The Homepump C-Series is intended for continuous infusion of medications for general infusion use, including chemotherapy and pain management. Routes of administration include intravenous, subcutaneous, intramuscular and epidural.
The KVO model of the Homepump C-Series is intended for general purpose drug and/or diluent delivery at a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The Y-site at the distal end of the administration set allows piggy back infusions. The routes of administration include intravenous, subcutaneous and intramuscular.

Device Description

The Homepump C-Series is an elastomeric infusion pump with an integrated administration set. The elastomeric membranes function as the fluid reservoir and the pressure source. The pressure that pumps the fluid comes from the strain energy of the elastomeric membranes which are forced to expand when the pump is filled. The incorporation of fixed diameter flow control tubing or glass orifice combined with the elastomeric pressure source produces the desired flow rate. Homepump C-Series models are available in fill volumes from 50 to 500 ml and flow rates from 0.5 to 10 ml/hr. The One•Step KVO models of the Homepump C-Series have an optional Y-site and optional check valve attached to the distal end of the administration set. The following accessories are available: carry case, E-clip and power ring.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the I-Flow Homepump C-Series device based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Priming/Residual Volume:
<= 10 ml for 500 ml volume pump	Not explicitly stated but assumed met by "Testing occurred at standard operating conditions"
<= 9 ml for 270 ml volume pump	Not explicitly stated but assumed met by "Testing occurred at standard operating conditions"
<= 4 ml for 125 ml volume pump	Not explicitly stated but assumed met by "Testing occurred at standard operating conditions"
<= 3 ml for 65 ml volume pump	Not explicitly stated but assumed met by "Testing occurred at standard operating conditions"
Operating Temperature:
31°C skin temperature (88°F)	Testing occurred at standard operating conditions (which includes this temperature)
Test Solution:
0.9% NaCl	Testing occurred with 0.9% NaCl
Pressure Source:
6.0 psi	Testing occurred with a 6.0 psi pressure source
Head Height:
0"	Testing occurred at 0" head height
Flow Rate Accuracy:
±10% at 95% confidence interval	"All models produced an average flow rate and pressure within the ±10% accuracy claim."

Study Details

Based on the provided document, the submission is a 510(k) for an elastomeric infusion pump. The information focuses on demonstrating substantial equivalence to a predicate device, and the "study" described is primarily focused on performance testing of the device's physical specifications.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices or test runs. The document states "All models produced an average flow rate and pressure within the ±10% accuracy claim," implying that multiple units of each model (various fill volumes and flow rates) were tested.
- Data Provenance: The data appears to be from internal testing conducted by I-Flow Corporation. There is no mention of external validation, clinical trials, or specific countries of origin for the data beyond being generated by the manufacturer. The testing described is retrospective in the sense that it was conducted as part of the device development and regulatory submission process.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this submission. The "ground truth" for this device's performance is objective measurement against specified engineering and performance criteria (e.g., flow rate accuracy, pressure, temperature). It does not involve human interpretation or expert consensus in the way a diagnostic imaging study would.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in studies where human interpretation (e.g., of medical images) is involved and discrepancies need to be resolved. This document describes objective performance testing.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices involving human readers. The Homepump C-Series is a medical device for infusion, not an AI or diagnostic imaging tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance test was done. The described testing ("All models produced an average flow rate and pressure within the ±10% accuracy claim") is a standalone performance evaluation of the device itself, without a human operator's influence on the core performance metrics being evaluated. It measures the device's ability to maintain a flow rate and pressure according to its design specifications. There is no "algorithm" in the sense of a software-based AI algorithm for this device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device's performance is based on pre-defined engineering specifications and direct physical measurement. For instance, flow rate is measured against a target rate, and accuracy is determined by how close the measured rate is to the target.
The sample size for the training set:
- This question is not applicable. The Homepump C-Series is a mechanical/elastomeric infusion pump, not a learning algorithm or AI model that requires a "training set" of data.
How the ground truth for the training set was established:
- This question is not applicable for the same reasons as above.

Summary

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

K99/513

Image /page/0/Picture/1 description: The image shows the text "JUN 21 1999" at the top. Below that is the I-FLOW logo, which is a stylized version of the word "I-FLOW" inside of a rounded rectangle. The text "I-FLOW CORPORATION" is printed below the logo.

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

SUMMARY OF SAFETY AND EFFECTIVENESS

April 29, 1999

Trade Name: Homepump C-Series and Homepump C-Series One•Step KVO

Common Name: Elastomeric Infusion Pump

Classification Name: Pump, Infusion, Elastomeric

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}------------------------------------------------

GENERAL INFORMATION 1.0

Purpose of Submission 1.1

This submission is intended to notify the Federal Food and Drug Administration 1.1.1 that I-Flow Corporation is adding two new optional components to the Homepump C-Series (K944692).
- Regulator (optional) 1.1.1.1
  - The optional requlator controls the decreasing 1.1.1.1.1 pressure (14 to 9 psi) of the Homepump C-Series to a fixed 6.0 psi.
- Flow Indicator (optional) 1.1.1.2
  - An optional flow indicator component 1.1.1.2.1 incorporates a flow status column indicator with the glass orifice flow restrictor.

Note: The PainBuster Infusion Kit (K980558 and K982946), the On-Q Infusion Kit (K980558 and K982946) and the Nerve Block Infusion Kit (K984502) use the Homepump C-Series infusion pumps in their kits. Neither the regulator nor the flow indicator components change the intended use of the Homepump C-Series when used in the PainBuster, On-Q or Nerve Block Infusion Kits.

1.2 Statement of Equivalence

The Homepump C-Series is substantially equivalent to the existing I-Flow 1.2.1 Homepump C-Series (K944692) and the 3M IV Flow Regulator (K896907).

2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTONS

2.1 Description of Device

The Homepump C-Series is an elastomeric infusion pump with an integrated 2.1.1 administration set.
2.1.2 The elastomeric membranes function as the fluid reservoir and the pressure source.
2.1.3 The pressure that pumps the fluid comes from the strain energy of the elastomeric membranes which are forced to expand when the pump is filled.
2.1.4 The incorporation of fixed diameter flow control tubing or glass orifice combined with the elastomeric pressure source produces the desired flow rate.

2.2 Product Configuration

2.2.1 Homepump C-Series models are available in fill volumes from 50 to 500 ml and flow rates from 0.5 to 10 ml/hr. The One•Step KVO models of the Homepump C-Series have an optional Y-site and optional check valve attached to the distal end of the administration set.
2.2.2 The following accessories are available: carry case, E-clip and power ring.

2.3 Components and Materials

All fluid path materials are in compliance with ISO 10993 Part 1.

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

2.4 Power Requirements

The Homepump C-Series is a mechanical device that utilizes elastomeric 2.4.1 membranes for power. No additional external power is required.

OPERATIONAL SPECIFICATIONS AND DESCRIPTIONS 3.0

3.1 Standard Operating Conditions:

Priming/Residual Volume:	<= 10 ml for 500 ml volume pump<= 9 ml for 270 ml volume pump<= 4 ml for 125 ml volume pump<= 3 ml for 65 ml volume pump
Operating Temperature:	31°C skin temperature (88°F)
Test Solution:	0.9% NaCl
Pressure Source:	6.0 psi
Head Height:	0"
Flow Rate Accuracy:	±10% at 95% confidence interval

Flow Rate and Pressure Performance Data: Testing occurred at standard 3.2 operating conditions. All models produced an average flow rate and pressure within the ±10% accuracy claim.

3.3 Safety/Alarm Functions

The Homepump C-Series provides a fixed flow and as such is not subject 3.3.1 to fluid runaway conditions similar to that of some electronic pumps.
3.3.2 This device contains no alarms for flow; however, each set may include an optional flow indicator component that indicates the flow status of the device.
3.3.3 This device contains no alarms or indicators to detect air in line or an occlusion; however, each set may include an optional, integrated aireliminating filter.

4.0 BIOLOGICAL SPECIFICATIONS

4.1 Biological testing is in conformance with ISO 10993 Part 1 for all fluid path components.

CHEMICAL AND DRUG SPECIFICATIONS 5.0

5.1 Compatibility
- 5.1.1 There are no specific drugs referenced in the labeling for the Homepump C-Series.

6.0 INTENDED USE

6.1 The Homepump C-Series is intended for continuous infusion of medications for general infusion use, including chemotherapy and pain management. Routes of administration include intravenous, subcutaneous, intramuscular and epidural.
6.2 The KVO model of the Homepump C-Series is intended for general purpose drug and/or diluent delivery at a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The Y adapter at the distal end of the administration set allows piggyback infusions. The routes of administration include intravenous, subcutaneous and intramuscular.

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

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

STANDARDS 7.0

There are currently no performance standards established for elastomeric infusion 7.1 pumps.

8.0 PACKAGING

Packaging is suitable for radiation or ETO sterilization. 8.1

9.0 STERILIZATION

The methods of sterilization are gamma radiation (cobalt 60) or ETO gas. 9.1

10.0 COMPARISON TO LEGALLY MARKETED DEVICES

The Homepump C-Series has the same intended use and routes of administration 10.1 as the originally submitted Homepump C-Series. The optional regulator of the Homepump C-Series is similar to the 3M IV Flow Regulator.

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 1999

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

Re : K991513 Homepump C-Series and Homepump C-Series One-Trade Name: Step KVO Regulatory Class: II FPA Product Code: April 29, 1999 Dated: Received: April 30, 1999

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, qood 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 requlations 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) requlation (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.

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

Page 2 - Mr. Bard

Please note: this response to your premarket notification ricable note? - one affect any obligation you might have under Bubmisblom acob our of the Act for devices under the Scections 331 chiregraadiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as Info iceci will and storemarket notification. The FDA described in your sie.it promalence of your device to a legally marketed predicate device results in a classification for your marice 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 ens regulation 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 obcarned from eno number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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

Image /page/6/Picture/0 description: The image shows the logo for I-FLOW Corporation. The logo consists of the text "I-FLOW" in a stylized font, with the "I" having a dot above it. The word "CORPORATION" is printed below the logo in a simple, sans-serif font. The logo is black and white.

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

K99/5/3

510(k) Number (if known):

Device Name: Homepump C-Series

Indications for Use:

1. The Homepump C-Series is intended for continuous infusion of medications for general infusion use, including chemotherapy and pain management. Routes of administration include intravenous, subcutaneous, intramuscular and epidural.
1. The KVO model of the Homepump C-Series is intended for general purpose drug and/or diluent delivery at a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The Y-site at the distal end of the administration set allows piggy back infusions. The routes of administration include intravenous, subcutaneous and intramuscular.

Patricia Cucenile

(Division Sign-Or Division of Dental, In and General Hosp 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.