AMSELF CLOSED CATHETERIZATION SYSTEM

K082831 · Amsino International, Inc. · FCM · Oct 23, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K082831
• Device Name: AMSELF CLOSED CATHETERIZATION SYSTEM
• Applicant: Amsino International, Inc.
• Product Code: FCM · Gastroenterology, Urology
• Decision Date: Oct 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMSelf™ Closed Catheterization System is intended for use in the drainage of urine from the bladder.

Device Story

AMSelf™ Closed Catheterization System is a single-use, closed-system device for urinary drainage. It consists of a PVC urological catheter and a drainage bag. The device is used to facilitate urine removal from the bladder. It is a configuration and assembly modification of the predicate AMSure™ Urethral Catheterization Tray. The system is intended for clinical use.

Clinical Evidence

No clinical data. Performance and biocompatibility testing were conducted to demonstrate safety and effectiveness.

Technological Characteristics

Single-use closed-system catheterization kit. Components include a PVC urological catheter and a drainage bag. Device is sterile.

Indications for Use

Indicated for patients requiring drainage of urine from the bladder.

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™ Urethral Catheterization Tray (K030712)

Submission Summary (Full Text)

{0}------------------------------------------------

Page / KO82831

OCT 2 3 2008

# 510(K) Summary of Safety and Effectiveness AMSelf™ Closed Catheterization System

| Company: | Amsino International, Inc.<br>855 Towne Center Drive<br>Pomona, CA 91767<br>[phone] |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ching Ching Seah, Ph.D.<br>Director of Regulatory Affairs |
| Date Prepared: | September 24, 2008 |
| Classification Name: | Tray, Catheterization, Sterile Urethral, with or without Catheter (876.5130) |
| Common Name: | Catheterization Kit |
| Proprietary Name: | <i>AMSelf</i> ™ Closed Catheterization System |
| Product Code: | FCM |
| Medical Specialty: | Gastroenterology/Urology |
| Device Class: | Class II |
| Unmodified Device: | <i>AMSure</i> ™ Urethral Catheterization Tray (K030712) |
| Device Description: | The <i>AMSelf</i> ™ Closed Catheterization System is a single-use patient device,<br>compromising a PVC urological catheter and a drainage bag assembled in a<br>closed-system configuration. |
| Intended Use: | The <i>AMSelf</i> ™ Closed Catheterization System is intended for use in the<br>drainage of urine from the bladder. |
| Comparison to Predicate: | The <i>AMSelf</i> ™ Closed Catheterization System is a configuration and<br>assembly modification of the <i>AMSure</i> ™ Urethral Catheterization Tray<br>(K030712) and is intended for the same use. |
| Non-Clinical Testing: | Performance and biocompatibility testing has demonstrated that the<br><i>AMSelf</i> ™ Closed Catheterization System is safe and effective for its<br>intended use. |

{1}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 2 3 2008

Ching Ching Seah, Ph.D. Director of Research, Development and Regulatory Affairs Amsino International, Incorporated 855 Towne Center Drive POMONA CA 91767

Re: K082831

Trade/Device Name: AMSelfTM Closed Catheterization System Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: FCM Dated: September 24, 2008 Received: October 8, 2008

Dear Dr. Seah:

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 such 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.

{2}------------------------------------------------

#### Page 2

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.

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 (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:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

loque M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Page 4 of 6

| Indications for Use Statement | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: (if known) | K082831 |
| Device Name: | <i>AMSelf</i> ^TM Closed Catheterization System |
| Indications for Use: | The <i>AMSelf</i> ^TM Closed Catheterization System is intended for use in the drainage of urine from the bladder. |

Prescription > Use (Per 21 CFR 801. 109)

. ... OR

Over-The-Counter Use___________________________________________________________________________________________________________________________________________________________________________

:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K082831 |