(68 days)
myPatch®sl is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety.
The myPatch®sl is intended for use by Adults and all Pediatric subgroups
The myPatch®sl (model # 3000sl) ambulatory electrocardiograph (ECG) recorder is a small, lightweight ambulatory ECG recorder that records ECG continuously. The unit records 1 or 2 channels of ECG up to 14 days and 3 channels up to 9 days. The device is composed of a large ECG electrode and an ECG recorder. The ECG recorder snaps onto the electrode and records until the recorder is turned off or the battery is drained. At the end of the recording, the recorder can be plugged into a PC via a USB cable. The ECG recording can be transferred to a pc where processing software can transfer the data to a format that can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers. Only the recorder is part of this 510(k) application.
The myPatch®sI recorder also incorporates an Event feature where the patient double taps on the recorder when they feel a symptom.
The myPatch®sI recorder has a power button on the recorder. Once depressed for 1 second, the green LED flashes. The LED will flash for 30 seconds as a "start-up" period. This gives the user time to apply the electrode to the patient's sternum without recording artifact during the hookup period. To power off the recorder, the button is held down 2 seconds. A red light will flash and the recording period ends.
As the mvPatch®sl is worn continuously up to 14 davs it will be worn (used) in homes. healthcare facilities, hospitals, and where ever the patient may go.
The associated accessories that are part of the myPatch®-sl recorder are a lead wire, USB cable and the mvPatch®-sI electrode.
Per the Class II Special Controls Guidance Document: Electrocardiograph Electrodes, issued on July 21, 2011 "the FDA has determined that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of this generic type of device if the manufacturer follows the recommendations in this special controls guidance to address the issues identified in this guidance." The scope of the guidance includes "bare ECG electrodes or ECG electrodes that incorporate as part of their design, a conductive gel, an adhesive system or a lead wire". Per this guidance, we have the device specifications, composition, formulation, component specifications, engineering drawings with dimensions & composition, written description of how the electrode connects to the myPatch®sI and a list of features and specifications in tabular format.
The lead wire has been tested by the manufacturer to EN 55024:1998 +A1:2001 +A2:2003 and EN 55022:1998+A1:2000+A2:2003 standards. The copy of the Certificate of Conformity is in our files.
The myPatch®sI records ECG in accordance to the standard IEC 60601-2-47:2012 for ambulatory ECG Recorders.
During the recording the patient wears the myPatch®sI connected to an electrode on the upper sternum. The myPatch®sI consists of a microprocessor, recording circuit, memory, data storage, light-emitting diode (trans-illuminates the power button), and snap contacts to the electrode. In addition to that, myPatch®sI contains firmware to control the recording of the ECG data and software to transfer the recorded ECG file to the pc.
The battery is a rechargeable lithium polymer battery with a built-in protection circuit. The charge of the myPatch®sI is by use of a USB cable with a proprietary connector which can only be connected to myPatch®sl when it is not connected to the electrode.
The myPatch®sI has a serial number and product number in a bar code format and numbers to secure the traceability of the equipment and the data during and after the studies.
mvPatch®sI is reusable.
The electrode (accessory to myPatch®sl) is the passive part. The electrode consists of one laver of one-sided adhesive tape that runs the full length of the electrode. This adhesive tape allows the electrode to be placed on the upper sternum. The electrode gel is placed on the underneath side of the adhesive tape. Through this electrode qel the ECG of the patient is recorded. The top side of the electrode has 4 snaps that will connect in only one way to the myPatch®sl and one snap for an optional lead wire. The conductor paths are flex strips that run between the connector and the electrode gel. A release liner is placed on the underside of the electrode. The release liner covers the adhesive tape and the electrode gel. This liner is torn off when placing the myPatch®sl on the upper sternum. The electrode must be connected to the myPatch®sI to have any practical use. The electrode is a single use device and is disposed of after the one single use.
When recording a 3 channel ECG, a standard lead wire is attached to the snap on the front, bottom of the electrode. This lead wire attaches to any standard ECG electrode. The normal placement of this electrode is the V5 position.
The case of the myPatch®sI recorder is a Sabic/Lexan HP1 high flow polycarbonate for medical device applications and has the following certifications: ISO10993 or USP Class VI.
The provided document contains information about the myPatch®sl ambulatory ECG recorder. It describes the device's characteristics, comparison to a predicate device, and various non-clinical performance data. However, it explicitly states that clinical studies were not required to support substantial equivalence. Therefore, the document does not contain acceptance criteria and a study proving the device meets those criteria in a clinical context involving human outcomes or expert assessment of diagnostic accuracy.
Here's an analysis of the information that is available, and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical study with predefined acceptance criteria for diagnostic performance is reported, this table cannot be fully populated as requested. The document focuses on performance relative to engineering and safety standards.
| Acceptance Criteria (Not explicitly stated for diagnostic performance) | Reported Device Performance |
|---|---|
| Device Characteristics (Comparison to Predicate) | |
| Type of ECG Recorder | Patch (Same as predicate) |
| Number of ECG Channels | 1, 2 or 3 (Predicate: 1 or 2) - Similar |
| Wear Time | Up to 14 days (Predicate: Up to 7 days) - Different (Improved) |
| Recording Format | Continuous (Same as predicate) |
| Power Requirement | Lithium Polymer 3.7v 600 mAh (Predicate: 3.7v 350 mAh) - Similar |
| Dimensions | 1.75"x 2" x .5" (Slightly larger than predicate) - Similar |
| Weight | 25 grams (Slightly heavier than predicate) - Similar |
| Frequency Response | 0.05Hz – 175Hz (Predicate: 0.05Hz – 110 Hz) - Similar |
| Input Impedance | >10MOhms (Same as predicate) |
| Resolution | 12 bits (Same as predicate) |
| Performance Standard | Design Verification IEC 60601-2-47 (Same as predicate) |
| Safety | IEC 60601-1 Basic Safety & Essential Performance IEC 60601-2-47 (Same) |
| Duration of Skin Contact | Up to 14 days (Predicate: Up to 7 days) - Different (Improved) |
| Recording Period | Up to 14 Days (Predicate: Up to 7 Days) - Different (Improved) |
| Compliance with Standards (Non-clinical) | |
| IEC 60601-1:2005 (Basic Safety) | Designed and tested for compliance |
| IEC 60601-1-6:2010 (Usability) | Designed and tested for compliance |
| IEC 60601-1-11:2015 (Basic Safety) | Designed and tested for compliance |
| IEC 60601-2-47:2012 (Ambulatory ECG Systems) | Designed and tested for compliance, records ECG in accordance with standard |
| IEC 62366:2007 (Usability Engineering) | Followed guidance |
| IEC 62304:2006 (Software Life Cycle) | Designed and manufactured according to standard |
| IEC 62133:2012 (Battery Safety) | Compliant / Certified, larger battery is certified |
| IEC/EN 60601-1-2 (2015) (EMC) | Designed and tested for compliance |
| ISO 15223-1:2012 (Symbols for Medical Devices) | Designed and tested for compliance |
| ANSI/AAMI EC12 (Disposable ECG Electrodes) | Designed and tested for compliance |
| 21 CFR Part 820 (Quality Systems) | Designed and manufactured according to regulation |
| ISO 10993 (Biocompatibility) | Evaluation conducted in compliance (Parts 5 & 12) |
| FDA Guidance for Premarket Submissions for Software | Software verification and validation testing conducted following guidance |
| ISO 14971 (Risk Management) | Risk Management process performed according to standard |
| IP Rating | IP 68 for submersion up to 2 meters for 1 hour |
| Recording data storage | Able to store data for 14 days (at 128 sample rate) |
2. Sample Size Used for the Test Set and Data Provenance
As no clinical study with a "test set" for diagnostic performance was conducted or reported for this submission:
- Sample Size for Test Set: Not applicable / Not reported for diagnostic performance.
- Data Provenance: Not applicable for diagnostic performance.
However, the document mentions "Usability Testing" with human subjects:
- Usability Testing Sample Sizes:
- Ocean swimming activities: 45 subjects (20 aged 11-20 years, 25 aged 21-59 years).
- Daily activities with showers: 65 subjects (25 aged 5-20 years, 40 aged 20-75 years).
- Gym workouts, showers, daily activities: 25 subjects (aged 19-59 years).
- Daily environment with baths: 15 tests on age group 2 months to 1 year.
- Two-week validation studies: 40 studies (20 in 6-19 years, 20 in 21-78 years) + 15 studies (ages 2 months to 1 year).
- Provenance of Usability Data: The context suggests these were prospective, in-house tests, likely conducted in the US (given the FDA submission, though not explicitly stated for individual subjects).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical study with a diagnostic "ground truth" was reported.
4. Adjudication Method for the Test Set
Not applicable, as no clinical study with adjudication of a test set for diagnostic performance was reported.
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
Not applicable. The device is an ECG recorder, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable for diagnostic algorithm performance. The device records ECG data, which is then transferred to a Holter analysis system (provided by other manufacturers) and analyzed by qualified healthcare providers. The submission focuses on the recorder's ability to accurately capture and store ECG signals per standards, not on automated diagnostic interpretation.
7. The Type of Ground Truth Used
- For the non-clinical performance data (e.g., electrical safety, EMC, battery safety, biocompatibility, software validation, mechanical testing), the "ground truth" is defined by compliance with established international and FDA-recognized standards (e.g., IEC 60601 series, ISO 10993, 21 CFR Part 820). The device demonstrates its performance against these engineering and safety benchmarks.
- For Usability Testing, the "ground truth" is subjective user feedback and observation of device function during use, demonstrating its practical application and adherence.
8. The Sample Size for the Training Set
Not applicable, as this device submission does not describe an AI/machine learning algorithm that requires a training set for diagnostic classification. The device itself is a data acquisition tool.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/machine learning algorithm is described.
Summary of Device Rationale for Substantial Equivalence:
The myPatch®sl demonstrates substantial equivalence to its predicate device (myPatch®s) primarily through:
- Comparison of technological characteristics: Most characteristics are similar, with improvements in wear time (up to 14 days vs. 7 days) and battery capacity. These differences are argued not to impact safety and effectiveness.
- Compliance with recognized standards: Extensive testing was performed against IEC, ISO, AAMI, and FDA regulations for safety, essential performance, software, biocompatibility, and usability.
- Non-clinical performance data: Mechanical testing, environmental robustness (IP68 rating), and extended battery life were verified.
- No clinical data required: The FDA determined that clinical data was not necessary to support substantial equivalence, implying that the non-clinical data and comparison to the predicate were sufficient to assure safety and effectiveness for its intended use.
§ 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).