The I-Flow Variable Rate Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intraarterial, subcutaneous, intramuscular and epidural.
The I-Flow Variable Rate 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 Description

The I-Flow Variable Rate Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. This special 510(k) proposes a new component that incorporates a variable flow rate mechanism.

AI/ML Overview

The provided document is a 510(k) summary for the I-Flow Variable Rate Elastomeric Pump. It establishes substantial equivalence to existing devices and approves the device for marketing. However, it does not contain any information about specific acceptance criteria, study data, or performance metrics that would be typically found in a clinical study report or a detailed validation summary.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on specific performance data against acceptance criteria.

Summary

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K020660

MAR 2 0 2002

1-Flow Variable Rate Elastom

SPECIAL 510(K) - SUMMARY OF SAFETY AND EFFECTIVENESS

March 15, 2002

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

Shane Noehre Contact: Manager, Requlatory Affairs I-Flow Corporation

Trade Name: I-Flow Variable Rate Elastomeric Pump

Common Name: Infusion Pump and Administration Set

Classification Name: Pump, Infusion

Existing Device: I-Flow Elastomeric Pump (K932740, K944692, K984502, K991513 and K992072)

Device Description: The I-Flow Variable Rate Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. This special 510(k) proposes a new component that incorporates a variable flow rate mechanism.

Technology Comparison:

The Variable Flow Rate Component is identical to the one recently cleared under K020251.

Conclusion: The I-Flow Variable Rate Elastomeric Pump is substantially equivalent to the existing I-Flow Elastomeric Pump and the variable flow rate component cleared under K020251.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2002

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

Re: K020660

Trade/Device Name: I-Flow Variable Rate Elastomeric Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump and Administration Sets Regulatory Class: II Product Code: MEB Dated: February 26, 2002 Received: March 1, 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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Page 2 - Mr. Shane

You must comply with all the Act's requirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu lisung (21 CFR Part 007), laceling (21 cms (QS) regulation (21 CFR Part 820); and if requirences as bet form in als quadision 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 I ins icter will and w yours of copies of substantial equivalence of your device to s rotky promation novice 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 If you dosire specific at 1 Part 809.10 for in vitro diagnostic devices), please contact the alle additionally 21-01-11 301) 594-4618. Additionally, for questions on the promotion and Office of Compliance vice, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under nothernon (11 CF IT I I I I I i I i i is on of Small Manufacturers, International and the Act may be occained 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,

Susan Punpr

ETimothy 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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Ko20660

Image /page/3/Picture/1 description: The image shows the logo for I-Flow Corporation. The logo consists of the text "I-FLOW" inside of a rounded rectangle. There is a registered trademark symbol to the right of the rectangle. Below the logo is the text "I-Flow Corporation".

20202 Windrow Drive
Lake Forest, CA 92630
Tel: 800.448.3569 or 949.206.2700
Fax: 949.206.2600
www.i-flowcorp.com

Verl 3 - 4/24/96

Applicant:

I-Flow Corporation

510(k) Number (if known): K020660

I-Flow Variable Rate Elastomeric Pump Device Name:

Indications For Use:

1. The I-Flow Variable Rate Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intraarterial, subcutaneous, intramuscular and epidural.
1. The I-Flow Variable Rate 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)

Patricio Lucciarini

Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________

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).