PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200

{0}------------------------------------------------ K 032831 ## AUG 3 1 2004 ## 510(k) Summary of Safety and Effectiveness ## PRO2® Pulse Reflectance Oximeter System This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. #### Submitter ConMed Corporation 525 French Road Utica, NY 13502 #### Contact Person Ira Duesler Director, Regulatory Affairs/Quality Assurance ConMed Corporation 525 French Road Utica, NY 13502 Phone: 315-624-3072 Fax: 315-624-3089 e-mail: ira_duesler@mail.conmed.com #### Date Prepared: September 10, 2003 #### Name of Device Pro2 Pulse Reflectance Oximeter System ## Classification Names Oximeter #### Device Classification | Regulatory Class: | Class II | |-----------------------|-----------------------------| | Product Code: | 74 DQA | | Classification Panel: | Cardiovascular Device Panel | | Regulation Number: | 21 CFR 870.2700 | #### Predicate Devices | K012706 | IM2001 Pulse Oximeter | Imagyn Medical Technologies | |---------|--------------------------------------------------------------|-------------------------------| | K012891 | OxiMAX Pulse Oximetry<br>System with N-595 Pulse<br>Oximeter | Nellcor Puritan Bennett, Inc. | {1}------------------------------------------------ ### Description of Device The Pro2® Pulse Reflectance Oximeter System consists of a reusable sensor that emits The Pro2 "Fulse Hellectance Oximotor System Serbie sensor holder to attach the Sensor and delect red and infrarrounight, a lia monitor incorporating control, processing, and displav units. The Pro2® Monitor contains an internal battery to power the unit when AC power is not The FTD2 Twonitor contains an internal battly to percentage of oxygen saturation in the blood, pulse rate, signal quality, and alarms. The Pro2 Sensor geometry includes light sources that emit light in three different The 1102 "School goomstly areas defined by two photodetector rings arranged wavelengths, and detection arous as in the center. The rings constitute an annular shape, which allow a multi-path acquisition of signals from a larger tissue area. The which allow a multi path acquient upon specific wavelengths of light detected by its sensor. The Pro2® device has a disposable sensor holder; Model # AHL-200 for adults and pediatric use. The Pro2 Sensor Holder provides optical isolation for external light and is pediatho aco: The Proz - Shesive that is incorporated as part of the Sensor Holder. ### Indications For Use The Proo® Pulse Reflectance Oximeter System is indicated for the continuous, noninvasive monitoring Pro Pulse Reflectance Oximeter System of functional oxygen invasive moniton of arterial hemoglobin (SpO2) and pulse rate. The Pro2® is intended to monitor Suttifulion on the back and forehead locations in pediatric and adult populations. The Pro2 is for use in hospital, hospital-type facilities, and intra hospital transport environment. ## Nonclinical Performance The Pro2 Pulse Reflectance Oximeter System was tested and passed all required electrical and biocompatibility testing. ## Clinical Performance The Pro2® Pulse Reflectance Oximeter System performance was tested with clinical data and the results met the acceptable criteria. ## Conclusion The Pro2® Pulse Reflectance Oximeter System is substantially equivalent to the following 510(k) cleared devices: Imagyn IM2001 Pulse Reflectance Oximeter (K012706) Nellcor OxiMAX Pulse Oximetry System with N-595 Pulse Oximeter (K012891) {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # AUG 3 1 2004 Imagyn Medical Technologies, Incorporated C/O Ms. Ira Duesler Director, Regulatory Affairs/Quality Assurance ConMed Corporation 525 French Road Utica, New York 13502 レス… Re: K032831 Trade/Device Name: PRO2 Plus Reflectance Oximeter System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: July 27, 2004 Received: July 29, 2004 Dear Ms. Duesler: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becares in ned the device is substantially equivalent (for the itelefocu above and nave acteriminoure) to legally marketed predicate devices marketed in includions for use bated in are a 28, 1976, the enactment date of the Medical Device incrolic confinered prior to they are reclassified in accordance with the provisions of Amendinens, or to act 100 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 approvisions of the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 (1 Nr.), it may of such 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 - Ms. Duesler Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 issualled of a bases and its with other requirements mean that FDA has made a determination that your device complies with one project mean that FDA has made a decemination administered by other Federal agencies. of the Act or any Federal statutes and regulations administered by other Federal spaciences in of the Act or ally rederal statutes and regations, but not limited to: registration You must comply with an the Hot b rog 21 CFR Part 801); good manufacturing practice. and ifsuing (21 CFR int 007), lacelity systems (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality systems (QS) regulation (21 CFR Part 18, Cit requirements as set form in the quality of sections (Sections 531-542 of the Act); ﮩﯿﮟ 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mained of your device of your device to a premarket notification. The PDF Imalis 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), if you desire specific advice for Jour do at (301) 594-4646. Also, please note the regulation prease contact the Office or Octification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain outer general international and Consumer Assistance at its toll-free . Drember (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Quarr 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 {4}------------------------------------------------ ## Indications for Use | 510(k) Number: | K032831 | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | PRO₂ Pulse Reflectance Oximeter System | | Indications for Use: | The PRO₂ Pulse Reflectance Oximeter System is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (PR). The PRO₂ is intended to monitor arterial saturation on the back or forehead locations in pediatric and adult populations. The PRO₂ is for use in hospitals, hospital-type facilities and intra-hospital transport environment. | Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) lame Gyulcom (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 285 510(k) Number: Page 1 of 1