1. The Paragon Infusion System is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain medications for general, subcutaneous, intramuscular and epidural.
1. The Paragon Infusion System is also intended for continuous and/or intermittent infusion of medication (such as local anesthetics or narcotics) to surgical wound sites for postoperative pain relief via percutaneous or indwelling catheter.

Device Description

The Paragon Infusion System consists of a reusable mechanical infusion pump and various types of single use administration sets. This special 510(k) proposes a new line of administration sets that incorporates a variable flow rate mechanism.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Paragon Infusion System) and does not contain the detailed study information required to populate the acceptance criteria table and answer the specific questions.

The provided text is a summary of safety and effectiveness, focused on demonstrating substantial equivalence to existing devices for regulatory approval, not a scientific study report with performance metrics.

Therefore, I cannot provide the requested information from the given input. To answer these questions, a document detailing the actual performance testing, clinical study results, and ground truth establishment would be needed.

Summary

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1)20251

FEB 1 5 2002

SPECIAL 510(K) - SUMMARY OF SAFETY AND EFFECTIVENESS

January 23, 2002

Submitter:

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

Contact:

Shane Noehre Manager of Regulatory Affairs I-Flow Corporation

Paragon Infusion System

Trade Name:

Infusion Pump and Administration Set Common Name:

Pump, Infusion Classification Name:

Existing Device:

Device Description:

Paragon Infusion System (K923875, K984146, K984063, K984638)

Technology Comparison:

The Paragon Infusion System with Variable Flow Rate utilizes the same technology for regulating flow rate (i.e. flow control tubing) and similar devices with variable flow rate components exist in the market (Novacon DIB-Infusor-RA - K960318 and Baxter Flow Regulator -K890489).

Conclusion: The Paragon Infusion System is substantially equivalent to the existing Paragon Infusion System and other variable flow rate devices currently being legally marketed.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo. The logo is circular in shape and contains an image of a bird with three wing-like lines. The bird is facing to the right. The text "HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2002

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

Re: K020251

Trade/Device Name: Paragon Infusion System Regulation Number: 880.5440 and 880.5725 Regulation Name: Infusion Pump and Administration Set Regulatory Class: II Product Code: FPA and FRN Dated: January 23, 2002 Received: January 24, 2002

Dear Mr. Noehre:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed your 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 (1 w 1), it is a 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. Noehre

You must comply with all the Act's requirements, including, but not limited to: registration increative You must comply with an the Act S requirements, and 801); good manufacturing practice and listing (21 CFR Part 807); labeling (21 CFR Part 800); Books (21 CFR Pat 820); and if
requirements as set forth in the quality systems (QS) regulation (21 -542 of the Ac requirements as set forth in the quality systems (Sections (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 This letter will allow you to begin marketing your several aequivalence of your device to
510(k) premarket notification. The FDA finding of server device and thus 510(k) premarket nouncation. The I Dr I minute of securities in for your device and thus, a regally managevice to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 If you desire specific advice for your active on vitro diagnostic devices), please contact the promotion and additionally 21 CFR Part 809.10 tor in Vito ungliocally, for questions on the promotion and
Office of Compliance at (301) 594-4618 . Additionally, for questions on the pr Office of Compliance at (301) 594-4016 : Tradition of Compliance at (301) 594-4639.
advertising of your device, please contact the Office of Compliance at a respectical advertising of your avvises posses inteled, "Misbranding by reference to premarket Also, please note the regulation on active general information on your responsibilities under
notification" (21CFR Part 807.97). Other general informational and notification" (ZICFK Fall 807.97). Outlor get Small Manufacturers, International and the Act may be obtained from the Drivision of 800 638-2041 or (301) 443-6597 or at its
Consumer Assistance at its toll-free number (800) 443-6597 or at its m Consumer Assistance at his ton free hances (on)/dsma/dsmamain.html

Sincerely yours

Timothy A. Ulatowski

A. Ulatowski Timothy 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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Ver/ 3 - 4/24/96

Applicant:

I-Flow Corporation

510(k) Number (if known):

Device Name:

Paragon Infusion System

Indications For Use:

1. The Paragon Infusion System is intended for continuous andor intermittern infrasion of
  ten interest and informating increason, including antibiotic delivery, chemotherapy The Paragon Infusion System is intended to continuous antibiotic delivery, chemotherapy and pain
  medications for general infusion use, including antibiotic delivery, chematic medications for general infusion use, induding antibiotic delliery, entributions for general, subcutaneous, intramuscular and epidural.
intramuscular arts epidian.
The Paragon Infusion System is also intended for continuous and/or internities for postoperative The Paragon Infusion System is also intention wound sites for postoperative
medication (such as local anesthetics or narcotics) to surgical wound sites for postoperative medication (such as local anesthetics or narcolics) to suglour wound the first and painter or percutaneous.

Atan Ciceut

(Division Sign-Off) vision of Dental, Infection Control, ് General Hospital Devic ്ര(k) Number -

(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)

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).