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Pisces Quad Model 3487A, Pisces Quad Compact Model 3887, Pixees Quad Plus Model 3888, Pisces Z Quad Model 3890, Pisces Z Quad Compact Model 3891, Pisces Z Quad Plus Model 3892, Specify Model 3998, Pisces Octad Model 3898, SymMix Model 3982A, Temporary Screening Lead Model 3861, and Verify Model 3862 are indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs.

Resume II Model 35874 and Resume TL Model 3986A are indicated for Spinal Cord Stimulation to aid m the management of chronic intractable pain of the trunk and/or limbs. They are also indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.

On-Point Model 39874 is indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.

Resume II 3587A, Resume TL 3986A, On-Point 3987A, and SymMix 3982A are quadripolar implantable neurostimulation surgical leads with in-line connector.

Pisces Quad 3487A, Pisces Quad Compact 3887, and Pisces Quad Plus 3888 are percutaneous quadripolar implantable neurostimulation leads.

Pisces Z Quad 3890, Pisces Z Quad Compact 3891, and Pisces Z Quad Plus 3892 are low impedance percutaneous quadripolar implantable neurostimulation leads.

Pisces Octad 3898 is a percutaneous octapolar implantable neurostimulation lead.

Temporary screening lead 3861 is a percutaneous bipolar implantable neurostimulation lead to be used for no more than 10 days.

Verify 3862 is a percutaneous quadripolar implantable neurostimulation lead to be used for no more than 10 days.

Specify 3998 is an octapolar implantable ncurostimulation surgical lead.

The provided document is a 510(k) summary for Medtronic Neurostimulation Leads. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance data from a clinical study with acceptance criteria.

The document states:

• D. Performance Data: "Performance data that supports the safety and effectiveness of the modified neurostimulation leads are included in this 510(k) premarket notification." However, this summary does not include the specific performance data or any acceptance criteria that would typically be associated with a clinical trial or algorithm performance study.

• E. Conclusion: "Medtronic neurostimulation leads (list of leads) are substantially equivalent to the noted predicate devices based on the similarities of technological characteristics, the identical indications for use, and the results of the testing." This reinforces that the submission aims for substantial equivalence based on testing results (not specified in detail here) and technological characteristics, not necessarily against predefined performance acceptance criteria for a novel device.

Therefore, based solely on the provided text, it is not possible to fill out the requested table regarding acceptance criteria and device performance, nor can questions 2-9 be answered.

The submission is for a medical device (neurostimulation leads), which typically involves rigorous engineering and biocompatibility testing, but this type of 510(k) summary often does not detail the specific pass/fail criteria or results for each test. It focuses on the conclusion of substantial equivalence.

If this were a submission for an AI/ML-driven diagnostic or prognostic device, the requested information would be critical and typically present. However, for physical medical devices seeking 510(k) clearance via substantial equivalence, the "performance data" often refers to bench testing, biocompatibility, and electrical safety, which would be compared to standards and predicate device data rather than defined clinical performance metrics like sensitivity, specificity, or reader improvement.

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