(17 days)
The device is indicated for diagnostic evaluation of patients who experience transient symptoms such as; dizziness, palpitations, syncope, or chest pain. The device is intended to record cardiac activity associated with these infrequent and transient symptoms. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician.
Braemar ER900 Series Enhanced Algorithm ECG Event Recorder
The provided text is a 510(k) premarket notification letter from the FDA to Braemar, Inc. regarding their ER900 Series Enhanced Algorithm ECG Event Recorder. This document does not contain the information requested about acceptance criteria, device performance, study details, or ground truth establishment.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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..."
This indicates that the device was cleared based on its substantial equivalence to a predicate device, not necessarily through a formal study with detailed acceptance criteria and performance metrics described in this specific document. The FDA's 510(k) pathway often relies on demonstrating equivalence rather than requiring extensive clinical trials with predefined performance endpoints for novel devices.
Therefore, I cannot provide the requested table or answer the specific questions based solely on the provided text. The information regarding acceptance criteria, device performance, study design, sample sizes, expert qualifications, and ground truth establishment would typically be found in the manufacturer's 510(k) submission, which is a much more extensive document than the FDA's clearance letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2007
Braemar, Inc. c/o Darren Dersham 1285 Corporate Center Dr., Suite 150 Eagan, MN 55121
Re: K071011
Trade/Device Name: Braemar ER900 Series Enhanced Algorithm ECG Event Recorder Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: WMJ Dated: March 30, 2007 Received: April 10, 2007
Dear Mr. Dersham:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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, l'isting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your devine can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, UDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Dersham
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blummlman
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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07/01/
Indications for Use
510(k) Number (if known):
Braemar ER900 Series Enhanced Algorithm ECG Event Recorder Device Name:
Indications For Use:
The device is indicated for diagnostic evaluation of patients who experience transient symptoms such as; dizziness, palpitations, syncope, or chest pain. The device is intended to record cardiac activity associated with these infrequent and transient symptoms. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Zimmerman
(Action Sign-Off)
1 of Cardiovascular Devices
Number K071011
Page 1 of
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).