HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP

{0}------------------------------------------------ K033054 36 DEC 1 6 2003 # 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: July 23, 2003 Trade Name: Harvard 1 Syringe Pump, Harvard 1 with PCA Pump Common Name: Syringe Infusion Pump Classification Name: Infusion Pump ## Predicate Devices Harvard 2 Syringe Pump, Medex Protégé, B. Braun Horizon with Dose Scan, Baxter PCA-II #### Intended Use ### Harvard 1 The Harvard 1 is designed to provide, intra-arterial, or epidural delivery of drugs, blood or blood products or other parenteral fluids when administered by a health care professionals such as physicians and nurses. The Harvard 1 is compatible for use inside the MRI room when mounted outside the 150 gauss line with MRI systems of 1.5 tesla or less. ### Harvard 1 with PCA Harvard with PCA to provide patient controlled analgesia, intra-arterial, or epidural delivery of drugs, blood or blood products, or other parenteral fluids when administered by a health care professionals such as physicians and nurses. The Harvard 1 with PCA is compatible for use inside the MRI room when mounted outside the 150 gauss line with MRI systems of 1.5 tesla or less. Harvard 1 / Harvard 1 with PCA Premarket Notification - 23 July, 2003 {1}------------------------------------------------ # 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 operation. The rotary Data Entry knob provides scrolling and selection of data and memu items as well as state selection. 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 supervisor which monitors the status of the system. The pump has sensors which permit its microprocessors to determine the syringe size loaded, determine if the syringe plunger is 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 Harvard 1 with PCA extends the Harvard 1 functionality to include Patient Controled Analgesia capability through the addition of an optional PCA pendent and PCA cover and lock assembly. PCA capability allows the patient to request delivery of a dose of pain medication from a regimen prescribed by the physician. 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}------------------------------------------------ | Warnings / Status | Purge | Purge | Purge | Purge | Purge<br>Stop | Infusion near end | | Hold time exceeded | |-------------------------------------------|-------------------------------------------|----------------------------------------|----------------------------------------|----------------------------------------|---------------|-----------------------|--|--------------------| | Setup | Setup | Setup | Setup | Setup | | Infusion end | | Low battery | | Stop | Stop | Stop | Stop | Stop | | Hi-pressure-Occlusion | | Low flow from | | Run | Run | Run | Run | Run | | System Malfunction | | | | Bolus | Bolus | Bolus | Bolus | Bolus | | Syringe not capture | | | | AC Power | AC Power | AC Power | AC Power | AC Power | | Plunger disengaged | | | | Battery Charging | Battery Charging | Battery Charging | Battery Charging | Battery Charging | | Low Battery | | | | Remote | Remote | Remote | Remote | Remote | | | | | | Syringe will be empty<br>in 15 minutes | Syringe will be empty<br>in 15 minutes | Syringe will be empty<br>in 15 minutes | Syringe will be empty<br>in 15 minutes | Syringe will be empty<br>in 15 minutes | | | | | | Battery will be depleted<br>in 30 minutes | Battery will be depleted<br>in 30 minutes | | | Low Battery | | | | | . Harvard 1 / Harvard 1 with PCA Premarket Notification - 23 July, 2003 {3}------------------------------------------------ | | Harvard 1 | Harvard with PCA | Harvard 2 | Baxter PCA II | Protégé 3010 | B. Braun<br>Horizon Lite | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Alarms | Occlusion<br>Battery will be depleted<br>in 5 minutes<br>Syringe plunger not<br>captured<br>Syringe barrel<br>Pusher moved<br>Syringe Empty<br>System Fault<br>System Fault - Battery<br>Depleted | Occlusion<br>Battery will be depleted<br>in 5 minutes<br>Syringe plunger not<br>captured<br>1 hour limit reached<br>Syringe barrel<br>Pusher moved<br>Syringe Empty<br>System Fault<br>System Fault - Battery<br>Depleted | Occlusion<br>Battery will be depleted<br>in 5 minutes<br>Syringe plunger not<br>captured<br>Syringe barrel<br>Pusher moved<br>Syringe Empty<br>System Fault<br>System Fault - Battery<br>Depleted | Occlusion<br>Door open<br>Door unlocked<br>1 hour limit reached<br>Syringe plunger not<br>captured<br>Syringe empty<br>Battery depleted<br>System Fault | Infusion end<br>Hi-pressure-Occlusion<br>System Malfunction<br>Syringe not capture<br>Plunger disengaged<br>Low Battery | Air-in-line<br>Container empty<br>Door open<br>Downstream occlusion<br>container<br>System error<br>Upstream occlusion<br>Set improperly loaded | | Inputs | Concentration<br>Rate<br>Bolus amount<br>Bolus time<br>Syringe manufacturer<br>Syringe size3<br>Patient weight<br>Dose amount<br>Dose time<br>Number of doses<br>Dose interval | Concentration<br>Rate<br>Bolus amount<br>Bolus time<br>Syringe manufacturer<br>Syringe size<br>Patient weight<br>Dose amount<br>Dose time<br>Number of doses<br>Dose interval<br>PCA dose<br>1 hour limit | Concentration<br>Rate<br>Bolus amount<br>Bolus time<br>Syringe manufacturer<br>Syringe size<br>Patient weight<br>Dose amount<br>Dose time<br>Number of doses<br>Dose interval | Concentration<br>Basal Rate<br>Bolus Amount<br>PCA Amount<br>1 Hour limit<br>PCA Delay time<br>Number of PCA does<br>Dose interval | Concentration<br>Rate<br>Bolus amount<br>Bolus time<br>Syringe manufacturer<br>Syringe size<br>Patient weight<br>Dose amount<br>Dose time<br>Number of doses<br>Dose interval | Concentration<br>Rate<br>Bolus amount<br>Bolus time<br>Patient weight<br>Dose amount<br>Dose time<br>Number of doses<br>Dose interval | | Serial<br>Communications | Bidirectional | Bidirectional | Bidirectional | None | Bidirectional | Unknown | | Barcode Reader | Optional laser scanning<br>reader | Optional laser scanning<br>reader | None | None | None | Laser scanning reader | | MRI<br>Compatibility | Yes | Yes | No | No | Yes | No | ³ Detected by syringe size mechanism and confirmed by user. Harvard 1 / Harvard 1 with PCA Premarket Notification - 23 July, 2003 {4}------------------------------------------------ Performance testing using prototype pumps which functionally reflect the final design configuration was performed to substantial equivalence claims. Cravimetric Rate Accuracy and occlusion system cesting per IRC-601-2-24 - Particular requirement cesting per IEC-601-2-24 - Particular requirement for safety of infusion pump ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ slusion test results indicate a mean error within specified range of the device. arvard 1 / Harvard 1 with PCA Premarket Notification - 23 July, 200 {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 6 2003 Harvard Clinical Technology Ms. Susan Gill Responsible Third Party Official Underwriters Laboratories, Incorporated 12 Laboratory Drive Research Triangle Park, North Carolina Re: K033054 Trade/Device Name: Harvard 1 Syringe Pump/ Harvard 1 with PCA Syringe Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA, FRN Dated: December 1, 2003 Received: December 2, 2003 Dear Ms. Gill: 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. {6}------------------------------------------------ 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 (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely vours, Carl Chiu Lin, Ph.D. hiu 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 {7}------------------------------------------------ # INDICATIONS FOR USE Harvard Clinical Technology, Inc 510(k) Number (if known): Device Name: Ko33054 Harvard 1 Harvard 1 with PCA Syringe Pumps Indications For Use: Harvard 1 The Harvard 1 is designed to provide, intravenous, intra-arterial, or epidural delivery of drugs, blood or blood products or other parenteral fluids when administered by a health care professionals such as physicians and nurses. The Harvard 1 is compatible for use inside the MRI room when mounted outside the 150 gauss line with MRI systems of 1.5 tesla or less. Harvard 1 with PCA Harvard 1 with PCA is designed provide patient controlled analgesia, intravenous, intra-arterial, or epidural delivery of drugs, blood or blood products, or other parenteral fluids when administered by a health care professionals such as physicians and nurses. The Harvard 1 with PCA is compatible for use inside the MRI room when mounted outside the 150 gauss line with MRI systems of 1.5 tesla or less. Patrizio Curante Division Sign-Off) (Division Sign-Olf) Division of Anesthesiology, General Hospit Infection Control, Dental De Infection Control: 510(k) Number: K033054 510(k) Number. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)