(170 days)
The 12-lead ECG Analysis is useful in the diagnosis and treatment of patients with acute myocardial infarction (AMI). 12-lead ECG Analysis is also useful in the interpretation and documentation of other transient cardiac arrhythmias that may occur. When used in the prehospital setting, the 12-lead analysis results can be of assistance in diagnosis and treatment decisions once the patient has arrived in the hospital emergency department.
Not Found
The provided document is a 510(k) clearance letter for the ZOLL M Series 12SL™ Analysis Option. This document confirms the device's substantial equivalence to a predicate device and outlines its indications for use. However, it does not contain the detailed study information, acceptance criteria, or performance data that would allow for a comprehensive answer to your request.
Specifically, the letter does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets.
- Data provenance, expert qualifications, or adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance.
- Details on how ground truth was established for either test or training sets.
To provide a complete answer, I would need access to the actual 510(k) submission document (or a summary thereof) which would typically contain the study design, methodologies, and results used to demonstrate substantial equivalence.
Therefore, I cannot fully answer your request based solely on the provided text.
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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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with three curved lines representing arms or wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1999
Mr. Paul Dias QA Enqineer ZOLL Medical Corporation 32 Second Avenue Burlington, MA 01803-4420
Re: K991556 ZOLL M Series 12 SL Analysis Option Requlatory Class: III (three) Product Code: 74 MKJ, LOS Dated: August 25, 1999 Received: August 26, 1999
Dear Mr. Dias:
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 requlations 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 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 requlatory 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.
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Page 2 - Mr. Paul Dias
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/dsma/dsmamain.html".
Sincerely yours,
foaine Aubertsheush
from, Wolf Sapirstein, M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K991556 510(k) NUMBER (IF KNOWN): ____________________________________________________________________________________________________________________________________________________
DEVICE NAME : ZOLL M Series 12SL™ Analysis Option
INDICATIONS FOR USE:
The 12-lead ECG Analysis is useful in the diagnosis and treatment of patients with acute myocardial infarction (AMI). 12-lead ECG Analysis is also useful in the interpretation and documentation of other transient cardiac arrhythmias that may occur. When used in the prehospital setting, the 12-lead analysis results can be of assistance in diagnosis and treatment decisions once the patient has arrived in the hospital emergency department.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter-Use (Optional Format 1-2-96)
U. Ryz
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.