(30 days)
The Sherlock™ Tip Location System (TLS) Detector quickly locates and confirms the position of specially designed, magnet-tipped Peripherally.Inserted Central Catheters (PICCs) and Central Venous Catheters (CVCs) during initial placement. This device may be used by appropriate caregivers in hospitals, long-term care facilities or home-care settings. The Sherlock™ Tip Location System (TLS) Detector provides rapid feedback to the caregiver, but was not designed to replace conventional methods of placement verification. Users are urged to confirm correct placement according to their established institutional protocol and clinical judgment.
The Sherlock™ Tip Location System (TLS) Detector is a battery or line powered hand held device which detects the location of a magnet-tipped catheter stylet. A battery charger is also provided. The Sherlock™ Tip Location System (TLS) Detector uses only passive field sensors, and does not emit energy of any sort into the patient. The Sherlock™ Tip Location System (TLS) Detector is designed (and labeled) to be used only with a compatible PICC or CVC intravascular catheter stylet which contains one or more small, specially oriented magnets encapsulated at the distal end. It provides rapid feedback to a caregiver about the location and orientation of these magnet-tipped devices during initial placement.
Acceptance Criteria and Device Performance for Sherlock™ Tip Location System (TLS) Detector
1. Acceptance Criteria and Reported Device Performance
The provided document indicates the following acceptance criteria and device performance:
| Characteristic Tested | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy | (Not explicitly stated, but implied to be sufficient for its intended use.) | Meets accuracy claim |
| User Interface | (Not explicitly stated, but implied to be satisfactory.) | Meets requirements |
Note: The document only provides broad statements ("Meets accuracy claim" and "Meets requirements") rather than specific quantitative acceptance criteria or numerical performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "Bench" testing.
3. Number of Experts Used and Their Qualifications for Ground Truth
The document does not specify the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed, nor does it provide information on human reader improvement with or without AI assistance. The device is a "Tip Location System (TLS) Detector," which sounds like a standalone device rather than an AI-assisted interpretation system for human readers.
6. Standalone (Algorithm Only) Performance
The document describes the "Sherlock™ Tip Location System (TLS) Detector" as a "battery or line powered hand held device which detects the location of a magnet-tipped catheter stylet." This implies that the device operates as a standalone system (algorithm only) to provide rapid feedback on catheter tip location, without a human-in-the-loop for interpreting its output. The "Bench" testing for "Accuracy" and "User interface" would reflect its standalone performance.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the bench testing. Given that it's a "Tip Location System," the ground truth for accuracy would likely be established through precise physical measurements or imaging techniques (e.g., X-ray, fluoroscopy) to independently verify the actual position of the magnet-tipped stylet compared to the device's reading.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This suggests the device's underlying technology (passive field sensors) may not rely on machine learning or deep learning models that typically require large training datasets.
9. How Ground Truth for the Training Set Was Established
Since there is no mention of a training set, there is no information on how its ground truth might have been established.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”