The Bolus Accessory Set, in combination with a positive pressure, continuous flow infusion pump, is intended to deliver fixed boluses of medication upon demand by the patient or healthcare provider. Routes of administration include intravenous, epidural, intramuscular, subcutaneous, intra-operative (as the one the same and percutaneous.

Device Description

The Bolus Accessory may connect to any positive pressure, continuous flow rate infusion pump with an 8 to 17 psi pressure source 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.

AI/ML Overview

The provided document describes the I-Flow Bolus Accessory Set, a mechanical device intended to deliver fixed boluses of medication. The primary focus of the document is on the specifications and equivalence to previously marketed devices (510(k) submission).

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Bolus Volume Accuracy: ±10% at 95% confidence interval at the identified refill times.	All models performed within the specified accuracy when tested at nominal conditions. (This is the reported performance for the Bolus Accessory based on testing at standard operating conditions).
Priming/Residual Volume: <= 0.75 ml	Not explicitly stated as an "acceptance criterion" in a pass/fail format, but listed as a "Standard Operating Condition" with a value of "≤ 0.75 ml". The document does not explicitly state that the device "met" this, but lists it as a specification.
Operating Temperature: 88 ± 2°F (skin temperature)	Not explicitly stated as an "acceptance criterion" or "met" performance, but listed as a "Standard Operating Condition."
Test Solution: Normal saline (0.9% NaCl)	Used for testing (implied by "Test Solution: normal saline (0.9% NaCl )").
Operating Pressure: 8 to 17 psi pressure source	Tested within this range (implied by "Operating Pressure: 8 to 17 psi pressure source").
Head Height: 0"	Tested at this condition (implied by "Head Height: 0"").
Biocompatibility: Conformance with ISO 10993 Part 1 for all fluid path components.	Biological testing is in conformance with ISO 10993 Part 1 for all fluid path components.
Sterilization: Suitable for gamma radiation (cobalt 60) or ETO sterilization.	The method of sterilization is gamma radiation (cobalt 60). Packaging is suitable for radiation or ETO sterilization. (The document states the method used and the packaging suitability).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified. The document only states "All models performed within the specified accuracy when tested at nominal conditions." It does not provide the number of devices tested or the number of boluses delivered during testing.
Data Provenance: The document does not explicitly state the country of origin. Given the submission to the US FDA, it's highly likely the testing was conducted to US standards, but the specific lab location is not provided. The data is retrospective as it's part of a 510(k) submission for a device already developed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to this type of device and study. The "ground truth" for a mechanical infusion device like the Bolus Accessory is typically established by direct physical measurement (e.g., precise liquid volume measurement for bolus accuracy) using calibrated laboratory equipment, not by human expert consensus or clinical assessment of images/outcomes.

4. Adjudication Method for the Test Set:

Not applicable. As the "ground truth" is established by direct measurement with equipment, there is no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret and classify medical cases. The Bolus Accessory is a mechanical infusion device, and its performance is assessed by mechanical and accuracy tests, not by human interpretation of its output in a clinical diagnosis context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, in essence, a standalone performance study was done. The described "Performance Data" and "Accuracy" testing are essentially standalone algorithm/device performance evaluations. The device's ability to deliver accurate bolus volumes is measured directly without human intervention in the delivery mechanism or interpretation of its output. The device itself is a mechanical system, not an algorithm in the traditional AI sense, but its performance is evaluated in a standalone manner against its specifications.

7. Type of Ground Truth Used:

The ground truth used for accuracy and performance testing would be based on direct, calibrated laboratory measurements of physical properties. For example:
- Bolus Volume: Measured using highly accurate volumetric measuring equipment.
- Priming/Residual Volume: Measured volumetrically.
- Biocompatibility: Assessed through laboratory tests following ISO 10993 Part 1 standards.

8. Sample Size for the Training Set:

Not applicable. This device is a mechanical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design and engineering are based on principles of fluid dynamics and mechanics, not data-driven training.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for a mechanical device, there is no ground truth to establish for it.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for I-FLOW Corporation. The logo consists of the text "I-FLOW" inside of a rounded rectangle. Below the logo, the text "I-FLOW CORPORATION" is printed in a simple sans-serif font.

20202 Windrow Drive Lake Forest, CA 92630 (800) 448-3569 (949) 206-2700 Fax (949) 206-2600

SEP 1 5 1999

K992072

SUMMARY OF SAFETY AND EFFECTIVENESS

June 17, 1999

Trade Name: 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

1.1 Purpose of Submission

This submission is intended to notify the Federal Food and Drug 1.1.1 Administration that I-Flow Corporation intends to market a new administration set called the Bolus Accessory Set, hereafter identified as the Bolus Accessory.
Trade Name: Bolus Accessory Set 1.1.2
Common Name: Bolus Accessory 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 the I-Flow Paragon 1.2.1 Bolus Accessory Set (K984638), the Patient Control Module (K884505) marketed by Baxter Healthcare Corporation and the I-Flow Bolus Dispenser (K935811).

PHYSICAL SPECIFICATIONS AND DESCRIPTIONS 2.0

Description of the Bolus Accessory 2.1

The Bolus Accessory may connect to any positive pressure, continuous 2.1.1 flow rate infusion pump with an 8 to 17 psi pressure source to deliver fixed boluses of medication upon demand by the patient or healthcare provider.
The Bolus Accessory consists of plastic housing, medication reservoir, 2.1.2 bolus button activator and wrist bands.
The bolus button allows patient controlled administration of medication as 2.1.3 needed.

2.2 Product Configuration

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

2.3 Components and Materials

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

2.4 Power Requirements

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

3.0 OPERATIONAL SPECIFICATIONS AND DESCRIPTIONS

3.1 Standard Operating Conditions:

Bolus Volume:	0.5 ml
Refill Time:	variable, determined by pressure source flow rate
Priming/Residual Volume:	<= 0.75 ml
Operating Temperature:	88 ± 2°F (skin temperature)

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Test Solution:	normal saline (0.9% NaCl )
Operating Pressure:	8 to 17 psi pressure source
Head Height:	0"
Accuracy:	bolus volume: ±10% at 95% confidence interval atthe identified refill 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 Functions 3.3

This device contains no alarms or indicators for flow other than visual. 3.3.1
3.3.2 The non-linear refill adds additional patient safety if the bolus button is pressed prior to the refill 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.
- 5.1.2 The Bolus Accessory is intended for general purpose drugs and pain medication.

6.0 INTENDED USE

The Bolus Accessory, in combination with a positive pressure, continuous flow 6.1 infusion pump. is intended to deliver fixed boluses of medication upon demand by the patient or healthcare provider. Routes of administration include intravenous, epidural, intramuscular, subcutaneous, percutaneous and intra-operative.
6.2 The Bolus Accessory is not intended for continuous delivery.
6.3 The Bolus Accessory is single patient use only.
The Bolus Accessory is suitable for use as an ambulatory device and is intended 6.4 for use in the hospital, home environment or alternative care sites.
No testing has been conducted to determine the efficacy of Bolus Accessory for 6.5 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.

7.0 STANDARDS

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

8.0 PACKAGING

Packaging is suitable for radiation or ETO sterilization. 8.1

9.0 STERILIZATION

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

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COMPARISON TO LEGALLY MARKETED DEVICES 10.0

10.1 The Bolus Accessory is identical to the I-Flow Paragon Bolus Accessory Set with the exception of the source pressure specification. The Bolus Accessory has the same intended use as the following predicate devices: the I-Flow Paragon Bolus Accessory Set, the Baxter Patient Control Module and the I-Flow Bolus Dispenser. The Bolus Accessory has similar bolus volumes and refill times as its predicate device.

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Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 1999

Mr. Stan Fry Vice President Regulatory and Legal Affairs I-Flow Corporation 20202 Window Drive Lake Forest, California 92630

K992072 Re : Bolus Accessory Set Trade Name: Requlatory Class: II Product Code: FPA Dated: June 17, 1999 Received: June 19, 1999

Dear Mr. Fry:

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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

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Page 2 - Mr. Fry

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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 Other qeneral 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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20202 Windrow Drive Lake Forest. CA 92630 (800) 448-3569 (949) 206-2700 Fax (949) 206-2600

510(k) Number (if known): __

Bolus Accessory Set Device Name:

Indications for Use:

1. The Bolus Accessory Set, in combination with a positive pressure, continuous flow infusion pump, is intended to deliver fixed boluses of medication upon demand by the patient or healthcare provider. Routes of administration include intravenous, epidural, intramuscular, subcutaneous, intra-operative (as the one the same and percutaneous.
  Patrua Cresente

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

510(k) Number 1992072

(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)

Over-The-Counter Use

(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.