The SideKick Infusion Kit is intended to provide continuous infusion of a local anesthetic directly into an intraoperative (soft tissue / body cavity) site for general surgery for postoperative pain management. Additional routes of administration include percutaneous, subcutaneous, intramuscular and epidural infusion.

Device Description

The SideKick Infusion Kit is identical to the I-Flow Paragon Infusion Kit with the exception of the SideKick pump and administration set replacing the Paragon pump and administration set. The kit is comprised of a SideKick pump and administration set and various kit components such as catheter, needle, syringe, Y adapter, dressing, tape, gauze and carry case. The SideKick administration set is intended to attach to the kit catheter at the distal end of the set to provide continuous infusion of a local anesthetic directly into the intraoperative site for general surgery for postoperative pain management. The SideKick administration set is a disposable device intended for single patient use. The SideKick pump is reusable. The SideKick is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

AI/ML Overview

This document describes the SideKick Infusion Kit, an infusion pump kit. Here's an analysis of the acceptance criteria and supporting study information:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Operational Specification)	Reported Device Performance (Flow Rate Performance Data)
Residual Volume: < 5 ml	Not explicitly stated in "Flow Rate Performance Data," but listed as a standard operating condition.
Operating Temperature: 31°C skin temperature (90°F)	Testing occurred at standard operating conditions (which include this temperature).
Test Solution: 0.9% NaCl	Testing occurred at standard operating conditions (which include this solution).
Operating Pressure: 9 to 1 psi pressure source	Testing occurred at standard operating conditions (which include this pressure).
Head Height: 0"	Testing occurred at standard operating conditions (which include this head height).
Accuracy: ±15% at 95% confidence interval	All models produced an average flow rate within the ±15% accuracy claim.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size used for the test set. It mentions "All models produced an average flow rate within the ±15% accuracy claim," implying multiple units were tested for each model.

The data provenance is internal to I-Flow Corporation ("Testing occurred at standard operating conditions"). No information is given about the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" for infusion pump performance is based on direct physical measurements and engineering specifications, not expert consensus or interpretation.

4. Adjudication Method for the Test Set

This is not applicable. As stated above, the evaluation of infusion pump performance relies on direct measurement against predefined specifications, not on an adjudication process involving human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, often with and without AI assistance. The SideKick Infusion Kit is a physical medical device (infusion pump) and its performance is evaluated through engineering and functional testing, not through human reader interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm-only performance study was not done. This concept is applicable to AI/ML software. The SideKick Infusion Kit is a mechanical infusion pump, and its performance is inherently "standalone" in the sense that it operates according to its mechanical design without an "algorithm" in the AI/ML sense or human-in-the-loop performance influencing its fundamental flow rate accuracy. Its performance is tested as a direct measure of its function.

7. The Type of Ground Truth Used

The "ground truth" for the performance (specifically accuracy) of the SideKick Infusion Kit is based on engineering specifications and direct physical measurement of flow rates under controlled standard operating conditions using a 0.9% NaCl test solution. The accuracy is defined as ±15% at a 95% confidence interval.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. The SideKick Infusion Kit is a mechanical device, not an AI/ML algorithm that is "trained" on data. Its design and manufacturing ensure its performance characteristics.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set for a mechanical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the date 4/23/99 at the top left. Below the date is the I-FLOW logo, which is a stylized oval shape with the words "I-FLOW" inside. Underneath the logo, the words "I-FLOW CORPORATION" are printed in a simple, sans-serif font. The logo and text are centered.

20202 Windrow Drive Lake Forest. CA 92630 (800) 448-3569 (949) 206-2700 Fax (949) 206-2600

1990425

SUMMARY OF SAFETY AND EFFECTIVENE

February 9, 1999

Trade Name: SideKick Infusion Kit

Common Name: Infusion Pump Kit

Classification Name: Pump, Infusion

All questions and/or comments concerning this document should be made to:

Robert J. Bard, Esq., R.A.C. Vice President of Regulatory and Legal Affairs

I-Flow Corporation 20202 Windrow Drive Lake Forest, CA 92630

Telephone: 949.206.2700 Fax: 949.206.2600

{1}------------------------------------------------

1.0 GENERAL INFORMATION

1.1 Purpose of Submission

This submission is intended to notify the Federal Food and Drug 1.1.1 Administration that I-Flow Corporation intends to market a new kit, the SideKick Infusion Kit.
Trade Name: SideKick Infusion Kit 1.1.2
1.1.3 Common Name: Infusion Pump Kit
1.1.4 Classification Name: Pump, Infusion
Classification Panel: General Hospital and Personal Use Device 1.1.5

1.2 Statement of Equivalence

1.2.1 The SideKick Infusion Kit includes components that are legally marketed (either pre-amendment devices or devices that have been granted permission to market via premarket notification regulation).
1.2.2 The SideKick Kit is substantially equivalent to the I-Flow Paragon Infusion Kit (K984146), the I-Flow Paragon Infusion System (K923875), the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422), the I-Flow Homepump C-Series (K944692) and the McKinley Outbound Disposable Syringe Infuser (K982256).

2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTIONS

2.1 Description of the SideKick Infusion Kit

2.1.1 The SideKick Infusion Kit is identical to the I-Flow Paragon Infusion Kit with the exception of the SideKick pump and administration set replacing the Paragon pump and administration set.
2.1.2 The kit is comprised of a SideKick pump and administration set and various kit components such as catheter, needle, syringe, Y adapter, dressing, tape, gauze and carry case.
- 2.1.2.1 The Paragon Infusion Kit contains all the above components except for a Paragon pump and administration set instead of the SideKick pump and administration set.
2.1.3 The SideKick administration set is intended to attach to the kit catheter at the distal end of the set to provide continuous infusion of a local anesthetic directly into the intraoperative site for general surgery for postoperative pain management.
2.1.4 The SideKick administration set is a disposable device intended for single patient use. The SideKick pump is reusable.
2.1.5 The SideKick is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

2.2 Product Configuration

2.2.1 The SideKick Infusion Kit models are available in 100 ml fill volumes with 1 or 2 ml/hr flow rates.
2.2.2 Each model consists of a SideKick administration set with the following optional components/accessories:

{2}------------------------------------------------

SideKick pump, catheter, needle, syringe, dressing, carry case, 2.2.2.1 antiseptic skin swabs, tape, gauze and Y adapter.

2.3 Components and Materials

All fluid path components of the SideKick administration set are identical to the fluid path components of the Paragon administration set.

2.4 Power Requirements

The SideKick pump is a mechanical pump that utilizes spring energy for 2.4.1 power. No additional external power source is required.

3.0 OPERATIONAL SPECIFICATIONS AND DESCRIPTIONS

3.1 Standard Operating Conditions:

Residual Volume:	< 5 ml
Operating Temperature:	31°C skin temperature (90°F)
Test Solution:	0.9% NaCl
Operating Pressure:	9 to 1 psi pressure source
Head Height:	0"
Accuracy:	±15% at 95% confidence interval

3.2 Flow Rate Performance Data: Testing occurred at standard operating conditions. All models produced an average flow rate within the ±15% accuracy claim.

3.3 Safety / Alarm Functions

3.3.1 The SideKick pump and administration set provide a continuous fixed flow and as such is not subject to fluid runaway conditions similar to that of some electronic pumps.

4.0 BIOLOGICAL SPECIFICATIONS

4.1 Biological testing is in conformance with ISO 10993 Part 1 for all fluid path components of the SideKick administration set.

5.0 CHEMICAL AND DRUG SPECIFICATIONS

5.1 Compatibility
- 5.1.1 There are no specific drugs referenced in the labeling for the SideKick Infusion Kit.
- 5.1.2 The SideKick Infusion Kit is intended for use with general local anesthetics and epidural medications.

6.0 INTENDED USE

6.1 The SideKick Infusion Kit is intended to provide continuous infusion of a local anesthetic directly into an intraoperative (soft tissue / body cavity) site for general surgery for postoperative pain management.
6.2 Additional routes of administration include percutaneous, subcutaneous, intramuscular and epidural infusion.
6.3 The SideKick pump is re-usable. The disposable SideKick administration set is single patient use only.

{3}------------------------------------------------

6.4 No testing has been conducted to determine the efficacy of the SideKick for the delivery of blood, blood products, lipids or fat emulsions. The SideKick is not intended for the delivery of blood, blood products, lipids or fat emulsions.
The SideKick is suitable for use as an ambulatory device and is intended for use in the 6.5 hospital, home environment or alternative care sites.

7.0 PACKAGING

Packaging is suitable for either radiation or ETO sterilization. 7.1

8.0 STERILIZATION INFORMATION

8.1 The method of sterilization is ETO gas.

9.0 COMPARISON TO LEGALLY MARKETED DEVICES

9.1 The SideKick Infusion Kit has similar routes of administration and components as the following predicate devices: the Paragon Infusion Kit, the Paragon Infusion System, PainBuster Infusion Kit, Sgarlato Pain Control Infusion Pump (PCIP), Homepump C-Series and McKinley Outbound Syringe Infuser.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle's perimeter. The text is in all capital letters and is arranged to follow the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 1999

Robert J. Bard, Esq., R.A.C. Vice President Regulatory and Legal Affairs I-Flow Corporation 20202 Window Drive Lake Forest, California 92630

Re: K990425 SideKick Infusion Kit Trade Name: Regulatory Class: II Product Code: FRN Dated: February 9, 1999 February 11, 1999 Received:

Dear Mr. Bard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{5}------------------------------------------------

Page 2 - Mr. Bard

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours

L. G. Whatrust

Timot Wy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

K990425

Image /page/6/Picture/1 description: The image shows the logo for I-Flow Corporation. The logo consists of the words "I-Flow" inside of a rounded rectangle. The word "Corporation" is printed below the logo.

20202 Windrow Drive Lake Forest, CA 92630 (800) 448-3569 (949) 206-2700 Fax (949) 206-2600

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: __ SideKick Infusion Kit

Indications for Use:

The SideKick Infusion Kit is intended to provide continuous infusion of a local anesthetic directly into an intraoperative (soft tissue / body cavity) site for general surgery for postoperative pain management. Additional routes of administration include percutaneous, subcutaneous, intramuscular and epidural infusion.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K990425

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use __

(Optional Format 1-2-96)

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).