RHYTHMSTAT XL by DATA CRITICAL CORP.

The RhythmStat XL System is indicated for use in the diagnostic evaluation and recording of ECG waveforms from a cardiac event recorder. It is intended to provide remote access to ECG data by transtelephonic transmission from an ambulatory cardiac event monitor to the portable PSION palmtop computer with RhythmStat XL software, where the ECG waveforms are demodulated, recorded, displayed and stored.

Device Description

The RhythmStat XL System is a telephone electrocardiograph (ECG) receiving system used for recording and reporting of ECG data from a cardiac event recorder. The System has three main components:

. A commercially available cardiac event recorder such as the Micromedical Industries BIOLOG or the Instromedix® Heart Card™, that conditions and transmits ECG data in the form of a frequency-modulated acoustic waveform to the PSION Series 3 palmtop computer:
Two proprietary software programs, contained in the commercially available PSION Series 3 . palmtop computer, that 1) recondition the received signal format and display the signal to the physician on the computer screen, then 2) transmit the ECG data, along with the physician's comments, from the PSION palmtop computer to the Reporting Server via modem; and
. The Data Critical Reporting Server that accepts the ECG data and commentary and generates a printed report that is automatically transmitted to the physician's office via fax.

AI/ML Overview

The provided K971650 document describes a 510(k) premarket notification for the RhythmStat XL System. This system is a telephone electrocardiograph (ECG) receiving system. The performance data section focuses on demonstrating equivalency to predicate devices, rather than establishing specific, quantified acceptance criteria and proving the device meets them in a traditional sense with statistical endpoints.

Here's an attempt to extract the requested information based on the provided text, with significant limitations due to the nature of the submission (an equivalency claim, not a de novo study with strict acceptance criteria).

Acceptance Criteria and Study Details for RhythmStat XL System

1. Table of Acceptance Criteria and Reported Device Performance

Note: The submission does not explicitly state numerical acceptance criteria in the format typically seen in more recent device studies. Instead, it relies on a comparative assessment of "measurable comparability" and "equivalent quality" to predicate devices. The "performance" described is the outcome of this comparative assessment against a qualitative benchmark.

Acceptance Criteria (Implicitly Derived)	Reported Device Performance
ECG waveforms produced by the RhythmStat XL System must be measurably comparable to those produced by predicate devices (Micromedical BIOLOG and Instromedix LifeSigns Receiving Center) in terms of amplitude and duration of QRS segments.	The RhythmStat XL System's ECG waveforms were analyzed for the amplitude and duration of the first ten QRS segments, and the total duration of all QRS segments. These measurements were compared to those obtained from the Micromedical BIOLOG and Instromedix LifeSigns Receiving Center. The system "demonstrated acceptable performance, producing ECG waveforms which were measurably comparable" to the waveforms of the predicate devices.
ECG waveforms produced by the RhythmStat XL System must be of equivalent quality to those produced by predicate devices (Micromedical BIOLOG and Instromedix LifeSigns Receiving Center).	The RhythmStat XL System "produced ECG waveforms which were... of equivalent quality to the waveforms of the Micromedical and Instromedix products." The method for assessing "quality" beyond the QRS measurements is not explicitly detailed but is implied to be part of the comparative evaluation.

Acceptance Criteria (Implicitly Derived)

Reported Device Performance

ECG waveforms produced by the RhythmStat XL System must be measurably comparable to those produced by predicate devices (Micromedical BIOLOG and Instromedix LifeSigns Receiving Center) in terms of amplitude and duration of QRS segments.

The RhythmStat XL System's ECG waveforms were analyzed for the amplitude and duration of the first ten QRS segments, and the total duration of all QRS segments. These measurements were compared to those obtained from the Micromedical BIOLOG and Instromedix LifeSigns Receiving Center. The system "demonstrated acceptable performance, producing ECG waveforms which were measurably comparable" to the waveforms of the predicate devices.

ECG waveforms produced by the RhythmStat XL System must be of equivalent quality to those produced by predicate devices (Micromedical BIOLOG and Instromedix LifeSigns Receiving Center).

The RhythmStat XL System "produced ECG waveforms which were... of equivalent quality to the waveforms of the Micromedical and Instromedix products." The method for assessing "quality" beyond the QRS measurements is not explicitly detailed but is implied to be part of the comparative evaluation.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The text mentions "Subjects were tested" and that "ECG recordings were obtained with the BIOLOG, then played back to and recorded by the PSION/RhythmStat XL". This implies recordings from at least one subject were used, but the number of unique subjects or recordings is not quantified.
Data Provenance: The study was conducted by Data Critical Corporation. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective. Given the testing methodology described (obtaining recordings with one device and playing them back to others), it suggests a controlled, prospective setup within the company's testing environment rather than a large-scale clinical study with patient data.

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

Number of Experts: Not specified. The analysis of QRS segments ("amplitude and duration of the first ten QRS segments were analyzed and measured, along with the total duration of all QRS segments") does not explicitly state who performed these measurements or whether expert review was involved in establishing a "ground truth" beyond the measurements themselves. The document states the PSION displays the signal "to the physician," but this pertains to the intended use, not necessarily the ground truth establishment for the performance study.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not specified. The study describes a direct comparison of physical output (ECG printouts) by measurement, rather than an expert review process requiring adjudication of disagreements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on direct device output comparison, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

Standalone Performance Study: Yes, a standalone performance assessment was conducted for the RhythmStat XL System in the context of comparing its output (ECG waveforms) to predicate devices. The system's output was directly measured and compared without human interpretation being explicitly part of the performance evaluation method, although it implicitly aims to produce output suitable for human interpretation.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this study is the direct measurement of QRS amplitude and duration from ECG printouts produced by the predicate devices. The predicate devices' outputs serve as the reference standard for "measurable comparability" and "equivalent quality." This is a measurement-based comparative standard rather than an expert consensus, pathology, or outcomes data ground truth.

8. Sample Size for the Training Set

Sample Size for Training Set: The document does not mention a training set. This system is described as a receiving and reporting system, not an AI/machine learning algorithm that typically requires a training set. If there's internal calibration or development data, it's not disclosed as a "training set" in the context of machine learning.

9. How Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as no training set is mentioned in the context of an AI/machine learning algorithm.

Summary

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K971650

SECTION 2 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

DEC - 4 1997

Submitter's Name: Data Critical Corporation 100 North Broadway, Suite 2200 Oklahoma City, OK 73102 Telephone: (405) 236-4441 Contact Person: David E. Albert, MD, Chief Scientist

Date of Summary: May 5, 1997

Device Name: RhythmStat XL System

Device Classification: Telephone electrocardiograph transmitter and receiver (74 DXH); 21 CFR § 870.2920

Legally Marketed Devices To Which Equivalence Is Claimed: The legally marketed predicate devices are the Hewlett-Packard M1490A Wireless Patient Data Communicator (Palm Vue System) (K945277); the Instromedix® LifeSigns™ Receiving Center (a preAmendment device); and the Micromedical Industries BIOLOG (K915624).

Device Description: The RhythmStat XL System is a telephone electrocardiograph (ECG) receiving system used for recording and reporting of ECG data from a cardiac event recorder. The System has three main components:

. A commercially available cardiac event recorder such as the Micromedical Industries BIOLOG or the Instromedix® Heart Card™, that conditions and transmits ECG data in the form of a frequency-modulated acoustic waveform to the PSION Series 3 palmtop computer:
Two proprietary software programs, contained in the commercially available PSION Series 3 . palmtop computer, that 1) recondition the received signal format and display the signal to the physician on the computer screen, then 2) transmit the ECG data, along with the physician's comments, from the PSION palmtop computer to the Reporting Server via modem; and
. The Data Critical Reporting Server that accepts the ECG data and commentary and generates a printed report that is automatically transmitted to the physician's office via fax.

Intended Use: The RhythmStat XL System is indicated for use in the diagnostic evaluation and recording of ECG waveforms from a cardiac event recorder. It is intended to provide remote access to ECG data by transtelephonic transmission from an ambulatory cardiac event monitor to the portable PSION palmtop computer with RhythmStat XL software, where the ECG waveforms are demodulated, recorded, displayed and stored.

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Descriptive Summary Of Technological Characteristics And Those Of Predicate

Devices: The RhythmStat XL System is indicated for use in the diagnostic evaluation and recording of ECG waveforms from a cardiac event recorder. It is intended to provide remote access to ECG data by transtelephonic transmission from an ambulatory cardiac event monitor to the portable PSION palmtop computer with RhythmStat XL software, where the ECG waveforms are demodulated, recorded, displayed and stored. The waveforms and accompanying information are then transmitted via modem to the Data Critical Reporting Server for generation of a printed report, which is then faxed to the physician's office. In addition, the PSION palmtop computer with RhythmStat XL software has the capability of relaying the most recently acquired ECG data as an acoustic signal to another PSION with RhythmStat XL software or to a conventional transtelephonic ECG receiving system such as the Instromedix LifeSigns Receiving Center.

The Hewlett-Packard M1490A Wireless Patient Data Communicator (PalmVue System) is intended to provide remote access to data from an HP patient monitoring system by transmitting data from a patient monitor through a Palm Vue dispatch station and paging service provider to a portable handheld Medical Palmtop personal computer. The HP system requires the use of a Hewlett Packard monitoring system and dispatch station. Palm Vue transmission software, an interface card, modem, and a paging service to support the system functions.

The Instromedix® LifeSigns™ Receiving Center is intended to receive, by telephone, ECG data from patients using ambulatory cardiac event monitors or pacer data transmitters. This tabletop device is line-powered and provides a printed record of ECG data; with an optional interface, it allows data to be communicated to a computer.

The Micromedical Industries BIOLOG is intended to acquire, record and store single-lead or 12-lead ECG waveforms via direct patient contact or through a patient cable with electrodes. This portable, hand-held device has an LCD screen, is battery-powered, and is capable of transtelephonic data transmission or receipt. It interfaces directly with the Micromedical Printer to provide a printed record of ECG data.

Performance Data: Testing was conducted by Data Critical Corporation on the RhythmStat XL System to compare its performance to that of two legally marketed predicate devices, the Micromedical Industries BIOLOG recorder and the Instromedix LifeSigns Receiving Center. Subjects were tested using the PSION palmtop computer with RhythmStat XL software and the BIOLOG recorder: additional testing was then conducted with three devices: the PSION with RhythmStat XL software, the BIOLOG recorder, and the Instromedix LifeSigns Receiving Center. ECG recordings were obtained with the BIOLOG, then played back to and recorded by the PSION/RhythmStat XL and printed by the RhythmStat XL Reporting Server. The same recording was then printed out by the predicate devices. the BIOLOG and the LifeSigns Receiving Center. For each ECG printout the amplitude and duration of the first ten QRS segments were analyzed and measured, along with the total duration of all QRS segments. The RhythmStat XL System demonstrated acceptable performance, producing ECG waveforms which were measurably comparable and of equivalent quality to the waveforms of the Micromedical and Instromedix products.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/4 description: The image shows the date "DEC - 4 1997" in bold, black font. The month is abbreviated to "DEC", followed by a hyphen, the number 4, and the year 1997. The text is clear and easily readable against a white background.

Ms. Lisa S. Jones Data Critical Corporation c/o Devices For The Future, LLC 9223 Ilona Lane 77025-4218 Houston, Texas

K971650 Re : RhythmStat XL System Regulatory Class: II (two) 74 DXH Product Code: September 29, 1997 Dated: Received: October 1, 1997

Dear Ms. Jones:

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 Existing major regulations affecting your device additional controls. can be found in the Code of Federal Requlations, 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 requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. In addition, FDA may publish further announcements regulatory action. 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 - Ms. Lisa S. Jones

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. Callahan

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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K971650

SECTION 2 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

DEC - 4 1997

Submitter's Name: Data Critical Corporation 100 North Broadway, Suite 2200 Oklahoma City, OK 73102 Telephone: (405) 236-4441 Contact Person: David E. Albert, MD, Chief Scientist

Date of Summary: May 5, 1997

Device Name: RhythmStat XL System

Device Classification: Telephone electrocardiograph transmitter and receiver (74 DXH); 21 CFR § 870.2920

. A commercially available cardiac event recorder such as the Micromedical Industries BIOLOG or the Instromedix® Heart Card™, that conditions and transmits ECG data in the form of a frequency-modulated acoustic waveform to the PSION Series 3 palmtop computer:
Two proprietary software programs, contained in the commercially available PSION Series 3 . palmtop computer, that 1) recondition the received signal format and display the signal to the physician on the computer screen, then 2) transmit the ECG data, along with the physician's comments, from the PSION palmtop computer to the Reporting Server via modem; and
. The Data Critical Reporting Server that accepts the ECG data and commentary and generates a printed report that is automatically transmitted to the physician's office via fax.

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Descriptive Summary Of Technological Characteristics And Those Of Predicate

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/6/Picture/4 description: The image shows the date "DEC - 4 1997" in bold, black font. The month is abbreviated to "DEC", followed by a hyphen, the number 4, and the year 1997. The text is clear and easily readable against a white background.

Ms. Lisa S. Jones Data Critical Corporation c/o Devices For The Future, LLC 9223 Ilona Lane 77025-4218 Houston, Texas

K971650 Re : RhythmStat XL System Regulatory Class: II (two) 74 DXH Product Code: September 29, 1997 Dated: Received: October 1, 1997

Dear Ms. Jones:

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Page 2 - Ms. Lisa S. Jones

Sincerely yours,

Thomas J. Callahan

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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May 5,1997

Page 1 of 1

510(k) Number:

Device Name: Rhythm Stat XL System

Indications for Use: The RhythmStat XL System is indicated for use in the diagnostic evaluation and recording of ECG waveforms from a cardiac event recorder. It is intended to provide remote access to ECG data by transtelephonic transmission from an ambulatory cardiac event monitor to the portable PSION palmtop computer with RhythmStat XL software.

(Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Ruy

(Division Sign-Off) Division of Cardiova and Neurological De 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

Regulation Number and Section

§ 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).