(24 days)
Not Found
Not Found
No
The description details standard microprocessor control, sensors, and a drug library function, but does not mention any AI or ML algorithms for decision-making, data analysis, or adaptive control.
No
The device delivers drugs or parenteral fluids; it does not directly treat a disease or condition itself.
No
Explanation: The device is described as a pump for the delivery of parenteral fluids, not for diagnosing any medical condition. Its function is to administer drugs or fluids, not to detect or identify diseases or conditions.
No
The device description clearly details hardware components such as an LCD display, rotary knobs, multiple microprocessors, sensors, a motor, and a barcode reader. While it mentions an optional computer program ("The Harvard Library"), the core device is a physical pump with integrated hardware and software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of drugs or parenteral fluids into the body (intravenous, intra-arterial, epidural). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description focuses on the mechanics of delivering fluids from a syringe, controlling flow rates, and managing drug libraries. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
The device is a syringe pump, which is a medical device used for administering fluids to a patient.
N/A
Intended Use / Indications for Use
The Harvard 2 provides intravenous, intra-arterial, or epidural delivery of drugs or other parenteral fluids when administered by health care professionals such as physicians and nurses.
Product codes
FRN
Device Description
The Harvard Pump is intended for the delivery of parenteral fluids. It accommodates syringe sizes from 1 through 60 ml from multiple manufacturers.
Its user interface consists of an active matrix color LCD display with two rotary knobs for controling pump peration. The rotary Data Entry knob provides scrolling and selection of data and menu items as well as state Jection. The knob is turned to scroll, and pressed for selection. The rotary Function knob controls the state (Purge, Setup, Stop, Run and Bolus) of the pump.
The pump has several microprocessors, one master which controls operation of the device, one pump processor which controls the operation of the motor and sensors specific to the syringe drive mechanism, and one upervisor which monitors the status of the system.
The pump has sensors which permit its microprocessors to determine the syringe size loaded, determine if the I ne pain nas securely captured by the pusher block assembly, measure occlusion force and calculate the proper rate and distance the plunger of the syringe must travel to cause an infusion of fluid at a given rate and volume.
The pump provides for bidirectional remote communications via an RS232 serial port.
The pump may be used with The Harvard Library, an optional computer program which runs on MS Windows based personal computers. The Harvard Library is capable of downloading and uploading drug information in the form of a drug library to and from the pump. After downloading, the drug library is resident in flash memory within the pump, enabling the pump to provide drug specific defaults for drug concentrations, pumping rates, bolus amounts, and bolus times.
Barcode versions of the pump provide a laser scanning barcode reader is used to scan a label placed on the syringe which selects a drug from the pump's resident drug library. This allows the pump to retrieve from its internal memory the drug's specific parameters such as concentration, infusion rate etc. in an effort to minimize user input errors.
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
Not Found
Intended User / Care Setting
health care professionals such as physicians and nurses.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Harvard 1 Syringe Pump, Harvard 2 Syringe Pump
Reference Device(s)
Not Found
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
Attachment 4
FEB 1 1 2005
510(K) SUMMARY
Harvard Clinical Technology, Inc. 22 Pleasant Street South Natick MA 01760
Contact Person:
Eric J. Flachbart Vice President, Research and Development Harvard Clinical Technology, Inc. 22 Pleasant Street South Natick, MA 01760 (508)-655-2000 (508)-655-2211 Fax eflachbart@harvardclinical.com
Date Prepared: January 11, 2005
Trade Name: Harvard 2 Syringe Pump Jommon Name: Syringe Infusion Pump Classification Name: Infusion Pump
Predicate Devices Harvard 1 Syringe Pump, Harvard 2 Syringe Pump
Intended Use
The Harvard 2 provides intravenous, intra-arterial, or epidural delivery of drugs or other parenteral fluids when administered by health care professionals such as physicians and nurses.
Device Description:
The Harvard Pump is intended for the delivery of parenteral fluids. It accommodates syringe sizes from 1 through 60 ml from multiple manufacturers.
Its user interface consists of an active matrix color LCD display with two rotary knobs for controling pump peration. The rotary Data Entry knob provides scrolling and selection of data and menu items as well as state
Jection. The knob is turned to scroll, and pressed for selection. The rotary Function knob controls the state (Purge, Setup, Stop, Run and Bolus) of the pump.
1
The pump has several microprocessors, one master which controls operation of the device, one pump processor which controls the operation of the motor and sensors specific to the syringe drive mechanism, and one upervisor which monitors the status of the system.
The pump has sensors which permit its microprocessors to determine the syringe size loaded, determine if the I ne pain nas securely captured by the pusher block assembly, measure occlusion force and calculate the proper rate and distance the plunger of the syringe must travel to cause an infusion of fluid at a given rate and volume.
The pump provides for bidirectional remote communications via an RS232 serial port.
The pump may be used with The Harvard Library, an optional computer program which runs on MS Windows based personal computers. The Harvard Library is capable of downloading and uploading drug information in the form of a drug library to and from the pump. After downloading, the drug library is resident in flash memory within the pump, enabling the pump to provide drug specific defaults for drug concentrations, pumping rates, bolus amounts, and bolus times.
Barcode versions of the pump provide a laser scanning barcode reader is used to scan a label placed on the syringe which selects a drug from the pump's resident drug library. This allows the pump to retrieve from its internal memory the drug's specific parameters such as concentration, infusion rate etc. in an effort to minimize user input errors.
2
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which consists of a stylized caduceus with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2005
Mr. Eric J. Flachbart Vice President, Research and Development Harvard Clinical Technology, Incorporated 22 Pleasant Street South Natick, Massachusetts 01760
Re: K050107
Trade/Device Name: Harvard 2 Syringe Pump, Model 2001-001 Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: January 11, 2005 Received: January 19, 2005
Dear Mr. Flachbart:
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 mendments, 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 (1 Wri), it hay of casyon in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Eederal Register.
3
Page 2 - Mr. Flachbart
Please be advised that FDA's issuance of a substantial equivalence determination does not Flease be auvrsou that I DT o losained on that your device complies with other requirements mean that I DA mas made a autes and regulations administered by other Federal agencies. of the Act of ally I oderal banks as requirements, including, but not limited to: registration Tourinust comply with and are labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 807), accling (QS) regulation (21 CFR Part 820); and if requirenchis as set form in the quality ijon 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) Prins letter will anon you to began finding of substantial equivalence of your device to a premaired notified.com - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific af 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 may obtain other generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Cart
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
Attachment 2 Indications for Use Statement
510(k) Number: _KOSOLO 7
Device Name: Harvard 2 Syringe Pump
Indications for Use:
The Harvard 2 provides intravenous, intra-arterial, or epidural delivery of drugs or other parenteral fluids when The Travard 2 provides mara rofessionals such as physicians and nurses.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cinta Vihant
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Wision of Anesthesiology, General Hospital,
Ansion Or Anesthesiology, General Devices ്ങളിന് of Anestholsions
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