RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO

{0}------------------------------------------------ K081927 FEB - 6 2009 # 510(k) Summary . Submitters Name and Address: ReNu Medical, Inc. 9800 Evergreen Way Everett. WA 98024 Phone: 425-353-1110 Fax: 425-353-9116 ## FDA Registration Number: 3034520 Contact Person: L. Bruce Pierson Chief Operating Officer Date Summary Prepared: Trade or Proprietary Name(s): ReNu Medical Reprocessed Oximetry Sensors Common Name: Oximetry Sensors Classification: Oximeter (21 CFR 870.2700) / NLF Equivalent Device(s) The ReNu Medical Reprocessed Oximetry Sensors are substantially equivalent to the Masimo 110 LNCS Adtx, LNCS Pdtx, LNCS Inf and LNCS Neo Oximetry sensors. ### Device Description: The ReNu Medical Reprocessed Masimo™ LNCS probes are accessory devices to an oximeter monitoring system. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components; two light emitting diodes (LEDs) serve as light sources and one photodiode acting as a light detector LED and sensor are contained in a laminated envelope provided with an adhesive bandage for attachment a patient. A sensor package is attached to a cable terminated in a multi-pin connector that plugs into the oximeter. {1}------------------------------------------------ ## Intended Use The ReNu Medical Reprocessed Oximetry Sensors are intended as single patient use O2 transducer/accessory sensors for use in conjunction with the Masimo™ Oximeter system. The LNCS Adult is used for patients >30 kg. The LNCS Pediatric is used for patients 10-50 kg. The LNCS Infant is used for patients 3-20 kg. The LNCS Neo is used for neonates <3 kg or adults >40 kg. All sensors are used for non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate. The predicate devices and the ReNu Medical Reprocessed devices contain identical components (LED, photodiode, laminated envelope, cable, and connector.) The means of patient attachment (adhesive bandage) is identical. #### Summary of Comparison Tests Based on an assessment consisting of bench testing and clinical performance data the ReNu Medical Reprocessed Oximetry Sensors function in a manner that is Substantially Equivalent to that of the predicate devices. {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # - 6 2009 Mr. L. Bruce Pierson Chief Operating Officer Renu Medical. Incorporated 9800 Evergreen Way Everett, Washington 98204 K081927 Re: > Trade/Device Name: ReNu Reprocessed Masimo Oximeter Sensor Model LNCS Adult, LNCS Pediatric, LNCS Infant, LNCS Neo Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: January 26, 2009 Received: January 28, 2009 Dear Mr. Pierson: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. {3}------------------------------------------------ # Page 2 – Mr. Pierson 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Suite Y. Michaud. Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use # 510(k) Number (if known): K081927 Device Name: ReNu Reprocessed Masimo Oximeter Sensor Model LNCS Adult, LNCS Pediatric, LNCS Infant, LNCS Neo. #### Indications For Use: The ReNu Medical Reprocessed Oximetry Sensors are intended as single patient use O2 transducer/accessory sensors for use in conjunction with the Masimo™ Oximeter system. The LNCS Adult is used for patients >30 kg. The LNCS Pediatric is used for patients 10-50 kg. The LNCS Infant is used for patients 3-20 kg. The LNCS Neo is used for neonates <3 kg or adults >40 kg. All sensors are used for non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate. Prescription Use XX (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) Fritz (Division Sign-Off) Division of Anesthesiology, General Hos ital Infection Control, Dental Devices 108192 510(k) Number: