(202 days)
No
The summary describes a motor-driven syringe pump with a computer processor for controlled fluid delivery and pressure calculation, but there is no mention of AI or ML technologies.
No.
The device is a pump intended for controlled delivery of medication and fluids, not for treating a condition or disease.
No
The device is described as a pump for delivering medication and fluids in a controlled manner, and its performance evaluation focuses on dispensing accuracy and pressure calculation. There is no mention of it being used to diagnose a medical condition.
No
The device description explicitly lists multiple hardware components including a motor-driven piston syringe pump, internal and external pressure transducers, a syringe retainer, an LCD, a power supply, a foot pedal, and a power cord. The performance studies also evaluate "machine performance" in addition to software.
Based on the provided information, the CompuFlo device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to deliver medication and other fluids into the body through various routes (intravenous, intra-arterial, subcutaneous, epidural, and enteral). This is a therapeutic or delivery function, not a diagnostic one.
- Device Description: The description details a pump mechanism, pressure transducers, and a computer processor for controlling fluid delivery. There is no mention of analyzing biological samples or performing tests on them.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The CompuFlo does not perform any such analysis.
The CompuFlo is an infusion pump, designed for controlled delivery of substances into the body, not for analyzing substances from the body.
N/A
Intended Use / Indications for Use
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.
Product codes
FRN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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)
1
Intended Use / Indications for Use
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.
Technological Characteristics
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.
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.
2
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.
3
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
4
Indications for Use Statement
Kes 355 y 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: CompuFlo
Indications for Use:
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.
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