I-FLOW ELASTOMERIC PUMP

K020862 · I-Flow Corp. · MEB · Mar 26, 2002 · General Hospital

Device Facts

• Record ID: K020862
• Device Name: I-FLOW ELASTOMERIC PUMP
• Applicant: I-Flow Corp.
• Product Code: MEB · General Hospital
• Decision Date: Mar 26, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotheraly and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural. 2. The I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.

Device Story

I-Flow Elastomeric Pump provides continuous or intermittent medication delivery via elastomeric pressure source and integrated administration line. Device operates mechanically; no external power source required. Used in clinical settings for general infusion and regional anesthesia/pain management. Change from latex to polyisoprene outer bladder material; inner bladder remains unchanged to maintain drug compatibility. Outer bladder does not contact fluid path. Healthcare providers manage infusion setup; device provides consistent flow rate based on elastomeric pressure. Benefits include portable, non-electric medication delivery for various clinical applications.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological comparison and material properties.

Technological Characteristics

Elastomeric infusion pump; consists of elastomeric pressure source and integrated administration line. Outer bladder material: polyisoprene. Inner bladder material: unchanged from predicate. Non-electric, mechanical operation.

Indications for Use

Indicated for patients requiring continuous or intermittent medication infusion, including antibiotics, chemotherapy, and pain management. Routes include IV, intra-arterial, subcutaneous, intramuscular, epidural, intraoperative, perineural, or percutaneous for regional anesthesia and pain management.

Regulatory Classification

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.

Predicate Devices

• I-Flow Elastomeric Pump (K932740)
• I-Flow Elastomeric Pump (K944692)
• I-Flow Elastomeric Pump (K984502)
• I-Flow Elastomeric Pump (K991513)
• I-Flow Elastomeric Pump (K992072)
• I-Flow Elastomeric Pump (K020660)

Submission Summary (Full Text)

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**MAR 2 6 2002**

I-Flow Corporation

K020862

## SPECIAL 510(K) - SUMMARY OF SAFETY AND EFFECTIVENESS

March 15, 2002

Submitter:

| | 20202 Windrow Drive<br>Lake Forest, CA 92630 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Shane Noehre<br>Manager, Regulatory Affairs<br>I-Flow Corporation |
| Trade Name: | I-Flow Elastomeric Pump |
| Common Name: | Infusion Pump and Administration Set |
| Classification Name: | Pump, Infusion |
| Existing Device: | I-Flow Elastomeric Pump (K932740, K944692, K984502, K991513,<br>K992072, and K020660 (pending)). |
| Device Description: | The I-Flow Elastomeric Pump consists of an elastomeric pressure<br>source with an integrated administration line. This special 510(k)<br>proposes a change from latex to polyisoprene for the outer bladder.<br>The outer bladder is not in contact with the fluid path and thus does<br>not require biocompatibility. The inner bladder will remain the same<br>and thus drug compatibility will not be affected. |
| Technology<br>Comparison: | There is no change in technology. The latex and polyisoprene |

Conclusion: The I-Flow Elastomeric Pump with polyisoprene bladder is substantially equivalent to the existing I-Flow Elastomeric Pump with latex bladder.

bladder are two different types of elastomers with similar properties.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/1/Picture/12 description: The image shows a circular logo for the Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus with three intertwined snakes and a staff. The emblem is positioned to the right of the text, which is arranged in a circular pattern around the emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

MAR 2 6 2002

Mr. Shane Noehre Manager, Regulatory Affairs I-Flow Corporation 20202 Windrow Drive Lake Forest, California 92630

Re: K020862

Trade/Device Name: I-Flow Elastomeric Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: March 15, 2002 Received: March 18, 2002

Dear Mr. Noehre:

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.

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.

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You must comply 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 (OS) 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 and additionally 21 CFR Part 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 the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Quonor

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

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for I-Flow Corporation. The logo consists of the text "I-FLOW" in a bold, sans-serif font, with a small droplet icon above the "I". The text is enclosed in a rounded rectangle. Below the logo is the text "I-Flow Corporation" in a smaller font.

20202 Windrow Drive
Lake Forest, CA 92630
Tel: [phone] or 949.206.2700
Fax: [phone]
www.i-flowcorp.com

| Ver/ 3 | - 4/24/96 |
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Applicant:

I-Flow Corporation

510(k) Number (if known):

Device Name:

I-Flow Elastomeric Pump

Indications For Use:

- 1. The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotheraly and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
- 2. The I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Patacus Cuscetta

r: of Dental, Infer Theral Hospital I