(164 days)
Not Found
No
The summary describes a simple event recorder that captures ECG data upon patient activation and transmits it. There is no mention of any analytical capabilities, pattern recognition, or learning algorithms within the device itself or the data processing workflow described.
No
The device is a recorder for diagnostic purposes and does not provide any therapeutic function.
Yes
The device is described as an "ECG heart arrhythmia data" recorder, which implies that it helps in identifying or characterizing a medical condition (arrhythmia) by recording physiological data (ECG). This falls under the definition of a diagnostic device.
No
The device description explicitly states "The ER700 Series is a family of patient-activated ambulatory electrocardiograph event recorders," indicating it is a hardware device that records ECG data. While it involves data transmission and potential PC transfer, the core function is performed by a physical recorder.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "RECORD INFREQUENT AND ELUSIVE ECG HEART ARREHYTHMIA DATA." This describes a device that records physiological signals from the patient's body.
- Device Description: It's described as a "patient-activated ambulatory electrocardiograph event recorder." An electrocardiograph records electrical activity of the heart, which is a physiological measurement, not an in vitro test.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
The device is a diagnostic tool, but it falls under the category of physiological monitoring or recording devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
To RECORD INFREQUENT AND ELUSIVE ECG HEART ARREHYTHMIA DATA. ONCE THE EVENT IS RECORDED PATIENTS TRANSMIT THE RECORDED ECG DATA OVER THE TELEPHONE, OR, AS AN ALTER NATE, THE ER 700 SERIES ALLOWS THE ECG DATA To BE TRANSFERRED DIRECTLY To A HOST PC IF THE PATIENT RETURNS THE UNIT To THE CLINIC.
Product codes
DXH
Device Description
The ER700 Series is a family of patient-activated ambulatory electrocardiograph event recorders.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol features a stylized human figure within a circle, while the text reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in bold, sans-serif font. The logo is black and white.
May 18, 2018
Braemar Corp. David Norberg Regulatory Affairs Representative 11481 Rupp Dr. Burnsville, Minnesota 55337
Re: K981394
Trade/Device Name: Braemar ER700 Series Ambulatory ECG Event Monitor Models ER710, ER720 Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone electrocardiograph transmitter and receiver Regulatory Class: Class II Product Code: DXH Dated: July 15, 1998 Received: July 17, 1998
Dear David Norberg:
This letter corrects our substantially equivalent letter of September 28. 1998.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting of medical device-related adverse events) (21 CFR 803); good
1
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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang
-S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1
510(k) NUMBER (IF KNOWN): K981394
DEVICE NAME: ER 700 SERIES AECG EVENT MONITOR
INDICATIONS FOR USE:
To RECORD INFREQUENT AND ELUSIVE ECG HEART ARREHYTHMIA DATA. ONCE THE EVENT IS RECORDED PATIENTS TRANSMIT THE RECORDED ECG DATA OVER THE TELEPHONE, OR, AS AN ALTER NATE, THE ER 700 SERIES ALLOWS THE ECG DATA To BE TRANSFERRED DIRECTLY To A HOST PC IF THE PATIENT RETURNS THE UNIT To THE CLINIC.
( PLEASE DO MOT WRITE BELOW THIS LINE-CONFINUE 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
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number
.. :.
3
SEP 28 1998
SECTION 2. SUMMARY & CERTIFICATION
510(k) SUMMARY
- Submitted By: Braemar, Inc. . 11481 Rupp Drive Burnsville, MN 55337
- Contact Person: David Norberg ●
- ER700 Series Cardiac Event Monitor ● Device: Class: Da
- The ER700 Series is a family of patient-activated ambulatory . Description: electrocardiograph event recorders.
- To record infrequent and elusive ECG heart arrhythmia data. Once ● Intended Use: an event is recorded, patients transmit the recorded ECG data over the telephone. Or, as an alternative, the ER700 Series allows the ECG data to be transferred directly to a host PC if the patient returns the unit to the clinic.
- Substantially Equivalent (SE) To: ●
Braemar ER300 Series 510(k) # K923930
| Attribute | ER700 Series | ER300 Series |
|---|---|---|
| Liquid Crystal Display | ||
| (LCD) | Yes | No |
| Looping memory | Yes | Yes |
| Memory type | Flash (non-volatile) | Solid State (volatile) |
| Number of ECG channels | One or two | One or two |
| Transtelephonic data transfer | Yes | Yes |
| Belt clip | Yes | Yes |
| Direct Data Transfer | Yes | No |
| Battery | Two AAA | One 9V |
- Comparison To The SE Device: ●