HARVARD 2 SYRINGE PUMP, MODEL 2001-001

K050107 · Harvard Clinical Technology · FRN · Feb 11, 2005 · General Hospital

Device Facts

• Record ID: K050107
• Device Name: HARVARD 2 SYRINGE PUMP, MODEL 2001-001
• Applicant: Harvard Clinical Technology
• Product Code: FRN · General Hospital
• Decision Date: Feb 11, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Harvard 2 Syringe Pump delivers parenteral fluids via intravenous, intra-arterial, or epidural routes. Device accommodates 1-60 ml syringes. User interface features color LCD and rotary knobs for state control (Purge, Setup, Stop, Run, Bolus) and data entry. System architecture includes three microprocessors: master, pump (motor/sensor control), and supervisor (system monitoring). Sensors detect syringe size, plunger capture, and occlusion force to calculate infusion rates/volumes. Optional barcode reader scans syringe labels to retrieve drug-specific parameters (concentration, rate) from internal flash memory. Device supports RS232 remote communication and integrates with 'The Harvard Library' PC software for drug library management. Used in clinical settings by physicians and nurses to automate fluid delivery, minimize input errors, and ensure precise dosing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Syringe infusion pump; accommodates 1-60 ml syringes. Features: color LCD, rotary control knobs, RS232 serial port, barcode scanner (optional). Microprocessor-based control system (master, pump, supervisor). Flash memory for drug library storage. Connectivity: PC-based software for library management. Power source: electrical.

Indications for Use

Indicated for intravenous, intra-arterial, or epidural delivery of drugs or parenteral fluids by healthcare professionals (physicians/nurses).

Regulatory Classification

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.

Predicate Devices

• Harvard 1 Syringe Pump
• Harvard 2 Syringe Pump

Submission Summary (Full Text)

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

# Attachment 4

FEB 1 1 2005

K050107

# 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 [e-mail]

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 [phone]. 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 [phone] or [phone] 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

Minion Sign-Off) nivision Sign-Off)
Wision of Anesthesiology, General Hospital,
Ansion Or Anesthesiology, General Devices ്ങളിന് of Anestholsions

Page 1 of

| 10(k) Number:_