The Paragon Bolus Accessory Set is intended to deliver fixed boluses of medication upon demand by the patient or healthcare provider. The routes of administration are intravenous, epidural, intramuscular and subcutaneous.

Device Description

The Bolus Accessory may connect to any Paragon administration set to deliver fixed boluses of medication upon demand by the patient or healthcare provider. The Bolus Accessory consists of plastic housing, medication reservoir, bolus button activator and wrist bands. The bolus button allows patient controlled administration of medication as needed. The Bolus Accessory is available in 0.5 ml bolus volume. The Bolus Accessory is a mechanical device that requires no external power.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Paragon Bolus Accessory Set, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Bolus Volume Accuracy: ±10% at 95% confidence interval at the identified lockout times.	"All models performed within the specified accuracy when tested at nominal conditions." (Implies meeting the ±10% at 95% CI for the 0.5 mL bolus volume)
Priming/Residual Volume: <=4 ml	"Priming/Residual Volume: <=4 ml" (Likely tested to confirm this specification)

Note: The document only explicitly states the accuracy acceptance criterion and then broadly confirms that all models performed within specified accuracy. Other operational specifications like "Refill Time: variable," "Operating Temperature: 90 ± 2°F," "Calibration Solution: 0.9% NaCl," "Operating Pressure: 6.0 psi pressure source," and "Head Height: 0" are listed as standard operating conditions under which performance was assessed.

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "All models performed within the specified accuracy," implying that multiple units were tested, but does not provide a specific number for the test set.
- Data Provenance: Not specified, but likely obtained prospectively through in-house testing by I-Flow Corporation. No mention of country of origin for the data is made, but the company is based in Lake Forest, CA, USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a mechanical medical device (bolus accessory for an infusion system). The "ground truth" for its performance (e.g., bolus volume accuracy) would be established through instrumental measurements rather than expert human interpretation. Therefore, this question is not applicable in the context of this device's testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as the testing involves direct measurement of mechanical performance, not expert review or adjudication of subjective data.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a mechanical accessory; it does not involve human readers interpreting images or data, nor does it incorporate AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical accessory, not an algorithm. However, the performance data provided (accuracy) is for the device itself acting autonomously within its mechanical function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the performance testing, the ground truth would be based on physical measurements using calibrated instruments to determine the actual bolus volume delivered.
The sample size for the training set:
- Not applicable. As a mechanical medical device, there is no "training set" in the context of machine learning or AI. Performance is based on physical design and manufacturing tolerances.
How the ground truth for the training set was established:
- Not applicable for the same reasons as point 7.

Summary

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Image /page/0/Picture/0 description: The image shows the date 2/9/99 at the top left. Below the date is the I-FLOW logo, which is a rounded rectangle with the words "I-FLOW" inside. Underneath the logo, the words "I-FLOW CORPORATION" are printed in a smaller, sans-serif font. The logo has a registered trademark symbol.

20202 Windrow Rd. Lake Forest, CA 92630 (800) 448-3569 (714) 206-2700 Fax (714) 206-2600

K984638

SUMMARY OF SAFETY AND EFFECTIVENESS

December 30, 1998

Trade Name: Paragon Bolus Accessory Set

Common Name: Bolus Accessory

Classification Name: Set, Administration, Intravascular

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: 949.206.2700 Fax: 949.206.2600

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GENERAL INFORMATION 1.0

Purpose of Submission 1.1

This submission is intended to notify the Federal Food and Drug 1.1.1 Administration that I-Flow Corporation intends to market an accessory device for the Paragon Infusion System (K923875), originally identified as the SideKick 50 Plus and SideKick 100 Plus. This new accessory will be known as the Paragon Bolus Accessory Set, hereafter identified as the Bolus Accessory. No change will be made to the existing Paragon pump or administration sets.
Trade Name: Paragon Bolus Accessory Set 1.1.2
Common Name: Bolus Accessory Set 1.1.3
Classification Name: Set. Administration, Intravascular 1.1.4
Product Code: 80 FPA 1.1.5
Device Classification: Class II, 880.5440 1.1.6
Classification Panel: General Hospital and Personal Use Device 1.1.7

Statement of Equivalence 1.2

The Bolus Accessory is substantially equivalent to Patient Control Module 1.2.1 (K884505) marketed by Baxter Healthcare Corporation and the I-Flow Bolus Dispenser (K935811).

2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTIONS

Description of the Bolus Accessory 2.1

Wherever the Paragon pump and administration set are mentioned, they may be replaced by any constant 6 psi pressure system.

The Bolus Accessory may connect to any Paragon administration set to 2.1.1 deliver fixed boluses of medication upon demand by the patient or healthcare provider.
2.1.2 The Bolus Accessory consists of plastic housing, medication reservoir, bolus button activator and wrist bands.
The bolus button allows patient controlled administration of medication as 2.1.3 needed.

Product Configuration 2.2

The Bolus Accessory is available in 0.5 ml bolus volume. 2.2.1

2.3 Components and Materials

All fluid path components of the Bolus Accessory are in conformance with 2.3.1 ISO 10993 Part 1.

2.4 Power Requirements

2.4.1 The Bolus Accessory is a mechanical device that requires no external power.

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OPERATIONAL SPECIFICATIONS AND DESCRIPTIONS 3.0

Standard Operating Conditions: 3.1

Bolus Volume:	0.5 ml
Refill Time:	variable
Priming/Residual Volume:	<=4 ml
Operating Temperature:	90 ± 2°F
Calibration Solution:	0.9% NaCl
Operating Pressure:	6.0 psi pressure source
Head Height:	0"
Accuracy:	bolus volume: ±10% at 95% confidence interval atthe identified lockout times.

Performance Data: Testing occurred at standard operating conditions. All 3.2 models performed within the specified accuracy when tested at nominal conditions.

Safety / Alarm Funtions 3.3

This device contains no alarms or indicators. 3.3.1
The non-linear refill adds additional patient safety if the bolus button is 3.3.2 activated prior to the lockout time.

BIOLOGICAL SPECIFICATIONS 4.0

Biological testing is in conformance with ISO 10993 Part 1 for all fluid path 4.1 components.

CHEMICAL AND DRUG SPECIFICATIONS 5.0

5.1 Compatibility
- There are no specific drugs referenced in the labeling for the Bolus 5.1.1 Accessory.
- The Bolus Accessory is intended for general purpose drugs and pain 5.1.2 medication.

INTENDED USE 6.0

The Bolus Accessory is intended to deliver fixed boluses of medication upon 6.1 demand by the patient or healthcare provider.
6.2 The routes of administration intravenous, epidural, intramuscular and subcutaneous.
The Bolus Accessory is not intended for continuous delivery. 6.3
6.4 The Bolus Accessory is single patient use only.
6.5 The Bolus Accessory 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 Bolus Accessory for 6.6 the delivery of blood, blood products, lipids or fat emulsions. The Bolus Accessory is not intended for the delivery of blood, blood products, lipids or fat emulsions.

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7.0 STANDARDS

There are currently no standards established for mechanical PCA infusion 7.1 devices.

PACKAGING 8.0

Packaging is suitable for radiation or ETO sterilization. 8.1

9.0 STERILIZATION

The method of sterilization is gamma radiation (cobalt 60). 9.1

COMPARISON TO LEGALLY MARKETED DEVICES 10.0

The Bolus Accessory has the same intended use as the predicate Baxter Pain 10.1 Control Module and the I-Flow Bolus Dispenser. The Bolus Accessory has similar bolus volumes and lockout times as its predicate devices.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 8 1999

Robert J. Bard, Esq., R.A.C. Vice President Regulatory and Legal Affairs I-Flow Corporation 20202 Window Drive Lake Forest, California 92630

Re: K984638 Paragon Bolus Accessory Set Trade Name: Requlatory Class: II FPA Product Code: December 30, 1998 Dated: Received: December 31, 1998

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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Bard

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the 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 at its toll-free number (800) 638-2041 or (301) 443-6597 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 Radiological Health

Enclosure

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510(k) Number (if known): _K984638

Device Name: __ Paragon Bolus Accessory Set

Indications for Use:

1. The Paragon Bolus Accessory Set is intended to deliver fixed boluses of medication The Fargon Bolus Accessery Get it and incare provider. The routes of administration are intravenous, epidural, intramuscular and subcutaneous.
  (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)

Patrose Current Over-The-Counter Use
(Division Sign Off)

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

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
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.(b)
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.