(297 days)
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The provided text does not contain any K/DEN numbers for reference devices. Therefore, I cannot extract them.
No
The device description focuses on a physical heat exchange mechanism and basic electronic controls (on-off switch, LED monitor). There is no mention of AI, ML, or any complex data processing or learning capabilities.
No
The device is an infusion warmer, which warms fluids before infusion into the body, but it does not directly treat or diagnose a disease or condition. Its purpose is to mitigate complications associated with cold infusions.
No
Explanation: The device is described as a "Blood and Infusion Warmer" used to heat infusate to reduce complications. Its function is to alter the temperature of fluids, not to diagnose a medical condition.
No
The device description clearly outlines physical components such as a metal Heat Exchanger, I.V. Tubing Extension Set, power source, on-off switch, LED temperature monitor, and a clamp for I.V. pole attachment. This indicates it is a hardware device with potentially some software control, but not a software-only medical device.
Based on the provided information, the Biegler BW385L Blood and Infusion Warmer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "heat infusate" and "reduce complications associated with the infusion of blood and other liquids that are cooler than normal body temperature." This describes a device that physically modifies a substance (warms it) before it is introduced into the body.
- Device Description: The description details a physical warming mechanism using a heat exchanger and tubing. It focuses on the process of warming the fluid.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Biegler BW385L does not perform any analysis or testing of a specimen. It simply warms a fluid.
Therefore, the Biegler BW385L Blood and Infusion Warmer is a therapeutic device used to prepare fluids for administration to a patient, not an IVD device used for diagnostic testing.
N/A
Intended Use / Indications for Use
The Biegler BW385L Blood and Infusion Warmer has the same intended use as several devices now marketed in the U.S. The DW1000, Baxter, the HotlineR1, Level 1; the FloTemR2, DataChem and the FenwalR3, Baxter are all used to heat infusate.
Product codes
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Device Description
The Biegler BW385L Blood & Infusion Warmer is designed to reduce complications associated with the infusion of blood and other liquids that are cooler than normal body temperature. The BW385L warms the fluid by means of a metal Heat Exchanger which is adjacent to an I.V. Tubing Extension Set through which the fluid to be heated flows. The cylindrical Heat Exchanger has a series of grooves; the Extension Set tubing is 'wrapped' around the Exchanger and into these grooves. The BW385L operates on a 120 volt (or where required 220 Volt) A.C. power source and is controlled by an on-off switch on the plastic face of the instrument. Above the on-off switch is an LED temperature monitor. The BW385L Blood & Infusion Warmer weighs 2.5 Kg. and is equipped with a dual knob clamp at the back of the instrument for I.V. pole attachment. The infusate is warmed to approximate body temperature as it travels a path around the constantly monitored and regulated Heat Exchanger. The BW385L is UL / C-UL approved and units placed to date have received special CSA inspection certification.
The BW385L by comparison has a dry-wall channelled Heat Exchanger heated by a 400 Watt element.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Data compiled by Biegler G.m.b.H. using the BW385L Blood & Infusion Warmer with Biegler Extension Sets, ambient temperature of 21 oC., with liquids at initial temperatures of both 18 oC. and 07 oC. indicate that at moderate infusion rates (to 6 litres / hour) the BW385L adds sufficient heat to the liquid medium to claim substantial equivalence to the warmers mentioned above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Section Six 510(K) Summary
AUG - 8 1996
BIGGLE
medical products inc
X954769
Date : Submitter : Contact : Trade Name : Common Name : Classification Name :
September 27, 1995. Biegler Medical Products Inc. Martin Costello Biegler BW385L Blood & Infusion Warmer Infusion and/or Blood Warmer Warmer (Classification Names for Medical Devices & In Vitro Medical Diagnostic Products ]
The Biegler BW385L Blood & Infusion Warmer is designed to reduce complications associated with the infusion of blood and other liquids that are cooler than normal body temperature. The BW385L warms the fluid by means of a metal Heat Exchanger which is adjacent to an I.V. Tubing Extension Set through which the fluid to be heated flows. The cylindrical Heat Exchanger has a series of grooves; the Extension Set tubing is 'wrapped' around the Exchanger and into these grooves. The BW385L operates on a 120 volt (or where required 220 Volt) A.C. power source and is controlled by an on-off switch on the plastic face of the instrument. Above the on-off switch is an LED temperature monitor. The BW385L Blood & Infusion Warmer weighs 2.5 Kg. and is equipped with a dual knob clamp at the back of the instrument for I.V. pole attachment. The infusate is warmed to approximate body temperature as it travels a path around the constantly monitored and regulated Heat Exchanger. The BW385L is UL / C-UL approved and units placed to date have received special CSA inspection certification.
The Biegler BW385L Blood and Infusion Warmer has the same intended use as several devices now marketed in the U.S. The DW1000, Baxter, the HotlineR1, Level 1; the FloTemR2, DataChem and the FenwalR3, Baxter are all used to heat infusate. The Hotline uses a fluid heat exchange system while the others utilize 'dry-wall' Heat Exchangers. The DW1000 has a cylindrical, metal, heated Exchanger over which a plastic cuff is fixed. The infusate is heated as it flows through this cuff. The Fenwal envelopes the infusate 'bag' between heated, metal exchanger plates. The FloTem Heat Exchanger is channelled allowing I.V. tubing to be fitted into the grooves. The four aforementioned warmers operate by means of heating elements that range from 300 to 360 Watts. These units provide sufficient heat for the fluid to approximate normal body temperature distal to the warmers.
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RI'HOTLINE is Registered Trademark of Level 1 Technologies R2FloTem is a Registered Trademark of DataChem R3Fenwal is a Registered Trademark of Baxter Health Care
P.O. Box 160, Carlisle, Ontario, Canada LOR 1H0 Tel: (905) 689-9444 FAX: (905) 689-9447
1
BIEGLER BW385L [510(K)]
Section Six (Summary continued) 510(K) Summary
The BW385L by comparison has a dry-wall channelled Heat Exchanger heated by a 400 Watt element. Data compiled by Biegler G.m.b.H. using the BW385L Blood & Infusion Warmer with Biegler Extension Sets, ambient temperature of 21 oC., with liquids at initial temperatures of both 18 oC. and 07 oC. indicate that at moderate infusion rates (to 6 litres / hour) the BW385L adds sufficient heat to the liquid medium to claim substantial equivalence to the warmers mentioned above.