ORBIT

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for QRS Music Technologies. The logo consists of the letters "QRS" in a bold, sans-serif font. The letters are connected to each other, forming a single, unified shape. There is a trademark symbol to the right of the letter "S". ### Technology in Practice™ ### Date: 3/15/12 ... ... . APR 1 9 2012 Submitter: National Biomedical LLC, dba QRS Diagnostic Street Address: 6901 E. Fish Lake Road #188 City: Maple Grove State: MN Zip Code: 55369 Telephone: 763-559-8492 Facsimile: 763-559-2961 Contact: Mary Kay Jensen Phone: 763-515-5323 Facsimile: 763-559-2961 e-mail: mkjensen@grsdiagnostic.com ### Device Name: Trade Name: Orbit Spirometer Common Name: Spirometer Classification Name: Spirometer, Diagnostic Classification: Listed as Class II Panel Code: BZG Regulation Number: 868.1840 Identification of Legally Marketed (Unmodified) Device (Predicate Device): | Name of<br>Predicate | Manufacturer | Use | 510K) | Date<br>Cleared | |----------------------|----------------|------------|---------|-----------------| | SpiroCard | QRS Diagnostic | Spirometer | K973138 | 10/8/1998 | ### Device Description: The QRS Orbit product model Z-7000-0101 consisting of a spirometer, pressure tube, disposable pneumotachometer, Office Medic Software and a host computer is a compact and versatile personal computer (PC) based pulmonary function analyzer (spirometer). The product measures a patient's expiratory and inspiratory airflow, analyzes the data with print options that includes the measured and predicted values and flow vs. volume or volume vs. time graphs. The Orbit spirometer includes the following components: - . Spirometer - Spirometer Pressure Tube . - Disposable pneumotachometer (mouthpiece) � - Office Medic Software . {1}------------------------------------------------ - Host PC (User Provided) . ### Indications for Use - Device Functionality: Spirometry . - Primary Spirometric Parameters: FVC, MVV, SVC and FEF . - Patient Population: Male/Female, Pediatric to Adult . - Environment of Use: Hospital, Clinic and Home Use under trained professional . supervision (Prescription Use) The QRS Diagnostic Orbit Spirometer is intended for the acquisition, analysis, display and print of measurements and waveforms of pulmonary function for the purposes of assily any clinicians in the diagnosis of various pulmonary function diseases and/or treatment regimens. ## Technological Comparison to (Unmodified) Predicate Device: The following summary table of comparisons compares the Modified Orbit Device to the Previously Cleared SpiroCard Device: | # | Area | Modified Device<br>(Orbit) | Previously Cleared<br>Device<br>(SpiroCard) | Same | Different | |-----------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------|-----------| | Indications for Use | | | | | | | 1 | Patient Population | Male/Female<br>Pediatric to Adult | Male/Female<br>Pediatric to Adult | X | | | 2 | Environment of Use | Hospital, Clinic,<br>Home Use | Hospital, Clinic,<br>Home Use | X | | | Fundamental Scientific Technology | | | | | | | 3 | Interpretation Algorithm | Interpretation<br>Algorithm functions<br>per specification | Interpretation<br>Algorithm functions<br>per specification | X | | | 4 | Device Components | • Spirometer (PCB,<br>Pressure<br>Transducer and<br>Enclosure)<br>• Plastic Mouthpiece<br>• Pressure Tube<br>• Computer with<br>Windows OS<br>• Software | • Spirometer (PCB,<br>Pressure<br>Transducer and<br>Enclosure)<br>• Plastic Mouthpiece<br>• Pressure Tube<br>• Computer with<br>Windows OS<br>• Software | X | | | Contraindications | | | | | | | 5 | Contraindications | No contraindications | No contraindications | X | | | Sterility/Expiration Dating | | | | | | | 6 | N/A | N/A | N/A | X | | | Energy Type | | | | | | | # | Area | Modified Device<br>(Orbit) | Previously Cleared<br>Device<br>(SpiroCard) | Same | Different | | 7 | Energy Type | AC or Battery Based<br>upon computer<br>utilized | AC or Battery<br>Based upon<br>computer utilized | X | | | | Environmental Specifications | | | | | | 8 | Temperature | -15 to 50° C | -15 to 50° C | X | | | 9 | Relative Humidity | 90% Maximum (non-<br>condensing) | 90% Maximum (non-<br>condensing) | X | | | 10 | Atmospheric Pressure | 700 to 1060 hPa | 700 to 1060 hPa | X | | | | Operating Specifications | | | | | | 11 | Temperature | 15 to 40° C | 15 to 40° C | X | | | 12 | Relative Humidity | 10 to 90% (non-<br>condensing) | 10 to 90% (non-<br>condensing) | X | | | 13 | Atmospheric Pressure | 700 to 1060 hPa | 700 to 1060 hPa | X | | | | Performance Standards | | | | | | 14 | American Thoracic<br>Society (ATS/ERS)<br>2005 Standard | Complies | Complies | X | | | 15 | British Thoracic Society<br>(BTS) Standard | Complies | Complies | X | | | 16 | National Institute for<br>Health and Clinical<br>Excellence (NICE)<br>Guidelines | Complies | Complies | X | | | 17 | Safety - IEC/EN 60601-<br>1 | Complies | Complies | X | | | 18 | Electromagnetic<br>Compatibility (EMC) -<br>IEC/EN 60601-1-2 | Complies | Complies | X | | | | Hardware | | | | | | 19 | Enclosure Dimensions | 127mm (L) x 102mm<br>(W) x 51mm (H) | 140(L) mm x 53 mm<br>(W) x 16 mm (H) | | X | | 20 | Enclosure Material | Metalized LCP | ABS and<br>Polycarbonate | | X | | 21 | Pressure Transducer | New-Improved<br>Performance-<br>+/- 10 inches of water | +/- 10 inches of<br>water | | X | | 22 | Analog front-end | A more precise<br>instrumentation<br>amplifier was used<br>with active filtering.<br>Pressure: +/- 6.2 | Pressure: +/- 6.2<br>inches of water<br>Gain=127 v/v | | X | | | | inches of water<br>Gain=96 v/v<br>Bandwidth= 16 Hz | Bandwidth=16 Hz | | | | # | Area | Modified Device<br>(Orbit) | Previously Cleared<br>Device<br>(SpiroCard) | Same | Different | | 23 | A/D Converter | 16-bit<br>resolution Sampling<br>rate = 125 Hz | 16-bit resolution<br>Sampling Rate= 100<br>Hz | | × | | 24 | Power Supply | New-Designed for<br>USB provided power | Designed for<br>PCMCIA power | | × | | 25 | Interface Connection<br>Type | USB | PCMCIA | | × | | | Software/Firmware | | | | | | 26 | Micro Processor | Updated | Existing | | × | | 27 | Sample Rate | 125 samples/second | 100 samples/second | | × | | 28 | Software Drivers | USB Connection<br>Driver | PCMCIA/Serial<br>Connection Driver | | × | | 29 | Spirometry Calculation<br>DLL | Add interface for<br>USB Spirometer | No interface for USB<br>Spirometer | | × | {2}------------------------------------------------ 전 a , 来 ,对于 {3}------------------------------------------------ ### Summary of Performance Testing: The QRS Diagnostic Orbit Spirometer has been tested or found otherwise to comply with applicable sections of the following standards: - American Thoracic Society (ATS/ERS) 2005 Standard . - Safety IEC/EN 60601-1 30 Ed., Medical electrical equipment Part 1: . General requirements for basic safety and essential performance - Electromagnetic Compatibility (EMC) IEC/EN 60601-1-2 30 Ed., Medical . Electrical Equipment - Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Test. ### Conclusions: The results of the tests discussed above, indicate that the modified QRS Diagnostic Orbit device is as safe, as effective, and performs as well as or better than the non-modified device. {4}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002. ### Ms. Mary Kay Jensen Ouality Assurance/Regulatory Affairs Consultant National Biomedical LLC, dba QRS Diagnostic 6901 E. Fish Lake Road #188 Maple Grove, Minnesota 55369 Re: K120880 Trade/Device Name: Orbit Spirometer Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: March 19, 2012 Received: March 23, 2012 #### Dear Ms. Jensen: 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. ### APR 1 9 2012 {5}------------------------------------------------ ### Page 2 - Ms. Jensen 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 (reporting of medical device-related 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 1000-1050. 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 /ucm115809.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 Part 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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health #### Enclosure {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): To be determined Device Name: Orbit Spirometer Indications for Use: - Device Functionality: Spirometry . - Primary Spirometric Parameters: FVC, MVV, SVC and FEF . - Patient Population: Male/Female, Pediatric to Adult . - Environment of Use: Hospital, Clinic and Home Use under trained professional supervision (Prescription Use) The QRS Diagnostic Orbit Spirometer is intended for the acquisition, analysis, display and print of measurements and waveforms of pulmonary function for the purpose of assisting clinicians in the diagnosis of various pulmonary function diseases and/or treatment regimens. Prescription Use X (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) L. Schutter . Page 1 of 1 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: _______________________________________________________________________________________________________________________________________________________________