(90 days)
No
The summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on electrical stimulation and hardware components.
Yes
The device is specifically indicated for "symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain," which are therapeutic applications.
No
The device is a therapeutic device designed for symptomatic relief of pain through peripheral nerve stimulation. It does not perform any diagnostic functions.
No
The device description explicitly states it is comprised of physical components including percutaneous electrodes, an introducer needle, and a wearable external Pulse Generator (stimulator), which are hardware.
Based on the provided information, the SPRINT Peripheral Nerve Stimulation (PNS) System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SPRINT PNS System Function: The SPRINT PNS System is a therapeutic device that delivers electrical stimulation to peripheral nerves to relieve pain. It is implanted percutaneously and interacts directly with the patient's body, not with specimens taken from the body.
- Intended Use: The intended use clearly states "Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; Symptomatic relief of post-traumatic pain; Symptomatic relief of post-operative pain." This is a therapeutic indication, not a diagnostic one.
- Device Description: The description details electrodes placed in proximity to nerves and an external pulse generator, all components involved in delivering therapy, not analyzing biological samples.
Therefore, the SPRINT PNS System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days for:
- Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain;
- Symptomatic relief of post-traumatic pain;
- Symptomatic relief of post-operative pain.
The SPRINT PNS System is not intended to be placed in the region innervated by the cranial and facial nerves.
Product codes
NHI
Device Description
The SPRINT PNS System is comprised of one or two percutaneous electrodes placed via introducer needles in proximity to target peripheral nerves associated with a painful area and a wearable external Pulse Generator (stimulator) that delivers stimulation therapy to the percutaneous electrode(s). The SPRINT PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode (MicroLead) is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted and remain indwelling for the duration of the therapy (up to 60 days). The Pulse Generator and accessory components provide tools for percutaneous MicroLead placement, system programming by the clinician, and system use by the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The bench and non-clinical performance testing support the substantial equivalence of this device. No clinical performance data were included in support of this submission. Updated nonclinical testing of the subject device includes biocompatibility testing per the standards listed in Table 2: ISO 10993-5, ISO 10993-6, ISO 10993-7, ISO 10993-18. Moreover, the subject device conforms to all applicable standards associated with electrical testing (safety and electromagnetic compatibility), software verification and validation, system performance testing, human factors, sterility, biocompatibility, and magnetic resonance compatibility, which were leveraged from the previously cleared predicate device (K211801).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
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January 25, 2023
SPR Therapeutics, Inc. Kathryn Stager, MS. RAC Vice President of Regulatory Affairs and Quality Systems 22901 Millcreek Blvd. Suite 500 Cleveland, Ohio 44122
Re: K223306
Trade/Device Name: SPRINT Peripheral Nerve Stimulation (PNS) System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NHI Dated: October 26, 2022 Received: October 27, 2022
Dear Kathryn Stager:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Lauren E. Woodard -S
for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K223306
Device Name
SPRINT Peripheral Nerve Stimulation (PNS) System
Indications for Use (Describe)
The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days for:
- Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain;
- Symptomatic relief of post-traumatic pain;
- Symptomatic relief of post-operative pain.
The SPRINT PNS System is not intended to be placed in the region innervated by the cranial and facial nerves.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for SPRINT PNS SYSTEM. The word "SPRINT" is in large, white, sans-serif letters on a green background. Below "SPRINT" is the text "PNS SYSTEM" in smaller, white, sans-serif letters. The logo has a registered trademark symbol.
510(k) Summary
1. SUBMITTER
SPR Therapeutics, Inc 22901 Millcreek Boulevard, Suite 500 Cleveland, OH 44122 216-378-9108 (phone) 216-674-2303 (fax)
Contact Person: Kathryn Stager, MS, RAC, Vice President of Regulatory Affairs & Quality Systems Telephone: 216-378-9067
Date Prepared: January 25, 2023
2. DEVICE
| Trade/Proprietary Name: | SPRINT Peripheral Nerve Stimulation (PNS) System |
|---|---|
| Common/Usual Name: | Peripheral Nerve Stimulator |
| Regulation Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Regulation Number: | 21 CFR 882.5890 |
| Regulatory Class: | II |
| Product Code: | NHI |
3. PREDICATE DEVICE
SPRINT PNS System (K211801)
4. DEVICE DESCRIPTION
The SPRINT PNS System is comprised of one or two percutaneous electrodes placed via introducer needles in proximity to target peripheral nerves associated with a painful area and a wearable external Pulse Generator (stimulator) that delivers stimulation therapy to the percutaneous electrode(s). The SPRINT PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode (MicroLead) is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted and remain indwelling for the duration of the therapy (up to 60 days). The Pulse Generator and accessory components provide tools for percutaneous MicroLead placement, system programming by the clinician, and system use by the patient.
The therapeutic benefit of PNS is mediated via the activation of sensory fibers, such as muscle proprioceptive afferents, which drive afferent mediated mechanisms at the spinal and/or supraspinal level. At the level of the spinal cord, gate-control mechanisms provide pain relief. Stimulation of large, myelinated afferents is thought to inhibit the
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transmission of pain signals from the spinal cord to higher centers in the central nervous system to decrease the perception of pain, as described by Melzack and Wall's gatecontrol theory. Stimulation of peripheral sensory afferents is believed to "close the gate" by decreasing the relay of pain signals via cells in the spinothalamic tract (STT), one of the primary pain pathways. Activation of these non-nociceptive afferent fibers for pain relief can be accomplished by direct stimulation of the afferent nerves or by evoking comfortable muscle contractions, which in turn activate sensory afferents.
In addition, there is now growing evidence that chronic pain is associated with changes at the supraspinal level that maintain the pain experience even when the causative factors are no longer active or are less severe. There is also evidence that cortical plasticity related to chronic pain can be modified by behavioral interventions that provide feedback to the brain areas that were altered by somatosensory pain memories. Thus, it is possible that afferent activation due to peripheral nerve stimulation alters the pain experience. The plausibility of this hypothesis is supported by studies that demonstrate that electrical stimulation is a powerful modality for providing feedback to the central nervous system with resultant neuroplastic changes. A recent publication1 describes Peripherally-Induced Reconditioning of the Central Nervous System (CNS) as a new theory for the mechanism for treating pain using neuromodulation. This theory may explain why pain relief can be sustained after the treatment is complete.
ડ. COMPARISON OF INDICATIONS FOR USE WITH THE PREDICATE DEVICE
Indications Statement:
The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days for:
- . Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain;
- . Symptomatic relief of post-traumatic pain;
- Symptomatic relief of post-operative pain. ●
The SPRINT PNS System is not intended to be placed in the region innervated by the cranial and facial nerves.
Comparison:
The indication for use statement is identical to that cleared in K211801 with the exception of a wording change in the last sentence that is intended to increase clarity for prescribing physicians (i.e., "be placed" was previously "treat pain").
1 Deer, T. R. et al. Peripherally Induced Reconditioning of the Central Nervous System: A Proposed Mechanistic Theory for Sustained Relief of Chronic Pain with Percutaneous Peripheral Nerve Stimulation. J Pain Res 14, 721-736, doi:10.2147/JPR.S297091 (2021).
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6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
SPR has made some design modifications to the SPRINT PNS System to improve ease of use and reliability of the system. None of the changes affect the intended use or fundamental functionality of the device.
The key modifications include the following:
- Introduction of a new system configuration called the Conversion Kit. The Conversion Kit does not introduce any new components or change the treatment being provided. It is a new sales configuration that allows a patient to receive a second lead if they start their 60-day treatment period with a single lead but their physician later decides a second lead is medically necessary. If the patient receives a single-lead system and then a Conversion Kit, it is no different than receiving a dual-lead system.
- Introduction of new external system components to make lead securement easier to achieve. This includes the addition of a breakaway connection (intended to reduce the risk of force being inadvertently applied to the lead) and additional desinsulating contact points on the MicroLead Connector to improve the reliability of the connection.
These changes, and the other minor changes described throughout, do not alter the fundamental delivery of peripheral nerve stimulation to the target nerve(s) using the identical stimulus waveform and limited by the identical charge delivery. Therefore, these changes do not affect the safety or effectiveness of the subject device. Refer to Table 1 for a comparison of technological characteristics.
| Feature/Characteristic | Subject Device: SPRINT PNS | Predicate: SPRINT PNS
(K211801) |
|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| System Configurations | | |
| Single Lead | Yes | Same |
| Dual Lead | Yes | Same |
| Conversion Kit | Yes | No |
| Stimulation Therapy | | |
| Amplitude range,
mA
volts p-p | 0.2-30
0-45 | Same
Same |
| Stimulating phase,
duration range, μsec | 10-200 | Same |
| Frequency, Hz | 5-150 | Same |
| Duty cycle, % |