclosure

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K033477 510(k) NUMBER (if Known):

Hydrophilic-Antibacterial Intermittent Catheter DEVICE NAME:

INDICATIONS FOR USE:

Urethral catheter for urological use only. The Rochester Medical Corporation Urentral calleter for urbrogream aso only. This as intended for urinary bladder drainage Hydropmit-Antibacterial internation on their in the management of incontinence, in adult males and remails requiring cather.com.com of the Hydrophilic-Antibacterial volume dystunction, and surgear prooocal to: 1 infection during intermittent use has not Intermittent Catherer in prevening armaly traot micented as a treatment for active urinary tract infection.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) ( . . . . . . Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________ Prescription Use _ X OR

(Per 21 CFR 801.109)

David br. hegeman
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number

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K033477 510(k) NUMBER (if Known):

Intermittent Catheter Closed System Kit DEVICE NAME:

INDICATIONS FOR USE:

For urological use only. The Intermittent Catheter Closed System Kit is intended for use by patients for the purpose of bladder drainage.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

Daniel R. Lagemann

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