(10 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description and intended use focus on recording and transmitting ECG data, which are standard functions for this type of device.
No
The device records ECG data for review, which is a diagnostic function, not a therapeutic intervention.
Yes
The device records ECG heart arrhythmia data, which is then transmitted for review. The purpose of recording and reviewing this data is to identify or characterize an arrhythmia, which falls under diagnostic activity. The "Intended Use" explicitly states "To record infrequent and elusive ECG heart arrhythmia data," indicating its role in identifying a medical condition.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. The intended use describes recording and transmitting ECG data, which could be achieved through software, but it doesn't explicitly state that the device itself is solely software. The predicate devices listed are hardware ECG recorders, further suggesting the possibility of a hardware component in the subject device.
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 arrhythmia data." This describes a device that measures physiological signals directly from the patient's body (in vivo).
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens, including blood, tissue, and urine, taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not process such specimens.
- Anatomical Site: The anatomical site is the "heart," indicating direct interaction with the patient's body.
The device is clearly designed for in vivo measurement of electrical activity of the heart, not for analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
To record infrequent and elusive ECG heart arrhythmia data. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review.
The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded form the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently the ECG is the most prominent and widely used noninvasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data, which provides a powerful basis for evaluation of these biophysical signals.
Product codes
MWJ
Device Description
The essence of this modification is a change to the recorder hardware to a smaller configuration with reduced power consumption and to reinstate existing arrhythmia functionality to maintain competitiveness with other devices within the domestic marketplace. In connection with the modification the device performance has been validated as reported herein. Note all devices meet the same performance standards of AAMI-EC38, EN60601-1-1, EN60601-1-2, and EN60601-2-47.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
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
§ 870.2800 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).
0
SECTION 3. 510(k) SUMMARY
. .
Substantially Equivalent (SE) To: . Ambulatory Devices
Braemar Model ER700 510(k) K981394
MAR 2 8 2003
Biosensor Model 1005 510(k) K950944
Braemar Model DXP1000 510(k) K993618
Modification Background
The essence of this modification is a change to the recorder hardware to a smaller configuration with reduced power consumption and to reinstate existing arrhythmia functionality to maintain competitiveness with other devices within the domestic marketplace. In connection with the modification the device performance has been validated as reported herein. Note all devices meet the same performance standards of AAMI-EC38, EN60601-1-1, EN60601-1-2, and EN60601-2-47.
The above changes do not affect the intended use of the device or alter the fundamental scientific technology of the device as is demonstrated in this submission.
| Attribute | ER800 | ER700 | Model 1005 | DXP1000 |
|---|---|---|---|---|
| Storage capacity | Up to 30 minutes, | |||
| Looping | ||||
| Memory | Up to 30 minutes, | |||
| Looping | ||||
| Memory | 1 day, 24 hours | 2 days, 48 hours | ||
| Memory type | Flash | |||
| (non-volatile) | Flash | |||
| (non-volatile) | Flash | |||
| (non-volatile) | Compact | |||
| Flash (non-volatile) | ||||
| On-board | ||||
| analysis | Yes | No | Yes | No |
| Liquid Crystal | ||||
| Display (LCD) | No | Yes | No | Yes |
| Data transfer | ||||
| method | TTP | |||
| Transtelephonic | TTP or RS232 | |||
| Serial | Bi-directional | |||
| parallel I/O | USB I/O | |||
| Pacemaker | ||||
| detection & | ||||
| reporting | Yes | No | Yes | Yes |
| Belt clip | Yes | No | No | Yes |
| Battery | One AA | Two AAA | Four AA | Two AA |
| Battery Life | 30 days | 14 days | 24 hours | 48 hours |
Comparison To The SE Devices: .
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, arranged in a row. Above the profiles are three curved lines that resemble a stylized wing or banner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2003
Braemar, Inc. c/o Mr. David Norberg Regulatory Affairs Representative 11481 Rupp Drive Burnsville, MN 55337
Re: K030856
Trade Name: ER800 Series ECG Event Recorder Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II (two) Product Code: MWJ Dated: March 12, 2003 Received: March 18, 2003
Dear Mr. Norberg:
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.
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
2
Page 2 - Mr. David Norberg
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
XQeletM
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SECTION 4. INDICATIONS FOR USE, INTENDED USE
Indications for Use: (No change from predicate devices)
To record infrequent and elusive ECG heart arrhythmia data. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review.
The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded form the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently the ECG is the most prominent and widely used noninvasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data, which provides a powerful basis for evaluation of these biophysical signals.
Vellath
Prescription Use Only