(48 days)
No
The device description focuses on data acquisition and storage, explicitly stating that data analysis occurs separately using previously cleared software. There is no mention of AI or ML in the device description or intended use.
No
The device is a diagnostic tool used for monitoring and recording cardiac rhythm; it does not provide any treatment or therapeutic intervention.
Yes
The device detects arrhythmias, evaluates treatment efficacy for known arrhythmias, and assesses pacemaker function, all of which involve identifying or monitoring a medical condition or its status.
No
The device description clearly states that the SD360 Digital Recorder is a physical recording device that includes hardware components such as electrodes, wires, a recorder unit, an LCD screen, and an SD card. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The NorthEast Monitoring, Inc. SD360 Digital Recorder is an ambulatory monitor (Holter) that records the electrical activity of the heart while being worn by the patient. It collects physiological data directly from the patient's body.
- Lack of Specimen Analysis: The device description explicitly states that "The data obtained by monitoring is not analyzed at the time of recording. After the recording is complete, the data must later be downloaded to a compatible NorthEast Monitoring holter analysis system to be analyzed." This analysis is of the recorded electrical signals, not of a biological specimen.
Therefore, because the device collects data directly from the patient's body and does not analyze biological specimens in vitro, it does not fit the definition of an In Vitro Diagnostic device. It is a medical device used for physiological monitoring.
N/A
Intended Use / Indications for Use
- Detection of Arrhythmias: The NorthEast Monitoring, Inc. SD360 Digital Recorder is indicated for use in continuous monitoring of cardiac rhythm when intermittent arrhythmia are suspected due to patient symptoms such as palpitations, transient ischemic attacks (TIAs), syncope (fainting), or other such symptoms as determined by the physician.
- Efficacy of Treatment: The NorthEast Monitoring Inc. SD360 Digital Recorder is indicated for use to determine whether current pharmacological treatment(s) of known arrhythmia is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment.
- Pacemaker Evaluation: The NorthEast Monitoring Inc. SD360 Digital Recorder is indicated for use to evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits.
- The NorthEast Monitoring SD360 Digital Recorder is to be used by or on the order of a physician.
Product codes
MWJ
Device Description
An ambulatory monitor, sometimes called a Holter, is a painless method to monitor the heart beat for a All anloulatory moments, osmethics or 72 hours). The Holter is a small recording device that records the heart beat while being worn by the patient.
The physician or technician places electrodes and wires on the patient. The wires are connected to the I he prysicial or connectar patient is asked to write down a diary of daily activity including the time and character of any symptoms.
The patient can push a patient event button to mark an event. The patient must write down details about the event in their diary so that physician or technician can relate the event to specific symptoms or activities !
The NorthEast Monitoring SD360 Digital Recorder is a holter monitor designed to facilitate the ambulatory cardiac monitoring, on the order of a physician, of those patients who may benefit from such monitoring including but not limited to those with complaints of palpitations, syncope, chest pains, shortness of breath, or those who need to be monitored to judge their current cardiac function, such as patients who have recently received pacemakers.
The SD360 Digital Recorder package includes:
- . SD360 Digital Recorder
- . Operation Manual
- SD Card .
- Patient Cable
- Pouch ●
The data obtained by monitoring is not analyzed at the time of recording. After the recording is complete, the data must later be downloaded to a compatible NorthEast Monitoring holter analysis system to be analyzed. The Holter Analysis Software was cleared by FDA under K930564.
The SD360 is not intended to replace real time telemetry monitoring for patients suspected of having life-threatening arrhythmias.
The SD360 digital recorder is powered by one 1.5 volt AA alkaline battery (MN1500 or the equivalent), one AA rechargeable NiMH (nickel metal hydride) battery, or one AA Eveready Lithium L91 battery. Batteries should not be re-used for a second patient. The batteries are not included; users are instructed to purchase 2 AA batteries.
The device is compatible with standard silver / silver chloride ECG electrodes. Electrodes are not provided with the subject device. The user is instructed to purchase standard silver / silver chloride ECG electrodes.
The SD360 digital recorder uses NorthEast Monitoring SD360 patient cables with either seven leads or five leads for a 3-channel holter recording. The patient cable connects to the recorder via a 9-pin female connector on the recorder. A patient cable is provided with the SD360 Digital Recorder.
The SD360 has a small LCD that is used to display either time of day (during the recording), error messages (during the hookup procedure or during recording), or lead quality (during the hookup procedure).
The data collected by the SD360 digital recorder is stored on a removable SD Card. To store 24 hours in normal mode, the minimum capacity of the SD Card should be 28 megabytes; 56 megabytes are required for 24 hours in high resolution mode. To store 24 hours in 360 samples/sec mode, 112 megabytes are required. To stored 24 hours in 720 samples/sec, 224 megabytes are required. Double all storage requirements for 48 hour recordings, and triple them for 72 hour recordings. The SD360 is provided with an SD memory card with at least 32 megabytes.
The SD360 is packaged in a plastic bag in a cardboard shipping carton. The shipping carton will also include a patient cable and a pouch. The pouch is used by the patient to hold the digital recorder while in use.
The physician or technician can optionally use a PC as an interface to key in patient information. If a PC were used, the patient information would be keyed into the SD card using the NorthEast Monitoring Holter Analysis software (cleared under a separate 510k).
Another option for entering patient information is through the use of a PDA (i.e. Palm Pilot). Patient information such as patient name, sex, date of birth, identification number, scan number, hookup tech name or initials, physician name, indications, and medications.
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
Physician, technician / 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)
The subject device has been subjected to and passed electrical safety and EMC testing requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NorthEast Monitoring DR180 II Holter Recorder K001288
Reference Device(s)
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
K041901
p. 1 of 4
510(k) Summary AUG 3 1 2004
Date Prepared [21 CFR 807.92(a)(1)]
July 9, 2004
Submitter's Information [21 CFR 807.92(a)(1)]
Joseph M. Azary C/o NorthEast Monitoring Inc. 543 Long Hill Avenue Shelton, CT. 06484
Azary Technologies has received authorization to submit this 510(k) on behalf of the sponsor NorthEast Monitoring Inc. NorthEast Monitoring Inc. located at Two Clock Tower Place, Suite 360, Maynard, MA 01754, is an FDA-registered medical device under establishment# 1224919.
Trade Name, Common Name, Classification [21 CFR 807.92(2)(2)]
Device trade names are: NorthEast Monitoring SD360 Digital Recorder, SD360 Digital Holter Recorder Common Name: Ambulatory ECG Recorder, Ambulatory Electrocardiograph (without analysis) Classification: Class II, 21 CFR 870.2800, MWJ
Predicate Device |21 CFR 807.92(a)(3)|
-
NorthEast Monitoring DR180 II Holter Recorder K001288 .
The subject device has the same indications for use as the predicate. Both the subject device and predicate device can be used for 3 channel recording. The main differences between the subject device and predicate device are as follows: -
. The subject device is smaller and thinner.
-
The subject device weighs less. .
-
The subject device requires only one AA battery (as opposed to two AA batteries required by the . predicate).
-
. The subject device does not have 12 lead capabilities (this was not a heavily used option in the predicate device).
-
. The LCD screen in the subject device is smaller. The LCD screen of predicate device showed waveforms, whereas the LCD screen of the subject device shows lead quality as a numeric value.
-
The subject device uses SD cards instead of flash cards for memory. The SD cards are smaller, but . have the same memory capabilities as the flash cards.
1
Description of the Device [21 CFR 807.92(a)(4)]
An ambulatory monitor, sometimes called a Holter, is a painless method to monitor the heart beat for a All anloulatory moments, osmethics or 72 hours). The Holter is a small recording device that records the heart beat while being worn by the patient.
The physician or technician places electrodes and wires on the patient. The wires are connected to the I he prysicial or connectar patient is asked to write down a diary of daily activity including the time and character of any symptoms.
The patient can push a patient event button to mark an event. The patient must write down details about the event in their diary so that physician or technician can relate the event to specific symptoms or activities !
The NorthEast Monitoring SD360 Digital Recorder is a holter monitor designed to facilitate the ambulatory cardiac monitoring, on the order of a physician, of those patients who may benefit from such monitoring including but not limited to those with complaints of palpitations, syncope, chest pains, shortness of breath, or those who need to be monitored to judge their current cardiac function, such as patients who have recently received pacemakers.
The SD360 Digital Recorder package includes:
- . SD360 Digital Recorder
- . Operation Manual
- SD Card .
- Patient Cable
- Pouch ●
The data obtained by monitoring is not analyzed at the time of recording. After the recording is complete, the data must later be downloaded to a compatible NorthEast Monitoring holter analysis system to be analyzed. The Holter Analysis Software was cleared by FDA under K930564.
The SD360 is not intended to replace real time telemetry monitoring for patients suspected of having life-threatening arrhythmias.
The SD360 digital recorder is powered by one 1.5 volt AA alkaline battery (MN1500 or the equivalent), one AA rechargeable NiMH (nickel metal hydride) battery, or one AA Eveready Lithium L91 battery. Batteries should not be re-used for a second patient. The batteries are not included; users are instructed to purchase 2 AA batteries.
2
The device is compatible with standard silver / silver chloride ECG electrodes. Electrodes are not provided with the subject device. The user is instructed to purchase standard silver / silver chloride ECG electrodes.
The SD360 digital recorder uses NorthEast Monitoring SD360 patient cables with either seven leads or five leads for a 3-channel holter recording. The patient cable connects to the recorder via a 9-pin female connector on the recorder. A patient cable is provided with the SD360 Digital Recorder.
The SD360 has a small LCD that is used to display either time of day (during the recording), error messages (during the hookup procedure or during recording), or lead quality (during the hookup procedure).
The data collected by the SD360 digital recorder is stored on a removable SD Card. To store 24 hours in normal mode, the minimum capacity of the SD Card should be 28 megabytes; 56 megabytes are required for 24 hours in high resolution mode. To store 24 hours in 360 samples/sec mode, 112 megabytes are required. To stored 24 hours in 720 samples/sec, 224 megabytes are required. Double all storage requirements for 48 hour recordings, and triple them for 72 hour recordings. The SD360 is provided with an SD memory card with at least 32 megabytes.
The SD360 is packaged in a plastic bag in a cardboard shipping carton. The shipping carton will also include a patient cable and a pouch. The pouch is used by the patient to hold the digital recorder while in use.
The physician or technician can optionally use a PC as an interface to key in patient information. If a PC were used, the patient information would be keyed into the SD card using the NorthEast Monitoring Holter Analysis software (cleared under a separate 510k).
Another option for entering patient information is through the use of a PDA (i.e. Palm Pilot). Patient information such as patient name, sex, date of birth, identification number, scan number, hookup tech name or initials, physician name, indications, and medications.
3
| Characteristic | Specification |
|---|---|
| Dimensions | 8.7cm (length) x 6.5cm (width) x 2cm (depth) |
| Weight | 70.9 grams (2.5 oz) without battery |
| 99.3 grams (3.5 oz) with battery | |
| Recording Bandwidth | 0.05 to 70 hertz in 180 samples/sec mode; 0.05 to 150 hertz |
| in 360 or 720 samples/sec mode. | |
| Prefilter Sampling Rate | 720 samples/sec |
| Data Stored | In 180 samples/sec mode, data stored at 180 samples/sec (4 |
| sample average), in 360 samples/sec mode, data stored at 360 | |
| samples/sec (2 sample average), in 720 samples/sec mode. | |
| data stored at 720 samples/sec. | |
| Pacemaker Sensitivity | 2 millivolts |
| Pacemaker Pulse Duration | 100 to 2500 microseconds |
Physical and Electrical Specifications:
Intended Use [21 CFR 807.92(a)(5)]
- Detection of Arrhythmias: The NorthEast Monitoring, Inc. SD360 Digital Recorder is indicated for use న్న in continuous monitoring of cardiac rhythm when intermittent arrhythmia are suspected due to patient symptoms such as palpitations, transient ischemic attacks (TIAs), syncope (fainting), or other such symptoms as determined by the physician.
- Efficacy of Treatment: The NorthEast Monitoring Inc. SD360 Digital Recorder is indicated for use to 6. determine whether current pharmacological treatment(s) of known arrhythmia is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment.
- Pacemaker Evaluation: The NorthEast Monitoring Inc. SD360 Digital Recorder is indicated for use to 7. evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits.
- The NorthEast Monitoring SD360 Digital Recorder is to be used by or on the order of a physician. 8.
Technological Characteristics [21 CFR 807.92(a)(6)]
NorthEast Monitoring, Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device has the same indications for use as the predicate.
The main technological difference is the device is smaller, thinner, weighs less, uses only one battery, does not have 12 lead capabilities, uses SD cards instead of flash cards for memory, and can be used with a Palm Pilot to enter patient information.
Performance Data [21 CFR 807.92(b)(1)|
The subject device has been subjected to and passed electrical safety and EMC testing requirements.
Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minor and conclude that the subject is as safe and effective as the predicate devices.
4
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure.
AUG 3 1 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Azary Technologies, LLC c/o Mr. Joseph M. Azary President 543 Long Hill Avenue Shelton, CT 06484
Re: K041901
K041901
Trade Name: Northeast Monitoring SD360 Digital Recorder Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: II (two) Product Code: MWJ Dated: July 14, 2004 Received: July 14, 2004
Dear Mr. Azary:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Security (10(x) premaince in substantially equivalent (for the indications
referenced above and have determined the device is substants and in interstat referenced above and nave decembied the arresed predicate devices marketed in interstate for use stated in the enclosure) to legally mancede produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug commerce prior to May 28, 1970, the chance with the provisions of the Federal Food. Drug, devices that have been reculted in accordance with as proval approval application (PMA).
and Cosmetic Act (Act) that do not require approval assessor oval application of the and Cosmetic Act (Act) that do not require approvate or are al controls provisions of the Act. The
You may, therefore, market the device, subject to the general posignisti You may, therefore, market the device, sayeer to the governments for annual registration, listing of
general controls provisions of the Act include requirements misbranding a general controls provisions of the riot net merator required in the branding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional controlist - Existing major of 998. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Federal Regarmers
publish further announcements concerning your device in the Federal Register.
5
Page 2 – Mr. Joseph M. Azary
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a succession complies with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decernmation that your as res by other Federal agencies. You must or any Federal statutes and regulations administered of excistration and listing (21 list.).
comply with all the Act's requirements, including, but not limited to: registrame comply with all the Act s requirements, more and manufacturing practice requirements as setting CFK Part 807), labeling (21 CFR Part 800); good manat 820); and if applicable, the electronic forth in the quality systems (QD) regalication (Sections 531-542 of the Act); 21 CFR 100-1050. product radiation control provisions (Decions over device as described in your Section 5 10(k)
This letter will allow you to begin marketing your device to a logic I his letter will anow you to begin maneting your antial equivalence of your dever to a legally premarket nothcation. The PDA mixing of backandal square and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please If you desire specific advice for your active of case ante the regulation entitled, contact the Office of Companies at (301) sifection" (21CFR Part 807.97). You may obtain Milsoraliums by reference to premainters with the Act from the Division of Small other geleral Informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Gozess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nul R.L. Ogden
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K041901
Device Name: NorthEast Monitoring Inc. SD360 Digital Recorder
Indications For Use:
- Detection of Arrhythmias: The NorthEast Monitoring, Inc. SD360 Digital Recorder is indicated 1. Detection of Arrily annual Price Northern when intermittent arrhythmia are suspected for use in continuous montoring of sitations, transient ischemic attacks (TIAs), syncope (fainting), or other such symptoms as determined by the physician.
- (1amiling), or other bases of the NorthEast Monitoring Inc. SD360 Digital Recorder is indicated for 2. Ellicacy of Treatment. The Northback Homent(s) of known arrhythmia is effective use to determine when barrent pharmator together arrhythmia compared to the frequency and duration prior to treatment.
- Pacemaker Evaluation: The NorthEast Monitoring Inc. SD360 Digital Recorder is indicated for 3. r acemaker Lyanaton. The NorthLasted pacemakers to insure that the pacemaker is functioning within prescribed limits.
- The NorthEast Monitoring SD360 Digital Recorder is to be used by or on the order of a 4. physician.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil Rpogh
(Division Sign-Off)
Division of Cardiovascular Devices
fw 892
510(k) Number_
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