BPCARD

{0}------------------------------------------------ K031964 SEP - 5 2003 Image /page/0/Picture/2 description: The image shows the letters QRS in a stylized font. The letters are black and bold, and they are surrounded by a thin black oval. The letters are slightly overlapping, and the oval is slightly offset from the letters. The image is simple and clean, and it is likely a logo or a symbol. ## 510(K) SUMMARY of SAFETY and EFFECTIVENESS # A. General Information | 1. Submitter,'s Name: | QRS Diagnostic, LLC | |-------------------------|-----------------------------------------------| | 2. Address: | 14755 27th Avenue North<br>Plymouth, MN 55447 | | 3. Telephone: | 763-559-8492, Ext. 958 | | 4. Contact Person: | Mary Kay Jensen | | 5. Date Prepared: | June 21, 2003 | | 6. Registration Number: | 2133542 | ### B. Device | 1. Name: | BPCardTM | |-------------------------|------------------------------------------------| | 2. Trade Name: | BPCard | | 3. Common Name: | Blood Pressure Monitor | | 4. Classification Name: | Non-Invasive Blood Pressure Measurement System | | 5. Product Code: | DXN | | 6. Class: | II | | 7. Regulation Number: | 870.1130 | {1}------------------------------------------------ #### C. Identification of Legally Marketed Devices - Accutracker DX 1. Name: - 2. K Number: K913844 - 3. Date Cleared: July 14, 1992 #### D. Description of the Device The BPCard™ is a non-invasive Blood Pressure Monitor. The patient population is for both male and female, pediatric and adult. The BP Card has been tested to the following standards: - AAMI SP10-1992-Electronic or Automated Sphygmomanometers I - FDA-1997-NIBP Monitor Guidance 트 - EN1060-1-Non-Invasive Sphygmomanometers General Requirements ■ - 트 EN1060-3-Non-Invasive Sphygmomanometers Supplementary Requirements - EN980-Symbols 트 - EN46001-Quality 육 - EN1441-Risk Analysis - 트 EN60601-1-2-EMC - 트 EN60601-1-Electrical Safety - 트 93/42/EEC-MDD - 트 89/336/EEC-EMC Directive - 트 92/37/EEC-Product Safety - 트 93/465/EEC-Conformity Assessment and CE Marking - 트 UL 2601-1-Safety US - 배 ISO 10993-1-Biological Evaluation - 이 ISO 9001:1994-Quality - 트 ISO 9001:2000-Quality - 트 ISO 13485:1996/1998-Medical Devices - l 21CFR Part801-Labeling - 21CFR Part820-QSR - 해 FDA Blue Book Memorandum G95-1-Biocompatibility The BPCard is a non-invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method in both male and female, pediatric and adult subjects. The BPCard also measures heart rate. It is to be used by health care professionals in a hospital, clinic or home environment. It is contraindicated in patients who are not ambulatory, have heart failure, arrhythmia, or cardiac valve abnormality. It is not to be operated in an explosive atmosphere nor in proximity to any equipment that has the potential to generate a {2}------------------------------------------------ sufficiently large electromagnetic field as to interfere in any manner with the operation of the BPCard. The BPCard is a Prescription Device, not life supporting or live sustaining, not an implant, supplied non-sterile with a cuff, valve and microphone that requires a Personal Computer with the following requirements: - Windows 2000 Operating System - 32 MB RAM . - 1 GB Free Hard Disc Space ● - 133 MHz Processor #### E. Intended Use Statement The BPCard can be used by health care professionals to measure blood pressure values (systolic and diastolic) and heart pulse rate in adults and children. #### F. Components/ Part Numbers - BPCard User's Manual - 6000-XXXX - BPCard - PCMCIA Blood Pressure Monitor - 7000-XXXX - Cuff, Valve, Bulb and Microphone 5000-XXXX ● - BPCard Software Version 1.0 9000-0088 ● #### G. Table of Comparisons The following summary tables of comparisons compare the new device (BPCard) to the predicate device: Accutracker DX. | # | Area | New Device:<br>BPCard™ | Predicate Device:<br>Accutracker DX | Same | Different | |---|-------------------------------------------|-----------------------------------|-------------------------------------|------|-----------| | 1 | Non-Invasive<br>Blood Pressure<br>Monitor | NIBP | NIBP | X | | | 2 | Patient Population | Male/Female<br>Pediatric to Adult | Male/Female<br>Pediatric to Adult | X | | | 3 | Environment | Hospital, Clinic, Home<br>Use | Hospital, Clinic,<br>Home Use | X | | | 4 | Heart Rate | Heart Rate | Heart Rate | X | | | 5 | Technique | Auscultatory | Auscultatory | X | | | 6 | SP10<br>Conformance | Yes | Yes | X | | | 7 | Accuracy | SP10 - Trained Observer | SP10 - Trained<br>Observer | X | | {3}------------------------------------------------ | 8 | Power Source | Via Personal or Portable<br>Computer (Battery) | Battery | | X | |----|--------------------------|------------------------------------------------|----------------------------------|---|---| | 9 | Diastolic | 5th Korotkoff Sound | 5th Korotkoff Sound | X | | | 10 | Weight | < 6 ounces | 12.6 ounces | | X | | 11 | Size | 53 x 140 x 26<br>W D H in mm | 825 x 330 x 127<br>W D H in mm | | X | | 12 | Deflation | 2-3 mm Hg/ second | 2, 3, 4, 5 or 6 mm<br>Hg/ Second | | X | | 13 | Operating<br>Environment | 10 to 40° C<br>15 - 95% | 10 to 40° C<br>< 95% | X | | | 14 | Storage<br>Environment | -20 to 50° C<br>15 - 95% | -20 - 50° C<br>< 95% | X | | | 15 | Certification | UL, CE | UL, CE | X | | | 16 | Prink Reports | No | Yes | | X | | 17 | Safety Standards | Yes | Yes | X | | | 18 | EMC | Yes | Yes | X | | | 19 | Prescription<br>Device | Yes | Yes | X | | | 20 | Range Systolic | 60-250 mm Hg | 10-250 mm Hg | | X | | 21 | Diastolic Range | 40-220 mm Hg | 10-250 mm Hg | | X | | 22 | Bladder Deflation | Automatic | Automatic | X | | | 23 | Programmable | No | Yes | | X | | 24 | Inflation Method | Bulb | Automatic | | X | | 25 | Part of System | No | Yes | | X | | 26 | Sampling | No | Yes | | X | | 27 | Cuff Sizes | Multiple | Multiple | X | | | 28 | Clinical Reports | No | Yes | | X | | 29 | Print outs | No | Yes | | X | | 30 | Sampling Periods | No | Yes | | X | | 31 | 510(k) Summary | Yes | No | | X | | 32 | Supplied Non-<br>Sterile | Yes | Yes | X | | ### H. Discussion of Similarities and Differences The BPCard and Accutracker DX have the following similarities: - NIBP Monitor . - . Patient Population - Environment ● - . Heart Rate - Technique . - SP10 Conformance ● {4}------------------------------------------------ According to the FDA's NIBP Monitor Guidance "substantial equivalence can be demonstrated by showing either; - 1. Sufficient comparison testing with a legally-marketed predicate device - 2. Conformance to SP10 Standard - 3. Conformance to any foreign or domestic standard which meets or exceeds the requirements of the SP10 Standard." Furthermore, the FDA states, "It is strongly recommended that substantial equivalence be demonstrated by showing conformance to the SP10 Standard." Thus, even though the BPCard is not identical to Accutracker DX, it does comply with the SP10 Standard and we at QRS believe it should be granted substantial equivalence by its conformance to SP10. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines connecting them. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP - 5 2003 ORS Diagnostic, LLC. c/o Ms. Mary Kay Jensen 14755 27th Ave. North Plymouth, MN 55447 Re: K031964 Trade Name: BPCard™ Regulation Number: 21 CFR §870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: June 21, 2003 Received: June 25, 2003 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. 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. 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 {6}------------------------------------------------ ### Page 2 - Ms. Mary Kay Jensen 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 (301) 594-4646. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html Sincerely yours, Bram D. Zuckerman, M.D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ 510(k) Number (if known): KO31964 Device Name: BPCard Indications For Use: The BPCard is a non-invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method in both male and female, pediatric and adult subjects. The BPCard also measures heart rate. It is to be used by health care professionals in a hospital, clinic or home environment. It is contraindicated in patients who are not ambulatory, have heart failure, arrhythmia, or cardiac valve abnormality. It is not to be operated in an explosive atmosphere nor in proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the BPCard. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)  (Division Sign-Off)(Division Sign-On) Division of Cardiovascular Devices 510(k) Number K031964 Prescription Use (Pcr 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)