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.

AI/ML Overview

Here's an analysis of the provided information regarding the Diagnostic Monitoring DM-400 Holter ECG Cassette Recorder, focusing on acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the performance testing of the DM-400 Holter ECG Cassette Recorder against its design specifications and to ensure it performs as intended with accuracy and repeatability. However, explicit, quantifiable acceptance criteria with pass/fail thresholds are not directly stated in the summary. Instead, the document frames the testing around verification of functionality and adherence to design specifications, and comparison to predicate devices.

Here's a table summarizing the areas tested and the reported performance:

Acceptance Criteria (Implied)	Reported Device Performance
Functionality and adherence to design specifications	Met design specifications and performed as intended
Accuracy of ECG recording	Performed as intended with accuracy
Repeatability of ECG recording	Showed consistent results
Power supply and low battery features	Verified
Complete circuitry	Tested and verified
Unit calibration	Verified
ECG amplifier	Verified
Event signals	Tested
Baseline centering	Tested
Frequency response (0.05 to 100 Hz (-3dB))	Tested (implicitly met, as it's a design spec shared with predicate devices)
Common mode rejection (60 dB minimum, 1 volt peak-to-peak 60 Hz)	Tested (implicitly met, as it's a design spec shared with predicate devices)
Motor Controller Circuit operation	Tested
Dynamic testing (electronic package with mechanical package)	Performed to assure correct function
24-hour Calibration test	Performed
Visual inspection	Performed
Scanning verification	Performed
Performance within expected parameters of substantially equivalent devices	Confirmed that features and characteristics perform within expected parameters of predicate devices

2. Sample Size for the Test Set and Data Provenance

Sample Size: The document does not specify a numerical sample size for the test set. It mentions "units" in the plural ("units met the design specifications," "repeatability testing of the units").
Data Provenance: The testing was performed by Diagnostic Monitoring, the manufacturer of the device. The data is prospective in the sense that it was generated specifically for the 510(k) submission to demonstrate the device's performance. The country of origin of the data is implicitly the USA, as the company is based in Irvine, CA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. The testing described is primarily engineering and functional verification against design specifications, not clinical performance or diagnostic accuracy assessed by experts against a ground truth from patient data.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The testing performed was internal engineering and functional verification, not a clinical study requiring expert adjudication of results.

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

There was no MRMC comparative effectiveness study and no AI component mentioned in the document. The device is a Holter ECG cassette recorder, a hardware device for recording ECGs, not an AI-powered diagnostic tool. The comparison is made against existing predicate hardware devices to establish substantial equivalence in technical characteristics and intended use.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a hardware recorder, not an algorithm, and does not involve human-in-the-loop performance in the context of an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing described was primarily the device's own design specifications and the expected operational parameters of similar, legally marketed predicate devices. It involved functional checks and verification of engineering parameters such as frequency response and common mode rejection, rather than a clinical ground truth like pathology or expert consensus on clinical findings.

8. The Sample Size for the Training Set

This information is not applicable. The device is a hardware recorder, not an AI model, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable. As stated above, there is no AI model or training set involved.

Summary

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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. CIrvine, CA 92614
c.	Company Phone:	(714) 568-1695
d.	Contact Person:	Raymond CohenPresident
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 HolterECG Recorder	K921068	March 30,1992
Zymed	MultiTrak AmbulatoryECG Recorder	K930894	November 11, 1993

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DEVICE DESCRIPTION 19.4

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

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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

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Manufacturer	Diagnostic Monitoring	Datrix
Model No.	DM-400 Holter ECG Recorder	XR-300 Holter ECG Recorder
Intended use	ECG recording of ambulatorypatients.	ECG recording of ambulatorypatients.
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 minimum1 volt peak-to-peak60 Hz common mode signal	60 dB minimum1 volt peak-to-peak60 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

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DEVICE COMPARISON CHART #1 Diagnostic Monitoring DM-400 Holter ECG Cassette Recorder & Datrix XR-300 Holter ECG Recorder

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DEVICE COMPARISON CHART #2 Diagnostic Monitoring DM-400 Holter ECG Cassette Recorder & Zymed MultiTrak Ambulatory ECG Record

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Manufacturer	Diagnostic Monitoring	Zymed
Model No.	DM-400 Holter ECG Recorder	MultiTrak Ambulatory ECG Recorder(3 channel configuration)
Intended use	ECG recording of ambulatorypatients.	ECG recording of ambulatorypatients.
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 minimum1 volt peak-to-peak60 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

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Dagnostic Monitoring DM-400 Holter ECG Cassette Recorder & Zymed MultiTrak Ambulatory ECG Record

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: : : :

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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

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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 devicedesigned 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)

Atel. A. Ciark.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K970298 510(k) Number __

Prescription Use ✓

Over-The-Counter Use ________________

(Per 21 CFR 801.109) .

Status

Regulation Number and Section

§ 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).