(160 days)
The Merlin PSA Patient Cable EX3150 is a three-channel resterilizable patient cable intended to connect the Merlin PSA to as many as three IS-1 leads or to SJ4 leads.
The Merlin PSA Patient Cable Adapter EX3170 is a three-channel adapter intended to connect the Merlin PSA to as many as three disposable patient cables. The EX3170 Cable Adapter can connect to the Models 4051/4051A disposable patient cables for IS-1 leads or to the Model 4161 disposable patient cable for SJ4 leads. The opposite ends of the disposable patient cables connect to implantable pacing leads.
The Merlin PSA "M" Adapter Model EX3180 is intended to connect the Merlin PSA to the twochannel Medtronic Model 2292 re-sterilizable patient cable. The opposite end of the Medtronic Model 2292 cable connects to implantable pacing leads.
Following use, the patient cables must either be disposed or re-sterilized, depending on the requirements of the cable.
The Merlin PSA Patient cable, Model EX3150 is an accessory to the Merlin PSA EX3100 system, which is intended to assess the pacing and sensing performance of the lead system prior to pulse generator implantation, or during invasive lead system troubleshooting.
The PSA Patient cable is intended to connect one to three implanted leads to the Merlin PSA EX3100, which is the patient interface part of the PSA product. The PSA Patient cable is the interface between the implanted leads and the PSA unit. The ODU connector end of the cable is connected to the Merlin PSA and the Alligator clip end is connected to the leads. The PSA Patient cable is re-sterilizable.
Patient Cable Adapters - Merlin PSA Cable Adapter EX 3170, Merlin PSA "M" Adapter EX 3180 connects the Merlin PSA to commonly used PSA patient cables
Merlin PSA Cable Adapter EX3170 connects to the currently marketed disposable surgical cables 4051/4051A and 4161.
Merlin PSA "M" Adapter EX3180 connects to the Medtronic Model 2292 patient cable.
The provided document, K101982, describes the premarket notification for the Merlin™ PSA Patient Cable EX3150 and Merlin™ PSA Patient Cable Adapters EX3170 and EX3180. This submission focuses on demonstrating substantial equivalence to predicate devices for these accessories to a Pacemaker System Analyzer (PSA). As such, the studies described are primarily engineering verification and validation tests rather than clinical studies involving human readers, ground truth establishment, or comparative effectiveness with AI.
Therefore, many of the requested categories related to clinical studies and AI performance are not applicable to this 510(k) summary. I will answer the applicable questions based on the provided text.
Acceptance Criteria and Device Performance
The acceptance criteria are generally implied by the successful completion of the various verification and validation activities listed. The device performance is deemed acceptable if these tests pass, demonstrating the device's fitness for its intended use and substantial equivalence to predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material and Biocompatibility | All units tested passed the acceptance criteria (Merlin PSA Patient Cable EX3150). Biocompatibility testing was not required for adapters EX3170 and EX3180 as they do not make blood tissue contact. |
| Packaging and Shelf Life (EX3150) | Tests demonstrated integrity and robustness of packaging and shelf-life aging conditions. The cable assembly (EX3150) is packaged in a Tyvek Sterile pouch, product box, and 20-multipack box. |
| Packaging and Shipping (EX3170/3180 Adapters) | Tests demonstrated package integrity and robustness of shipping conditions. The adapters are packaged in a resealable bag and a 50-multipack box. |
| Sterilization (EX3150) | Sterilization validation was performed, verifying a sterility assurance level of 10-6 using 100% Ethylene Oxide. |
| Re-sterilization (EX3150) | Efficiency of specified reprocessing methods (cleaning and re-sterilization) was documented. Integrity of product performance after aging for re-usable cables was documented. |
| Design Verification (EX3150) | Performed; documented in reports. |
| Flexibility Verification (EX3150) | Performed; documented in reports. |
| Aging for Re-usable cables (EX3150) | Documented. |
| Adapter Verification (EX3170/3180) | Performed; documented in reports. |
| PSA System Verification | Performed; documented in reports. |
Additional Information:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not provide specific numerical sample sizes for each test listed (e.g., how many cables were tested for biocompatibility, or how many packages for shipping). It generally states that "All units tested passed the acceptance criteria" or that tests "were carried out and are reported."
- Data provenance is not specified. The tests are engineering or laboratory-based verification and validation activities.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a medical device accessory 510(k) focusing on physical and electrical performance, sterility, and biocompatibility, not on diagnostic accuracy based on expert interpretation. The "ground truth" for these tests would be established by objective measurements against predefined specifications (e.g., sterility level, material properties, electrical continuity, packaging integrity).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for the reasons stated above.
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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. This is not an AI-enabled device and no MRMC studies were conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI-enabled device. The "standalone" performance refers to the device's functional and safety performance as an accessory to the Merlin PSA system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the clinical sense. The "ground truth" for these engineering tests would be established through:
- Standardized Test Methods and Specifications: e.g., electrical resistance measurements, material composition analysis, sterility assurance level (SAL) requirements, packaging integrity standards (ISTA 3A), and biocompatibility standards.
- Industry Standards and Regulations: Conformance to relevant national and international standards for medical devices and their accessories.
- Not applicable in the clinical sense. The "ground truth" for these engineering tests would be established through:
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The sample size for the training set
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
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How the ground truth for the training set was established
- Not applicable.
§ 870.3720 Pacemaker electrode function tester.
(a)
Identification. A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.(b)
Classification. Class II (performance standards).