HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO

K991513 · I-Flow Corp. · FPA · Jun 21, 1999 · General Hospital

Device Facts

• Record ID: K991513
• Device Name: HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO
• Applicant: I-Flow Corp.
• Product Code: FPA · General Hospital
• Decision Date: Jun 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 adapter at the distal end of the administration set allows piggyback infusions. The routes of administration include intravenous, subcutaneous and intramuscular. The Homepump C-Series is single patient use only. The Homepump C-Series is suitable for use as an ambulatory device and is 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 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.

Device Story

Elastomeric infusion pump; utilizes strain energy of elastomeric membranes as pressure source for fluid delivery; integrated administration set; optional flow regulator controls pressure to fixed 6.0 psi; optional flow status column indicator; optional air-eliminating filter. Used in hospital, home, or alternative care sites; operated by clinicians or patients. Provides continuous infusion for chemotherapy, pain management, or KVO maintenance. Mechanical operation; no external power required. Output is fixed flow rate (0.5 to 10 ml/hr) based on fixed diameter tubing or glass orifice. Benefits include ambulatory drug delivery without electronic pump runaway risks.

Clinical Evidence

Bench testing only. Performance data evaluated flow rate and pressure under standard conditions (31°C, 0.9% NaCl). All models demonstrated average flow rate and pressure within ±10% accuracy claim at 95% confidence interval. Fluid path materials confirmed compliant with ISO 10993 Part 1.

Technological Characteristics

Elastomeric infusion pump; mechanical power via elastomeric membranes; no external power. Fluid path materials compliant with ISO 10993 Part 1. Flow control via glass orifice or fixed diameter tubing. Optional regulator (fixed 6.0 psi), flow indicator, and air-eliminating filter. Sterilization via gamma radiation or ETO gas. Dimensions: 50-500 ml fill volumes; 0.5-10 ml/hr flow rates.

Indications for Use

Indicated for continuous infusion of medications (chemotherapy, pain management) or maintenance of IV line patency (KVO model) in patients requiring intravenous, subcutaneous, intramuscular, or epidural administration. Suitable for ambulatory use in hospital, home, or alternative care sites. Not for blood, blood products, lipids, or fat emulsions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Homepump C-Series (K944692)
• 3M IV Flow Regulator (K896907)

Reference Devices

• PainBuster Infusion Kit (K980558 and K982946)
• On-Q Infusion Kit (K980558 and K982946)
• Nerve Block Infusion Kit (K984502)

Submission Summary (Full Text)

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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 [phone] [phone] Fax [phone]

# 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: [phone] Fax: [phone]

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# 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.

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## 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<br><= 9 ml for 270 ml volume pump<br><= 4 ml for 125 ml volume pump<br><= 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.

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- 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.

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the office of Compliance at [phone]. 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 [phone] or [phone] 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

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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 [phone] [phone] Fax [phone]

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.
- 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-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)