(21 days)
Not Found
No
The document describes a standard electromechanical infusion pump with software for managing settings, alerts, and logs. There is no mention of AI or ML capabilities for data analysis, prediction, or decision support.
No.
The device is an infusion system that delivers fluids and medications. While these substances are therapeutic, the device itself is a delivery mechanism and not a therapeutic agent that directly treats a medical condition.
No
The device is an infusion system designed for the delivery of fluids, solutions, and drugs, and it does not mention any function for diagnosing medical conditions.
No
The device description clearly states it is comprised of an electromechanical infusion pump (hardware) and accessories, including an optional wireless communications module (hardware). While it includes software (Abbott MedNet Software), it is not solely software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for the "delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products" via various routes of administration (parenteral, enteral, intravenous, etc.). This describes a device that administers substances into the body, not a device that tests samples from the body.
- Device Description: The description details an "electromechanical infusion pump" that meters fluids. This aligns with the function of delivering substances, not analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information based on sample analysis
- Using reagents or test kits
The device is clearly described as an infusion system designed to deliver substances to a patient.
N/A
Intended Use / Indications for Use
The Abbott Phoenix Infusion System with Abbott MedNet Software is intended for the delivery of fluids, solutions, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.
It is intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/Surgical Centers. Long Term Care, Transport and Physician Offices.
Product codes
FRN, FPA
Device Description
The Abbott Phoenix Infusion System with Abbott MedNet™ Software is comprised of an Abbott Phoenix Infuser and accessories. The accessories consist of dedicated infusion administration sets, an optional wireless communications module and optional software that can manage default settings, drug limit alerts and history logs through the communications connections.
The infuser is an electromechanical infusion pump (hereinafter referred to as a pump) that uses a DC motor along with an in-line cassette to meter intravenous (I.V.) fluids through a dedicated administration set. The pump is manufactured for Abbott Laboratories and distributed by Abbott Laboratories. The administration sets are manufactured by and distributed by Abbott Laboratories.
The pump is manufactured as a one-channel or two-channel fluid delivery device. The clinician can configure the pumps by connecting them together. The two-channel pump can be connected to a one-channel pump to form a three-channel pump. Two two-channel pumps can be connected together to form a four-channel pump. However, two one-channel pumps cannot be connected together, nor can more than two pumps be connected together. When the devices are connected, local communication between the pumps is accomplished through Infrared Data Association® (IrDA) sensors.
The pump's large LCD-touch screen allows the healthcare practitioner to program fluid delivery in a variety of weight- and surface area-based units such as micrograms/kg/hour, grams/m2/hr, and other delivery specifications.
The display provides visible indication of several functions including active pump operations, alarm and program status, and fluid flow parameters.
Both the bredicate and the proposed devices can be used for primary and secondary fluid delivery.
The pumps can transmit and receive data by using a cable connected to a data port directly or through a wireless communications module. Data handling is accomplished using the Abbott MedNet Software. Data can include downloading customized drug library and/or customized pump configuration, uploading event/alarm logs, triggering a nurse callback, and/or sending current pumping parameters to another computer or device. The wireless communications module allows the pump to be connected to a hospital information system or infusion medication management software system.
The pumps manufactured without a wireless board are enabled for wireless upgrade. The pumps can be converted to have wireless functionality at a later date by inserting an optional wireless communications module in the pump.
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
Primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/Surgical Centers. Long Term Care, Transport and Physician Offices.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
0
Abbott Laboratories, Inc. Confidential
Original 510(k) Premarket Notification April 2004 Abbott Phoenix Infusion System with Abbott MedNet™ Software
JUN 3 0 2004
510(k) SUMMARY র্ব
| 1. Submitted by: | Abbott Laboratories, Inc.
D-389. Bldg. J-45
200 Abbott Park Rd
Abbott Park, IL 60064 | Phone: (847) 938-3718
Fax: (847) 938-7867
Contact: Patricia Melerski |
| ------------------ | ----------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------- |
|---|
-
- Date Prepared: April 16, 2004
-
- Name/Classification Infusion Pump, Class II of Device: 80 FRN - 21 CFR Parts 880.5725
Administration Sets 80 FPA - 21 CFR Reference: 880.5440
-
- Abbott Phoenix Infusion System with Abbott MedNet™ Trade Name of Proposed Device: Software
- Abbott Pium A+® Infusion Pump with HPL/RS with the 5. Predicate Devices: plug-and-play Module (K031185) Abbott Gemstar™ I.V. Infusion Pump system (K023062)
6. Proposed Device Description:
The Abbott Phoenix Infusion System with Abbott MedNet™ Software is comprised of an Abbott Phoenix Infuser and accessories. The accessories consist of dedicated infusion administration sets, an optional wireless communications module and optional software that can manage default settings, drug limit alerts and history logs through the communications connections.
The infuser is an electromechanical infusion pump (hereinafter referred to as a pump) that uses a DC motor along with an in-line cassette to meter intravenous (I.V.) fluids through a dedicated administration set. The pump is manufactured for Abbott Laboratories and distributed by Abbott Laboratories. The administration sets are manufactured by and distributed by Abbott Laboratories.
The pump is manufactured as a one-channel or two-channel fluid delivery device. The clinician can configure the pumps by connecting them together. The two-channel pump can be connected to a one-channel pump to form a three-channel pump. Two two-channel pumps can be connected together to form a four-channel pump. However, two one-channel pumps cannot be connected together, nor can more than two pumps be connected together. When the devices are connected, local communication between the pumps is accomplished through Infrared Data Association® (IrDA) sensors.
1
The pump's large LCD-touch screen allows the healthcare practitioner to program fluid delivery in a variety of weight- and surface area-based units such as micrograms/kg/hour, grams/m2/hr, and other delivery specifications.
The display provides visible indication of several functions including active pump operations, alarm and program status, and fluid flow parameters.
Both the bredicate and the proposed devices can be used for primary and secondary fluid delivery.
The pumps can transmit and receive data by using a cable connected to a data port directly or through a wireless communications module. Data handling is accomplished using the Abbott MedNet Software. Data can include downloading customized drug library and/or customized pump configuration, uploading event/alarm logs, triggering a nurse callback, and/or sending current pumping parameters to another computer or device. The wireless communications module allows the pump to be connected to a hospital information system or infusion medication management software system.
The pumps manufactured without a wireless board are enabled for wireless upgrade. The pumps can be converted to have wireless functionality at a later date by inserting an optional wireless communications module in the pump.
7. Statement of Intended Use:
The Abbott Phoenix Infusion System with Abbott MedNet Software is intended for the delivery of fluids, solutions, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.
It is intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/Surgical Centers. Long Term Care, Transport and Physician Offices.
8. Summary of Technological Characteristics of New Device Compared to Predicate Device
The proposed Abbott Phoenix Infusion System with Abbott MedNet Software and the predicate devices are similar in fundamental technology (fluid delivery), programming options, materials of construction. intended use and labeling. Therefore, the Abbott Phoenix Infusion System with Abbott MedNet Software is substantially equivalent to Abbott Plum A+® Infusion Pump with HPURS with the plug-and-play Module and the Abbott Gemstar® I.V. Infusion Pump. The proposed device does not raise new issues of safety and effectiveness.
The substantial equivalence claim is supported by the information provided in the 510(k) submission.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2004
Abbott Laboratories C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K041550
Trade/Device Name: Hospira Phoenix Infusion System with Hospira MedNet Software Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: June 22, 2004 Received: June 24, 2004
Dear Mr. Devine:
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 Eederal Register.
3
Page 2 - Mr. Devine
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,
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
4
Indications for Use
510(k) Number (if known):
Hospira Phoenix Infusion System with Hospira MedNet Software Device Name:
Indications For Use:
The Hospira Phoenix Infusion System with Hospira MedNet Software has the following indications for use:
The Hospira Phoenix Infusion System with Hospira MedNet Software is intended for the delivery of fluids, solutions, drugs, aqents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.
It is intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as, but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/Surgical Centers, Long Term Care, Urgent Care, Transport and Physician Offices.
x Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
ﺣﯿﺮﺕ
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)
Anton Vrons
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control Dental Devices
510(k) Number:_人ゆy /SSQ
Page 1 of 1