← Product Code [DPS](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS) · K974220 # MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE (K974220) _Micromedical, Inc. · DPS · Aug 25, 1998 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K974220 ## Device Facts - **Applicant:** Micromedical, Inc. - **Product Code:** [DPS](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS.md) - **Decision Date:** Aug 25, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2340 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The Micromedical™ 12 Lead Simultaneous Cable is intended for use in acquiring a patient ECG signal via 10 leads connected to the patient's chest, converting the ECG patient DOO siguir 11-2-2, and transferring this information to a Micromedical™ monitor using a proprietary digital data transfer protocol. ## Device Story Device is a 12-lead simultaneous cable; connects electrodes to patient chest; acquires ECG signals via 10 leads; converts analog ECG signals to digital format; transfers data to Micromedical monitor via proprietary digital protocol. Used in clinical settings; operated by healthcare professionals. Facilitates ECG monitoring by enabling signal transmission from patient to monitor. ## Clinical Evidence Bench testing only. ## Technological Characteristics 10-lead cable assembly; proprietary digital data transfer protocol; converts analog ECG signals to digital format for monitor interface. ## Regulatory Identification An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart. ## Predicate Devices - MAX 1 Exercise Testing System ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K97430 # AUG 25 1998 - #### 510(k) SUMMARY #### Submitted by: Malcom Castle, President Micromedical, Inc. 255 Revere Drive Suite 111 Northbrook, IL 60062 #### Date Prepared: October 19, 1997 Proposed Device: 12 Lead Simultaneous Cable # Predicate Device: MAX 1 Exercise Testing System # Proposed Device Description: The proposed device is a 12 Lead Simultaneous Cable to connect electrodes to an electrocardiograph or to a Micromedical™ monitor. # Statement of Intended Use; The 12 Lead Simultaneous Cable acquires a patient's ECG via 10 leads connected to a patient's chest, converts the ECG signal into a digital format, and transfers this information to a Micromedical™ monitor using a proprietary digital data transfer protocol. The proposed device is intended to be used to acquire a patient's ECG signal and transmit it to a Micromedical™ monitor. # Discussion of Non-Clinical Tests; Conclusions Drawn from Non-Clinical Tests Non-clinical testing was performed to compare the device to the predicate device. Testing showed the proposed device to be substantially equivalent to the predicate device. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 25 1998 Mr. Malcom Castle President Micromedical, Inc. 255 Revere Drive, Suite 111 Northbrook, IL 60062 Re: K974220 12-Lead Simultaneous Cable Requlatory Class: II (two) Product Code: DPS Dated: August 13, 1998 Received: August 19, 1998 Dear Mr. Castle: 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 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). 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 Requlations, 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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 Reqister. Please note: this response to your premarket notification submission does not affect any {2}------------------------------------------------ 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 requlations. 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? (21CFR 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/dsma/dsmamain.html". Sincerely yours, Thomas J. Callahan Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Indication for Use K974220 510(k) Number: Device Name: Micromedical™ 12 Lead Simultaneous Cable Indication for Use: The Micromedical™ 12 Lead Simultaneous Cable is intended for use in acquiring a patient ECG signal via 10 leads connected to the patient's chest, converting the ECG patient DOO siguir 11-2-2, and transferring this information to a Micromedical™ monitor using a proprietary digital data transfer protocol. **Prescription Use** **(Per 21 CFR 801.109)** V. Dale Tull (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K974220](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K974220) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com