PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers 9, 8, 1, 2, 6, and 5. The numbers are written in a connected manner, with some overlap between them. The handwriting style is casual and slightly uneven. # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR HEWLETT-PACKARD COMPANY # PAGEWRITER 200i INTERPRETIVE CARDIOGRAPH MODEL M1770A with ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENT APPLICATION ### MODEL M1791A - DATE SUMMARY PREPARED 1. April 2, 1998 。 #### SUBMITTER'S NAME AND ADDRESS 2. Hewlett-Packard Company 3000 Minuteman Road Andover, MA 01810-1099 #### CONTACT PERSON 3. Mr. George Diller Engineering Product Manager (978) 659-4971 Telephone: (978) 659-3168 Facsimile: #### 4. DEVICE NAME PageWriter 200i Model M1770A Interpretive Cardiograph Proprietary Name: with Acute Cardiac Ischemia Time Insensitive Predictive Instrument (ACI-TIPI) Model M1791A Application. Common Name: Cardiograph Classification Name: Electrocardiograph {1}------------------------------------------------ #### PREDICATE DEVICES 5. The legally marketed devices to which equivalence is being claimed are listed below. | Manufacturer | Predicate Device | Model | 510(k) Number | |-----------------|------------------|-----------------------|---------------| | Hewlett-Packard | PageWriter XLi | M1700A<br>with M1791A | K951978 | | Hewlett-Packard | PageWriter 200i | M1770A | K935772 | The interpretative cardiographic functions of the PageWriter 200i Model M1770A with ACI-TIPI Model M1791A are identical to the predicate PageWriter 200i Model M1770A (K935772). The optional software application, acute cardiac ischemia time insensitive instrument (ACI-TIPI) Model M1791A, is identical to the ACI-TIPI application that is commercially available for use with the predicate PageWriter XLi Model M1700A (K951978). #### DEVICE DESCRIPTION 6. The ACI-TIPI Model M1791A is an optional software application for the commercially available predicate PageWriter 200i M1770A interpretive · cardiograph. This optional software application is used to provide the cardiologist with an additional tool to aid in the assessment of acute cardiac ischemia. The ACI-TIPI application regression formula for ACI combines patient data (age, sex, and chest pain status) with measurements from the ECG. The computation yields a probability index of acute cardiac ischemia in the range of 0-100%. This index is intended to be used with the currently established data in evaluation of the subject patient population. As an index, the physician can correlate values with their current diagnostic results and then use the index to support their diagnosis, or to initiate further action. For example, the physician can use the index as part of the diagnostic data set used to assess a patient. This index is never used alone or in place of other pertinent information normally used in acute ischemia determinations. #### 7. INTENDED USE The intended use of the PageWriter 200i Model M1770A with ACI-TIPI Model M1791A is similar to the intended use of the predicate PageWriter 200i Model {2}------------------------------------------------ They are both intended to be used for acquisition, digitization, M1770A. recording of conventional diagnostic 12 simultaneous lead ECG waveforms and ECG data, and measuring and interpreting ECGs. In addition, the PageWriter 200i Model M1770A with ACI-TIPI Model M1791A has the same intended use as the predicate PageWriter XLi Model M1700A with ACI-TIPI Model M1791A. Specifically, they both are intended to provide a tool to aid in assessment of acute cardiac ischemia by correlation of the patient demographics, symptoms and ECG measurements. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 8. The PageWriter 200i Model M1770A with ACI-TIPI Model M1791A has the same interpretive cardiograph characteristics as the predicate PageWriter 200i Model M1770A. For example, they both contain the same ECG measurements, adult and pediatric analysis programs, ECG basic controls, conventional 12 simultaneous lead ECGs and both have the same recording techniques. The PageWriter 2001 Model M1770A with ACI-TIPI Model M1791A has the same predictive algorithm characteristics as the predicate PageWriter XLi Model M1700A with ACI-TIPI Model M1791A. In fact, the exact same ACI-TIPI Model M1791A application is used with both interpretive cardiographs. In addition, the same parameters are entered by the user (patient ID, name, age, gender, height, weight and presence of chest pain) and the same input parameters are needed for the predictive algorithm (ACI-TIPI). #### NONCLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE 9. The safety of the PageWriter 200i Model M1770A with ACI-TIPI Model M1791 A is already proven because the interpretive cardiograph which will host the ACI-TIPI algorithm is commercially available for market worldwide. In addition, the ACI-TIPI Model M1791A application is also commercially available on another Hewlett-Packard interpretive cardiograph. The ACI-TIPI Model M1791A application has been validated and system testing was performed to verify that the addition of the ACI-TIPI Model M1791A application did not adversely alter the functionality of the PageWriter 200i Model M1770A interpretive cardiograph. {3}------------------------------------------------ #### CONCLUSIONS FROM NONCLINICAL TESTING 10. The addition of the ACI-TIPI Model M1791A application to the predicate PageWriter 200i Model M1770A interpretive cardiograph has been successfully completed and passed validation testing. In addition, system testing verified that the addition of the ACI-TIPI Model M1791A application does not affect the interpretive cardiograph functionalities of the host PageWriter 200i Model M1770A. {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion. The logo is black and white. ### Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### JUN 23 1998 Ms. Renee J. Thibeault Associate Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760 Re: K981265 Hwelett-Packard Page Writer 200I Model M1770A with ACI-TIPI Model M1791A Regulatory Class: III (three) Product Code: LOS Dated: April 2, 1998 Received: April 7, 1998 Dear Ms. Thibeault: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {5}------------------------------------------------ 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 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 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.qov/cdrh/dsmamain.html". Sincerely yours, Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ 510(k) Number (if known): K981265 ## Device Name: Howlett-Packard Page Writer 200i Model M 1770A Interpretive Cardioeranh with Acute Cardiac Techemia Time Insensitive Predictive Instrument Application (ACI-TIPI) Model M1791A. Indications For Use: The Page Writer 2001 Model 1770A is intended to provide acquisition, digitization and recording of couventional diagnostic 12 simultaneous lead ECG wavelorms and ECG Data, The Page Writer 200i Model M1770A also displays ECC waveforms and records patient information entered through the alphanimeric keyboard. Additionally, it measures and provides interpretation. The Page Writer 200i Model M1770A interpreted FCC7 with measurements and diagnostic statements is offered to the physician un an advisory basis only, and the physician is asked to overread and validate (or change) the ECG interpretation. In addition, the PageWriter 2001 Model M.1770A with ACI-TIPI Model M1791A is intended to provide the cardiologist with an additional tool to aid in assessment of acute cardiac ischemia. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE) N. Qullh Tille (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number Prescription Use (Per 21 CFR 801.109) X OR Over-The-Counter Use (Optional Format 1-2-96) 4/2/98 Hewlett-Packard Company 510(k) CONFIDENTIAL PageWriter 200i Model M1770A with ACI-TIPI Model M1791A Page vi