ENFLOW IV FLUID WARMER INSULATED STRAP

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '130867'. The characters are written in a simple, clear style, and they appear to be on a white background. ## GE Healthcare 510(k) Premarket Notification Submission Image /page/0/Picture/3 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white, with the letters and border appearing in white against a black background. # JUN 1 4 2013 ### 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: | Date: | March 26, 2013 | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Vital Signs Inc., A GE Healthcare Company | | | 20 Campus Road | | | Totowa, NJ 07512 | | | Telephone: (973) 597-1800 | | Primary Contact Person: | Stacie Geffner-Atiya | | | Regulatory Affairs Manager | | | Vital Signs Inc., A GE Healthcare Company | | | Telephone: (973) 956-5491 | | | Fax: (973) 956-5442 | | | Email: stacie.geffner-atiya@ge.com | | Secondary Contact<br>Person: | Trishia Dwyer | | | Regulatory Affairs Leader | | | GE Healthcare | | | Telephone: (608) 221-1551 x500-3074 | | | Fax: (608) 646-6488 | | | Email: trishia.l.dwyer@ge.com | | Device Trade Name: | enFlow IV Fluid Warmer, enFlow IV Fluid Warmer Insulated<br>Strap | | Common/Usual Name: | enFlow, Insulated strap, i-strap | | Classification Names: | Warmer, Thermal, Infusion Fluid | | Product Code: | LGZ | | | BSB - 21 CFR 864.9205 | | Predicate Device(s): | K121775, enFlow IV Fluid Warmer Strap | | Device Description: | The Insulated Strap is an accessory to the enFlow IV Fluid<br>Warmer which is used to secure the warmer component of the<br>enFlow IV Fluid Warmer System to the patient during transport.<br>The Insulated strap consists of a silicone strap, an insulating<br>element and a mounting plate, into which the user can secure<br>the enFlow IV Fluid Warmer. | | Intended Use: | The enFlow IV Fluid Warmer System is indicated for warming<br>blood, blood products and intravenous solutions prior to<br>administration. It is intended to be used by healthcare<br>professionals in hospital, clinical and field environments to help<br>prevent hypothermia. | | Technology: | The enFlow IV Fluid Warmer with Insulated Strap accessory<br>does not change the fundamental scientific technology of the<br>enFlow IV Fluid Warmer with Strap, its predicate device.<br>The Insulated Strap is equivalent in performance to the<br>predicate strap, but introduces new materials which compose<br>the insulating element and the mounting plate. | | Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests:<br>The enFlow IV Fluid Warmer with Insulated Strap and its<br>accessories comply with voluntary standards. The following<br>quality assurance measures were applied to the development<br>of the system:<br>Risk Analysis - Risk Management was employed throughout<br>the development and implementation of the enFlow IV Fluid<br>Warmer System. Design & Performance Verification Testing including<br>functional, packaging and labeling evaluations - verified<br>that the enFlow Fluid Warmer IV System meets the defined<br>specifications. Biocompatibility testing - The materials used in the<br>Insulated strap meet the biocompatibility requirements per<br>ISO 10993. User Validation Testing - User testing was performed to<br>'validate the enFlow IV Fluid Warmer Insulated Strap against<br>its intended use. Summary of Clinical Tests:<br>The subject of this premarket submission, enFlow IV Fluid<br>Warmer Insulated Strap, did not require clinical studies to<br>support substantial equivalence. | | Conclusion: | GE Healthcare considers the enFlow IV Fluid Warmer System<br>with the Insulated Strap to be as safe, as effective, and to<br>perform in a substantially equivalent manner to the current<br>enFlow IV Fluid Warmer System, and to the predicate device<br>enFlow IV Fluid Warmer Strap. | 33 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters and the border are in black, while the background is white. ## GE Healthcare 510(k) Premarket Notification Submission {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are solid black, creating a strong contrast against the white background. - ### GE Healthcare 510(k) Premarket Notification Submission 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - : and the same of the same . and the state of the same - : . and the control control of the control of {3}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 ### June 14, 2013 Vital Signs, Incorporated, A GE Healthcare Company Ms. Stacie Geffner-Atiya Regulatory Affairs Manager 20 Campus Road TOTOWA NJ 07512-1210 Re: K130867 Trade/Device Name: enFlow IV Fluid Warmer Regulation Number: 21 CFR 864.9205 Regulation Name: Blood and Plasma Warming Device Regulatory Class: Unclassified Product Code: LGZ Dated: May 24, 2013 Received: May 29, 2013 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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 vours. Mary-S. Susan Runner DDS, MA Runner -S Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 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. | Prescription Use | x | |------------------|---| |------------------|---| AND/OR Over-The-Counter Use (Part 21 CFR 801 Subport C) (Part 21 CFR 801 Sub part D) (PLEASE DO NOT-WRITE BELOW THIS LINE - CONTINUE ON AÑOTHER PAGE IF NEEDED) Image /page/5/Picture/10 description: The image shows a logo with the letters FDA. The letters are stylized and made up of multiple parallel lines. The letters are arranged horizontally, with the F on the left, the D in the middle, and the A on the right. The logo is black and white. Richard C. Chapman 2013.06.14 11:32:3.1 -04'00' (Division Sign-Off) Division of Anesthesiology, General Hospital Intection Control, Dental Devices 130867 510(k) Number: _