(78 days)
Harvard 2 Syringe Pump, Medex Protégé, B. Braun Horizon with Dose Scan, Baxter PCA-II
Not Found
No
The description details standard microprocessor control, sensor-based calculations, and data storage/retrieval, without mentioning any AI or ML algorithms for decision-making, pattern recognition, or learning.
Yes
The device is designed to deliver drugs and other parenteral fluids, including for patient-controlled analgesia, which are therapeutic interventions.
No
This device is designed for the delivery of fluids, not for diagnosing medical conditions. It is a pump that administers drugs, blood, or other parenteral fluids.
No
The device description clearly details hardware components such as an LCD display, rotary knobs, microprocessors, sensors, a motor, and a syringe drive mechanism. While it mentions optional software ("The Harvard Library"), the core device is a physical pump with integrated hardware and software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "intravenous, intra-arterial, or epidural delivery of drugs, blood or blood products or other parenteral fluids". This describes a device used for administering substances into the body, not for testing samples from the body to diagnose conditions.
- Device Description: The description focuses on the mechanical and electronic aspects of a pump designed to deliver fluids from a syringe. It details features related to syringe size, flow rate, occlusion detection, and communication, all consistent with an infusion pump.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Harvard 1 and Harvard 1 with PCA are infusion pumps, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
MEA, 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-arterial, epidural, intravenous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals such as physicians and nurses / inside the MRI room
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)
Performance testing using prototype pumps which functionally reflect the final design configuration was performed to substantial equivalence claims.
Gravimetric Rate Accuracy and occlusion system testing per IEC-601-2-24 - Particular requirement for safety of infusion pump.
Occlusion test results indicate a mean error within specified range of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Harvard 2 Syringe Pump, Medex Protégé, B. Braun Horizon with Dose Scan, Baxter PCA-II
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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
in 15 minutes | Syringe will be empty
in 15 minutes | Syringe will be empty
in 15 minutes | Syringe will be empty
in 15 minutes | Syringe will be empty
in 15 minutes | | | | |
| Battery will be depleted
in 30 minutes | Battery will be depleted
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
Horizon Lite |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Alarms | Occlusion
Battery will be depleted
in 5 minutes
Syringe plunger not
captured
Syringe barrel
Pusher moved
Syringe Empty
System Fault
System Fault - Battery
Depleted | Occlusion
Battery will be depleted
in 5 minutes
Syringe plunger not
captured
1 hour limit reached
Syringe barrel
Pusher moved
Syringe Empty
System Fault
System Fault - Battery
Depleted | Occlusion
Battery will be depleted
in 5 minutes
Syringe plunger not
captured
Syringe barrel
Pusher moved
Syringe Empty
System Fault
System Fault - Battery
Depleted | Occlusion
Door open
Door unlocked
1 hour limit reached
Syringe plunger not
captured
Syringe empty
Battery depleted
System Fault | Infusion end
Hi-pressure-Occlusion
System Malfunction
Syringe not capture
Plunger disengaged
Low Battery | Air-in-line
Container empty
Door open
Downstream occlusion
container
System error
Upstream occlusion
Set improperly loaded |
| Inputs | Concentration
Rate
Bolus amount
Bolus time
Syringe manufacturer
Syringe size3
Patient weight
Dose amount
Dose time
Number of doses
Dose interval | Concentration
Rate
Bolus amount
Bolus time
Syringe manufacturer
Syringe size
Patient weight
Dose amount
Dose time
Number of doses
Dose interval
PCA dose
1 hour limit | Concentration
Rate
Bolus amount
Bolus time
Syringe manufacturer
Syringe size
Patient weight
Dose amount
Dose time
Number of doses
Dose interval | Concentration
Basal Rate
Bolus Amount
PCA Amount
1 Hour limit
PCA Delay time
Number of PCA does
Dose interval | Concentration
Rate
Bolus amount
Bolus time
Syringe manufacturer
Syringe size
Patient weight
Dose amount
Dose time
Number of doses
Dose interval | Concentration
Rate
Bolus amount
Bolus time
Patient weight
Dose amount
Dose time
Number of doses
Dose interval |
| Serial
Communications | Bidirectional | Bidirectional | Bidirectional | None | Bidirectional | Unknown |
| Barcode Reader | Optional laser scanning
reader | Optional laser scanning
reader | None | None | None | Laser scanning reader |
| MRI
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)