(24 days)
The device is intended to be used for stimulation of peripheral nerves for diagnostic purposes.
The coils MCF-B65, MCF-75, MCF-125 and Cool-B65 are used as an accessory together with a Magnetic stimulator used for magnetic stimulation. The coils transfer the magnetic stimulation to the tissue. All four coils are constructed the same way. A coil winding element encapsulated in a plastic housing. The coil winding element is inside the housing surrounded by a liquid cooling media. The cooling media absorb the heat built up during use. The coil Cool-B65 is furthermore connected to an external Coil Cooler unit that generates an active circulation of the cooling media, which allows the coil to operate for an even longer period. They are either circular or butterfly shaped. They are from 65 to 125 mm in diameter.
The provided text is a 510(k) summary for magnetic stimulation coils (MCF-B65, MCF-75, MCF-125, Cool-B65). This type of document focuses on establishing substantial equivalence to a legally marketed predicate device rather than presenting a study to prove acceptance criteria for a novel device. Therefore, much of the requested information (such as acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth methodologies) is not typically found in these types of submissions, as the device is not a new algorithm or diagnostic AI.
However, I can extract the relevant information regarding the equivalence asserted in the document.
Acceptance Criteria and Device Performance:
Since this is a 510(k) special submission, the acceptance criteria are implicitly met by demonstrating substantial equivalence to existing predicate devices. The "performance" is therefore the assertion that the new coils function similarly and safely to the predicate devices.
| Acceptance Criteria Category | Reported Device Performance (Assertion) |
|---|---|
| Intended Use | Stimulation of peripheral nerves (same as predicate) |
| Technological Features | Same as predicate, with a modification to the cooling system (liquid cooling media vs. molding material). Magnetic field is not affected. Built-in thermo sensor. |
| Safety | No new issues of safety raised (implied by design and testing). Compliance with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC). CE-marked, complies with MDD 93/42/EEC. |
| Effectiveness | No new issues of effectiveness raised (implied by design and testing). |
| Physical Characteristics | Similar in size, shape, and application (circular or butterfly shaped, 65 to 125 mm diameter). |
Study Information (Based on a 510(k) Special Submission):
- Sample size used for the test set and the data provenance: Not applicable. A test set in the traditional sense of a clinical or performance study is not described. Substantial equivalence is demonstrated through comparative analysis of features and adherence to standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment by experts for a test set is described.
- Adjudication method for the test set: Not applicable. No adjudication method is described.
- 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 device is a magnetic stimulation coil, not an AI or imaging device requiring MRMC studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of typical device performance studies. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices and the assertion that the modified device maintains those characteristics.
- The sample size for the training set: Not applicable. No training set is described as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Equivalence:
The submission asserts that the new coils (MCF-B65, MCF-75, MCF-125, Cool-B65) are substantially equivalent to the predicate devices (K061645: MC-125, MC-B70, C-100, C-B60, MMC-140-II) based on the following:
- Same intended use: Stimulation of peripheral nerves.
- Same technological features: Similar construction with a coil winding element, and all coils have a built-in thermo sensor.
- Physical comparability: Similar in size, shape, and application (circular or butterfly, 65 to 125 mm diameter).
- Minor modification: The only significant difference is the cooling media (liquid for new coils vs. molding material for predicate coils). The submission explicitly states that "The magnetic field is not affected by the modification."
- Safety and regulatory compliance: The coils are CE-marked, comply with the Medical Device Directive 93/42/EEC, are developed and manufactured according to EN13485, and comply with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC), as tested by a certified center (UL Demko).
The FDA reviewed these claims and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. The acceptance criteria for this type of submission are therefore met by demonstrating this equivalence through documentation of design, intended use, and adherence to relevant standards, rather than through a traditional clinical study with detailed performance metrics against a defined ground truth.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).