FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the text "K06 1191" in a handwritten style. Below this text, the date "MAY 22 2006" is printed in a bold, sans-serif font. The date indicates that the image or document is related to May 22, 2006. Image /page/0/Picture/1 description: The image shows the logo for Measurement Specialties. The logo consists of the word "measurement" in bold, sans-serif font, with the word "SPECIALTIES" in a smaller, sans-serif font underneath. To the right of the word "measurement" is a series of dots that get progressively larger. movation performance reliability # Section 10 - Premarket Notification 510(k) Summary Premarket Notification 510(k) Summary As required by section 807.92 SpO2 Sensors for use with Nellcor® R-Cal SpO2 (Finger sensor, reusable; Ear sensor, reusable; Neonatal-Adult sensor, disposable; Adult/Pediatric sensor, disposable) ### GENERAL COMPANY INFORMATON as required by 807.92(a)(1) ### COMPANY NAME/ADDRESS/PHONE/FAX: Measurement Specialties, Inc 1000 Lucas Way Hampton, VA 23666 Telephone: 757-766-1500 Fax: 757-766-4347 NAME OF CONTACT: Susan Zaks, Product Line Manager, Optical products DATE: April 25, 2006 ### DEVICE NAME as required by 807.92(a)(2) ### TRADE NAME(S): Finger Sensor for use with Nellcor® R-Cal SpO2 Ear Sensor for use with Nellcor® R-Cal SpO2 Neonatal-Adult Adhesive Sensor for use with Nellcor® R-Cal SpO2 Adult/Pediatric Adhesive Sensor for use with Nellcor® R-Cal SpO2 ### COMMON NAME: SpO2 Sensor (accessory to pulse oximeter and ear oximeter) # CLASSIFICATION NAME: 수수 The following Class II classification appear applicable DQA 21 CFR 870.2700, Finger Sensor for use with Nellcor® R-Cal SpO2 DQA 21 CFR 870.2700, Neonatal-Adult Adhesive Sensor for use with Nellcor® R-Cal SpO2 > 1000 Lucas Way. Hampton, VA 23666 Toll Free: 800 745 8008 ● Tcl: 757 766 1500 ● Fax: 757 766 4297 www.meas-spec.com , {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for "measurement SPECIALTIES". The word "measurement" is in bold, black, sans-serif font. Below it, "SPECIALTIES" is in a smaller, less bold font. To the right of the text, there is a curved line of black dots that decrease in size as they move away from the text. nnovation performance reliability ### DQA 21 CFR 870.2700, Adult/Pediatric Adhesive Sensor for use with Nellcor® R-Cal SpO2 DPZ 21 CFR 870.2710. Ear Sensor for use with Nellcor® R-Cal SpO2 # NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3) SpO2 sensors for use with Nellcor® R-Cal SpO2 (Finger sensor, reusable; Ear sensor, reusable; Neonatal-Adult sensor, disposable; Adult/Pediatric sensor, disposable) are substantially equivalent to the predicate SpO2 sensors: K042704 Flexi-Stat(tm) Finger clip SpO2 sensor K042675 Flexi-Stat(tm) Ear sensor K042705 All-fit Flexi-Stat(tm) Disp SpO2 sensor (Nellcor-compatible) K041522 Flexi-Stat(tm) Disposable Adhesive SpO2 sensor (Nellcor-compatible) # DEVICE DESCRIPTION as required by 807.92(a)(4) SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor body contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The sensor body is connected to a cable that is terminated with a 9-pin D-connector for connecting the sensor to a patient monitor or an interconnect cable. The Finger and Ear sensors are durable, multiple-patient-use sensors. The sensor structure has a spring structure that easily and comfortably accomodates the sensor to the application site. The Neonatal-Adult and Adult/Pediatric sensors are disposable single-patient-use sensors. The attachment mechanism of these sensors is a soft adhesive tape that is wrapped around the application site. # INTENDED USE as required by 807.92(a)(5) ### Finger sensor: The Finger sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg. ### Ear sensor: . The Ear sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 10 kg. ### Neonatal-Adult sensor: 1000 Lucas Way, Hampton, VA 23666 Toll Free: 800 745 8008 ● Tel: 757 766 1500 ● Fax: 757 766 4297 www.meas-spec.com {2}------------------------------------------------ Image /page/2/Picture/0 description: The image contains the words "measurement" in large bold font on the top line and "SPECIALTIES" in smaller font on the second line. The word "measurement" is the primary focus of the image. There are some decorative dots on the right side of the image. novation performance reliability The Neonatal-Adult sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, noninvasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients. ### Adult/Pediatric Sensor: The Adult/Pediatric sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, noninvasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg. # SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6) The Finger sensor, Ear sensor, Neonatal-Adult sensor and Adult/Pediatric sensor use the same theory and principle of operation as the predicate devices. Design characteristics are equivalent in terms of safety and effectiveness, as demonstrated by validation tests. # SUMMARY OF THE PERFORMANCE TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3) SpO2 accuracy testing was conducted during induced hypoxia studies on healthy adult volunteer subjects during no motion conditions conducted in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO2) of the sensors was compared to arterial hemoglobin oxygen value determined from blood samples with a laboratory co-oximeter. The accuracy of the sensors in comparison to the co-oximeter samples was measured to be +/-3 digits over the SpO2 range 70-100%. Bench testing with a simulator and the same patient monitors was performed to verify pulse rate measurement accuracy. Patient interface temperature (Sensor surface temperature) testing was conducted to ensure the sensor surface temperature during the use of the sensors is not higher than for the predicate devices. ### CONCLUSION: The summary above shows that there are no new questions of safety and effectiveness for the SpO2 sensors Finger Sensor for use with Nellcor® R-Cal SpO2, Ear Sensor for use with Nellcor® R-Cal SpO2, Neonatal-Adult Adhesive Sensor for use with Nellcor® R-Cal SpO2 and Adult/Pediatric Adhesive Sensor for use with Nellcor® R-Cal SpO2 as compared to the predicate devices. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, a symbol often associated with the United States. Public Health Service MAY 2 2 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Measurement Specialties, Incorporated C/O Ms. Krista Oakes Amica Solutions 2300 McDermott Road, #200-207 Plano, Texas 75025 Re: K061191 Trade/Device Name: Finger Sensor for use with Nellcor R-cal SpO2, Ear Sensor for use with Nellcor R-cal SpO2, Neonatal-Adult Sensor for use with Nellcor R-cal SpO2, Adult/Pediatric Sensor for use with Nellcor R-cal SpO2 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA, DPZ Dated: April 28, 2006 Received: April 28, 2006 Dear Ms. Oakes: 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. 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. {4}------------------------------------------------ #### Page 2 - Ms. Oakes 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Sylite y. Michael Dm's Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health #### Enclosure {5}------------------------------------------------ # Section 5 - Indications For Use Statement Indications for Use # 510(k) Number (if known): ΚΟ 6 || 91 Device Name(s): Finger Sensor for use with Nellcor R-cal SpO2, Ear Sensor for use with Nellcor Rcal SpO2, Neonatal-Adult Sensor for use with Nellcor R-cal SpO2, Adult/Pediatric Sensor for use with Nellcor R-cal SpO2. #### Indications for Use: #### Finger sensor: The Finger Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg. #### Ear sensor: The Ear Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 10 kg. #### Neonatal-Adult sensor: The Neonatal-Adult Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, noninvasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients. #### Adult/Pediatric Sensor: The Adult/Pediatric Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, noninvasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg. 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | <img alt="Signature" src="signature.png"/> | |-----------------------------------------------|--------------------------------------------| | (Sign-Off) | | | Division of Anesthesiology, General Hospital, | | | Section Control, Dental Devices | | | K Number: | K061191 | | | 23 |