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 Description

The STA Cath® Attachable Infusion Catheter is an open end style catheter similar to the Alpha Cath™ Infusion Catheter. This catheter consists of a length of PVC 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.

The distal end of the catheter has a short length of tubing attached to it. A loop of monofilament extends beyond both ends of this attached tube, and is used by the physician to draw a 4-0 suture, placed at an attachment site in the patient, through the attached tube in order to temporarily hold the catheter in place.

AI/ML Overview

The provided document is a 510(k) summary for the STA Cath® Attachable Infusion Catheter. This document is a regulatory submission to the FDA, detailing the device's characteristics and its substantial equivalence to existing predicate devices. It does not contain acceptance criteria for performance studies, nor does it describe specific studies proving a device meets such criteria in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity).

The document's purpose is to establish "substantial equivalence" to predicate devices, which means demonstrating the new device is as safe and effective as a legally marketed device. This is typically achieved through comparisons of technological characteristics, intended use, and sometimes non-clinical performance data (e.g., biocompatibility, sterilization validation, mechanical testing), rather than clinical efficacy studies with acceptance criteria as one would find for an AI/ML medical device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The other requested information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance are also not applicable or present in this type of regulatory submission for a physical medical device.

To directly answer your request based on the provided document:

A table of acceptance criteria and the reported device performance: Not applicable. The document establishes substantial equivalence to predicate devices, not discrete acceptance criteria for performance metrics.
Sample sized used for the test set and the data provenance: Not applicable. This document does not describe a test set or clinical study with sample sizes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a test set with ground truth established by experts.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device, and no MRMC study is described.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

The "study" presented here is essentially the argument for substantial equivalence based on comparing the device's design and intended use to existing, legally marketed devices.

Key points from the document related to "proving" the device:

Technological Comparison: The document states, "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 is an "attachment feature" which allows the catheter to be temporarily attached to body tissues.
Substantial Equivalence Argument: The attachment feature is compared functionally to similar retention features on other catheters like "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."
Conclusion: "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."

Summary

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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: 909.305 0895 www.advancerlinfusion.com

OCT 1 8 2006

510(k) SUMMARY -- Safety and Effectiveness

STA Cath® Attachable Infusion Catheter
Owner:	Advanced Infusion, Inc.920 E. University Drive. Suite D202Tempe. Arizona 85281(480) 768-9747(480) 894-5288 fax
Contact:	James ChristensenVice President Operations(909) 394-4916
Date Prepared:	June 12, 2006
Trade Name:Common Name:Classification Name:	STA Cath® Attachable Infusion CatheterInfusion PumpInfusion Pump(21 CFR 880.5725. Product Code MEB)
Predicate Devices:	K021964 – Alpha Infusion Pump and CathetersK042264 - Multi Drip® Infusion CathetersK003915 - Accufuser and Accufuser PlusK040260 – Chronic Hemodialysis CatheterK030020 - HemoSplit Long-Term Hemodialysis CatheterK020577 – Applied Ureteral CatheterK990500 - Ultramer Coude Foley Catheter
Device Description:	The STA Cath® Attachable Infusion Catheter is an open end stylecatheter similar to the Alpha Cath™ Infusion Catheter. Thiscatheter consists of a length of PVC tubing which functions as aflow restrictor. The proximal end of the tubing has a stainlessneedle for insertion into the Alpha Infusion Pump. The distal endof the tubing contains axial slit ports near the distal tip which aredesigned to infuse medication in case the end of the catheterbecomes blocked.
	The distal end of the catheter has a short length of tubing attachedto it. A loop of monofilament extends beyond both ends of thisattached tube, and is used by the physician to draw a 4-0 suture,placed at an attachment site in the patient, through the attachedtube 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: 909.305.0895 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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:

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: ____________________________________________________________________________________________________________________________________________________________

Page 1 of

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
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.(b)
Classification. Class II (performance standards).