PARAGON INFUSION SYSTEM WITH BOLUS

• K Number: K023827
• Device Name: PARAGON INFUSION SYSTEM WITH BOLUS
• Manufacturer: I-FLOW CORP.
• Date Cleared: 2002-12-13 ( 25 days)
• Product Code: FRN
• Regulation Number: 880.5725

Intended Use

1. The Paragon Infusion System with Bolus 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, subcutaneous, intramuscular and epidural. 2. The Paragon Infusion System with Bolus is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.

Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text does not contain any keywords or descriptions related to AI or ML technology.

Therapeutic

Yes
The device is described as an "Infusion System" intended for "continuous and/or intermittent infusion of medications" for various medical purposes, including "antibiotic delivery, chemotherapy and pain management," which are all therapeutic interventions.

Diagnostic

No
The device is described as an "Infusion System" intended for the delivery of medications, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The summary describes an "Infusion System," which inherently implies hardware components (pump, tubing, etc.) for delivering medication. There is no mention of the device being solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Paragon Infusion System with Bolus is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
• Paragon Infusion System Function: The description clearly states the device is intended for the infusion of medications into the body through various routes (intravenous, subcutaneous, intramuscular, epidural, intraoperative, percutaneous). This is a therapeutic function, delivering substances into the patient, not analyzing samples from the patient.

The intended use and routes of administration described are characteristic of a therapeutic device, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

• 1. The Paragon Infusion System with Bolus 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, subcutaneous, intramuscular and epidural.
• 2. The Paragon Infusion System with Bolus is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.

Product codes

FRN

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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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).

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle's head is facing left, and its beak is slightly open. The text "DEPARTMENT OF HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2002

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

Re: K023827

Trade/Device Name: Paragon Infusion System with Bolus Regulation Number: 880.5725 . Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: November 14, 2002 Received: November 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 vour 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.

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Page 2 - Mr. Noehre

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. 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 (QS) 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), 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/cdrb/dsma/dsmamain.html

Sincerely yours,

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

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Verl 3 - 4/24/96

Applicant:

Flow Corporation

510(k) Number (if known):

Device Name:

Paragon Infusion System with Bolus

Indications For Use:

• 1. The Paragon Infusion System with Bolus 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, subcutaneous, intramuscular and epidural.
• 2. The Paragon Infusion System with Bolus is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.

Patricia Ciuente

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. K023827

(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)