(25 days)
The Transoma Medical Sleuth Implantable ECG Monitoring System is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:
- Patients with clinical syndromes or situations at increased risk of cardiac . arrhythmias
- Patients who experience transient symptoms that may suggest a cardiac . arrhythmia
The Sleuth Implantable ECG System is an electrocardiogram (ECG) monitoring system that includes an implantable component and that provides continuous ECG monitoring and episodic or segmented ECG recording. The Sleuth Implantable ECG System comprises three interrelated components: Implantable Monitoring Device (IMD), Activator and Base Station.
The modification described in this Special 510(k) is the addition of an 8 cm Antenna Accessory Kit option (Model 3000-08) for use with the IMD, Model 2010.
The 8 cm antenna gives the physician an additional option. The Accessory Kit contains an 8 cm antenna and torque wrench. No changes have been made to the torque wrench.
The only difference between the original 6 cm antenna and the 8 cm antenna is the length. The antenna measures 8 cm from the IS-1 connector to tip.
The provided document is a 510(k) summary for the Transoma Medical Model 3000-08 Antenna Accessory Kit, which is an accessory to the Sleuth Implantable ECG System. This submission is for a modification to an existing device, specifically the addition of an 8 cm antenna. The summary focuses on demonstrating substantial equivalence to a predicate device (Sleuth Implantable ECG System K063035 with a 6 cm antenna). As such, the study design described is primarily non-clinical bench testing to prove the accessory's safety and performance and its substantial equivalence to the previously cleared device.
Therefore, many of the typical elements of a study proving a new device meets acceptance criteria, particularly clinical performance metrics, reader studies, and ground truth establishment, are not applicable in this context. The document aims to show that the new 8 cm antenna has comparable features and performance to the 6 cm antenna through engineering and physical tests.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Test Category) | Reported Device Performance (Summary of Findings) |
|---|---|
| Visual/dimensional inspection | Demonstrated to be substantially equivalent to the predicate device (6 cm antenna). The only difference is the length (8 cm from IS-1 connector to tip). |
| IS-1 testing | Demonstrated to be substantially equivalent to the predicate device. |
| Resistance testing | Demonstrated to be substantially equivalent to the predicate device. |
| Impedance testing | Demonstrated to be substantially equivalent to the predicate device. |
| Tensile/flexural strength testing | Demonstrated to be substantially equivalent to the predicate device. |
| Protection of the device from external defibrillation and high-power electrical fields testing | Demonstrated to be substantially equivalent to the predicate device. |
| Radiated immunity testing | Demonstrated to be substantially equivalent to the predicate device. |
| ESD immunity testing | Demonstrated to be substantially equivalent to the predicate device. |
| Electrical environmental effects (E3) testing | Demonstrated to be substantially equivalent to the predicate device. |
| Overall Conclusion (Substantial Equivalence) | Based on the non-clinical test summary, the 8 cm Antenna Accessory Kit is concluded to be substantially equivalent to the 6 cm Antenna Accessory Kit, suggesting it meets the same safety and performance standards established for the predicate device. The only stated difference is the length (8cm vs 6cm). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for each bench test conducted. Non-clinical bench tests often involve testing a small batch of devices (e.g., 3-5 units) per test, but this information is not explicitly stated.
- Data Provenance: The data is generated from non-clinical bench testing. The tests were likely performed in a laboratory setting by the manufacturer, Transoma Medical, Inc., located in Arden Hills, MN. This is prospective data generation for the purpose of this 510(k) submission. No specific country of origin for patients or previous data is applicable here as it's a bench test for an accessory.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation is based on non-clinical bench testing against established engineering and regulatory standards, not on clinical assessment by medical experts to establish a "ground truth" for diagnostic accuracy. The "ground truth" for these tests would be the established performance characteristics and safety standards for medical device accessories, as demonstrated by the predicate device.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies when multiple human readers interpret data that might be subjective. For bench testing, results are typically objective measurements or pass/fail criteria against a specification, not subject to adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is used to evaluate the impact of a device (often AI) on human reader performance for diagnostic tasks. Since this 510(k) is for an antenna accessory and relies on bench testing for substantial equivalence, such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This device (an antenna accessory) does not involve an algorithm. The "standalone performance" concept usually applies to AI/software as a medical device. Here, the performance is evaluated through physical and electrical characteristics.
7. The Type of Ground Truth Used
The "ground truth" for this submission is implicitly the engineering specifications and safety standards that the predicate 6 cm antenna successfully met, and the regulatory requirements for medical devices. The new 8 cm antenna needed to demonstrate compliance with these same non-clinical performance benchmarks to establish substantial equivalence. It is not based on expert consensus, pathology, or outcomes data in the traditional sense.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or algorithms that require a "training set." The performance evaluation is based on direct measurement and testing of the physical accessory.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for this device.
§ 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).