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.

AI/ML Overview

The provided document is a 510(k) summary for the Biegler GinbH BW685/S fluid warmer, a medical device. It does not describe a study involving an algorithm or AI, nor does it present acceptance criteria and performance data in the context of such a study.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Biegler BW385L K954769) to gain market clearance. The "acceptance criteria" discussed are largely related to direct comparisons of device specifications and functional properties to the predicate device, or adherence to general safety standards.

Therefore, I cannot extract the requested information concerning a device performance study, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not relevant to this type of regulatory submission for this particular device.

Here's an analysis of the "acceptance criteria" and "performance" as presented in this 510(k) summary, reframed to align with the provided content:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison to a predicate device to establish substantial equivalence. The "acceptance criteria" in this context are effectively the specifications and operational characteristics of the predicate device, which the new device aims to meet or exceed without raising new questions of safety or effectiveness.

Attribute	Predicate Device (Biegler BW385L K954769) "Acceptance Criterion"	Proposed Device (Biegler BW685 and BW685 S) "Reported Performance"	Conclusion/Equivalency
Indications for Use	Intended to reduce complications associated with moderate rate infusion of cold blood and liquids.	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
Patient population	adult and pediatric	adult and pediatric	Identical
Fluid Contact materials	Extension sets PVC, ABS	Extension sets PVC, ABS	Identical (extension sets are identical)
Temperature Control	3 sensors: 1 monitored by software, two hardware	3 sensors: 1 monitored by software, two hardware	Identical
Alarm	Audio/Visual	Audio/Visual	Identical
Alarm Conditions	Audible and Visual: Low temperature (<36.5°C), High Temperature (>42.0°C)	Audible and Visual: Low temperature (<36.5°C), High Temperature (>42.0°C)	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°C. Default 38.5°C. (TubeFlow: Fixed 39.0°C)	Identical, except for TubeFlow (which adds selectable range and a higher fixed temp for the additional element)
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 (additional heating near patient)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The document mentions "Heater testing at various flow rates" and "Fault testing" but does not detail the sample sizes, test conditions (e.g., number of units tested, duration), or data provenance. The tests performed are listed as:

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

These tests are typically performed on a limited number of manufactured units in a controlled lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. This device is a fluid warmer, not a diagnostic imaging device or an AI algorithm that requires expert interpretation for a "ground truth" reference. The "ground truth" for a fluid warmer would be objective measurements of temperature, flow rates, and safety parameters, typically collected by engineers or technicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. As explained above, there's no diagnostic or interpretive task that would require expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. An MRMC study is relevant for AI-powered diagnostic tools or decision support systems. The BW685/S is a physical medical device (fluid warmer), not an AI system, and therefore, an MRMC study is not relevant to its regulatory submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable and not provided. The BW685/S is a physical medical device; it does not contain a standalone algorithm in the context of an AI-powered diagnostic or therapeutic system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The implied "ground truth" for this device would be:

Objective physical measurements: Accurate temperature readings (e.g., from calibrated thermometers), confirmed flow rates, electrical safety measurements, and leak detection.
Compliance with standards: Adherence to established performance and safety standards like ASTM F2172-02.

There is no "expert consensus," "pathology," or "outcomes data" ground truth referenced, as these are typically associated with diagnostic or therapeutic efficacy studies, not the functional performance of a fluid warmer.

8. The sample size for the training set

This information is not applicable and not provided. A training set is used for machine learning models. This document describes a physical medical device.

9. How the ground truth for the training set was established

This information is not applicable and not provided. As above, there is no training set for this device.

Summary

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K121198

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 NetauschekBiegler GmbHAllhangstrasse 18a3001 Mauerbach AustriaTel - (0043)1979210515Fax - (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 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

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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

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Premarket Notification 510(k)
Section 5 — 510(k) Summary

Biegler GmbH BW685/

510(k) Summary

omparison to Predica

Attribute	Biegler GmbHBW385LK954769	Biegler GmbHBW685 and BW685 S	Equivalency to at least one orboth devices
Indications forUse	The Biegler BW385L Blood & Infusion Warmerwas specifically designed to reduce thecomplications associated with the moderate rateinfusion of cold blood and liquids.	The BW685/S blood / fluid warming system isintended to deliver warm blood, blood products,and liquids to adult and pediatric patients.	Similar
Environments ofuse	Hospital	Hospital	Identical
Principle ofoperation	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 inBW685 and BW685S
Degree ofprotection againstelectric 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 patientreusable	Yes for accessories	Yes for accessories	Identical
Accessories	3 extension sets	3 extension sets	The three extension sets used withthe BW685/S are identical to thosein K954769
		Tube Flow	Tube Flow is an option for theBW685S. details below
Attribute	Biegler GmbHBW385LK954769	Biegler GmbHBW685 and BW685 S	Equivalency to at least one orboth devices
HeatingMechanism	Heating cylinder around which is wrapped anextension set	heating cylinder around which is wrapped anextension set, additional heating with TubeFlow	Identical except for TubeFlow.TubeFlow provides additionalheating near patient to compensatefor any thermal losses between685S and patient.
Fluid Contactmaterials	Extension sets PVC, ABS	Extension sets PVC, ABS	IdenticalThe extension sets are identical inevery respect
TemperatureControl	3 sensors: I monitored by software, two hardware	3 sensors: I monitored by software, twohardware	Identical
Alarm	Audio/Visual	Audio/ Visual	Identical
Product Code	LGZ	LGZ	Identical
Alarm Conditions	Audible and VisualLow temperature (<36.5C)High Temperature (>42.0C)	Audible and VisualLow temperature (<36.5C)High Temperature (>42.0C)	Identical
Operation	110/220 VAC with AC power	110/220 VAC with AC power	Identical
Electronics	Microprocessor Control	Microprocessor Control	Identical
InfusionTemperature	Fixed at 38.5°C	User selectable between 37 to 41°C atincrements of 0.5° Default 38.5°C	Identical, except for TubeFlow
		Tube Flow: Fixed 39.0°C
Attribute	Biegler GmbHBW385LK954769	Biegler GmbHBW685 and BW685 S	Equivalency to at least one orboth devices
Tube Flow	Not present	Present on BW685S	The additional heating element iscalled the TubeFlow and clampsover the I.V. line to thepatient. The TubeFlow iselectrically powered from theBW685S and contains a displayindicative of the heating status(green for heating) or overtemperature (yellow).
Tube FlowMaterials	NA	Housing: Same material as BW685 S housing:Sabic Cycoloy Resin C2800There are no materials of the TubeFlow whichcontact the patient or infusate.
Tube FlowControl	NA	The TubeFlow does not contain software. Theaddition in the BW685S is a power supply andsensing and control circuitry for controllingtemperature in the TubeFlow.
Tube Flow SetTemperature	NA	39.0°C
Tube FlowTemperatureControl	NA	The TubeFlow contains an independenttemperature sensor.It also contains an independent temperaturesensor in the silicone profile to detect over-temperature.

PDF Page 18 of 472 Page 5.3

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Premarket Notification 510(k)
Section 5 – 510(k) Summary

Biegler GmbH BW685/S

: :

Page 5.4
PDE Page 19 of 472

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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.

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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.

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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.

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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

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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

Regulation Number and Section

§ 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).