Devices

FDA-cleared temporary percutaneous peripheral nerve stimulation system with a wearable pulse generator, cleared January 2023 under 510(k) K223306. Thinly sourced; many cells stay Unreported.

Catalog specification sheet - Peripheral nerve

SPR SPRINT percutaneous PNS

Primary source →

Record ID
BTSD-FDA-0015
Reviewed
2026-10-08
Interface
pni
Evidence stage
human

Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.

SPR SPRINT percutaneous PNS

SPRINT is a temporary peripheral nerve stimulation system: a thin coiled percutaneous lead and a wearable pulse generator, indicated for up to 60 days. This sheet is a thin one built from the 510(k) clearance letter and summary text for K223306 (January 25, 2023). A 510(k) is a clearance, not a PMA approval.

Identity

FieldValue and source scope
DeviceSPR Therapeutics SPRINT Peripheral Nerve Stimulation (PNS) System: one or two percutaneous MicroLead electrodes and a wearable external pulse generator [1][2]
ManufacturerSPR Therapeutics, Inc., Cleveland, Ohio [1]
Interface classTemporary percutaneous peripheral nerve stimulation lead with a wearable stimulator [2]
OriginCommercial FDA-cleared device; 510(k) K223306 [1][3]
First demonstratedUnreported
First human implantUnreported
Species studiedUnreported
Regulatory status510(k) K223306 decision January 25, 2023, substantially equivalent; Class II, regulation 21 CFR 882.5890, product code NHI [1][3]
FunctionPeripheral nerve stimulation to relieve pain, indicated for up to 60 days [2]
Target tissueUnreported

Geometry and architecture

FieldValue and source scope
Interface typePercutaneous electrode (MicroLead): a sterile, flexible, coiled stainless steel wire inserted through an introducer needle near the target nerve [2]
Array layoutUnreported
Electrode countOne or two percutaneous electrodes per system; the second lead is a new sales configuration in K223306 [2]
PitchUnreported
Electrode lengthsUnreported
Shank width and thicknessUnreported
Tip and exposed site geometryUnreported
Contact coatingUnreported
InsulationUnreported
Insertion methodIntroducer needles placed in proximity to peripheral nerves associated with the painful area [2]
Anchoring and fixationRemains indwelling for the duration of therapy, up to 60 days [2]

Electrode and channel physics

FieldValue and source scope
Exposed site areaUnreported
Electrode materialStainless steel coiled wire [2]
Impedance (with measurement frequency)Unreported
Noise floor or SNRUnreported
Recording modalityUnreported
Sampling rateUnreported
Stimulation capabilityUnreported
Charge injection limitUnreported
Reference and groundUnreported

Tissue interface and bioresponse

FieldValue and source scope
Target tissueUnreported
Insertion trauma and BBB disruptionUnreported
Vascular disruption riskUnreported
Micromotion sensitivityUnreported
Gliosis and encapsulationUnreported
Neuron loss near sitesUnreported
Foreign-body response mitigationUnreported
Typical failure modesUnreported

System architecture

FieldValue and source scope
Onboard electronicsWearable external pulse generator delivers stimulation to the percutaneous electrodes [2]
Data pathUnreported
Telemetry bandwidthUnreported
Sampling rateUnreported
PowerUnreported
Thermal managementUnreported
Packaging and hermeticityUnreported
MRI compatibilityUnreported
Surgical complexityUnreported
Output connectorsUnreported

Performance envelope

FieldValue and source scope
Acute yieldUnreported
Chronic yieldUnreported
Stability over timeUnreported
LongevityUnreported
Revision and explant experienceUnreported
Adverse eventsUnreported
Notable demonstrationsUnreported

Clinical and preclinical evidence

FieldValue and source scope
Human subjectsUnreported
Preclinical cohortUnreported
Follow-up durationUnreported
IndicationsIndicated for up to 60 days for pain relief; the full indication list was in the enclosure and was not extracted here [2]
Trials and registriesUnreported
Primary outcomesUnreported
Key limitationsThis sheet uses only the clearance letter and its indications and comparison text. Lead dimensions, waveform and clinical data were not extracted. A 510(k) shows substantial equivalence, not an FDA efficacy approval [1][2]

Engineering tradeoffs

FieldValue and source scope
StrengthsUnreported
LimitationsUnreported
Scaling constraintsUnreported

Version boundary

K223306 adds a configuration that provides a second lead. Earlier clearances are not described here.

References

  1. FDA 510(k) clearance letter, K223306.
  2. FDA 510(k) summary text within K223306.
  3. FDA 510(k) database record, K223306.