(147 days)
Medtronic 9427 Wrist Electrode
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No
The device description and performance studies focus on the physical characteristics and electrical performance of the electrodes for ECG monitoring, with no mention of AI or ML for data analysis or interpretation.
No
The device is intended for monitoring and recording ECG data, not for treating a medical condition.
Yes
The device is described as being used for "home monitoring of pacemaker patients via telephone monitoring systems" and for "electrocardiographic monitoring," which are diagnostic purposes for assessing heart activity, albeit for a short duration.
No
The device description explicitly details physical hardware components (metallic electrodes, elastic wristbands, cables, connectors) and their physical interaction with the patient and a monitor. It is not solely software.
Based on the provided information, the Paceart Wrist Electrodes are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "home monitoring of pacemaker patients via telephone monitoring systems." This involves monitoring the electrical activity of the heart (ECG), which is a physiological measurement taken directly from the patient's body.
- Device Description: The device is described as "metallic electrodes with elastic wristbands intended for electrocardiographic monitoring." This further confirms its function is to acquire electrical signals from the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. The Paceart Wrist Electrodes do not process or analyze such specimens.
The device is used for in vivo monitoring (monitoring within the living body), not in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
Paceart Wrist Electrodes are intended to be used for home monitoring of pacemaker patients via telephone monitoring systems.
Paceart Wrist Electrodes are metallic electrodes with elastic wristbands intended for electrocardiographic monitoring.
Product codes (comma separated list FDA assigned to the subject device)
74DRX
Device Description
Paceart Wrist Electrodes are metallic electrodes with elastic wristbands intended for electrocardiographic monitoring. Physically the device consists of a flat metallic electrode fastened to a familiar metallic expansion band of the type commonly used with wrist watches. Ordinarily, the patient would have one electrode and band on each wrist. Each electrode has attached to it a single cable, attached to a connector with an oversized pin. The cable is used to provide the connection to the monitor. No gel or other skin preparation is indicated, and in general is not necessary: the patient slips on the bracelet so that the electrode is on the inside of the wrist, and connects the cable connector to a jack on the monitor. The plug is of sufficiently large diameter so that it will not fit into a outlet. The wrist electrode is used for home telephonic monitoring purposes, and in general will be in contact with the skin for a maximum of five minutes; it is not intended for use as a general-purpose electrocardiographic electrode or for long-term monitoring. The major patient population who is likely to use such an electrode is elderly (for example, pacemaker patients).
The electrode material is Type 304 stainless steel. The watch band is a commercial watch band. The cables are shielded, and the shield is connected to a segment of the connector. One end of each cable (one from each electrode) is permanently attached to one of the electrodes. The other ends are permanently connected to a small jack with a pin which is 3.5 mm in diameter, which is too large to fit into a power outlet. The jack is specifically made to mate with the Paceart Cardiophone, a trans-telephonic ECG transmitter. However, the electrodes can be used with any other transmitter with a compatible socket.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
wrist
Indicated Patient Age Range
The major patient population who is likely to use such an electrode is elderly (for example, pacemaker patients).
Intended User / Care Setting
home monitoring
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Tests: No AAMI standard exists for this type of electrodes. Therefore, the electrodes have been tested for d-c offset and internal noise, according to AMI standard EC12-1991, Paragraph 4.2.2.3, and AAMI standard EC12-1991, Paragraph 4.2.2.2. The tests were also run on the predicate device, and the results for the two devices are compared. Since the electrodes are in general used without gel, the offset voltages were measured both with gel (as specified by the standard) and without gel. The Paceart electrodes had a lower offset voltage without gel than did the Medtronic electrodes. For all tests, both devices had comparable results, and both are better than the AAMI requirements for reusable electrodes.
Clinical Comparison: The Paceart and Medtronic electrodes were compared with human subject, who wore both sets of electrodes simultaneously, and recorded an ECG using both electrodes at the same time. No gel was used in these tests. The results are virtually identical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Medtronic 9427 Wrist Electrode
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.
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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).
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§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.
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Paceart Associates LP 510 (k) Submission Paceart Wrist Electrodes 510 (K) Summary
JUL 18 1998
(1) Submitter Information: Name: Paceart Associates LP. Address: 22 Riverview Drive, Wayne New Jersey 07470 Telephone Number: 201-696-1122 Contact Person: Dr. George Myers, 201-438-2310
(2) Names:
Trade: Paceart Wrist Electrodes Usual Name: Electrocardiograph Common Wrist Electrodes Classification Name: Electrode, Electrocardiograph
- (3) Classification, Panel Class II, 74DRX
- (4) Predicate Device: Medtronic 9427 Wrist Electrode
- (5) Description
Paceart Wrist Electrodes are metallic electrodes with elastic wristbands intended for electrocardiographic Physically the device consists of a flat monitoring. metallic electrode fastened to a familiar metallic expansion band of the type commonly used with wrist watches. Ordinarily, the patient would have one electrode and band on each wrist. Each electrode has attached to it a single cable, attached to a connector with an oversized pin. The cable is used to provide the connection to the monitor. No gel or other skin preparation is indicated, and in general is not necessary: the patient slips on the bracelet so that the electrode is on the inside of the wrist, and connects the cable connector to a jack on the monitor. The plug is of sufficiently large diameter so that it will not fit into a outlet. The wrist electrode is used for home power telephonic monitoring purposes, and in general will be in contact with the skin for a maximum of five minutes; it is a s not intended for use a general-purpose electrocardiographic electrode or for long-term monitoring. The major patient population who is likely to use such an electrode is elderly (for example, pacemaker patients).
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(6) Intended Use
Paceart Wrist Electrodes are intended to be used for home monitoring of pacemaker patients via telephone monitoring systems.
- (7a) Predicate Devices
The predicate device for the Paceart Wrist Electrode is the Medtronic 9427 Wrist Electrode
(7b) Testing
The Paceart Wrist Electrode has been compared in tests to the predicate device with respect to noise and offset voltage. The values for the two devices are equivalent. Test reports show that the Paceart Electrode and strap are manufactured from a biologically-compatible stainless steel, Type 304.
These tests all show that the Paceart Wrist Electrode is safe and effective for its intended use.
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Photograph Paceart Wrist Electrode
Image /page/2/Picture/3 description: The image shows three electrical components with wires connecting them. The components are labeled with the letters 'L' and 'R', suggesting they might be related to left and right channels in an audio or electrical system. The components are placed on a textured surface, possibly a table or floor, with a dark background that contrasts with the lighter color of the components and wires. The wires are coiled and connected to the components, indicating a functional connection between them.
Image /page/2/Picture/4 description: The image shows two electronic devices with screens and attached cables, positioned against a dark background. The devices appear to be some sort of data loggers or sensors, possibly for environmental monitoring. The contrast in the image is high, making it difficult to discern details of the surrounding environment. The devices are placed at different angles, suggesting they are deployed in a field setting.
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Paceart Associates LP 510(k) Submission Paceart Wrist Electrodes Overview
December 4, 1995
I. Introduction and Intended Use
Paceart Wrist Electrodes are metallic electrodes with elastic wristbands intended for electrocardiographic monitoring. Physically the device consists of a flat metallic electrode fastened to a familiar metallic expansion band of the type commonly used with wrist watches. Ordinarily, the patient would have one electrode and band on each wrist. Each electrode has attached to it a single cable attached to a connector with an oversized pin. The cable is used to provide the connection to the monitor. No gel or other skin preparation is indicated, and in general is not necessary: the patient slips on the bracelet so that the electrode is on the inside of the wrist, and connects the cable to a jack on the monitor by menas of the connector. The plug is of sufficiently large diameter so that it will not fit into a power outlet. The wrist electrode is used for home telephonic monitoring purposes, and in general will be in contact with the skin for a maximum of five minutes; it is not intended for use as a general-purpose electrocardiographic electrode or for long-term monitoring. Since the major patient population who is likely to use such an electrode is quite elderly (for example, pacemaker patients), it is important that the electrode can be easily attached with a minimum of adjustment and preparation.
II. Construction
The device is shown in Figure 1, which shows both the electrode plate and the strap. The electrode material is Type 304 stainless steel, which is an accepted material for implants, a far more stringent application. The materials section has a certificate from the manufacturer showing the composition of this steel. The watch band is a commercial watch band which has been in commercial distribution in the United States for this purpose for some time, with no reported cases of any skin irritations. The cables are shielded, and the shield is connected to a segment of the connector.
One end of each cable (one from each electrode) İs permanently attached to one of the electrodes, and cannot be removed by the user. The other ends are permanently
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Paceart Wrist Electrodes
connected to a small jack with a pin which is 3.5 mm in diameter, which is too large to fit into a power outlet. The connections are shown in Figure 2, and the jack is shown schematically in Figure 3.
The jack is specifically made to mate with the Paceart Cardiophone, a trans-telephonic ECG transmitter. However, the electrodes can be used with any other transmitter with a compatible socket. Figure 4 shows more detail of the construction of the electrode.
III. Predicate Device
The predicate device for the Paceart wrist electrode is Medtronic 9427 wrist electrode, which has the same the intended use and virtually the same construction. The characteristics of the two electrodes are compared in the appropriate section of this submission.
IV. Biocompatibilıty
The only metal in contact with the patient's skin is Type 304 Stainless Steel (the material of both the bracelet and the electrode). Type 304 stainless steel is generally considered to be biologically inert and, in fact, is used for commercial metal watchbands. Since the electrode itself is worn for only short periods of time and is considered inert, there is no risk of biological reaction. Metals are not covered by the tri-partite agreement.
No plastic materials are in contact with the patient.
V. Bench Tests
No AAMI standard exists for this type of electrodes. Therefore, the electrodes have been tested for d-c offset and internal noise, according to AMI standard EC12-1991, Paragraph 4.2.2.3, and AAMI standard EC12-1991, Paragraph 4.2.2.2. The tests were also run on the predicate device, and the results for the two devices are compared. Results and protocols are in the bench test section.
Since the electrodes are in general used without gel, the offset voltages were measured both with gel (as specified by the standard) and without gel. The Paceart electrodes had a lower offset voltage without gel than did the Medtronic electrodes.
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For all tests, both devices had comparable results, and both are better than the AAMI requirements for reusable electrodes.
VI. Clinical Comparison
The Paceart and Medtronic electrodes were compared with human subject, who wore both sets of electrodes a simultaneously, and recorded an ECG using both electrodes at the same time. No gel was used in these tests. The results, shown in the Clinical Section, are virtually identical.
Figures
- l. Electrode plate and strap (drawing)
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- Connections
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- Drawing of connecting jack
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- Detail of electrode construction
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Image /page/6/Figure/0 description: This figure shows a Paceart Wrist Electrode from a perspective view. The figure includes a wrist strap that wraps around the wrist. An electrode is attached to the wrist strap. The figure is labeled as Figure 1.
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Image /page/7/Figure/0 description: This image shows a diagram of the Paceart Wrist Electrodes Placement and Connection. The diagram shows the right and left wrists, each with an electrode attached. Cables connect the electrodes to a connector, which is attached to a cardiophone. The image is labeled as Figure 2.
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Image /page/8/Figure/0 description: The image is a schematic drawing of a Paceart Wrist Electrode Connector. The drawing shows the cable to the electrodes connected to the body of the connector. The pin has a 3.5 mm diameter. The figure is labeled as Figure 3.
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Image /page/9/Figure/0 description: This figure shows two views of a Paceart wrist electrode. The first view is a side view of the electrode, showing the stainless-steel electrode and the plastic back. The second view is a plan view of the electrode, showing the watch-band metallic strap, the stainless-steel electrode, and the plastic back. The figure is labeled as Figure 4.