AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER

K101824 · Amsino International, Inc. · EZL · Sep 13, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K101824
• Device Name: AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER
• Applicant: Amsino International, Inc.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Sep 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMSURE® 3-Way Hydrophilic Latex Foley Catheter is intended to be used for bladder/urinary tract drainage and bladder/urinary tract irrigation for urological use only.

Device Story

The AMSURE® 3-Way Hydrophilic Latex Foley Catheter is a retention-type urological catheter designed for bladder drainage and irrigation. It consists of a silicone-coated natural latex tube featuring three lumens: one for urinary drainage, one for balloon inflation/deflation, and one for irrigation. The shaft includes a lubricious hydrophilic coating that becomes slippery when wet to facilitate insertion. The device is available in various French sizes (14Fr to 26Fr) and balloon capacities (5cc and 30cc). It is intended for single-use, sterile, and disposable application. Clinicians insert the catheter to manage urinary tract drainage and irrigation needs. The device connects to a urine collection container and utilizes a luer-activated valve for balloon control. By providing a lubricated, retention-based pathway, it facilitates patient comfort and effective fluid management in clinical settings.

Clinical Evidence

Bench testing only. Performance evaluated per ASTM F-623-99 and FDA guidance for Foley catheters. Testing included friction, hydrophilic coating distribution and uniformity, flow rates for drainage and irrigation lumens, balloon integrity, balloon volume integrity, and deflation reliability. Biocompatibility assessed per ISO 10993 based on the established safety history of the materials used in predicate devices.

Technological Characteristics

Materials: Silicone-coated natural latex. Design: 3-lumen retention catheter with hydrophilic coating. Dimensions: 14Fr-26Fr, 5cc/30cc balloon. Sterilization: Ethylene Oxide (EtO) per ISO 11135-1:2007. Standards: ASTM F-623-99, ISO 10993.

Indications for Use

Indicated for bladder/urinary tract drainage and irrigation in adult male and female patients. Contraindicated in individuals with known sensitivity or allergy to latex.

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

• AMSURE® HYDROPHILIC LATEX FOLEY CATHETER (k091699)
• AMSURE® FOLEY CATHETER (k030120)
• BARD, Bardex LubriSil 3-Way Foley Catheter (k002868)
• WELL-LEAD 3-Way Foley Catheter (k082815)

Submission Summary (Full Text)

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#### 510k SUMMARY

K101824
SEP 13 2010

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

| Submitter and Contact Person: | AMSINO International, Inc<br>855 Towne Center Drive<br>Pomona, CA 91767<br>Jesus T. Farinas<br>Manager, Quality Assurance & Regulatory Affairs |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Number | 2085175 |
| Name of the Device: | |
| Classification Name: | Urological Catheter/Catheter. Retention Type. |

Proprietary Name:

Balloon AMSURE® 3-WAY Hydrophilic Latex Foley Catheter

| 510k Number : | |
|------------------------------|----------|
| Regulation Number: | 876.5130 |
| Class: | II |
| Classification Product Code: | 78 EZL |

#### Predicate Devices:

AMSURE® HYDROPHILIC LATEX FOLEY CATHETER (k091699) AMSURE® FOLEY CATHETER (k030120) BARD, Bardex LubriSil 3-Way Foley Catheter (k002868) WELL-LEAD 3-Way Foley Catheter (k082815)

# Intended use of the Device:

The AMSURE® 3-Way Hydrophilic Latex Foley Catheter is intended to be used for bladder/urinary tract drainage and bladder/urinary tract irrigation for urological use only.

#### Device Description:

The AMSURE® 3-WAY Hydrophilic Latex Foley Catheter is a retention type urological catheter made of silicone coated natural latex material modified with the addition of a lubricious/hydrophilic coating to facilitate insertion of the catheter. This device is a Latex tube with three lumens: one lumen for urinary drainage which is to be connected to a urine collecting container; one lumen with two-way valve for inflation/deflation of the foley balloon and one lumen for irrigation of the bladder/urinary tract. The 3-Way Hydrophilic Latex Foley Catheter is coated with a lubricious hydrophilic coating which

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becomes slippery when wet. On the opposing end of the shaft are a connecting funnel and a luer activated valve. This product is available in a combination of French sizes, balloon capacities and lengths to accommodate adult male and female applications. The device will be offered in French sizes from 14Fr to 26Fr, balloon size of 5 cc and 30cc, The device is disposable, sterile (Ethylene Oxide Sterilization) and for single use only.

# Fundamental Scientific Technology:

The catheter described in this premarket notification has similar technological features and performance as the predicate device(s). The catheters are manufactured from silicone coated natural latex material and have lubricious, hydrophilic coating that facilitates insertion of the catheter. The device under submission having the same material, manufactured in the same manner and having a lubricious coat function have the same intended use as currently marketed devices raise no new issues of safety and effectiveness and are substantially equivalent.

The AMSURE® 3-Way Latex Foley Catheter, a modification of previously cleared device The AMSURE® Hydrophilic Latex Foley Catheter ( k091699) is substantially equivalent to the predicate device in fundamental technology, performance, and material used. The AMSURE® 3-Way Hydrophilic Latex Foley Catheter is made of silicone coated natural latex material that is substantially equivalent to the predicate devices in fundamental technology, performance and intended use. A table of comparison of the features of the device to the predicate device is included on this submission.

The device under this submission has the same Indication For Use ( drainage of fluids from the urinary tract/bladder and irrigation of urinary tract/bladder) as the predicate devices Well Lead 3-Way Catheters, (k082815) and Bard's Bardex LubriSil 3-Way Foley Catheter( k00286).

### Performance Testing

The Amsure® 3-Way Hydrophilic Latex Foley Catheter was evaluated in accordance with ASTM F-623-99 and FDA's Guidance for Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters - February 27, 1997. The performance data is presented herewith to demonstrate conformance to the performance requirements.

Friction Test Hydrophilic Coating Distribution Hydrophilic Coating Uniformity Flow rate through drainage and douche/irrigation lumens Balloon Integrity Balloon volume Integrity Deflation reliability

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# Biocompatibility Testing

AMSINO International has determined that compliance to the Biocompatibility requirement based on the Blue Book Memorandum # G95-1, entitled: Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part I: Evaluation and Testing" has been met by virtue of the predicate device(s) being made of materials that have been well characterized and have a long history of safe use.

### Sterilization

The Amsure® 3-Way Hydrophilic Latex Foley Catheter is sterilized by EtO as validated per ISO 11135-1:2007 -Sterilization of Healthcare Productts - Ethylene Oxide Part I: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices. Since the Amsure® 3-Way Hydrophilic Latex Foley Catheter is made of the same material, manufactured and processed in the same manner as the predicate device(s), no additional sterilization validation is required.

## Substantial Equivalence

The Amsure® 3-Way Hydrophilic Latex Foley Catheter is substantially equivalent as the predicate devices(s) since it is made of the same material, manufactured and processed in the same manner; meets all Performance Testing per ASTM F623; complies with Biocompatibility Requirements per ISO 10993 and Sterilization per ISO 11135; as the predicate device(s). There are no new issues of safety and effectiveness

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Jesus Farinas Senior Manager, Quality Assurance and Regulatory Affairs Amsino International, Inc. 855 Towne Center Drive POMONA CA 91767

SEP 1 3 2010

Re: K101824

. Trade/Device Name: AMSURE® 3-Way Hydrophilic Latex Foley Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: July 27, 2010 Received: August 6, 2010

Dear Mr. Farinas:

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 device-related .

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adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Lemmer MD

erbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# SEP 1 3 2010

# INDICATIONS FOR USE STATEMENT

510k number if known):

k101824

DEVICE NAME:

# AMSURE® 3-WAY HYDROPHILIC LATEX FOLEY CATHETER

INDICATIONS FOR USE:

AMSURE® 3-Way Hydrophilic Latex Foley Catheter is intended to be used for bladder/urinary tract drainage and bladder/urinary tract irrigation for urological use only.

PRECAUTIONS: Do not use petroleum based ointments or lubricants.

CONTRAINDICATIONS: Those individuals with known sensitivity or allergy to latex are excluded from the use o f this device. Product use should be discontinued should signs of sensitization occur.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription | | Over-the Counter |
|--------------------------------------------------------------|---------|------------------|
| Use | ✓ | Use _______ |
| (Per 21 CFR 801.109) | OR | |
| (Division Sign-Off) | | |
| Division of Reproductive, Abdominal and Radiological Devices | | |
| 510(k) Number | K101824 | |