SPIROVIT, MODEL SP-250

{0}------------------------------------------------ 4/30/99 FDA 510K SP-250 Image /page/0/Picture/2 description: The image shows the text "K98403i" in a handwritten style. Below the text is a logo or symbol that includes a rectangle, an oval, and an arrow. The rectangle is positioned horizontally, and the oval is placed partially over the right side of the rectangle. The arrow points downward and is positioned below the rectangle and oval. # 510 K Summary according to 21 CFR 807.92 #### A1 Address SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland Contact Name: Tel: Date: Mr. Markus Buetler 001 41 41 766 4252 28. April 1999 ## A2 Device Name 1. Trade Name: SPIROVIT SP-250 2. Common Name: Spirometer, Pulmonary Function Test Device ### A3 Legally Marketed Device Legally Marketed Device to which this submitted device is compared: SP-100 (K896120). #### A4 Intended Use The Spirovit SP-250 can be used to measure Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), FEV 10/ FVC, FEF 0.2.1.2, FEF 25.75%, FEF 75.85% , PEF 50%, FEF 50%, FEF 75%, FIVC, FIV 10, FIV 10 / FIVC, PIF, FIF 50%, SVC, ERV, IRV, TV, MVV, RR, TV, in patients 6 years of age or older {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a black arrow pointing to the right. The arrow is made up of a rectangle on the left and a triangle on the right. There is a gray oval above the arrow. The oval is slightly to the right of the rectangle. # Table of Comparison A5 Predicate device: SPIROVIT SP-100 (K896120) | | SP-100 (K896120) | SP-250 | |-------------------------------------------------------------|------------------------------------------------------------------------------|----------------------| | Dimensions: | | | | Flow Sensor | 15.5 cm | (1) 7.5 cm | | Handle | 9 cm | (1) 10 cm | | Sensor | fixed | (1) disposable | | Weight: | 340 g | (2) 180 g | | Environmental Conditions: | | | | Operating temperature | +10° - 40° C | same | | Storage temperature | -10° - +50° C | same | | Relative humidity | 25% - 95%<br>(non condensing) | same | | Electrostatic Discharge /<br>Electromagnetic Compatibility: | | | | ESD | Fully functional below 4 kV<br>(Open Air)<br>No damage below 8 kV (Open Air) | same | | Radiated Emissions | Less than 30 dB Microvolts | same | | Radiated Immunity | Less than 3 Volts per meter | same | | Data Communication | 12 bit serial | (3) RS-232 interface | Discusson of Differences: Discussion of Directores (1, 2 or 3) can be considered as safety relevant differences. Norte of the above diferences (1, 2 or 0) our bo considered as the Predicate (SP-100) device. {2}------------------------------------------------ FDA 510K SP-250 Image /page/2/Picture/1 description: The image shows a black and white diagram with a rectangular shape on the top left, an oval shape on the top right, and a triangular shape in the middle. The rectangular shape is positioned above the triangular shape, and the oval shape is positioned to the right of the rectangular shape. The triangular shape is pointing downwards. ## Non-Clinical Tests B1 - 1. Electrical Safety and Reliability The SP-250 device has been tested to be in accordance with the following standards: - ATS Spirometry Statement Medical Section of the American Lung Association November - 11th 1994 - IEC 601-1-1 (Safety) i - IEC 601-1-2 (EMC) ﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ - IEC 601-1-4 (Software Quality) - All tests are passed. - 4) Data related to software quality SCHILLER has reviewed its software development process following the guideline " reviewer guidance for computer controlled medical devices undergoing 510 (k) review". Device software requirements, software structure chart, software development, software revision/ ooktion, software identification, software verification, validation and testing are described in the data attached. - B2 Clinical Tests n.a. # Conclusions from Tests B3 The fulfilment of the above standards ensures the safety and effectiveness of the submitted device. We The familinent of the above octinaties as as and effective as the Predicate (SP-100) Device. {3}------------------------------------------------ Public Health Service Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # APR 3 0 1999 Mr. Markus Buetler SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland K984031 Re: SPIROVIT SP-250 SFIROVII Class: II (two) Regulator] Product Code: 73 BZG February 26, 1999 Dated: Dated: Dear Mr. Buetler: Dear Mr. Buelter. we have reviewed your Section 510 (k) notification of the ender is and we device referenced above and we have detections for use stated as the substantially equivalent (for the indications for use stated into of the enclosure) to legally marketed predicate devices marketed in enclosure) to legally marketed predicate devices marketed data enclosure) to Legally marketed predicate devices macket of the interstate commerce prior to May 28, 1976, the enacement accomments and Medical Device Amendients, or to devices that have been and in accordance with the provisions of the redetar room beys, subject to cosmetic Act (Act). You may, the Act. The general controls Cosmetic Act (Act). You may, the Act. The general controls the general controls provisions of the Act. The general controls the general controls provisions of the Act. "The general registration, the general of the Act include requirements for annual registration, erovisions of the Act include requirements for annually of the labeling, and ling, and ling, and list in the listing of devices, good manniatitiring pro- ff your devile is classified (see above) into either class II (Special If your device is class III (Premarket Approval), it may be subject to such IT your be additional controls. Existing major regulations, Title 21, Parts 800 can be found in the Code of Federal Regulations, Title 21, Parts 800 can be found in the Code of Federal Regulation assumes compliance to 895. A substantially equivalent delermination assumes as set to 895. A substantially equivalent determinates as set with the Current Good Manufacturing Practice requirements, as set with the Current Good Manufacturing Fractics Logical Devices: forth in the Quality System Regulation (QS) for Medical Devices: Christian (2) CER Rart 800) and that, through p forth in the Quality System Regulation (QS) 108 Novemberiodic QS General regulation (21 CFR Part 820) and that, through perify succify su General regulation (2) CFR Part 820) and chat, enroadyo ( inspections, the Food and Drug Admistiration (FDA) will werking in inspections. Failure to comply with the GMP regulation may result in assumptions. Failure to comply with the GMP regulation may no assumptions. Failure to comply with the can isonester announcements regulatory action. In the Federal Register. Plaase note: this regulatory action. In addition, Primalias paster. Please note: concerning your device in the retification submission does not af concerning your device in the redocal Registion does not affect any response to your premarket notification 532 of the Act response to your premirket holifications 531 through 542 of the Act obligation you might Flootronic Radiation Control provision obligation you might have under sections 351 cm one of 1999 for devices under the Electronic Product Radiation Control provisions, the devices under as magulations for devices and laws or regulations. {4}------------------------------------------------ Page 2 - Mr. Markus Buetler This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed prodicate 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/doma/domamain.html". Sincerely yours, Thomas J. Allelson Thomas J. Čallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Page 1 of 1 510(k) Number: K984031 Device Name: SCHILLER AG, Spirovit-250 Diagnostic Spirometer Indications For Use: The Spirovit SP-250 can be used to measure Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), FEV, JFVC, FEF 25-12, FEF 25-75%, FEF 75-85% PEF, FEF259, FEF50%, FEF75%, FIVC, FIV, JFIVC, PIF, FIF_0%, SVC, ERV, IRV, TV, MVV, MV, RR and TV, in patients 6 years of age or older. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_X (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96) Arthur A. Richards, L. (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number _