ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER

{0}------------------------------------------------ K121775 # NOV 2 8 2012 Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a circular shape. The circle is surrounded by a decorative, swirling pattern, giving the logo a classic and recognizable appearance. enFlow IV Fluid Warmer Strap Special 510(k) Premarket Notification ## 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. Name of Submitter, Contact Person and Date Summary Prepared: l. Name: Vital Signs, Inc., a GE Healthcare Company Address: Official Contact: Phone: Fax: 3. Regulatory Affairs Manager 973-956-5491 Stacie Geffner-Atiya 973-956-5442 20 Campus Rd. Totowa, NJ 07512 Alternate Contact: Agata Smieja 410-456-0329 Date of Preparation: June 14, 2012 - 2. Device Trade Name and Common Name: | Trade Name: | enFlow IV Fluid Warmer | |----------------------|--------------------------------------------------------------------------------| | Common/Usual Name: | Sterile Fluid Path, in-line Blood Fluid Warmer | | Classification Name: | Warmer, Thermal, Infusion Fluid<br>Warmer Blood, Non Electromagnetic Radiation | | Product Code: | LGZ<br>BSB - 21 CFR 864.9205 | | Device Class: | Class II | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are in black, contrasting with the white background. The logo is a well-known symbol associated with the General Electric company. ## enFlow IV Fluid Warmer Strap Special 510(k) Premarket Notification 4. Legally Marketed Predicate Device: > Substantial equivalence is claimed to: Vital Signs, Inc. enFlow Model IV Fluid Warmer (K112902) (a GE Healthcare Company) 5. Device and Change Description: > 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 infusate to a patient at a temperature of up to 40°C at flow rates of KVO (Keep vein open) to a maximum of 200ml/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. Description of Device Modification The basis for this submission is to notify the FDA of the addition of a Warmer Strap to the enFlow IV Fluid Warmer. The Strap is an accessory whose function is to secure the enflow IV Fluid Warmer to the arm. 6. Indications for Use: > The enFlow IV Fluid Warmer System 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* IV Fluid Warmer is substantially equivalent to the previously cleared enFlow IV Fluid Warmer (K112902). The basis for this submission is to notify the FDA of the addition of a strap to be sold as an accessory to the IV Fluid {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The frame has decorative flourishes at the top, bottom, and sides, giving it a vintage or classic appearance. The logo is black and white. enFlow IV Fluid Warmer Strap Special 510(k) Premarket Notification Submission Warmer. There have been no changes to either the intended use of the device or the fundamental scientific technology of the device. Discussion of Non-clinical Studies: 8. > 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 . - . Biocompatibility Testing - Performance Testing � #### Summary of Clinical Tests: 9. The modifications made to the enFlow IV Fluid Warmer did not require clinical testing to support substantial equivalence. #### Conclusion: l 0. Vital Signs, Inc. 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. {3}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, with three abstract shapes representing the head, body, and legs. The figure is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 NOV 2 8 2012 Ms. Stacie Geffner-Atiya Regulatory Affairs Manager Vital Signa. Incorporated A GE Healthcare Company 20 Campus Road Totowa, New Jersey 07512 Re: K121775 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: October 26, 2012 Received: October 31, 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 i 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. {4}------------------------------------------------ ## 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/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/ResourcesforYou/Industry/default.htm. Sincerely vours, 2012.11.28 Susan Runner DDS, MA -1-2:18:30 -05'00' Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular border. There are small, teardrop-shaped elements around the outer edge of the circle, giving it a slightly decorative appearance. The logo is black and white. ### enFlow IV Fluid Warmer Strap Special 510(k) Premarket Notification Submission #### Indications for Use Statement K121775 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) Digitally signed by Richard C. Chapman Date: 2012.11.28 12:12:25 -05'00' Page I of I (Division Sign-Off) (Division Sign-On) Division of Anasthesiology, General Hospital Infection Control, Dental Devices 510(k) Number:_ 15