ENFLOW IV FLUID WARMER
Device Facts
| Record ID | K112902 |
|---|---|
| Device Name | ENFLOW IV FLUID WARMER |
| Applicant | Vital Signs, Inc. |
| Product Code | LGZ · General Hospital |
| Decision Date | Mar 14, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The enFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
Device Story
enFlow IV Fluid Warmer system comprises a controller (power supply), warmer unit, and single-use sterile disposable cartridges (with or without IV tube extension). Device warms blood, blood products, and IV solutions to 40°C at flow rates between 1 ml/min and 200 ml/min. Sterile cartridges feature plastic housing and biocompatible coated aluminum extrusion forming enclosed fluid path; heat generated via electrical resistance transfers from warmer to fluid through extrusion. Standard Luer fittings connect to hospital IV lines. Used by healthcare professionals in hospital, clinical, and field environments to prevent hypothermia. Output is warmed fluid delivered to patient; healthcare providers monitor fluid administration to manage patient temperature.
Clinical Evidence
No clinical data. Modifications did not require clinical testing to support substantial equivalence.
Technological Characteristics
System includes controller, warmer, and sterile disposable cartridges. Materials include plastic housing and biocompatible coated aluminum extrusion. Heating via electrical resistance. Flow rates 1-200 ml/min; max temperature 40°C. Connectivity via standard Luer fittings. Software included. Sterilization and shelf life testing performed.
Indications for Use
Indicated for warming blood, blood products, and IV solutions prior to administration in patients requiring fluid warming to prevent hypothermia. Intended for use by healthcare professionals in hospital, clinical, and field settings.
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
- eFlow Model 100 IV Fluid Warmer (K060537)
Submission Summary (Full Text)
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## 1296 Vital Signs, a GE Healthcare Company 510(k) Premarket Notification
MAR 1 4 2012
# 510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
- 1. Name of Submitter, Contact Person and Date Summary Prepared:
| Name: | Vital Signs, Inc., a GE Healthcare Company |
|----------------------|----------------------------------------------------|
| Address: | 20 Campus Rd.<br>Totowa, NJ 07512 |
| Official Contact: | Stacie Geffner-Atiya<br>Regulatory Affairs Manager |
| Phone: | 973-956-5491 |
| Fax: | 973-956-5442 |
| Alternate Contact: | Agata Smieja<br>410-456-0329 |
| Date of Preparation: | September 30, 2011 |
- 2. Device Trade Name and Common Name:
| Trade Name: | enFlow IV Fluid Warmer | |
|--------------------|------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Classification Name: | Sterile Fluid Path, in-line Blood Fluid Warmer<br>Warmer, Thermal, Infusion Fluid<br>Warmer Blood, Non Electromagnetic Radiation |
| Product Code: | LGZ<br>BSB – 21 CFR 864.9205 | |
| Device Class: | Class II | |
- Legally Marketed Predicate Device: 4.
3.
Substantial equivalence is claimed to: eFlow Model 100 IV Fluid Warmer (K060537) Enginivity / Vital Signs
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#### 5. Description of the Device:
The Vital Signs, Inc. enFlow IV Fluid Warmer consists of a Warmer, Controller (Power Supply) and single use sterile disposable cartridges, which are available with or without an IV tube extension set. The warmer will deliver infuscate to a patient at a temperature of up to 40°C at flow rates of 1 ml/min to a maximum of 200 ml/min.
The sterile disposable cartridges consist of a plastic housing and biocompatible coated aluminum extrusion which when combined form an enclosed fluid path. Heat, generated by electrical resistance, is transferred from the warmer to the fluid through the extrusion. Standard Luer fittings at the input and output allow the connection of standard hospital IV lines to the enclosed fluid path. The Controller serves as the power supply for the Warmer unit.
#### ર. Intended Use of the Device:
The enFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
#### 7. Technology:
The Vital Signs, Inc. enFlow Fluid Warmer is substantially equivalent to the previously cleared eFlow IV Fluid Warmer (K060537). The basis for this submission is to notify the FDA of the accumulation of various modifications to the enFlow IV Fluid Warmer since the previous clearance, including minor labeling, shelf life, design and software modifications. There have been no changes to the fundamental scientific technology of the device.
#### 8. Discussion of Non-clinical Studies:
The following quality assurance and design control measures were applied to the development of the enFlow IV Fluid Warming system and, as described within the 510(k) notification, support the substantial equivalence of the device:
- � Risk Analysis
- � Requirements Development and Reviews
- . Software Verification and Validation
- . Performance/Functional Verification and Validation
- . Biocompatibility Testing
- Sterilization and Shelf Life Testing .
- Electrical Safety and EMC Testing .
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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters are stylized and connected, giving the logo a distinctive and recognizable appearance. The logo is in black and white.
. .
#### 9. Summary of Clinical Tests:
The modifications made to the enFlow IV Fluid Warmer did not require clinical testing to support substantial equivalence.
- 10. Conclusion:
Vital Signs, a GE Healthcare Company, considers the enFlow IV Fluid Warmer to be as safe, as effective, and the performance to be substantially equivalent to the predicate device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Stacie Geffner-Atiya Regulatory Affairs Manager Vital Signs, Incorporated 20 Campus Road Totowa, New Jersey 07512
MAR 1 4 2012
Re: K112902 Trade/Device Name: enFlow IV Fluid Warmer Regulation Number: 21 CFR 864.9205 Regulation Name: Blood and Plasma Warming Device
Regulatory Class: II Product Code: LGZ Dated: February 16, 2012 Received: February 17, 2012
Dear Ms. Geffner-Atiya:
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 Eederal Register.
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### Page 2- Ms. Geffner-Atiya
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/ucm 115809.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,
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
Enclosure
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Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: enFlow IV Fluid Warmer
Indications for Use:
The enFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
く Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. Chapman 3/8/12
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K112902
