The CompuFlo is intended for use in delivering medication and other fluids in a controlled manner. The CompuFlo is indicated for use in adults for the continuous or intermittent delivery of medications and other fluids through intravenous, intra-arterial, subcutaneous, epidural and enteral routes.

Device Description

The CompuFlo unit consists of a motor-driven piston syringe pump with an internal pressure transducer, an external pressure transducer (Meritrans™ Disposable Pressure Transducer (K920977)), a syringe retainer, a computer processor, a liquid crystal display (LCD), and a power supply. All but the external pressure transducer are contained in a plastic cabinet. A foot pedal and power cord are also included. The unit operates with a variety of user-provided disposable supplies, including Luer Lock plastic piston syringes, plastic syringe tubing, and needles.

AI/ML Overview

The CompuFlo 510(k) submission describes the device and its testing, but it does not provide specific acceptance criteria or a detailed study report in the format requested. The document is a 510(k) summary, which is a high-level overview.

Based on the provided text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the types of performance evaluated, but does not provide specific quantitative acceptance criteria or the actual numerical results against those criteria. It only states that "the CompuFlo functioned as intended" with minor exceptions not related to performance.

Performance Metric	Acceptance Criteria	Reported Device Performance
Travel distance of syringe plunger	Not specified	Functioned as intended
Volume dispensed	Not specified	Accurately dispense a desired quantity of medication or fluid
Flow rates	Not specified	Functioned as intended
Force measurements on syringe platform	Not specified	Functioned as intended
Accuracy of internal pressure sensor	Not specified	Capable of calculating the pressure at the needle tip according to the equation described
Accuracy of external pressure sensor	Not specified	Capable of calculating the pressure at the needle tip according to the equation described

2. Sample Size and Data Provenance for Test Set

Sample Size: Not specified. The document mentions "test results" but does not quantify how many tests or samples were used for each performance metric.
Data Provenance: The testing was "Machine performance of the CompuFlo was evaluated", implying it was conducted by the manufacturer or a contracted lab. Details like country of origin for the data are not provided, nor whether it was retrospective or prospective (though device performance testing is typically prospective).

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. This device's performance evaluation focuses on machine operation and physical measurements (e.g., volume, pressure, flow) rather than human interpretation of data where expert consensus for ground truth would be needed.
Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

Adjudication Method: Not applicable. As the testing involved machine performance metrics and physical measurements, there would be no need for an adjudication method by experts.

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

MRMC Study Done: No. This type of study is relevant for diagnostic or interpretive devices where human readers are making assessments. The CompuFlo is an infusion pump, and its performance is evaluated based on its mechanical and electronic accuracy in delivering fluids and measuring pressure.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done: Yes, in essence. The "Machine performance of the CompuFlo was evaluated" directly refers to the device's inherent functional performance without human intervention during the dispensing process. The entire "Performance Data" section describes this standalone testing. The device's ability to "accurately dispense a desired quantity of medication or fluid" and its "capability of calculating the pressure at the needle tip" are direct measures of its standalone performance.

7. Type of Ground Truth Used

Type of Ground Truth: Physical measurements and engineering specifications. For example, for "volume dispensed," the ground truth would be the known, expected volume based on the pump's settings and calibrated measurement equipment. For "pressure sensors," the ground truth would be the actual pressure applied as measured by a highly accurate reference instrument.

8. Sample Size for Training Set

Sample Size for Training Set: Not applicable. The CompuFlo is described as a "motor-driven piston syringe pump with an internal pressure transducer, an external pressure transducer, a syringe retainer, a computer processor, a liquid crystal display (LCD), and a power supply." This description suggests a classic electromechanical device with an embedded computer processor, likely controlled by deterministic software and calibrated rather than an AI/ML system that requires a "training set" in the modern sense. It is highly probable that the software and system were developed using traditional engineering principles and testing, not AI/ML training data.

9. How Ground Truth for Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as it's not an AI/ML device in the context of requiring a "training set" with ground truth in the AI/ML paradigm. The "ground truth" for its development would be engineering specifications, physical laws, and expected operational parameters against which the device's mechanical and electronic components were designed and calibrated.

Summary

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CompuFlo 510(k) Page 16

Kos 355 4

510(k) SUMMARY

JUL 1 0 2006 Milestone's CompuFlo Syringe Pump

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Howard Holstein Hogan & Hartson LLP Columbia Square 555 Thirteenth Street, NW Washington DC 20004-1109

Phone: (202) 637-5600

Date Prepared: December 20, 2005

Name of Device and Name/Address of Sponsor

CompuFlo™ Infusion Pump

Milestone Scientific, Inc. 220 S. Orange Avenue Livingston, NJ 07039

Common or Usual Name

Syringe Infusion Pump

Classification Name

Infusion Pump, Class II, 21 C.F.R. § 880.5725

Predicate Devices

· Harvard Clinical Technology, Inc.'s Harvard 2 Syringe Pump (K050107)
· Alaris Medical Systems, Inc.'s Medley Syringe Pump Module (K023264)
· Medex, Inc.'s Medex 3000 Series Infusion Pump (K040899)

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Intended Use / Indications for Use

Technological Characteristics

Performance Data

Machine performance of the CompuFlo was evaluated, in addition to the software items. The evaluation of machine performance included: travel distance of the syringe plunger and the volume dispensed; the volumes dispensed; the flow rates; the force measurements on the syringe platform; and, assessing the accuracy of the internal and external pressure sensors. Pressure testing was conducted in a static fashion. With the exception of several minor tests not directly related to device performance and explained in detail in Section XVI, the CompuFlo functioned as intended. These test results demonstrate that the CompuFlo can accurately dispense a desired quantity of medication or fluid, and is capable of calculating the pressure at the needle tip according to the equation described in this 510(k) notice.

Substantial Equivalence

The CompuFlo raises no new questions of safety or effectiveness as compared to Harvard Clinical Technology, Inc.'s Harvard 2 Syringe Pump (K050107), Alaris Medical Systems, Inc.'s Medley Syringe Pump Module (K023264), and Medex, Inc.'s Medex 3000 Series Infusion Pump (K040899). The CompuFlo has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the CompuFlo and its predicate devices raise no new issues of safety or effectiveness. Thus, the CompuFlo is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized representation of a human figure, composed of three overlapping profiles, symbolizing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 0 2006

Milestone Scientific, Incorporated C/O Mr. Howard Holstein Hogan & Hartson L.L.P. 555 Thirteenth Street, NW Washington, D.C. 20004

Re: K053554

Trade/Device Name: CompuFlo Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: June 27, 2006 Received: June 27, 2006

Dear Mr. Holstein:

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 your 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. Holstein

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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Suyite Y. Michino m.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Kes 355 y 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CompuFlo

Indications for Use:

Prescription Use _ X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cinta V.V.

i Chan-Off) icn of Anesthesiology, General Hospital, Jon Control. Dental Devices

Number: K45 5554

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).