(147 days)
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. 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 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.
Here's a breakdown of the acceptance criteria and study information for the Paceart Wrist Electrodes, based on the provided text:
Paceart Wrist Electrodes: Acceptance Criteria and Study Details
The provided submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than defining specific numerical acceptance criteria for novel performance. The "acceptance criteria" are implied by showing the Paceart device performs equivalently or better than the predicate device and meets relevant AAMI standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Paceart Wrist Electrodes Performance | Reference |
|---|---|---|---|
| Noise | Equivalent to Medtronic 9427 Wrist Electrode; Better than AAMI EC12-1991 standard. | Values are equivalent to the predicate device. Better than AAMI requirements for reusable electrodes. | {1}, {5} |
| Offset Voltage | Equivalent to Medtronic 9427 Wrist Electrode; Better than AAMI EC12-1991 standard. | Values are equivalent to the predicate device. Lower offset voltage without gel than Medtronic electrodes. Better than AAMI requirements for reusable electrodes. | {1}, {5} |
| Biocompatibility | No adverse biological reaction; Use of accepted material (Type 304 Stainless Steel). | Manufactured from biologically-compatible Type 304 stainless steel. Considered biologically inert. | {1}, {4} |
| ECG Signal Quality | Produce virtually identical ECG recordings compared to the predicate device. | ECG recordings using Paceart electrodes were virtually identical to those from Medtronic electrodes. | {5} |
| Safety (Electrical) | Pin diameter too large to fit into a power outlet. | Pin has a 3.5 mm diameter, which is too large to fit into a power outlet. | {3}, {4} |
| Ease of Use | Easily attached with a minimum of adjustment and preparation (for elderly users). | Patient slips on the bracelet; no gel or skin preparation necessary. | {0}, {3} |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "human subject" (singular) for the clinical comparison, suggesting a very small sample, possibly a single individual or a small, unspecified number.
- Data Provenance: The study was a "Clinical Comparison" with human subjects. The country of origin is not specified but implicitly in the context of a US 510(k) submission, it would often be the US. The study was prospective in nature, as it involved actively conducting tests with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" here is the recorded ECG signal and the physical characteristics/measurements. There were no human expert interpretations requiring consensus to establish ground truth for this device's performance. The comparison was directly between the output of the device and a predicate, and against established engineering standards.
4. Adjudication Method for the Test Set
Not applicable. This was a direct comparison of physical and electrical properties, not an interpretative task requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The study focused on the physical and electrical performance of the device itself, not on the improvement of human readers with or without AI assistance. This device is not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the bench tests for noise and offset voltage, as well as the biocompatibility assessment, represent standalone performance evaluations of the device's physical and electrical characteristics. The "Clinical Comparison" also evaluated the device's ability to record an ECG signal on its own, for direct comparison to a predicate, which also functions as a standalone assessment.
7. The Type of Ground Truth Used
- Bench Tests (Noise & Offset Voltage): The ground truth was established by direct physical measurement according to AAMI standard EC12-1991, Paragraph 4.2.2.3 and 4.2.2.2.
- Biocompatibility: The ground truth was established by material specification (Type 304 Stainless Steel is "biologically inert") and its historical use.
- Clinical Comparison (ECG Signal Quality): The ground truth was the ECG signal generated simultaneously by the predicate device, against which the Paceart device was compared for "virtually identical" results.
8. The Sample Size for the Training Set
Not applicable. This device is a passive medical component (electrodes), not an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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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)
-
- Connections
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- Drawing of connecting jack
-
- 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.
§ 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.