STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20

K061661 · Advanced Infusion, Inc. · MEB · Oct 18, 2006 · General Hospital

Device Facts

• Record ID: K061661
• Device Name: STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20
• Applicant: Advanced Infusion, Inc.
• Product Code: MEB · General Hospital
• Decision Date: Oct 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The STA Cath® Attachable Infusion Catheter is 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 STA Cath® Attachable Infusion Catheter is intended for use in the hospital or by an ambulatory patient.

Device Story

STA Cath® Attachable Infusion Catheter is an open-end PVC tubing device used with Alpha Infusion Pump for local anesthetic delivery. Proximal end features stainless steel needle for pump connection; distal end includes axial slit ports to maintain flow if tip is blocked. Device incorporates a monofilament loop attachment feature allowing physicians to secure catheter to patient tissue using 4-0 suture. Used in hospital or ambulatory settings; operated by clinicians or patients. Provides continuous post-operative pain management by delivering medication directly to surgical sites or body cavities.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, intended use, and technological comparison to predicate devices.

Technological Characteristics

PVC tubing; stainless steel needle connector; axial slit ports for flow; monofilament loop for suture-based tissue attachment. Functions as a flow restrictor. No new technology compared to predicate Alpha Cath™.

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 by patients requiring infusion therapy.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• Alpha Infusion Pump and Catheters (K021964)
• Multi Drip® Infusion Catheters (K042264)
• Accufuser and Accufuser Plus (K003915)
• Chronic Hemodialysis Catheter (K040260)
• HemoSplit Long-Term Hemodialysis Catheter (K030020)
• Applied Ureteral Catheter (K020577)
• Ultramer Coude Foley Catheter (K990500)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a logo for "Advanced Infusion". The logo features a large, stylized letter "A" with a circular swoosh design around it. Below the "A", the word "ADVANCED" is written in a larger font, and below that, the word "INFUSION" is written in a smaller font.

466 W. Arrow Hwy. • Unit H. • San Dimas. Gruffornia 91778 909.394.2916 • fax: [phone] www.advancerlinfusion.com

# OCT 1 8 2006

## 510(k) SUMMARY -- Safety and Effectiveness

| STA Cath® Attachable Infusion Catheter | |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner: | Advanced Infusion, Inc.<br>920 E. University Drive. Suite D202<br>Tempe. Arizona 85281<br>[phone]<br>[phone] fax |
| Contact: | James Christensen<br>Vice President Operations<br>[phone] |
| Date Prepared: | June 12, 2006 |
| Trade Name:<br>Common Name:<br>Classification Name: | STA Cath® Attachable Infusion Catheter<br>Infusion Pump<br>Infusion Pump<br>(21 CFR 880.5725. Product Code MEB) |
| Predicate Devices: | K021964 – Alpha Infusion Pump and Catheters<br>K042264 - Multi Drip® Infusion Catheters<br>K003915 - Accufuser and Accufuser Plus<br>K040260 – Chronic Hemodialysis Catheter<br>K030020 - HemoSplit Long-Term Hemodialysis Catheter<br>K020577 – Applied Ureteral Catheter<br>K990500 - Ultramer Coude Foley Catheter |
| Device Description: | The STA Cath® Attachable Infusion Catheter is an open end style<br>catheter similar to the Alpha Cath™ Infusion Catheter. This<br>catheter consists of a length of PVC tubing which functions as a<br>flow restrictor. The proximal end of the tubing has a stainless<br>needle for insertion into the Alpha Infusion Pump. The distal end<br>of the tubing contains axial slit ports near the distal tip which are<br>designed to infuse medication in case the end of the catheter<br>becomes blocked. |
| | The distal end of the catheter has a short length of tubing attached<br>to it. A loop of monofilament extends beyond both ends of this<br>attached tube, and is used by the physician to draw a 4-0 suture,<br>placed at an attachment site in the patient, through the attached<br>tube in order to temporarily hold the catheter in place. |

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Image /page/1/Picture/0 description: The image shows a logo for "Advanced Infusion". The logo features a large letter "A" with a circular shape wrapping around it. Below the "A" are the words "ADVANCED" in a larger font and "INFUSION" in a smaller font.

466 W. Arrow Hwy. • Unit H • San Dimas, California 91773 909.394.4916 · fax: [phone] www.advancedinfusion.com

### 510(k) SUMMARY - Safety and Effectiveness

Technological

Comparison:

Intended Use:

Conclusion:

The STA Cath® Attachable Infusion Catheter is 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 STA Cath® Attachable Infusion Catheter is intended for use in the hospital or by an ambulatory patient.

There is no new technology added in the construction of the STA Cath® Attachable Infusion Catheter compared to the Alpha Cath Infusion Catheter. The difference between the STA Cath® Attachable Infusion Catheter and the Alpha Cath™ Infusion Catheter is that the STA Cath® Attachable Infusion Catheter incorporates a feature which enables the catheter to be temporarily attached to body tissues.

The attachment feature on the STA Cath® Attachable Infusion Catheter function similarly to the attachment features on other catheters such as the suture holes on the connectors of hemodialysis catheters, the implantable cuffs on hemodialysis and central venous catheters, the balloons on Foley catheters, and the pigtails on urethral catheters. All of these retention features hold the catheter temporarily in place during use of the catheter.

The STA Cath® Attachable Infusion Catheter is substantially equivalent to the existing Alpha Cath™ Infusion Catheter in design and operation and is substantially equivalent to other catheters such as Foley catheters which use a temporary means to hold the catheter in place during use.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James Christensen Vice President Operations Advanced Infusion, Infusion 466 West Arrow Highway, Unit H San Dimas, California 91773

OCT 1 8 2006

Re: K061661

Trade/Device Name: STA Cath® Attachable Infusion Catheter Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: September 22, 2006 Received: September 25, 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 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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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. or me rot or any 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,

Shiu-Ling, Ph.D.

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 STA Cath® Attachable Infusion Catheter is 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 STA Cath Attachable Infusion Catheter is intended for use in the hospital or by an ambulatory patient.

Prescription Use X (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) ULLE . Clon Sign-Ciff) 1 . sion of Anesthesiology, General Hospital, In setion Control, Dental Devices

C ... (k) Number: ____________________________________________________________________________________________________________________________________________________________

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