(92 days)
The Syndeo PCA Syringe Pump is designed for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, spinal (or intrathecal), epidural (or subarachnoid), and for regional anesthesia applications.
The Syndeo PCA Syringe Pump is appropriate for use in hospital or alternate medical site environments, but it is not intended for use in homecare settings.
The Syndeo PCA Syringe Pump is not indicated for use with blood or blood products.
The Syndeo PCA Syringe Pump consists of a syringe infusion pump with locking cover, and a PCA button for delivery of bolus doses of medication upon request. The pump accommodates 60 mL plastic syringes or 50 mL prefilled syringes. The pump can communicate with wireless accessories such as commercially available infrared printers or computing tools with device communications that are compatible with the Palm Operating System.
The Syndeo pump is capable of continuous, intermittent, or continuous plus intermittent infusion of small volumes of medications, following standard patientrequest PCA regimens. The pump operates on 4 D-size alkaline batteries or the optional AC rechargeable pack. The pump uses microprocessor electronics for control of all functions. A large, color touch-screen display provides a userfriendly graphic user interface (GUI), and simple programming steps that lead the operator through programming. As an added safety feature, the pump employs a variety of sensors to ensure appropriate syringe loading and door closure prior to allowing initiation of infusion.
This document is a 510(k) summary for the Syndeo PCA Syringe Pump. It is a premarket notification for a medical device and therefore does not contain details of any clinical study or acceptance criteria related to software or AI performance.
The provided text describes the device, its intended use, and states that it is substantially equivalent to predicate devices. It mentions that the pump uses "microprocessor electronics for control of all functions" and a "large, color touch-screen display" but does not describe any AI or algorithmic components that would require performance criteria or studies as typically understood for AI/ML devices.
Therefore, I cannot provide the requested information about acceptance criteria or studies proving the device meets them, as those details are not present in the provided 510(k) summary. The nature of a 510(k) submission generally focuses on substantial equivalence to a legally marketed predicate device rather than detailed performance studies for novel AI components.
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K03/566
510(k) Summary of Safety and Effectiveness
Submitted by:
Jennifer M. Paine Manager, Requlatory Affairs Baxter Healthcare Corporation Medication Delivery Rte. 120 and Wilson Road Round Lake, IL 60073
Name/Classification of Device:
Infusion Pump/ Class II, 80MEA - 21 CFR 880.5725
Trade Name:
Syndeo PCA Syringe Pump
Predicate Devices:
PCA II Syringe Infusion Pump Ipump Pain Management System
Statement of Intended Use:
The Syndeo PCA Syringe Pump is designed for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, spinal (or intrathecal), epidural (or subarachnoid), and for regional anesthesia applications.
The Syndeo PCA Syringe Pump is appropriate for use in hospital or alternate medical site environments, but it is not intended for use in homecare settings.
The Syndeo PCA Syringe Pump is not indicated for use with blood or blood products.
Device Description:
The Syndeo PCA Syringe Pump consists of a syringe infusion pump with locking cover, and a PCA button for delivery of bolus doses of medication upon request. The pump accommodates 60 mL plastic syringes or 50 mL prefilled syringes. The pump can communicate with wireless accessories such as commercially available infrared printers or computing tools with device communications that are compatible with the Palm Operating System.
The Syndeo pump is capable of continuous, intermittent, or continuous plus intermittent infusion of small volumes of medications, following standard patientrequest PCA regimens. The pump operates on 4 D-size alkaline batteries or the
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optional AC rechargeable pack. The pump uses microprocessor electronics for control of all functions. A large, color touch-screen display provides a userfriendly graphic user interface (GUI), and simple programming steps that lead the operator through programming. As an added safety feature, the pump employs a variety of sensors to ensure appropriate syringe loading and door closure prior to allowing initiation of infusion.
Summary of Technological Characteristics of New Device to Predicate Devices:
The new and predicate devices have similar materials and basic design. The new device uses a touchscreen, color display and wireless communications technology.
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "U.S. Health & Human Services USA" around the edge. Inside the circle is a stylized eagle-like symbol with three curved lines representing the body and wings. The image is in black and white and appears to be a scan or photocopy due to the slightly blurred text and the presence of some artifacts.
Public Health Service
AUG 1 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jennifer M. Paine Manager, Regulatory Affairs Baxter Healthcare Corporation 7511 114" Avenue North Largo, Florida 33773
Re: K031566
Trade/Device Name: Syndeo PCA Syringe Pump Regulation Number: 880. 5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA Dated: May 16, 2003 Received: May 19, 2003
Dear Ms. Paine:
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, an 1 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. Iisting 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.
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Page 2 - Ms. Paine
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 Yours,
fiscing the first of the many of the successfully be
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Syndeo PCA Syringe Pump Device Name:
Indications For Use:
The Syndeo PCA Syringe Pump is designed for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, spinal (or intrathecal), epidural (or subarachnoid), and for regional anesthesia applications.
The Syndeo PCA Syringe Pump is appropriate for use in hospital or alternate medical site environments, but it is not intended for use in homecare settings.
The Syndeo PCA Syringe Pump is not indicated for use with blood or blood products.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR Counter Use _
Over-the-
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Paltare Cuccente
Division of Anesthesiology, General Hospital. Infection Control. Den
510(k) Number: K031564
SYNDEO 510(K) -- INDICATIONS FOR USE
BAXTER CONFIDENTIAL
PAGE 965 OF 975
§ 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).