(28 days)
The DL900 Series Holter Recorder is intended for patients requiring ambulatory (Holter) monitoring. Such monitoring is most frequently used for the indications below:
- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
- Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
- Evaluation of patients for ST segment changes.
- Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)
- Clinical and epidemiological research studies.
- Evaluation of patients with pacemakers.
- Reporting of time and frequency domain heart rate variability.
- Reporting of QT Interval
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria for the Braemar DL900 Series Holter Recorder or any studies conducted to prove the device meets such criteria. The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and supporting studies.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, wave-like design at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 4 2007
Braemar, Inc. c/o Mr. Darren Dershem Regulatory Affairs Representative 1285 Corporate Center Drive, Suite 150 Eagan, MN 55121
Re: K071733
Trade/Device Name: Model DL900 Series Holter Recorder Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II Product Code: MWJ Dated: June 18, 2007 Received: June 26, 2007
Dear Mr. Dershem:
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, 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Darren Dershem
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Bhimmar for
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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Indications for Use
510(k) Number (if known):
Device Name: Braemar DL900 Series Holter Recorder
Indications For Use:
The DL900 Series Holter Recorder is intended for patients requiring ambulatory (Holter) monitoring. Such monitoring is most frequently used for the indications below:
- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 1.
- Evaluation of ECG documenting therapeutic interventions in individual patients or 2. groups of patients.
- Evaluation of patients for ST segment changes. 3.
-
- Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)
- Clinical and epidemiological research studies. ನ.
-
- Evaluation of patients with pacemakers.
- Reporting of time and frequency domain heart rate variability. 7.
- Reporting of QT Interval 8.
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)
Blummo
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).