The Multi Drip™ Infusion Catheter is a single-use, short duration catheter intended for use with the Alpha Infusion Pump for the continuous infusion of medication directly into an intraoperative site for postoperative pain management. Infusions may also be administered percutaneously.

Device Description

The Multi Drip™ Infusion Catheter is designed to be used with the Alpha Infusion Pump (K021964) to deliver a continuous infusion of medication to a patient at a predetermined flow rate. It is a sterile, non-pyrogenic, single use device for use in the hospital or by an ambulatory patient. Except for the size of the exit ports and the closed distal end of the catheter, the Multi Drip Infusion Catheter is identical in construction and operation to the previously cleared Alpha Cath Infusion Catheter series (K021964). Like the Alpha Cath Infusion Catheter, the proximal end of the Multi Drip™ Infusion Catheter has a stainless steel needle attached to it for insertion of the catheter into the outflow septum of the Alpha Infusion Pump. The flow rate of the fluid delivered from the Alpha Infusion Pump through the catheter is determined by the preset delivery pressure of the pump and the internal diameter and length of the micro-bore PVC tubing forming the catheter. The Multi Drip™ Infusion Catheters are available in a range of lengths and flow rates identical to the Alpha Cath Infusion Catheters. Both catheter series are packaged in individual Tyvek pouches and sterilized by gamma irradiation.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Multi Drip™ Infusion Catheter) seeking substantial equivalence to existing devices. It does not describe a clinical study in the typical sense (e.g., comparing human readers with and without AI assistance). Instead, it focuses on demonstrating that the new device performs equivalently to previously cleared predicate devices through engineering tests and comparisons of design and materials.

Here's a breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Material & Construction Equivalence to Alpha Cath Infusion Catheter:	Identical materials and construction, differing only in port configuration.
Catheter Outer Diameter:	2 Fr. (0.6mm)
Catheter Length:	60 cm & 120 cm, ±10%
Catheter Breaking Strength:	Approximately 2.5 pounds
Catheter to Needle Bond Strength:	Catheter breaks, does not pull apart
Flow Rate Accuracy for Multi Drip™ Infusion Catheters:	±15% of the indicated flow rate
Flow Distribution through Ports (Multi Drip™):	At least 4 of the 6 holes present in all catheters demonstrated flow during testing.
Equivalence in Infusion Portion Design to Predicates (I-Flow Soaker and Stryker ExFen):	All three have a closed-off end, 6.5 cm or 12.5 cm infusion portion, and round holes spaced along this portion.
Overall Performance Equivalence to Predicate Devices:	The physical specifications and performance of the Multi Drip™ and Alpha Cath Infusion Catheters are identical (except for port configuration). The performance of the infusion portion of the Multi Drip™ was substantially equivalent to the I-Flow Soaker and Stryker ExFen catheters.

2. Sample size used for the test set and the data provenance

Sample Size: The document states that "Multi Drip™ Infusion Catheters are 100% tested for flow rate, as are the Alpha Cath Infusion Catheters, prior to release." This implies that every manufactured unit undergoes this specific test. For the flow distribution through ports, the statement "flow was achieved through at least 4 of the 6 holes present in all catheters" suggests that the testing of flow distribution was conducted on a sufficient number of catheters to make this generalization about "all catheters," although a specific sample size for this test is not explicitly given.
Data Provenance: The data appears to be from internal testing conducted by the manufacturer, Advanced Infusion, Inc. The document does not specify country of origin for the data or whether it is retrospective or prospective, but it's presumed to be prospective testing of their own manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This document describes performance testing of a medical device against engineering specifications and comparison to predicate devices, not a study involving human experts establishing ground truth for a test set in the context of diagnostic accuracy or AI performance. Therefore, this information is not applicable to this submission.

4. Adjudication method for the test set

Given the nature of the testing described (physical and flow rate performance of a catheter), there is no mention of an adjudication method as would be used in expert consensus for diagnostic accuracy. The performance criteria are objective measurements. Therefore, this information is not applicable to this submission.

5. 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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. This document describes the safety and effectiveness of a physical medical device (infusion catheter), not a diagnostic algorithm or AI system that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical infusion catheter, not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the performance of the Multi Drip™ Infusion Catheter is based on engineering specifications, objective physical measurements (like outer diameter, length, breaking strength, bond strength), and functional test results (flow rate accuracy, flow distribution through ports). The comparison to predicate devices also serves as a benchmark for "equivalent performance." It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic study.

8. The sample size for the training set

This document does not describe a machine learning or AI model, thus there is no training set in this context.

9. How the ground truth for the training set was established

As there is no training set for a machine learning model, this question is not applicable.

Summary

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AUG 31 2004

ADVANCED INFUSION, INC. PAGE 12 OF 39

510(k) Summar 19.

K042246

510(k) SUMMARY - Safety and Effectiveness

Multi Drip Infusion Catheter

1. Submitters Name:

Advanced Infusion, Inc. 6200 South McClintock #6 Tempe. AZ 85283 (480) 768-9747 (Phone) (480) 894-5288 (Fax) Contact: Dr. Reese Date Prepared: March 26, 2004

2. Name of Device:

Trade Name: Multi Drip™ Infusion Catheter Common Name: Infusion Catheter Classification Name: Pump, Infusion, Elastomeric

3. Predicate Device:

The proposed device, the Multi Drip™ Infusion Catheter, claims substantial equivalence to AI's currently marketed Alpha Cath Infusion Catheter (K021964) in function, design, materials of construction, operation, and intended use. Both catheters are for use with the AI Alpha Infusion Pump (K.021964).

In addition, the Multi Drip™ Infusion Catheter claims substantial equivalence to the I-Flow Soaker multiple port Catheter (K994374) and the Stryker (McKinley) ExFen multiple port Catheter (K033039) in regards to the function, overall design of the distal end of the catheter, and intended use.

4. Description of Device:

Except for the size of the exit ports and the closed distal end of the catheter, the Multi Drip Infusion Catheter is identical in construction and operation to the previously cleared Alpha Cath Infusion Catheter series (K021964).

Like the Alpha Cath Infusion Catheter, the proximal end of the Multi Drip™ Infusion Catheter has a stainless steel needle attached to it for insertion of the catheter into the outflow septum of the Alpha Infusion Pump. The flow rate of the fluid delivered from the

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Alpha Infusion Pump through the catheter is determined by the preset delivery pressure of the pump and the internal diameter and length of the micro-bore PVC tubing forming the catheter. The Multi Drip™ Infusion Catheters are available in a range of lengths and flow catherer. The Mail Drithe Alpha Cath Infusion Catheters. Both catheter series are packaged in individual Tyvek pouches and sterilized by gamma irradiation.

1. Statement of Intended Use
  The Multi Drip™ Infusion Catheter is a single-use, short duration catheter intended for use with the Alpha Infusion Pump for the continuous infusion of medication directly into an with the hipme myndton i amp stive pain management. Infusions may also be administered percutaneously.
1. Comparison to Predicate
  The proposed device, the Multi Drip™ Infusion Catheter, claims substantial equivalence to Advanced Infusion's currently marketed Alpha Cath Infusion Catheter (K021964) in Advanced intention be carrently and intended use. Both cather and intended use. Both catheters are for use with the Alpha Infusion Pump (K021964). Both catheters are constructed of the for use with the rip/ra 19/12/12/2019 11/2019 11/2019 11/2019 11/2 1/2 1/2 Same material, have and restrictor, have a needle attached to the proximal end for insertion that tuneter into the Alpha Infusion Pump, and have ports along the distal end of the of the catherer inly differences between the two catheters is that the end of the Alpha Cath Catheter. The only unferences of the Multi Drip™ Infusion Catheter is closed, and illiusion Catherer is openth Infusion Catheter are axial slits while the ports on the Multi Drip™ Infusion Catheter are tiny round holes.

If the distal end of the Alpha Cath Infusion Catheter should become blocked during use, the medication will continue to flow out of the axial slit ports along the side of the distal und of the catheter. In this condition, the Alpha Cath Infusion Catheter functions in exactly the same way as the Multi Drip™ Infusion Catheter. The Multi Drip™ Infusion Catheter is manufacture with the distal end of the catheter closed, so that flow will only Occur through the ports along the side of the distal end of the catheter. Therefore, the Multi occar through and ports and stantially equivalent to the Alpha Cath Infusion Catheter in function, design, materials of construction, operation, and intended use.

In addition, the Multi Drip™ Infusion Catheter is substantial equivalence to the I-Flow m ater Catheter (K994374) and the Stryker ExFen Catheter (K033039) in regards to function, design of the distal end of the catheter, and intended use. The function of the Soaker Catheter, the ExFen Catheter, and the Multi Drip™ Infusion Catheter, is to cause flow to occur through the side ports along the distal end of the catheters. This is accomplished by closing off the end of the catheters which causes flow to occur only through the side ports. The length of the distal portion of the catheter having ports is either 6.5 cm or 12.5 cm for all three style catheters.

The I-Flow Soaker Catheter has 0.13 mm diameter holes spaced approximately every 0.5 The I Tow South Lather. Buttion of the catheter. In order to obtain flow through all the holes, a ciff along the unstill portion of allaced inside the distal end of the catheter. As fluid seeps

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through the filter, it flows out the side port holes. However, during actual use, only a portion of the holes actually flow.

The Stryker ExFen Catheter has 0.13 mm diameter holes spaced approximately every 0.4 cm along the distal portion of the catheter. In order to obtain flow through all the holes, a tightly coiled stainless steel spring is placed inside the distal end of the catheter. As fluid seeps through the coils of the spring, it flows out the side port holes. However, during actual use, only a portion of the holes actually flow.

The Advanced Infusion Multi Drip™ Infusion Catheter has six 0.05 mm diameter holes spaced along the distal portion of the catheter. Spacing is either 1 cm or 2 cm depending on the length of the infusion portion of the catheter. In order to obtain flow through all the holes, the diameter and quantity of the holes is balanced to the flow rate through the catheter. During testing, flow was achieved through at least 4 of the 6 holes present in all catheters.

The Multi Drip™ Infusion Catheter is also substantially equivalent in function, overall design of the distal end, and intended use to the I-Flow Soaker Catheter and the Stryker ExFen Catheter.

Performance Data (summary) 7.
The Multi Drip™ Infusion Catheter is identical in materials and construction to the Alpha Cath Infusion Catheter except for the port configuration at the end of the catheter. The physical specifications and performance of the Multi Drip™ and Alpha Cath Infusion Catheter are identical.

Catheter Outer Diameter:	2 Fr. (0.6mm)
Catheter Length:	60 cm & 120 cm, ±10%
Catheter Breaking Strength:	approximately 2.5 pounds
Catheter to Needle Bond Strength:	catheter breaks, does not pull apart

Multi Drip™ Infusion Catheters are 100% tested for flow rate, as are the Alpha Cath Infusion Catheters, prior to release. The product flow rate accuracy is established at ±15% of the indicated flow rate.

The Multi Drip™ Infusion Catheter is equivalent in design of the infusion portion of the catheter to the I-Flow Soaker and Stryker ExFen catheters. All three catheters have a closed off end, have a 6.5 cm or 12.5 cm infusion portion along the distal end of the catheter, and have round holes spaced along the entire length of the infusion portion.

The I-Flow Soaker Catheter uses a hollow fiber to distribute fluid to all of its ports. The Stryker ExFen Catheter uses a coiled stainless steel spring to distribute fluid to all of its ports. However, during actual use, only a portion of the ports in either catheter actually flowed.

The Multi Drip™ Infusion Catheter uses a few small diameter holes to distribute fluid flow along the infusion portion of the catheter. The diameter of these ports in the Multi Drip

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Infusion Catheter was selected so that at least four out of the six ports flowed. The performance of the infusion portion of these three style catheters was substantially equivalent.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three swooping lines forming its body and wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2004

Advanced Infusion, Incorporated C/O Mr. Neil Devine, Jr. Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K042246

Trade/Device Name: Multi Drip™ Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: August 18, 2004 Received: August 19, 2004

Dear Mr. Devine:

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 Ameroducents, 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 approvisions 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 (1 Nr.), it may of bacyer to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can or roundsh further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Devine

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. of the Act of ally I ederal the Act's requirements, including, but not limited to: registration 1 ou must comply with and and many (21 CFR Part 801); good manufacturing practice and libiling (11 CF 1 forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as 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) I mis leter wification. The FDA finding of substantial equivalence of your device to a premarket notification. - The Fire 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), 11 you desire specific at 1.0 x 3.0 pliance at (301) 594-4618. 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 may other of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu-Lin, 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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Statement of Indications for Use 20.

INDICATIONS FOR USE

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)

Ann Sullivan

Page 1 of 1

(Division Sign-Division of Anesthesiolog Infection Control, De

510(k) Number: K042246

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).