(229 days)
Alaris Medley System with MMS, B. Braun Horizon Outlook with DoseCom
Not Found
No
The summary describes a system for connecting infusion pumps to a hospital network for data communication and remote monitoring, without mentioning any analytical or predictive capabilities typically associated with AI/ML.
No
The device is described as a "computerized wireless patient information and medication management tool" that provides access to information and enables remote viewing of pump status, alerts, and alarms. It does not directly provide therapy or interact with the patient's body for therapeutic purposes. Its function is to manage and communicate data related to infusion therapy, not to administer the therapy itself.
No
The device is described as a "computerized wireless patient information and medication management tool" that communicates infusion parameters, system configuration, history, events, trending, alarms, and status. It is intended to help manage infusion therapy and provide remote viewing of pump status, and enable secondary notification of pump alerts and alarms. It does not perform diagnosis or analyze symptoms to identify diseases.
No
The device description explicitly states that the Pump Connectivity Interface is a "system of hardware and software".
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Pump Connectivity Interface is described as a "computerized wireless patient information and medication management tool." Its primary function is to facilitate communication and data exchange between infusion pumps and hospital systems/devices. It allows healthcare practitioners to remotely view pump status, compare prescription information, and receive alerts/alarms.
- Lack of Biological Sample Analysis: There is no mention of this device analyzing any biological samples from a patient. Its operation is focused on managing and displaying data related to the infusion process and the infusion pump itself.
Therefore, the device's intended use and description clearly indicate it is a system for managing and monitoring infusion therapy, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Pump Connectivity Interface is a computerized wireless patient information and medication management tool that is integrated into an existing hospital network infrastructure and allows communications with external devices, including personal computers (PCs), Personal Digital Assistants (PDAs) or similar display/computing devices, hospital monitoring systems, and Hospital Information Management Systems (HIMS). Communication of data includes infusion parameters, system configuration, history, events, trending, alarms and status. It is intended for use in professional healthcare environments that use electronic, external infusion devices.
The Pump Connectivity Interface is intended to provide trained healthcare practitioners access to additional information needed to more safely manage infusion therapy via infusion pumps. lt enables remote viewing of pump status within the hospital and enables comparisons of pharmacyentered prescription information to programmed pump settings. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.
The Pump Connectivity Interface also enables secondary notification of pump alerts and alarms to remote users via a personal digital assistant (PDA) or similar display/computing device.
The Pump Connectivity Interface is intended for use by trained healthcare practitioners in accordance with the instructions provided in Pump Connectivity Interface labeling.
Product codes
FRN, FRN
Device Description
The Pump Connectivity Interface has been developed to expand upon previously cleared external monitoring features of legally marketed infusion pumps. As described above, the Pump Connectivity Interface is a system of hardware and software that enables external infusion pumps to be integrated into existing hospital network infrastructure. It is intended to provide trained healthcare practitioners with access to additional information needed to more safely manage infusion therapy via external infusion pumps.
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
trained healthcare practitioners in professional healthcare environments
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
The performance data indicate that the device will meet specified requirements and is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Alaris Medley System with MMS, B. Braun Horizon Outlook with DoseCom
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).
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NOV 3 0 2004
510(k) Summary of Safety and Effectiveness
Submitted by:
Jennifer M. Paine Manager, Global Regulatory Affairs Baxter Healthcare Corporation Medication Delivery Rte. 120 and Wilson Road Round Lake, IL 60073
Name/Classification of Device:
Infusion Pump/ Class II, 80FRN/80MEA - 21 CFR 880.5725
Trade Name:
Pump Connectivity Interface
Predicate Devices:
Alaris Medley System with MMS B. Braun Horizon Outlook with DoseCom
Statement of Intended Use:
The Pump Connectivity Interface is a computerized wireless patient information and medication management tool that is integrated into an existing hospital network infrastructure and allows communications with external devices, including personal computers (PCs), Personal Digital Assistants (PDAs), hospital monitoring systems and Hospital Information Management Systems (HIMS). Communication of data includes infusion parameters, system configuration, history, events, trending, alarms and status. It is intended for use in professional healthcare environments that use electronic, external infusion devices.
The Pump Connectivity Interface is intended to provide trained healthcare practitioners access to additional information needed to more safely manage infusion therapy via infusion pumps. It enables remote viewing of pump status within the hospital and enables comparisons of pharmacy-entered prescription information to programmed pump settings. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.
The Pump Connectivity Interface also enables secondary notification of pump alerts and alarms to remote users via a personal digital assistant (PDA) or similar device.
The Pump Connectivity Interface is intended for use by trained healthcare practitioners in accordance with the instructions provided in Pump Connectivity Interface labeling.
Device Description:
The Pump Connectivity Interface has been developed to expand upon previously cleared external monitoring features of legally marketed infusion pumps. As described above, the Pump Connectivity Interface is a system of hardware and software that enables external infusion pumps to be integrated into existing hospital network infrastructure. It is intended
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to provide trained healthcare practitioners with access to additional information needed to more safely manage infusion therapy via external infusion pumps.
Summary of Technological Characteristics of New Device to Predicate Devices:
A comparison of the technological characteristics of the Pump Connectivity Interface to the predicate devices has been performed. The results of this comparison demonstrate that the Pump Connectivity Interface is equivalent to the marketed predicate device in technological characteristics.
Performance Data:
The performance data indicate that the device will meet specified requirements and is substantially equivalent to the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2004
Mr. Robert L. Wilkinson, RAC Director, Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085
Re: K040985
Trade/Device Name: Pump Connectivity Interface Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: November 23, 2004 Received: November 24, 2004
Dear Mr. Wilkinson:
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.
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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 (OS) 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 (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 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.
Susan Runner
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
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Indications for Use
510(k) Number (if known):
Device Name: Pump Connectivity Interface
Indications For Use:
The Pump Connectivity Interface is a computerized wireless patient information and medication management tool that is integrated into an existing hospital network infrastructure and allows communications with external devices, including personal computers (PCs), Personal Digital Assistants (PDAs) or similar display/computing devices, hospital monitoring systems, and Hospital Information Management Systems (HIMS). Communication of data includes infusion parameters, system configuration, history, events, trending, alarms and status. It is intended for use in professional healthcare environments that use electronic, external infusion devices.
The Pump Connectivity Interface is intended to provide trained healthcare practitioners access to additional information needed to more safely manage infusion therapy via infusion pumps. lt enables remote viewing of pump status within the hospital and enables comparisons of pharmacyentered prescription information to programmed pump settings. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.
The Pump Connectivity Interface also enables secondary notification of pump alerts and alarms to remote users via a personal digital assistant (PDA) or similar display/computing device.
The Pump Connectivity Interface is intended for use by trained healthcare practitioners in accordance with the instructions provided in Pump Connectivity Interface labeling.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J. Thm. D.m.
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
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510(k) Number:_长中华ゆみぷ