DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Antony R. H. Fender · Official FDA Correspondent Jack's Electrodes, Inc. 2227 East Crescent Drive Altadena, California 91001 JAN 28 1998 Re: K974119 Disposable Needle Electrode (ALM and DLM) Trade Name: Regulatory Class: II Product Code: GXZ Dated: September 4, 1997 Received: October 31, 1997 Dear Mr. Fender: 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 The general controls provisions of the Act 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. ನ್ನ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 In addition, FDA may publish further announcements action. 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. {1}------------------------------------------------ #### Page 2 - Mr. Antony R. H. Fender 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. 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/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M. Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ **FEB 6 1998** f K974199 # SECTION 2 - SUMMARY AND CERTIFICATION ## 510(k) Summary of Safety and Effectiveness ് This Summary of 810(k) 590 and 21 CFR 807.92. | Submitter: | Marquette Medical Systems, Inc.<br>8200 W. Tower Avenue<br>Milwaukee, WI 53223<br>Telephone: (414) 355-5000<br>FAX: (414) 362-3553 | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Kristin Pabst | | Device: | Trade Name: Acute Cardiac Ischemia Time-Insensitive Predictive<br>Instrument (ACI-TIPI) Option<br>Classification Name: Computer, diagnostic, programmable<br>Detector and Alarm, Arrhythmia | | Predicate Device: | Hewlett- Packard Model 1791A ACI-TIPI | | Device Description: | Acute Cardiac Ischemia Time-Insensitive Predictive Instrument<br>(ACI-TIPI ) Option is a software option for Marquette MAC-series<br>electrocardiographs to aid the physician's decision-making process in<br>a chest pain setting by using patient age, gender, chest pain status<br>and ECG features to provide the predicted probability of acute cardiac<br>ischemia (which includes unstable angina pectoris and acute<br>myocardial infarction). | | Intended Use: | Acute Cardiac Ischemia Time-Insensitive Predictive Instrument<br>(ACI-TIPI ) Option is intended to be used in a hospital or clinic<br>environment by competent health professionals utilizing recorded<br>ECG data to produce a numerical score which is the predicted<br>probability of acute cardiac ischemia. Like any computer-assisted ECG<br>interpretation program, the Marquette ACI-TIPI evaluation and<br>probability score is intended to supplement, not substitute for the<br>physician's decision process. It should be used in conjunction with<br>knowledge of the patient's history, the results of a physical<br>examination, the ECG tracing, and other clinical findings.<br><br>ACI-TIPI is intended for adult patient populations. | | Technology: | ACI-TIPI option employs the same technology as the predicate<br>device. | | Performance: | The following quality assurance measures were applied to the<br>development of ACI-TIPI.<br><br>Requirements specification review, software testing and field tests of<br>the ACI-TIPI analysis. | Image /page/2/Picture/7 description: The image shows a sequence of six symbols. The first five symbols appear to be the number zero, each represented in a similar outlined style. The sixth symbol is a stylized image of a horse head, possibly representing a chess piece, rendered in solid black. {3}------------------------------------------------ The results of these measurements demonstrated that ACI-TIPI analysis is as safe, as effective, and performs as well as the predicate device, Hewlett-Packard Model 1791A ACI-TIPI. . එ 1255 - - - - {4}------------------------------------------------ Image /page/4/Picture/10 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines. Rockville MD 20857 FEB 6 1998 Ms. Kristin Pabst Regulatory Affairs Manager Marquette Medical Systems, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 Re : K974199 Acute Cardiac Ischemia Time-Intensive Predictive Instrument (ACI-TIPI) Option Requlatory Class: III (three) Product Code: 74 LOS November 7, 1997 Dated: Received: November 10, 1997 ------------------------------------------------------------------------------------------------------------------------------------------------ Dear Ms. Pabst: 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (Q&) for Medical Devices --------------------------------------------------------------------------------------------------------------General regulation (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.gov/cdrh/dsmamain.html". Sincerely yours, Thomas J. Callehan Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### 6 1998 FEB ### SECTION 11 - INTENDED USE STATEMENT Unknown - 510(k) filed August 29, 1997 510(k) Number (if known): Device Name: Acute Cardiac Ischemia Time-Insensitive Instrument (ACI-TIPI) Indications For Use: Acute Cardiac Ischemia Time-Insensitive Instrument (ACI-TIPI ) Option is intended to be used in a hospital or clinic environment by competent health professionals . TIPI utilizes recorded ECG data along with patient demographic and chest pain status to produce a numerical score which is the predicted probability of acute cardiac ischemia. Like any computer-assisted ECG interpretation program, the Marquette ACI-TIPI evaluation and probability score is intended to supplement, not substitue for the physician's decision process. It should be used in conjunction with knowledge of the patient's history, the results of a physical examination, the ECG tracing, and other clinical findings. ACI-TIP! is intended for adult patient populations. M. Puye 510(k) Num