(5 days)
The 12 Lead Simultaneous Cable is used to acquire a patient's ECG via 10 leads connected to a patient's chest. It converts the ECG signal into a digital format and transfers this information to a Micromedical monitor or software system using a proprietary digital data transfer protocol.
The proposed device is a 12 Lead Simultaneous Cable to connect electrodes to an electrocardiograph or to a Micromedical monitor or to a software system to display the ECG signal on a personal computer.
The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) summary for a "Modified 12 Lead Simultaneous Cable" and a letter from the FDA. It outlines the device description, its intended use, and states that "Nonclinical testing was performed to assure that the device works with the Cardio View 3000 software." However, it does not provide any specific details about the acceptance criteria for this testing, the methods used, or the results.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, ground truth, experts, adjudication, MRMC studies, or standalone performance.
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FEB 2 1999
510(k) SUMMARY
Submitted by:
Micromedical Industries Limited 11 Technology Drive Labrador Queensland 4215 Australia
Date Prepared:
January 26, 1999
Proposed Device:
Modified 12 Lead Simultaneous Cable
Predicate Device:
12 Lead Simultaneous Cable
Proposed Device Description:
The proposed device is a 12 Lead Simultaneous Cable to connect electrodes to an electrocardiograph or to a Micromedical™ monitor or to a software system to display the ECG signal on a personal computer.
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 or software system 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 or to a PC for display.
Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests
Nonclinical testing was performed to assure that the device works with the Cardio View 3000 software. Testing supported the proposed labeling change.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized eagle with three human profiles incorporated into its design.
Public Health Service
FEB 2 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen Cresswell MicroMedical Industries, Ltd. 11 Technology Drive Labrodor Queensland 4215 Austrailia
Re: K990266 12-Lead Simulataneous Cable Requlatory Class: III (three) Product Code: LOS Dated: January 26, 1999 Received: January 28, 1999
Dear Mr. Cresswell:
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 leqally 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 action. In addition, FDA may publish further announcements concerning your device in the Federal_Register. Please note: this
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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.
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) 594-4648. 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, 2Misbranding 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, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number:
12 Lead Simultaneous Cable Device Name:
Indication for Use:
The 12 Lead Simultaneous Cable is used to acquire a patient's ECG via 10 leads connected to a patient's chest. It converts the ECG signal into a digital format and transfers this information to a Micromedical monitor or software system using a proprietary digital data transfer protocol.
Prescription Use
(Per 21 CFR 801.109)
V.K. Tiller
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devic 510(k) Number
N/A