(164 days)
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.
The ER700 Series is a family of patient-activated ambulatory electrocardiograph event recorders.
The provided text is a 510(k) summary for the Braemar ER700 Series Ambulatory ECG Event Monitor. It focuses on establishing substantial equivalence to a predicate device (Braemar ER300 Series) rather than detailing a study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance evaluation is not available in the given document.
However, I can extract the following information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list acceptance criteria with corresponding performance data. Instead, it provides a comparison table between the ER700 Series and its predicate device (ER300 Series) based on device attributes for the purpose of demonstrating substantial equivalence.
| 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 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The 510(k) summary focuses on comparing device specifications rather than reporting on a clinical trial or performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided in the document. The device described appears to be an ECG event monitor, not an AI diagnostic tool that would typically involve human readers interpreting AI outputs.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The ER700 Series is a patient-activated ambulatory ECG event recorder. While it records ECG data, the document doesn't discuss any specific algorithms for standalone diagnostic performance beyond data recording and transmission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary of what the document does provide regarding device evaluation:
The document serves as an FDA 510(k) premarket notification. Its primary purpose is to demonstrate that the Braemar ER700 Series Ambulatory ECG Event Monitor is substantially equivalent to a legally marketed predicate device, the Braemar ER300 Series (K923930). The evaluation provided is a comparison of attributes and intended use between the new device and the predicate.
The intended use of the ER700 Series is "To record infrequent and elusive ECG heart arrhythmia data. Once an event is recorded, patients transmit the recorded ECG data over the telephone, or, as an alternate, the ER700 Series allows the ECG data to be transferred directly to a host PC if the patient returns the unit to the clinic." This intended use is assessed against the predicate's intended use to ensure they are the same or very similar.
The document highlights differences and similarities in device features, such as the presence of an LCD, memory type, number of ECG channels, data transfer methods, and battery type. The rationale for substantial equivalence is based on these technical comparisons, implying that any differences do not raise new questions of safety or effectiveness.
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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
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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
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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
.. :.
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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: ●
§ 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).