(205 days)
Not Found
No
The description focuses on the hardware and basic recording functions of a traditional Holter monitor, with no mention of AI or ML for analysis or interpretation.
No
The device is described as an ECG recording device for ambulatory patients, not one that provides therapy or treatment.
Yes
The device is described as a "Diagnostic Monitoring DM-400 Holter ECG Cassette Recorder" intended for "ECG recording of an ambulatory patient," which are typical functions of a diagnostic device used to assess heart activity.
No
The device description explicitly states it is a "battery operated ambulatory ECG recording device" and mentions hardware components like a "5 or 7 wire bonded lead set and silver/silver chloride self adhesive electrodes." The performance studies also detail testing of hardware components like the power supply, circuitry, amplifier, and motor controller.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The DM-400 Holter ECG Cassette Recorder records electrical activity of the heart from the patient's body using electrodes attached to the skin. This is a form of in vivo (within the living body) measurement.
- Intended Use: The intended use is "ECG recording of an ambulatory patient," which is a direct measurement of a physiological signal from the patient.
Therefore, based on the provided information, the DM-400 Holter ECG Cassette Recorder is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DM-400 Holter ECG Cassette Recorder is a device designed for ECG recording of an ambulatory patient.
Product codes (comma separated list FDA assigned to the subject device)
74 DSH
Device Description
The Diagnostic Monitoring DM-400 Holter ECG Cassette Recorder is a battery operated ambulatory ECG recording device. The DM-400 Holter Recorder is capable of recording three independent channels of ECG from an ambulatory patient. The patient is connected to the recorder by means of a 5 or 7 wire bonded lead set and silver/silver chloride self adhesive electrodes. The DM-400 Holter Recorder can perform either a 24 or 48 hour ECG recording. The recorder is equipped with self calibration and a patient event signal button.
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)
The DM-400 Holter ECG Cassette Recorder was tested for functionality and adherence to design specifications. The testing encompassed the major functional and specialized features of the DM-400 Recorder. Testing included verification of the power supply and low battery features, complete circuiry testing, verification of the unit calibration, ECG amplifier verification, testing of the event signals, baseline centering, frequency response testing, common mode rejection and Motor Controller Circuit operation. In addition, dynamic testing of the units was performed to assure that the electronic package functions correctly with the supplied mechanical package. A 24 hour Calibration test was performed, as well as a visual inspection of the unit and a scaming verification.
Results of the testing showed that the DM-400 Holter ECG Recorder units met the design specifications and performed as intended. Repeatability testing of the units showed that the DM-400 Recorder provides consistent results. Testing of the DM-400 Recorder verifies that the device is designed for accurate and safe ECG recording of an ambulatory patient. The testing also confirms that the features and characteristics of the DM-400 Recorder device perform within the expected parameters of the substantially equivalent devices with the same features and characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 19: SUMMARY OF SAFETY AND EFFECTIVENESS
AUG 20 1997
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
SUBMITTER INFORMATION 19.1
... . . . . . . . .
| a. | Company Name: | Diagnostic Monitoring |
|---|---|---|
| b. | Company Address: | 1176 Main Street, Bldg. C |
| Irvine, CA 92614 | ||
| c. | Company Phone: | (714) 568-1695 |
| d. | Contact Person: | Raymond Cohen |
| President | ||
| e. | Date Summary Prepared: | May 21, 1997 |
19.2. DEVICE IDENTIFICATION
- DM-400™ Holter ECG Cassette Recorder Trade/Proprietary Name: a.
- Medical Magnetic Tape Recorder Classification Name: b.
IDENTIFICATION OF PREDICATE DEVICE(S) 19.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Datrix | XR-300 Holter | ||
| ECG Recorder | K921068 | March 30,1992 | |
| Zymed | MultiTrak Ambulatory | ||
| ECG Recorder | K930894 | November 11, 1993 |
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DEVICE DESCRIPTION 19.4
The Diagnostic Monitoring DM-400 Holter ECG Cassette Recorder is a battery operated ambulatory ECG recording device. The DM-400 Holter Recorder is capable of recording three independent channels of ECG from an ambulatory patient. The patient is connected to the recorder by means of a 5 or 7 wire bonded lead set and silver/silver chloride self adhesive electrodes. The DM-400 Holter Recorder can perform either a 24 or 48 hour ECG recording. The recorder is equipped with self calibration and a patient event signal button.
SUBSTANTIAL EQUIVALENCE 19.5
The Diagnostic Monitoring DM-400 Holter ECG Cassette Recorder is substantially equivalent to other ambulatory ECG recorders currently in commercial distribution by Datrix and Zymed in terms of the intended use of achieving a safe and accurate ECG recording of an ambulatory patient. The fundamental technical characteristics are similar to those of the predicate devices and are listed on the comparison charts provided in Section 19.7 .
19.6 INTENDED USE
The DM-400 Holter ECG Cassette Recorder is a device designed for ECG recording of an ambulatory patient.
TECHNOLOGICAL CHARACTERISTICS 19.7
A comparison of the technological characteristics of the predicate and legally marketed devices is provided in the following device comparison charts. Finished product
2
specifications, schematic drawings and detailed description of the device have been provided.
The Device Comparison Chart #1 provides a side by side comparison of the characteristics of the Diagnostic Monitoring DM-400 Holter ECG Cassette Recorder and the Datrix XR-300 Holter ECG Recorder.
Device Comparison Chart #2 provides a side by side comparison of the characteristics of the Diagnostic Monitoring DM-400 Holter ECG Cassette Recorder and the Zymed MultiTrak Ambulatory ECG Recorder. J
As evidenced by the comparison charts the DM-400 Holter Recorder and the predicate devices are similar in their function and characteristics. There are no differences between the technologies which require further evaluation.
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DEVICE COMPARISON CHART #1 Diagnostic Monitoring DM-400 Holter ECG Cassette Recorder & Datrix XR-300 Holter ECG Recorder
)
....
.
| Manufacturer | Diagnostic Monitoring | Datrix |
|---|---|---|
| Model No. | DM-400 Holter ECG Recorder | XR-300 Holter ECG Recorder |
| Intended use | ECG recording of ambulatory | |
| patients. | ECG recording of ambulatory | |
| patients. | ||
| Design | ||
| -portable | Yes | Yes |
| -power source | 9V alkaline battery | 9V alkaline battery |
| -cassette tape | standard C60 | standard C60 |
| -number of heads | 1 | 1 |
| -channels | 4 | |
| (3 ECG, 1 timing track) | 4 | |
| (3 ECG, 1 timing track) | ||
| -tape speed | 1.0min/sec | 1.0mm/sec |
| - recording time | 24 or 48 hours | 25 hours, nominal |
| - frequency response | 0.05 to 100 Hz (-3dB) | 0.05 to 100 Hz (-3dB) |
| -common mode rejection | 60 dB minimum | |
| 1 volt peak-to-peak | ||
| 60 Hz common mode signal | 60 dB minimum | |
| 1 volt peak-to-peak | ||
| 60 Hz common mode signal | ||
| -electrolead cables | 5 or 7 lead | 5 or 7 lead |
| Manufacturer | Diagnostic Monitoring | Datrix |
| Features | ||
| -patient event button | Yes | Yes |
| -built-in calibration | Yes | Yes |
| -carrying case | Yes | Yes |
| -color coded ECG outputs | Yes | Yes |
4
DEVICE COMPARISON CHART #1 Diagnostic Monitoring DM-400 Holter ECG Cassette Recorder & Datrix XR-300 Holter ECG Recorder
ر
- 4
:
5
DEVICE COMPARISON CHART #2 Diagnostic Monitoring DM-400 Holter ECG Cassette Recorder & Zymed MultiTrak Ambulatory ECG Record
ﺮ
| Manufacturer | Diagnostic Monitoring | Zymed | |
|---|---|---|---|
| Model No. | DM-400 Holter ECG Recorder | MultiTrak Ambulatory ECG Recorder | |
| (3 channel configuration) | |||
| Intended use | ECG recording of ambulatory | ||
| patients. | ECG recording of ambulatory | ||
| patients. | |||
| Design | -portable | Yes | |
| -power source | 9V alkaline battery | ||
| -cassette tape | standard C60 | ||
| -number of heads | 1 | ||
| -recording channels | 4 | ||
| (3 ECG, 1 timing track) | |||
| -tape speed | 1.0mm/sec | ||
| - recording time | 24 or 48 hours | ||
| - frequency response | 0.05 to 100 Hz (-3dB) | ||
| -common mode rejection | 60 dB minimum | ||
| 1 volt peak-to-peak | |||
| 60 Hz common mode signal | |||
| -electrolead cable | 5 or 7 lead | ||
| Manufacturer | Diagnostic Monitoring | Zymed | |
| Features | -patient event button | Yes | Yes |
| -built-in calibration | Yes | Yes | |
| -input protection for defibrillator | Yes | Yes | |
| -carrying case | Yes | Yes |
6
Dagnostic Monitoring DM-400 Holter ECG Cassette Recorder & Zymed MultiTrak Ambulatory ECG Record
)
: : : :
7
PERFORMANCE DATA 19.8
The DM-400 Holter ECG Cassette Recorder has been demonstrated to perform as intended with accuracy and repeatability. A summary of the performance testing of the DM-400 Holter Recorder are presented in the following.
The DM-400 Holter ECG Cassette Recorder was tested for functionality and adherence to design specifications. The testing encompassed the major functional and specialized features of the DM-400 Recorder. Testing included verification of the power supply and low battery features, complete circuiry testing, verification of the unit calibration, ECG amplifier verification, testing of the event signals, baseline centering, frequency response testing, common mode rejection and Motor Controller Circuit operation. In addition, dynamic testing of the units was performed to assure that the electronic package functions correctly with the supplied mechanical package. A 24 hour Calibration test was performed, as well as a visual inspection of the unit and a scaming verification.
Results of the testing showed that the DM-400 Holter ECG Recorder units met the design specifications and performed as intended. Repeatability testing of the units showed that the DM-400 Recorder provides consistent results. Testing of the DM-400 Recorder verifies that the device is designed for accurate and safe ECG recording of an ambulatory patient. The testing also confirms that the features and characteristics of the DM-400 Recorder device perform within the expected parameters of the substantially equivalent devices with the same features and characteristics.
19.9 510(K) CHECKLIST
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
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Image /page/8/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 is a stylized representation of a human figure. The symbol is composed of three curved lines that form the shape of a person. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Raymond Cohen Diagnostic MonitoringTM ... ..... 1176 Main Street, Building C Irvine, California 92614
AUG 20 1997
・ . .
Re: K970298 DM-400 Holter ECG Cassette Recorder Requlatory Class: II (two) Product Code: 74 DSH Dated: May 22, 1997 Received: May 23, 1997
Dear Mr. Cohen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (BDA) will verify such assumptions. Failure to comply with the GMP requiation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Raymond Cohen
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
INDICATIONS FOR USE
| 510(k) Number: | To Be Assigned By FDA |
|---|---|
| Device Name: | Diagnostic Monitoring DM-400 Holter ECG Recorder |
| Indications For Use: | The DM-400 Holter ECG Cassette Recorder is a device |
| designed for ECG recording of an ambulatory patient. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1
Atel. A. Ciark.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K970298 510(k) Number __
OR
Prescription Use ✓
Over-The-Counter Use ________________
(Per 21 CFR 801.109) .
Status