AMSURE BLADDER IRRIGATION SET

K070873 · Amsino Intl., Inc. · LJH · Dec 19, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070873
• Device Name: AMSURE BLADDER IRRIGATION SET
• Applicant: Amsino Intl., Inc.
• Product Code: LJH · Gastroenterology, Urology
• Decision Date: Dec 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMSure® Bladder Irrigation Set is intended for the infusion of fluids to evacuate the bladder. It is also indicated for use in such procedures as cystoscopies and transurethral-resections as a means of continuous bladder irrigation.

Device Story

AMSure Bladder Irrigation Set; fluid delivery system for bladder evacuation and continuous irrigation. Components: tubing, catheter adapter, spikes with protectors, drip chamber, roller clamp, non-latex synthetic rubber connecting tube. Configurations: single-lead or multiple-lead (2 or 4 spikes). Used in clinical settings (e.g., OR, urology clinics) during cystoscopies or transurethral resections. Operates via gravity-fed infusion; flow controlled by roller clamp. Facilitates fluid delivery to bladder; assists in clearing debris/blood during urological procedures.

Clinical Evidence

Bench testing and biocompatibility testing only; no clinical data presented.

Technological Characteristics

Non-latex synthetic rubber tubing; single or multiple-lead spike configuration; drip chamber; roller clamp; catheter adapter. Gravity-fed fluid delivery. Sterilized device.

Indications for Use

Indicated for patients requiring bladder evacuation or continuous bladder irrigation during procedures such as cystoscopies and transurethral resections.

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

• Medline Y-Type TUR/Bladder Irrigation Set (K970946)

Submission Summary (Full Text)

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K070873
AMSINO

Bladder Irrigation Set 510K Submission

# 510(K) Summary of Safety and Effectiveness

| 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: | March 27, 2007 |
| | DEC 1 9 2007 |
| Classification Name: | System, Urological, Irrigation<br>Common/Usual Name: Bladder Irrigation Set, TUR Irrigation Set<br>Proprietary Name: AMSure® Bladder Irrigation System<br>Product Code: LJH<br>Medical Specialty: Gastroenterology/Urology<br>Device Class: Unclassified (510K) |
| Predicate Devices: | Medline Y-Type TUR/Bladder Irrigation Set (K970946) |
| Device Description: | The AMSure™ Bladder Irrigation Set is comprised of tubing with a<br>catheter adapter at one end and “spikes” with protectors on the other<br>end. The device is available in a single-lead (single spike), or<br>multiple-lead (2 or 4 spikes) configuration. All configurations have a<br>drip chamber and directly below the drip chamber is a roller clamp.<br>There is a flexible, non-latex, synthetic rubber connecting tube,<br>attached to the catheter adapter. |
| Intended Use: | The AMSure® Bladder Irrigation Set is intended for the infusion of<br>fluids to evacuate the bladder. It is also indicated for use in such<br>procedures as cystoscopies and transurethral-resections as a means of<br>continuous bladder irrigation. |
| Comparison to Predicate: | The AMSure® Bladder Irrigation System is equivalent to the predicate<br>device in operational principle, materials, configuration, technical<br>characteristics and intended use. Any existing differences do not<br>affect safety and effectiveness of the device. |
| Non-Clinical Testing: | Performance and biocompatibility testing have demonstrated that the<br>AMSure® Bladder Irrigation System is safe and effective for its<br>intended use. |

:

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### 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird with three parallel lines forming its body and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### DEC 1 9 2007

Yi Chen, Ph.D., RAC Vice President, Regulatory Affairs and Quality Assurance Amsino International, Inc. 855 Towne Center Drive POMONA CA 91767

Re: K070873

Trade/Device Name: AMSure® Bladder Irrigation Set Regulation Number: None Regulatory Class: Unclassified Product Code: LJH Dated: December 4, 2007 Received: December 11, 2007

#### Dear Dr. Chen:

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.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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.

Nancy Crogdon

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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K07 08 73

## AMSINO

Bladder Irrigation Set 510K Submission

| 510(k) Number:<br>(if known) | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | <i>AMSure</i> ^® Bladder Irrigation Set |
| Indications for Use: | The <i>AMSure</i> ^® Bladder Irrigation Set is intended for the infusion of fluids to evacuate the bladder. It is also indicated for use in such procedures as cystoscopies and transurethral-resections as a means of continuous bladder irrigation. |

### Indications for Use Statement

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|-----------------------|---|
| (Per 21 CFR 801. 109) | |

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

(Division Sign-Off)

Division of Reproductive, Abdominal and

Rauiological Devices

| 510(k) Number | B0P873 |
|---------------|--------|
|---------------|--------|

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