REDSENSE-ALARM UNIT AND SENSOR

{0}------------------------------------------------ K103242 PAGE 1 OF 3 FEB 1 0 2011 ## 510(k) Summary Submitter: Redsense Medical AB Rörkullsvägen 4 302 41 HALMSTAD SWEDEN +46 35 106030 Contact Information: Constance G. Bundy C. G. Bundy Associates, Inc. 435 Rice Creek Terrace Fridlev. MN 55432 763-574-1976 Fax: 763-571-2437 cgbundy@live.com Submission Date: October 26, 2010, Revised January 31, 2011 Device Name and Classification: Redsense-Alarm unit and sensor for Clinical Use (Model RA-1-RA001C), Class II, 876.5820, 876.5540, product code ODX Submission Purpose: Expand Intended Use for up to 8 hours clinical use. ## Equivalent Device Identification: | Redsense Medical AB K071013 | |-----------------------------| | Redsense Medical AB K092955 | | Gambro, Inc K070643 | Device Description: Redsense is a system for monitoring the vein needle during hemodialysis. Redsense consists of an alarm unit and optical sensor incorporated into an adhesive patch. The patch with the sensor is placed over the vein needle and detects any blood that drips onto the patch if the needle has been accidentally pulled out or if there is leakage during dialysis. If blood loss is detected, the device will alarm. Intended Use: The Redsense device is intended to monitor for potential blood loss from a hemodialysis access site in patients undergoing continuous hemodialysis treatment up to 8 hours in the clinical setting. The device includes a blood sensor incorporated into an adhesive sensor patch. The sensor monitors potential blood leakage from the venous needle puncture site via an infrared light and will alarm if blood leakage is detected via absorption onto the device's sensor patch. {1}------------------------------------------------ # K103242 PAGE 2 OF 3 ## Comparison Table: · س : | Parameter | Proposed Device | Predicate device 1 | Predicate 2 | Predicate Device 3 | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | Redsense Alarm<br>Unit, Clinical Use,<br>RA-1-RA001C | Redsense Alarm<br>Unit | Redsense Alarm<br>Unit. Home use | Phoenix<br>HEMODIALYSIS<br>DELIVERY<br>SYSTEM | | For use at: | Clinic | Clinic | Home or clinic | Clinic | | Intended<br>Use | The Redsense<br>device is intended to<br>monitor for potential<br>blood loss from the<br>hemodialysis access<br>site in hemodialysis<br>patients undergoing<br>continuous<br>hemodialysis<br>treatment up to 8<br>hours in the clinical<br>settings. The device<br>includes a blood<br>sensor incorporated<br>into an<br>adhesive sensor<br>patch. The sensor<br>monitors potential<br>blood leakage from<br>the venous needle<br>puncture site via an<br>infrared light and will<br>alarm if blood<br>leakage is detected<br>via absorption onto<br>the device's sensor<br>patch. | The Redsense device<br>is intended to monitor<br>for potential blood<br>loss from the<br>hemodialysis access<br>site in hemodialysis<br>patients undergoing<br>continuous<br>hemodialysis<br>treatment up to 5<br>hours in the clinical<br>setting. The device<br>includes a blood<br>sensor incorporated<br>into an<br>adhesive sensor<br>patch. The sensor<br>monitors potential<br>blood leakage from<br>the venous needle<br>puncture site via an<br>infrared light and will<br>alarm if blood leakage<br>is detected via<br>absorption onto the<br>device's sensor<br>patch. | The Redsense<br>device is intended to<br>monitor for potential<br>blood loss from the<br>hemodialysis access<br>site in hemodialysis<br>patients undergoing<br>hemodialysis<br>treatment up to 5<br>hours at home or in<br>the clinical setting.<br>The device includes a<br>blood sensor<br>incorporated into an<br>adhesive dressing.<br>The sensor monitors<br>potential blood<br>leakage from the<br>needle puncture via<br>an infrared light and<br>will alarm if needle<br>dislodgement or blood<br>leakage is detected.<br>All use must be<br>administrated under<br>physician's<br>prescription, and must<br>be observed by a<br>trained and qualified<br>person considered to<br>be competent in the<br>use of this device by<br>the prescribing<br>physician. | The Phoenix<br>Hemodialysis<br>delivery system is<br>intended to be used<br>to provide high flux<br>and low flux<br>hemodialysis,<br>hemofiltration and<br>ultrafiltration on<br>patients weighing 15<br>Kilograms or more.<br>The Phoenix<br>system is to be used<br>with either high or<br>low permeability<br>dialyzers.<br>The device is<br>intended to be used<br>by trained operators<br>when<br>prescribed by a<br>physician, in a<br>chronic care dialysis<br>facility or acute<br>care unit. | | Maximum<br>Dialysis<br>Time | 8 hours | 5 hours | 5 hours | 8 hours | {2}------------------------------------------------ <103242 Summary of Testing: Verification testing has been performed to verify that the Redsense device fulfills the Requirement Specifications and can be used for up to 8 hours in a clinical setting. Additional tests of the audible and visual capability of the alarm have been performed. Test results met the requirements of the standards used for testing. ## Conclusion: Redsense device is identical to the Redsense device previously cleared with the addition of the 8 hour clinical use indication. Verification testing showed the Redsense device to be safe and effective for its intended use. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 FEB 1 0 2011 Redsense Medical AB c/o Constance G. Bundy C. G. Bundy Associates, Inc. 435 Rice Creek Terrance FRIDLEY MN 55432 Re: K103242 Trade/Device Name: Redsense Alarm Unit for Clinical Use, Model RA-1-RA001C Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: ODX Dated: February 3, 2011 Received: February 8, 2011 Dear Ms. Bundy: 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, 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 of medical device-related {4}------------------------------------------------ Page 2 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 0,000-1050. 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/ucm115800.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 Pạrt 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 the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Huker Lemur MD Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health. ### Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): K103242 Device Name: Redsense Alarm Unit for Clinical Use, Model RA-1-RA001C Indications For Use: The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing continuous hemodialysis treatment up to 8 hours in the clinical settings. The device includes a blood sensor incorporated into an adhesive sensor patch. The sensor monitors potential blood leakage from the venous needle puncture site via an infrared light and will alarm if blood leakage is detected via absorption onto the device's sensor patch. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Hales Leun (Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number K103242 Page 1 o