(84 days)
Biegler BW385L K954769
Not Found
No
The device description details a system based on a controlled heat exchanger and temperature monitoring, with no mention of AI or ML algorithms for control, analysis, or prediction.
Yes.
The device is a blood/fluid warming system used to deliver warm blood, blood products, and liquids to patients, which is a therapeutic intervention aimed at reducing complications associated with infusions.
No
Explanation: The device is a blood/fluid warming system designed to warm fluids for infusion, not to diagnose medical conditions or analyze patient data.
No
The device description clearly details a physical device (blood/fluid warming system) with hardware components like an aluminum heat exchanger, electrical power, LED indicator, and clamps. While it mentions "controlled by an on-off switch" and "regulated heat exchanger," this implies hardware-based control and not a software-only device. The TubeFlow accessory is also described as not containing software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver warm blood, blood products, and liquids to adult and pediatric patients." This describes a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device warms fluids before they are administered to the patient. It does not analyze or test biological samples in vitro (outside the body) to provide diagnostic information.
- Lack of Diagnostic Function: The description focuses on the heating mechanism and temperature control. There is no mention of analyzing blood or fluid components, detecting markers, or providing any information about the patient's health status based on the fluid itself.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely to modify the temperature of fluids being administered to the patient.
N/A
Intended Use / Indications for Use
The BW685/BW685 S blood / fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
LGZ
Device Description
The BW685 and BW685S are blood and infusion fluid warmers designed to reduce complications associated with the infusion of blood or other liquids . They warm the fluid by means of an aluminum heat exchanger which is adjacent to an I.V. extension set through which the liquid to be heated flows. The electrically powered heat exchanger has a spiral groove through which the I.V. extension set is wrapped. There is no direct contact between the heat exchanger and infusate, the infusate only contacts the I.V. extension set.
The BW685 and BW685S operate on 120 VAC and are controlled by an on-off switch on the plastic face of the instrument. Above the on-off switch is an LED indicator which indicates the temperature setting as well as the measured temperature. The set temperature is selectable in increments of 0.5° C between 37 and 41°C. The default temperature is 38.5° C. The infusate is warmed to approximately the set temperature as it travels a path around the constantly monitored and regulated heat exchanger. The temperature is measured at the end of the extension set, where it leaves the spiral groove.
The BW685 / BW685 S weigh 1.9 and 2.0 kg respectively and are equipped with a dual knob clamp at the back of the devices for attachment to an I.V. pole; the devices may also be clamped to a bedrail.
The BW685 and BW685S are identical except that the BW685 S has provision and additional circuitry for connection to an additional heating element that can be placed nearer the patient. The additional heating element is called the TubeFlow and fits over the I.V. line to the patient. The TubeFlow is electrically powered from the BW685S and contains a display indicative of the heating status (green for heating) or over-temperature (red). The TubeFlow does not contain software.
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
Adult and pediatric
Intended User / Care Setting
Hospital
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)
The following testing was performed:
- Leakage testing
- Heater testing at various flow rates
- Fault testing
- Testing to the requirements of ASTM F2172-02 Standard Specification for Blood/ Intravenous Fluid/Irrigation Fluid Warmers
Testing was also performed to ensure that the proposed device met its specifications. A comparison of specifications in the tables found the proposed models to be equivalent.
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.
Biegler BW385L K954769
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
Premarket Notification 510(k) Section 5 - 510(k) Summary
Biegler GinbH BW685/S
510(k) Summary
Page 1 of 7
18-Apr-2012JUL 1222012
| Official Contact: | Friedrich Netauschek
Biegler GmbH
Allhangstrasse 18a
3001 Mauerbach Austria
Tel - (0043)1979210515
Fax - (0043)1979210516 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | BW685 and BW685S |
| Common/Usual Name: | Fluid Warmer |
| Classification Name: | Warmer, thermal, infusion fluid |
| Predicate Devices: | Biegler BW385L K954769 |
Device Description:
The BW685 and BW685S are blood and infusion fluid warmers designed to reduce complications associated with the infusion of blood or other liquids . They warm the fluid by means of an aluminum heat exchanger which is adjacent to an I.V. extension set through which the liquid to be heated flows. The electrically powered heat exchanger has a spiral groove through which the I.V. extension set is wrapped. There is no direct contact between the heat exchanger and infusate, the infusate only contacts the I.V. extension set.
The BW685 and BW685S operate on 120 VAC and are controlled by an on-off switch on the plastic face of the instrument. Above the on-off switch is an LED indicator which indicates the temperature setting as well as the measured temperature. The set temperature is selectable in increments of 0.5° C between 37 and 41°C. The default temperature is 38.5° C. The infusate is warmed to approximately the set temperature as it travels a path around the constantly monitored and regulated heat exchanger. The temperature is measured at the end of the extension set, where it leaves the spiral groove.
The BW685 / BW685 S weigh 1.9 and 2.0 kg respectively and are equipped with a dual knob clamp at the back of the devices for attachment to an I.V. pole; the devices may also be clamped to a bedrail.
The BW685 and BW685S are identical except that the BW685 S has provision and additional circuitry for connection to an additional heating element that can be placed
Page 5.1
PDF Page 16 of 472
1
510(k) Summary Page 2 of 7 18-Apr-2012
nearer the patient. The additional heating element is called the TubeFlow and fits over the I.V. line to the patient. The TubeFlow is electrically powered from the BW685S and contains a display indicative of the heating status (green for heating) or over-temperature (red). The TubeFlow does not contain software.
Indications for Use:
The BW685/BW685 S blood / fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients.
| Patient Population: | Adult and pediatric |
|---|---|
| Environment of Use: | Hospital |
| Contraindications: | None |
Table of Comparison and Differences vs. Predicates
We present a comparison of the proposed device and the predicate in the following table and then discuss the table and any differences.
Page 5.2
PDF Page 17 of 472
2
Premarket Notification 510(k)
Section 5 — 510(k) Summary
Biegler GmbH BW685/
510(k) Summary
omparison to Predica
| Attribute | Biegler GmbH
BW385L
K954769 | Biegler GmbH
BW685 and BW685 S | Equivalency to at least one or
both devices |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Biegler BW385L Blood & Infusion Warmer
was specifically designed to reduce the
complications associated with the moderate rate
infusion of cold blood and liquids. | The BW685/S blood / fluid warming system is
intended to deliver warm blood, blood products,
and liquids to adult and pediatric patients. | Similar |
| Environments of
use | Hospital | Hospital | Identical |
| Principle of
operation | Continuous flow electrically powered warmer | Continuous flow electrically powered warmer | Identical |
| Warm up time | 45-55 seconds | 45-55 seconds | Identical |
| Ingress Protection | IPX1 | IPX4 | Better liquid ingress protection in
BW685 and BW685S |
| Degree of
protection against
electric shock | Type B | Type B | Identical |
| Dimensions | 140 x 190 x 240mm | 228 x 278 x 132mm | |
| Prescriptive | Yes | Yes | Identical |
| Patient population | adult and pediatric | adult and pediatric | Identical |
| Single patient
reusable | Yes for accessories | Yes for accessories | Identical |
| Accessories | 3 extension sets | 3 extension sets | The three extension sets used with
the BW685/S are identical to those
in K954769 |
| | | Tube Flow | Tube Flow is an option for the
BW685S. details below |
| Attribute | Biegler GmbH
BW385L
K954769 | Biegler GmbH
BW685 and BW685 S | Equivalency to at least one or
both devices |
| Heating
Mechanism | Heating cylinder around which is wrapped an
extension set | heating cylinder around which is wrapped an
extension set, additional heating with TubeFlow | Identical except for TubeFlow.
TubeFlow provides additional
heating near patient to compensate
for any thermal losses between
685S and patient. |
| Fluid Contact
materials | Extension sets PVC, ABS | Extension sets PVC, ABS | Identical
The extension sets are identical in
every respect |
| Temperature
Control | 3 sensors: I monitored by software, two hardware | 3 sensors: I monitored by software, two
hardware | Identical |
| Alarm | Audio/Visual | Audio/ Visual | Identical |
| Product Code | LGZ | LGZ | Identical |
| Alarm Conditions | Audible and Visual
Low temperature (42.0C) | Audible and Visual
Low temperature (42.0C) | Identical |
| Operation | 110/220 VAC with AC power | 110/220 VAC with AC power | Identical |
| Electronics | Microprocessor Control | Microprocessor Control | Identical |
| Infusion
Temperature | Fixed at 38.5°C | User selectable between 37 to 41°C at
increments of 0.5° Default 38.5°C | Identical, except for TubeFlow |
| | | Tube Flow: Fixed 39.0°C | |
| Attribute | Biegler GmbH
BW385L
K954769 | Biegler GmbH
BW685 and BW685 S | Equivalency to at least one or
both devices |
| Tube Flow | Not present | Present on BW685S | The additional heating element is
called the TubeFlow and clamps
over the I.V. line to the
patient. The TubeFlow is
electrically powered from the
BW685S and contains a display
indicative of the heating status
(green for heating) or over
temperature (yellow). |
| Tube Flow
Materials | NA | Housing: Same material as BW685 S housing:
Sabic Cycoloy Resin C2800
There are no materials of the TubeFlow which
contact the patient or infusate. | |
| Tube Flow
Control | NA | The TubeFlow does not contain software. The
addition in the BW685S is a power supply and
sensing and control circuitry for controlling
temperature in the TubeFlow. | |
| Tube Flow Set
Temperature | NA | 39.0°C | |
| Tube Flow
Temperature
Control | NA | The TubeFlow contains an independent
temperature sensor.
It also contains an independent temperature
sensor in the silicone profile to detect over-
temperature. | |
PDF Page 18 of 472 Page 5.3
3
Premarket Notification 510(k)
Section 5 – 510(k) Summary
Biegler GmbH BW685/S
: :
Page 5.4
PDE Page 19 of 472
4
Premarket Notification 510(k)
Section 5 – 510(k) Summary
. . . .
Biegler GmbH·BW685/S
Page 5.5
5
510(k) Summary Page 6 of 7
18-Apr-2012
Discussion:
There are no significant differences which would affect safety and efficacy for patient safety.
Substantial Equivalence
The warming methodology of the BW685 and BW685 S are identical to the predicate. The fluid contact extension sets used with the BW685 and BW685 S are identical to the predicate.
The fundamental scientific technology of the BW685 and BW685 S is identical to the predicate.
The differences that exist between the devices are insignificant in the terms of safety or effectiveness.
Indications - Equivalent to the predicate
Technology - The technology is identical
Operating specifications - Equivalent-
Materials - The fluid contact materials are identical.
The only patient contact is the fluid / blood via the extension sets provided by Biegler for exclusive use with the proposed blood / fluid warmer. The extension sets are identical to those used in the predicate.
Environment of Use - Identical
Patient Population - Identical
Differences:
There are no significant differences between the proposed device and the predicate device.
6
Premarket Notification 510(k) Section 5 - 510(k) Summary
510(k) Summary Page 7 of 7 -18-Apr-2012
Comparative Performance and Specifications
We have performed the following testing:
- . Leakage testing
- Heater testing at various flow rates
- . Fault testing
- Testing to the requirements of ASTM F2172-02 Standard Specification for Blood/ Intravenous Fluid/Irrigation Fluid Warmers
WE have also performed testing to ensure that the proposed device met its specifications. As well we have done a comparison of specifications in the above tables and found the proposed models to be equivalent.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its wing, symbolizing strength and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biegler GmbH C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134
JUL 12 2012
Re: K121198
Trade/Device Name: BW685 and BW685S Regulation Number: None Regulation Name: None · Regulatory Class: Unclassified Product Code: LGZ Dated: June 18, 2012 Received: June 20, 2012
Dear Mr. Dryden:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
8
Page 2 - Mr. Dryden
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
9
Premarket Notification 510(k) Section 4 - Indications for Use Statement
Indications for Use Statement
Page 1 of 1
510(k) Number:
K121198 (To be assigned)
Device Name:
BW685 and BW685S
Indications for Use:
The BW685/BW685 S blood / fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients.
Prescription Use XX (Part 21 CFR 801 Subpart D) 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)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K121198
Page 4.2 PDF Page 15 of 472