POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6

K061356 · Advanced Infusion, Inc. · MED · Jul 3, 2006 · General Hospital

Device Facts

• Record ID: K061356
• Device Name: POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6
• Applicant: Advanced Infusion, Inc.
• Product Code: MED · General Hospital
• Decision Date: Jul 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6885
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Polyurethane Infusion Catheters are intended for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain. The Polyurethane Infusion Catheter are intended for use in the hospital or by an ambulatory patient.

Device Story

Polyurethane infusion catheter designed for use with Alpha Infusion Pump; delivers local anesthetic to surgical sites or body cavities for post-operative pain relief. Two configurations: Alpha Cath (open-end with axial slit ports for blockage bypass) and Multi Drip (closed-end with series of tiny ports for medication distribution). Tubing acts as flow restrictor; proximal end features stainless steel needle for pump connection. Used in hospital or ambulatory settings by patients or clinicians. Provides continuous pain management through controlled medication delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Medical grade polyurethane catheter tubing; stainless steel needle connector; flow-restricting tubing design; axial slit or multi-port distal tip configurations. Non-electronic, passive infusion device.

Indications for Use

Indicated for post-operative pain relief via infusion of local anesthetic into surgical sites or body cavities. Intended for use in hospital or ambulatory settings with the Alpha Infusion Pump.

Regulatory Classification

Identification

A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.

Special Controls

*Classification.* Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.

Predicate Devices

• Alpha Infusion Pump and Catheters (K021964)
• Multi Drip Infusion Catheter (K042246)
• Accufuser and Accufuser Plus (K003915)
• ARROWg+ard Blue Plus Antimicrobial Multi Lumen Catheter (K993691)

Submission Summary (Full Text)

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K061356

Image /page/0/Picture/1 description: The image shows the logo for Advanced Infusion. The logo features a stylized letter "A" with a circular shape partially surrounding it. Below the "A" is the word "Advanced" in a larger, bolder font, and below that is the word "Infusion" in a smaller font. The logo is in black and white.

920 East University Drive · Suite D202 · Tempe, Arizona 85281 480.768.9747 · fax: [phone] www.advancedinfusion.com

JUL - 3 2006

## 510(k) SUMMARY - Safety and Effectiveness

## Polyurethane Infusion Catheter

| Owner: |
|--------|
|--------|

Advanced Infusion, Inc. 920 E. University Drive, Suite D202 Tempe, Arizona 85281 [phone] [phone] fax

Contact:

James Christensen Vice President Operations [phone]

May 5, 2006

Date Prepared:

Trade Name: Common Name: Classification Name:

Predicate Devices:

Device Description:

Polyurethane Infusion Catheter Infusion Catheter Catheter, Conduction, Anesthetic (21 CFR 868.5120, Product Code BSO)

K021964 - Alpha Infusion Pump and Catheters K042246 - Multi Drip Infusion Catheter K003915 - Accufuser and Accufuser Plus K993691 - ARROWg+ard Blue Plus Antimicrobial Multi Lumen Catheter

The Polyurethane Infusion Catheter consists of two design options:

Alpha Cath™ open end style catheter: this style catheter consists of a length of tubing which functions as a flow restrictor. The proximal end of the tubing has a stainless needle for insertion into the Alpha Infusion Pump. The distal end of the tubing contains axial slit ports near the distal tip which are designed to infuse medication in case the end of the catheter becomes blocked.

Multi Drip® closed end style catheter: this style catheter consists of a length of tubing which functions as a flow restrictor. The proximal end of the tubing has a stainless needle for insertion

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Image /page/1/Picture/1 description: The image shows the logo for Advanced Infusion. The logo features a large letter 'A' with a ring orbiting around it. Below the 'A' are the words 'Advanced' and 'Infusion' stacked on top of each other.

920 East University Drive · Suite D202 · Tempe, Arizona 85281 480.768.9747 · fax: [phone] www.advancedinfusion.com

## 510(k) SUMMARY - Safety and Effectiveness

into the Alpha Infusion Pump. The distal end of the tubing has a series of tiny ports along the distal portion of the catheter which are designed to spread medication along an infusion zone.

Intended Use:

The Polyurethane Infusion Catheters are intended for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain. The Polyurethane Infusion Catheter are intended for use in the hospital or by an ambulatory patient.

Technological Comparison:

The Polyurethane Infusion Catheters are the same as the current Alpha Cath™ and Multi Drip™ Infusion Catheters except that the catheter material has been changed from PVC to medical grade polyurethane.

Conclusion:

The Polyurethane Infusion Catheters are substantially equivalent to the existing Alpha Cath™ and Multi Drip™ Infusion Catheter product lines.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 2006

Mr. James Christensen Vice President Operations Advanced Infusion, Incorporated 920 East University Drive, Suite D202 Tempe, Arizona 85281

Re: K061356

Trade/Device Name: Polyurethane Infusion Catheters Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: May 5. 2006 Received: May 15, 2006

Dear Mr. Christensen:

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 H (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning vour device in the Federal Register.

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Page 2 – Mr. Christensen

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 (OS) 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 [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CHR 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/cdrh/industry/support/index.html.

Sincerely vours.

Sulette Y. Michie Crist

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE 4.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

The Polyurethane Infusion Catheters are intended for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, postoperatively, for the relief of pain. The Polyurethane Infusion Catheters are intended for use in the hospital or by an ambulatory patient.

and the same of the same of the same of the same of the same of

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

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cuturng V. Nutton

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