The Baxa Corporation MicroFuse Dual Rate Infuser, is a battery powered, portable device that automates the injection of the contents of a syringe into a patient. Each MicroFuse has two pre-determined rates that are be preset at the manufacturing facility. These preset rates can not be modified by the user or patient. The MicroFuse is used with a sterile administration set for injecting the medication into a patient. It depresses the plunger of the syringe at a controlled, pre determined rate, delivering the dose in the syringe over an extended period of time. The MicroFuse is offered in a standard dual rate model. Some custom dual rate models with the only difference being the pre-determined infusion rates are also offered.

The MicroFuse System consists of the MicroFuse Dual Rate Infuser and a syringe and administration set. Both syringe and administration sets are sterile and disposable. Since only the accessory syringes and administration sets are in the fluid path, the MicroFuse has no patient contact materials. This also means the device is not provided sterile, nor is it sterilized in the field. The accessories have been previously cleared with the predicate device in K933506.

AI/ML Overview

Here's the analysis of the provided text regarding the Baxa MicroFuse™ Dual Rate Infuser, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Baxa MicroFuse™ Dual Rate Infuser was tested to and met "all applicable requirements of ANSI/AAMI ID26-1992. Standard for Infusion Devices."

Acceptance Criteria (Standard)	Reported Device Performance
ANSI/AAMI ID26-1992 requirements (Standard for Infusion Devices)	Met all applicable requirements of the Standard.

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

The document does not provide specific details on:

The exact sample size used for testing in relation to the ANSI/AAMI ID26-1992 standard.
The data provenance (e.g., country of origin, retrospective or prospective nature).

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

This information is not provided in the document. The testing appears to be based on engineering performance against a recognized standard rather than an assessment of clinical outcomes by experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of testing against an engineering standard, a formal adjudication method by experts is unlikely to have been part of this specific safety and effectiveness summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device and adherence to an engineering standard.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a physical infusion pump, not an AI algorithm. The performance described is "standalone" in the sense that it's the device's inherent operation.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the device's performance was the ANSI/AAMI ID26-1992 Standard for Infusion Devices. Performance was assessed against the technical specifications and requirements outlined in this standard.

8. The Sample Size for the Training Set

This question is not applicable. The Baxa MicroFuse™ Dual Rate Infuser is a hardware device, not an AI system. Therefore, there is no "training set" in the context of machine learning.

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

This question is not applicable for the same reason as above; there is no training set for a hardware device.

Summary of Key Findings from the Document:

The acceptance criteria for the Baxa MicroFuse™ Dual Rate Infuser were compliance with the ANSI/AAMI ID26-1992 Standard for Infusion Devices. The study (or testing) performed demonstrated that the device "met all the applicable requirements of the Standard." The document does not elaborate on the specifics of this testing, such as sample sizes, expert involvement, or adjudication methods, as it primarily serves as a summary for a 510(k) submission focused on substantial equivalence to a predicate device (Baxa Syringe Infuser 510(k) K933506).

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Baxa. The logo consists of a plus sign with a triangle at the bottom left of the plus sign, followed by the word "Baxa" in bold, sans-serif font. There is a horizontal line underneath the logo.

K983321

Baxa Corporation • 13760 E. Arapahoe Road • Englewood, CO 80112-3903 • 800-567-BAXA (2292) • 303-690-4804

6 1998 OCT

SAFETY AND EFFECTIVENESS SUMMARY Baxa MicroFuse™ Dual Rate Infuser

Name and address of Device Manufacturer submitting 510(k) Notification:

BAXA CORPORATION 13760 E. Arapahoe Road Englewood, Colorado 80112

Regulatory Correspondent of Device Manufacturer:

Patrick Hynes Baxa Corporation 13760 E. Arapahoe Road Englewood, Colorado 80112 Phone: (303)690-4204 FAX: (303)690-4802

Date Summary was prepared:

July 31,1998

Name of the device:

MicroFuse™ Dual Rate Infuser

Classification:

Indications for Use:

Description of the device:

Pump, infusion, Class II per 880.5725

The device is intended to be used for the intermittent administration of I.V. medication.

{1}------------------------------------------------

determined rate, delivering the dose in the syringe over an extended period of time. The MicroFuse is offered in a standard dual rate model. Some custom dual rate models with the only difference being the pre-determined infusion rates are also offered.

Substantial Equivalence:

The Baxa MicroFuse is substantially equivalent to:

Syringe Infuser 510(k) K933506, Cleared February 25, 1994 Baxa Corporation Englewood, CO

The MicroFuse™ has been tested to all applicable requirements of ANSI/AAMI ID26-1992. Standard for Infusion Devices. The MicroFuse met all the applicable requirements of the Standard.

Safety and Efficacy:

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 1898

Baxa Corporation C/O Mr. William E. McKay President Regulatory Consultants to the Medical Device Industry (RCMDI) 9712 S. Altamont Drive Sandy, Utah 84092

Re : K983321 Trade Name: MicroFuse™ Dual Rate Infuser Regulatory Class: II Product Code: RDN Dated: September 22, 1998 September 22, 1998 Received:

Dear Mr. McKay:

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 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), 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 895. ਬ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

{3}------------------------------------------------

Page 2 - Mr. McKav

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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" (21CFR 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/dsma/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

{4}------------------------------------------------

Page

510(k) Number (if known): Not yet assigned

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Baxa Corporation MicroFuse™Dual Rate Infuser is intended to be used for the intermittent administration of I.V. medication.

This intended use is identical to the intended use for the predicate device as cleared for marketing in K933506, Baxa Dual Rate Infuser, Cleared February 25, 1994.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office if Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

ン

OR Over-The-Counter Use

Patricia Cucenith(Optional Format 1-2-96)

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

2 of 53

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).