(84 days)
The intended use of the Holter Recorder Rz153+/ Cardio ID+ is to perform ambulatory ECG and impedance recording, on the order of a physician, on those patients who may benefit from such a recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers. The data obtained at recording is not analyzed at the time of the recording. The data is intended to be downloaded to an analysis software package after the recording is completed.
Detection of Arrhythmia. The Rozinn 153+ 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, syncope, and the symptoms as determined by the physician. Efficacy of treatment using the 153+ 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 is also indicated for use to evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits. This device is to be used only by the order of a physician
The basic operation of the Holter Recorder RZ153+ is to collect and store multiple channels of ECG data along with impedance measurements. The Holter scanner software reads this data and it can be printed out in tabular form or graphical form. This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. It can only display and store the data. The Holter for Windows software reads this data and provides ability to the user to review, edit and print the data collected.
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the structure you requested:
Acceptance Criteria and Device Performance Study for Holter Recorder Cardio ID+ RZ153+
The provided document describes a 510(k) summary for a new Holter Recorder, the Cardio ID+ RZ153+, seeking substantial equivalence to a predicate device, the Holter Recorder DR180 II (K001288). The acceptance criteria are implicitly defined by the technical specifications and performance characteristics of the predicate device. The study performed is a comparison of technology characteristics to demonstrate substantial equivalence, rather than a clinical performance study with specified numerical acceptance criteria for a diagnostic outcome.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are essentially the specifications of the predicate device, and the reported device performance is the specifications of the new device.
| Specification | Acceptance Criteria (Predicate Device: DR180 II) | Reported Device Performance (RZ153+ New Device) |
|---|---|---|
| Online data monitoring & alarm | No | No |
| Recorded ECG channels | Multiple | Multiple |
| Sample rate & resolution | 180/360/720 S/s & 12 bits | 1024 S/s & 12 bits |
| Bit resolution | 6.25 µV / LSB | 1.465 µV / LSB |
| Max. input voltage range | ± 1.5 mV | ± 6, ± 3 or ± 1.5 mV |
| Amplification factors | 1 | 1/2, 1 or 2 |
| Analogue bandwidth | 0.05 Hz to 20 Hz | 0.05 Hz to 75 Hz |
| Pacemaker detection & reporting | Yes | Yes |
| Open-Lead detection & reporting | Yes | Yes |
| Impedance Measurement | Yes | Yes |
| Preferred recording period | 24 h or continuously | 24h, 48h or user defined |
| Storage capacity | Up to 512MB | Up to 512 MB |
| Recording capacity | Up to 50 hours | Up to 120 hours / 5 days |
| Memory type | CompactFlash™ Memory Card | CompactFlash™ Memory Card Type II or Type I |
| Data transfer method | Via removable Memory Card | Via removable Memory Card |
| Memory Card data format | Standard file system | Standard file system |
| Data overwrite protection | Yes | Yes |
| Internal memory card management | Reformat, erase cards | Reformat, erase cards |
| Liquid crystal display (LCD) | Yes | Yes |
| Keyboard | protected touch keys | protected touch keys |
| Number of keys | 13 | 5 |
| Patient leakage current | 0 mA | < 1 µA |
| Size | 125 * 70 * 25 mm (4 7/8" * 2 3/4" * 1") | 108 * 79 * 22 mm (4 1/4" * 3 1/8" * 7/8") |
| Weight | 195 g/6.88oz | 145 g /5.12 oz |
| Belt clip / Carrier pouch | Carrier bag (Pouch) | Carrier bag (Pouch) |
| Battery | 2 * 1.5 V AA | 1 or 2 * 1.5 V AA |
| Accepts rechargeable batteries | Yes, 2 * 1.5 V AA | Yes, 1 or 2 * 1.2 V AA |
| Battery check prior recording | Yes | Yes |
| Internal Clock w. Battery | Yes | Yes |
| Clock setting functionality | Yes | Yes |
| External patient cable | Yes | Yes |
| Record identification procedure | Yes | Yes |
| ECG channel preview | Yes | Yes |
| Signal quality check prior recording | Yes | Yes |
| Multi-language support | Yes | Yes |
| Autostart when ready | Yes | Yes |
| Autostop on problems / data overwrite protection | Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: This document does not detail a specific "test set" in the context of clinical data for performance evaluation. The study relies on a comparison of technical specifications against a predicate device. Therefore, no sample size of patient data is reported for a "test set" to confirm performance against clinical endpoints.
- Data Provenance: Not applicable for a comparative technical specification study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. The study is a comparison of technical specifications, not a diagnostic performance study requiring expert ground truth on patient data.
4. Adjudication Method
- Not applicable. As described above, this is not a diagnostic performance study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This document does not describe an MRMC study. The device is a Holter recorder, which captures physiological signals for later analysis by software and human readers. The study focuses on the recorder's technical equivalence to a predicate device, not on the comparative effectiveness of a human-AI workflow for diagnosis.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
- No. The device itself is a Holter recorder; it "is not capable of any diagnosis nor can it provide any interpretation of the data." It only displays and stores data for later analysis by "Holter for Windows software" and the user. Therefore, there is no "algorithm only" performance reported in this submission for interpretation.
7. The Type of Ground Truth Used
- Technical Specifications: The "ground truth" in this context is the published technical specifications and performance characteristics of the legally marketed predicate device (Holter Recorder DR180 II). The new device's specifications are compared against these established benchmarks to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning model, and therefore, no training set is discussed or used.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for a machine learning model, this question is not relevant.
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OCT 2 4 2002
510(K) Summary
510 (k) Summary
Submitter:
Mark Rosoff, President Rozinn Electronics, Inc. 71-22 Myrtle Avenue Telephone: 718-386-5526 718-366-4574
718-366-4574
mark @roziml.com
Mark @roziml.com
7 318-30030ff
7 31 10030ff
7 31 10030ff
7 31 10030ff Fax: E-mail: Contact: Date of Summary:
Name of Device: Holter Recorder Cardio ID+ RZ153+ Common Name: RZ153+ Classification Name: Recorder, Magnetic Tape, Medical
Substantial Equivalence claimed to legally marketed device: Holter Recorder DR180 II (K001288)
Description of Device:
The basic operation of the Holter Recorder RZ153+ is to collect and store multiple channels of ECG data along with impedance measurements. The Holter scanner software reads this data and it can be printed out in tabular form or graphical form.
This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. It can only display and store the data. The Holter for Windows software reads this data and provides ability to the user to review, edit and print the data collected.
Intended Use of Device
The intended use of the Holter Recorder Rz153+/ Cardio ID+ is to perform ambulatory ECG and impedance recording, on the order of a physician, on those patients who may benefit from such a recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers. The data obtained at recording is not analyzed at the time of the recording.
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The data is intended to be downloaded to an analysis software package after the recording is completed.
| Specification | RZ153+ New Device | DR180 II PredicateDevice |
|---|---|---|
| Online data monitoring &alarm | No | No |
| Recorded ECG channels | Multiple | Multiple |
| Sample rate & resolution | 1024 S/s & 12 bits | 180/360/720 S/s & 12bits |
| Bit resolution | $1,465 \mu V / LSB$ | $6.25 \mu V / LSB$ |
| Max. input voltage range | $\pm 6, \pm 3 or \pm 1.5 mV$ | $\pm 1.5 mV$ |
| Amplification factors | 1/2, 1 or 2 | 1 |
| Analogue bandwidth | 0.05 Hz to 75 Hz | 0.05 Hz to 20 Hz |
| Pacemaker detection &reporting | Yes | Yes |
| Open-Lead detection &reporting | Yes | Yes |
| Impedance Measurement | Yes | Yes |
| Preferred recording period | 24h, 48h or user defined | 24 h or continuously |
| Storage capacity | Up to 512 MB | Up to 512MB |
| Recording capacity | Up to 120 hours / 5 days | Up to 50 hours |
| Memory type | CompactFlash™ Memory CardType II or Type I | CompactFlash™Memory Card |
| Data transfer method | Via removableMemory Card | Via removableMemory Card |
| Memory Card data format | Standard file system | Standard file system |
| Data overwrite protection | Yes | Yes |
| Internal memory cardmanagement | Reformat, erase cards | Reformat, erase cards |
| Liquid crystal display(LCD) | Yes | Yes |
| Keyboard | protected touch keys | protected touch keys |
| Number of keys | 5 | 13 |
| Patient leakage current | < 1 μΑ | 0 mA |
| Size | 108 * 79 * 22 mm4 1/4 * 3 1/8 * 7/8" | 125 * 70 * 25 mm4 7/8" * 2 3/4" * 1" |
| Weight | 145 g /5.12 oz | 195 g/6.88oz |
| Belt clip / Carrier pouch | Carrier bag (Pouch) | Carrier bag (Pouch) |
| Battery | 1 or 2 * 1.5 V AA | 2 * 1.5 V AA |
| Accepts rechargeablebatteries | Yes, 1 or 2 * 1.2 V AA | Yes, 2 * 1.5 V AA |
| Specification | RZ153+ New Device | DR180 II PredicateDevice |
| Battery check priorrecording | Yes | Yes |
| Internal Clock w. Battery | Yes | Yes |
| Clock setting functionality | Yes | Yes |
| External patient cable | Yes | Yes |
| Record identificationprocedure | Yes | Yes |
| ECG channel preview | Yes | Yes |
| Signal quality check priorrecording | Yes | Yes |
| Multi-language support | Yes | Yes |
| Autostart when ready | Yes | Yes |
| Autostop on problems /data overwrite protection | Yes | Yes |
Comparison of Technology Characteristics to the Predicate Device
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Conclusion
The Holter recorder RZ153+ and the Holter recorder DR180 II are both used in clinical applications to collect ambulatory electrocardiographic recordings that can be downloaded to the Holter for Windows® scanner software.
The RZ153+ conforms to Good Manufacturing Procedures outlined by the FDA cGMP. This recorder is safe and effective for the application for which it is intended and has been tested to confirm the safety and efficacy of the recorder. The RZ153+ is found to be substantially equivalent to the DR180II
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 24 2002
Rozinn Electronics, Inc. c/o Mr. Mark Rosoff President 71-22 Myrtle Avenue Glendale, NY 11385
Re: K022540
Trade Name: Cardio ID+RZ153+ Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: DSH Dated: July 29, 2002 Received: August 1, 2002
Dear Mr. Rosoff:
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.
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Page 2 - Mr. Mark Rosoff
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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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 yours,
Alejandro
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Us
1022541 510(K) number (if known):_
Device Name: Cardio ID+ RZ153+
Indications for use: Detection of Arrhythmia. The Rozinn 153+ 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, syncope, and the symptoms as determined by the physician. Efficacy of treatment using the 153+ 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 is also indicated for use to evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits. This device is to be used only by the order of a physician
Prescription Use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K022540
§ 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).