(90 days)
The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days in the back and/or extremities 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 treat pain in the craniofacial region.
The Sprint PNS System is comprised of a percutaneous electrode placed via an introducer needle in proximity to a target peripheral nerve associated with a painful area and a wearable external stimulator that delivers stimulation therapy to the percutaneous electrode. The Sprint PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted through the skin via an introducer needle and remain indwelling for the duration of the therapy (up to 60 days).
This document is a 510(k) premarket notification from the FDA, typically used for medical devices that are substantially equivalent to a legally marketed predicate device. The core of this submission is about extending the use duration of the SPRINT Peripheral Nerve Stimulation (PNS) System from 30 to 60 days.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies, while noting the limitations of this type of document as it's not a full study report:
Key Takeaway: This document is NOT a clinical study report with detailed acceptance criteria and performance data in the traditional sense for an AI/ML device. It's an FDA premarket notification (510(k)) for a nerve stimulator, where the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device, particularly for an extended duration of use. As such, many of the requested details about AI/ML device validation (e.g., MRMC studies, training set details, ground truth for AI) are not applicable to this physical device submission.
Analysis of Acceptance Criteria and Proving Device Performance
1. A table of acceptance criteria and the reported device performance
Based on the document, the "acceptance criteria" for this 510(k) submission are not quantitative performance metrics for a diagnostic algorithm, but rather demonstrations of safety and efficacy for the extended use duration (up to 60 days) to prove substantial equivalence to the predicate device.
| Acceptance Criterion (Implicit in 510(k)) | Reported Device Performance (as described) |
|---|---|
| Safety for extended 60-day use | - "Clinical testing on the subject device includes multiple completed and ongoing studies on chronic or intractable pain, post-surgical pain, and post-traumatic pain."- "These studies have demonstrated safety of the therapy."- "Adverse events reported in the studies included skin irritation, erythema, a blister, or a mild skin tear."- All reported adverse events "were resolved with little to no intervention and resolved within a few days, and none were classified as serious."- "Clinical experience from other electrical stimulation devices intended for the relief of pain... demonstrates that there are no different or increased risks resulting from the long-term use of electrical stimulation for pain." |
| Effectiveness for extended 60-day use (non-inferiority to predicate) | - "The Sprint PNS System has the same technological characteristics as the Smartpatch PNS System."- "Extending the treatment period to 60 days also does not raise different questions of effectiveness than the predicate or significantly increase an effectiveness concern."- Note: One specific study mentioned failed to show effectiveness for post-stroke shoulder pain, but this is presented as an outlier and not against the general claim of effectiveness for the approved indications. |
| Substantial Equivalence (Overall comparability to predicate) | - "The Sprint PNS System has been shown to be substantially equivalent to the identified predicate device."- The indications for use are identical to the predicate device except for the extended duration.- Minor modifications (lead length, tapes, battery capacity) are stated not to raise new safety/effectiveness questions. |
| Non-clinical performance | - "Nonclinical testing of this device includes biocompatibility testing, electrical testing (safety and electromagnetic compatibility), system performance testing, and software verification and validation." (No specific results provided, only that testing was done). |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document refers to "multiple completed and ongoing studies" for clinical data but does not provide specific sample sizes for these studies. It mentions one specific "randomized controlled trial" but gives no sample size for it either.
- Data Provenance: Not specified. It's implicitly clinical trial data used for regulatory submission, but details like country of origin or whether studies were retrospective or prospective are not provided in this summary. The mention of "ongoing studies" suggests prospective elements.
3. 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)
- This is not applicable to this device submission. This is a nerve stimulator, not an AI/ML diagnostic or image analysis device that requires expert review for "ground truth" establishment in the context of diagnostic accuracy. The "ground truth" for pain relief is typically patient-reported outcomes or physician assessment based on clinical criteria, not expert image annotation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device and submission. Adjudication methods like 2+1 or 3+1 are common in AI/ML image analysis studies where multiple readers determine ground truth or resolve discrepancies. This document describes clinical studies demonstrating safety and efficacy of a hardware device.
5. 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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device for nerve stimulation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance relates to patient outcomes, safety (adverse events), and clinician assessment of pain relief and condition improvement. This would typically be gathered through patient-reported outcome measures (e.g., pain scores), physical examinations, and adverse event logging during the clinical trials.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device with a distinct "training set." Clinical data is used for demonstrating safety and efficacy.
9. How the ground truth for the training set was established
- Not applicable.
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Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 26, 2017
SPR Therapeutics, LLC Kathryn Stager Manager of Regulatory Affairs 22901 Millcreek Blvd.. Suite 110 Cleveland, Ohio 44122
Re: K170902
Trade/Device Name: Sprint System. Single Procedure Kit. Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NHI Dated: March 28, 2017 Received: March 28, 2017
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. 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.
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
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
William J. Heetderks -S 2017.06.26 13:39:09 -04'00'
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170902
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 in the back and/or extremities 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 treat pain in the craniofacial region.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
1. SUBMITTER
SPR Therapeutics, LLC 22901 Millcreek Boulevard, Suite 110 Cleveland, OH 44122
216-378-9108 (phone) 216-378-9116 (fax)
Contact Person: Kathryn Stager, MS, RAC, Manager of Regulatory Affairs Telephone: 216-378-9067
Date Prepared: March 28, 2017
2. DEVICE
| Trade/Proprietary Name: | SPRINT PNS System |
|---|---|
| Common/Usual Name: | Peripheral Nerve Stimulator |
| Classification Name: | Percutaneous Electrical Nerve Stimulation (PENS devices (21 CFR 882.5890) |
| Regulatory Class: | II |
| Product Code: | NHI |
3. PREDICATE DEVICE
Smartpatch PNS System (K161154)*
4. DEVICE DESCRIPTION
The Sprint PNS System is comprised of a percutaneous electrode placed via an introducer needle in proximity to a target peripheral nerve associated with a painful area and a wearable external stimulator that delivers stimulation therapy to the percutaneous electrode. The Sprint PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode is a sterile,
* The Smartpatch PNS System is presently being marketed under the name Sprint PNS System as reported in K161154/A001. The name Smartpatch is being used in this 510(k) application for clarity.
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flexible, coiled, stainless steel wire designed to be percutaneously inserted through the skin via an introducer needle and remain indwelling for the duration of the therapy (up to 60 days).
5. 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 in the back and/or extremities 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 treat pain in the craniofacial region.
Comparison:
This indications statement is identical to the Smartpatch PNS System cleared in K161154 except that the duration of therapy was extended from 30 days to 60 days. Extending the treatment period to an upper limit of 60 days does not result in a new intended use when compared to the predicate device. In contrast to treatment periods longer than 60 days, this extension to an upper limit of 60 days does not raise different safety and effectiveness questions because the device, like the predicate device, is intended to provide treatment for the pain conditions specified in the indications statement (e.g., post-traumatic pain, post-operative pain) using a limited duration of therapy.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE 6. DEVICE
The purpose of this 510(k) is to obtain clearance for a change in the indication for use statement. The Sprint PNS System has the same technological characteristics as the Smartpatch PNS System. No changes have been made to the physical components of the system since clearance of K161154 other than:
- elimination of the longer lead length (clinical experience has revealed that . it provides no increased utility compared to the shorter lead, as the introducer needle is the same length),
- elimination of the lead connector tapes (clinical experience has revealed . that they provide no increased utility compared to commercially available bandages), and
- addition of a Pad that has a larger battery capacity (25mAhr compared to ●
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14mAhr) to reduce the frequency at which Pads need to be replaced.
These minor modifications to the Smartpatch PNS System are intended to result in a simpler and easier to use product for the end-users (called the Sprint PNS System). They do not raise new questions regarding safety and effectiveness.
7. PERFORMANCE DATA
Nonclinical testing of this device includes biocompatibility testing, electrical testing (safety and electromagnetic compatibility), system performance testing, and software verification and validation.
Clinical data was provided in K170902 to establish safety and effectiveness for extension of use (as per the IFU) of the SPRINT PNS system from 30 to 60 days. Clinical testing on the subject device includes multiple completed and ongoing studies on chronic or intractable pain, post-surgical pain, and post-traumatic pain. These studies have demonstrated safety of the therapy. The adverse events reported in the studies included skin irritation, erythema, a blister, or a mild skin tear. The majority of the adverse events were resolved with little to no intervention and resolved within a few days, and none were classified as serious. A randomized controlled trial failed to show that the Smartpatch was effective for post-stroke shoulder pain.
In addition to the clinical data provided in K170902, clinical experience from other electrical stimulation devices intended for the relief of pain, which deliver the same electrical stimulation therapy, demonstrates that there are no different or increased risks resulting from the long-term use of electrical stimulation for pain. Therefore, extending the treatment period to 60 days also does not raise different questions of effectiveness than the predicate or significantly increase an effectiveness concern.
8. CONCLUSIONS
The Sprint PNS System has been shown to be substantially equivalent to the identified predicate device.
§ 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).