BW685, BW685S

K121198 · Biegler GmbH · LGZ · Jul 12, 2012 · General Hospital

Device Facts

• Record ID: K121198
• Device Name: BW685, BW685S
• Applicant: Biegler GmbH
• Product Code: LGZ · General Hospital
• Decision Date: Jul 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The BW685/BW685 S blood / fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients.

Device Story

BW685/BW685S are electrically powered blood and infusion fluid warmers. Device uses aluminum heat exchanger with spiral groove to hold I.V. extension set; infusate flows through extension set without direct contact with heat exchanger. Temperature is user-selectable (37-41°C) via front panel controls; default 38.5°C. BW685S includes optional 'TubeFlow' heating element for additional warming near patient. Devices are clamped to I.V. poles or bedrails in hospital environments. Microprocessor-controlled system monitors temperature at end of extension set; provides audio/visual alarms for high/low temperature conditions. TubeFlow (BW685S only) provides independent temperature sensing and heating status display. System ensures infusate reaches target temperature, reducing complications associated with infusion of cold fluids.

Clinical Evidence

Bench testing only. Testing included leakage testing, heater performance at various flow rates, fault testing, and verification against ASTM F2172-02 Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers. No clinical data presented.

Technological Characteristics

Electrically powered (120 VAC) fluid warmer. Aluminum heat exchanger with spiral groove. Materials: PVC/ABS extension sets; Sabic Cycoloy Resin C2800 housing. Microprocessor-controlled. Temperature range 37-41°C. IPX4 ingress protection. TubeFlow (BW685S) provides secondary heating at 39.0°C. Complies with ASTM F2172-02.

Indications for Use

Indicated for delivery of warmed blood, blood products, and liquids to adult and pediatric patients in hospital settings. No contraindications.

Regulatory Classification

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.

Predicate Devices

• Biegler BW385L (K954769)

Submission Summary (Full Text)

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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 Netauschek<br>Biegler GmbH<br>Allhangstrasse 18a<br>3001 Mauerbach Austria<br>Tel - (0043)1979210515<br>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

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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.

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

Biegler GmbH BW685/

# 510(k) Summary

omparison to Predica

| Attribute | Biegler GmbH<br>BW385L<br>K954769 | Biegler GmbH<br>BW685 and BW685 S | Equivalency to at least one or<br>both devices |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Biegler BW385L Blood & Infusion Warmer<br>was specifically designed to reduce the<br>complications associated with the moderate rate<br>infusion of cold blood and liquids. | The BW685/S blood / fluid warming system is<br>intended to deliver warm blood, blood products,<br>and liquids to adult and pediatric patients. | Similar |
| Environments of<br>use | Hospital | Hospital | Identical |
| Principle of<br>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<br>BW685 and BW685S |
| Degree of<br>protection against<br>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<br>reusable | Yes for accessories | Yes for accessories | Identical |
| Accessories | 3 extension sets | 3 extension sets | The three extension sets used with<br>the BW685/S are identical to those<br>in K954769 |
| | | Tube Flow | Tube Flow is an option for the<br>BW685S. details below |
| Attribute | Biegler GmbH<br>BW385L<br>K954769 | Biegler GmbH<br>BW685 and BW685 S | Equivalency to at least one or<br>both devices |
| Heating<br>Mechanism | Heating cylinder around which is wrapped an<br>extension set | heating cylinder around which is wrapped an<br>extension set, additional heating with TubeFlow | Identical except for TubeFlow.<br>TubeFlow provides additional<br>heating near patient to compensate<br>for any thermal losses between<br>685S and patient. |
| Fluid Contact<br>materials | Extension sets PVC, ABS | Extension sets PVC, ABS | Identical<br>The extension sets are identical in<br>every respect |
| Temperature<br>Control | 3 sensors: I monitored by software, two hardware | 3 sensors: I monitored by software, two<br>hardware | Identical |
| Alarm | Audio/Visual | Audio/ Visual | Identical |
| Product Code | LGZ | LGZ | Identical |
| Alarm Conditions | Audible and Visual<br>Low temperature (<36.5C)<br>High Temperature (>42.0C) | Audible and Visual<br>Low temperature (<36.5C)<br>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 |
| Infusion<br>Temperature | Fixed at 38.5°C | User selectable between 37 to 41°C at<br>increments of 0.5° Default 38.5°C | Identical, except for TubeFlow |
| | | Tube Flow: Fixed 39.0°C | |
| Attribute | Biegler GmbH<br>BW385L<br>K954769 | Biegler GmbH<br>BW685 and BW685 S | Equivalency to at least one or<br>both devices |
| Tube Flow | Not present | Present on BW685S | The additional heating element is<br>called the TubeFlow and clamps<br>over the I.V. line to the<br>patient. The TubeFlow is<br>electrically powered from the<br>BW685S and contains a display<br>indicative of the heating status<br>(green for heating) or over<br>temperature (yellow). |
| Tube Flow<br>Materials | NA | Housing: Same material as BW685 S housing:<br>Sabic Cycoloy Resin C2800<br>There are no materials of the TubeFlow which<br>contact the patient or infusate. | |
| Tube Flow<br>Control | NA | The TubeFlow does not contain software. The<br>addition in the BW685S is a power supply and<br>sensing and control circuitry for controlling<br>temperature in the TubeFlow. | |
| Tube Flow Set<br>Temperature | NA | 39.0°C | |
| Tube Flow<br>Temperature<br>Control | NA | The TubeFlow contains an independent<br>temperature sensor.<br>It also contains an independent temperature<br>sensor in the silicone profile to detect over-<br>temperature. | |

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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

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### 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 [phone] or [phone] 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

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