· 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 Smartpatch PNS System is not intended to treat pain in the craniofacial region.

Device Description

The Smartpatch 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 Smartpatch 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 30 days). The diameter of the wire is 0.26mm. The wire is provided in two lengths (20cm, 40cm) with a maximum placement depth of approximately 10cm.

AI/ML Overview

The provided document outlines the substantial equivalence of the Smartpatch PNS System to a predicate device and does not contain detailed acceptance criteria or a dedicated study proving performance against such criteria. The document focuses on comparing the Smartpatch PNS System's characteristics to existing devices to establish its safety and effectiveness for market entry.

However, based on the information provided regarding performance data and clinical studies, we can infer some aspects related to effectiveness, even if not explicitly defined as acceptance criteria.

Inferred Acceptance Criteria and Reported Device Performance (based on available information):

Acceptance Criteria (Inferred)	Reported Device Performance (from document)
Safety: Minimal adverse events	Clinical studies demonstrated the safety of the therapy. Adverse events reported included skin irritation, erythema, a blister, or a mild skin tear. The majority of adverse events resolved with little to no intervention and resolved within a few days, and none were classified as serious.
Effectiveness (Symptomatic Relief of Pain): Improvement in pain symptoms (implied)	While the document states that "no effectiveness data are required to demonstrate substantial equivalence," it mentions that "clinical testing 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." It also states, however, that "A randomized controlled trial failed to show that the Smartpatch was effective for post-stroke shoulder pain." The general statement about demonstrating safety of therapy for the pain indications implies some level of positive output from these studies, even if detailed effectiveness metrics are not presented as formal acceptance criteria within this 510(k) summary. The failure to show effectiveness for post-stroke shoulder pain indicates a specific limitation or negative finding in one particular application of the device.
Biocompatibility: No adverse tissue reaction	Nonclinical testing included biocompatibility testing. (Implicitly, this testing would have met certain standards, indicating no unacceptable adverse tissue reactions.)
Electrical Safety & Performance: Meets electrical standards	Nonclinical testing included electrical testing (safety and electromagnetic compatibility) and system performance testing. (Implicitly, these tests met relevant standards for electrical safety and device functionality.)
Software Functionality: Verified and validated software	Nonclinical testing included software verification and validation. (Implicitly, the software performs as intended to control the device.)

Study Information (as provided within the document):

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for specific clinical studies. The document refers to "multiple completed and ongoing studies."
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be clinical trials conducted by the applicant, SPR Therapeutics, LLC. Whether they are retrospective or prospective is not specified, but the term "ongoing studies" implies prospective elements for some trials.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not applicable. The document discusses clinical studies for safety and effectiveness in pain relief, which typically rely on patient-reported outcomes or objective physiological measures rather than expert consensus on images or diagnostic classifications.
Adjudication Method for the Test Set: Not applicable. As the studies focus on pain relief, adjudication in the sense of expert review of data for ground truth establishment is not described.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is relevant for diagnostic imaging devices where human readers interpret cases. The Smartpatch PNS System is a therapeutic device for pain relief.
Standalone (Algorithm Only) Performance Study: Not applicable. The Smartpatch PNS System is a physical medical device (a peripheral nerve stimulator) with human interaction in its application and use, not an algorithm operating in isolation. Its performance is intrinsically linked to patient-device interaction and physiological response.
Type of Ground Truth Used: The clinical studies mentioned would have used patient-reported pain scores (e.g., VAS, NRS), functional assessments, and observation of adverse events to assess safety and effectiveness. This aligns broadly with outcomes data and patient-reported outcomes.
Sample Size for the Training Set: Not applicable. The context of a "training set" is typically for machine learning algorithms. The provided document details a medical device (a nerve stimulator), not an AI/ML algorithm.
How the Ground Truth for the Training Set Was Established: Not applicable, as there is no "training set" in the context of this device and document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The symbol is composed of three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 23, 2016

SPR Therapeutics, LLC c/o Susan Alpert, Ph.D., M.D. Consultant, SF A Consulting, LLC 200 Park Avenue, Unit 111 Minneapolis, MN 55415

Re: K161154

Trade/Device Name: Smartpatch PNS System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: NHI Dated: April 22, 2016 Received: April 25, 2016

Dear Dr. Alpert:

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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 -A for Carlos L. Peña, Ph.D., M.S. 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) K161154

Device Name

Smartpatch Peripheral Nerve Stimulation (PNS) System

Indications for Use (Describe)

The Smartpatch Peripheral Nerve Stimulation (PNS) System is indicated for up to 30 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 Smartpatch 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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Image /page/3/Picture/0 description: The image shows the logo for SPR Therapeutics. The logo features the letters "SPR" in large, bold, blue font. Above the letters is a yellow arc. Below the letters is the text "SPR Therapeutics" in a smaller blue font, followed by the text "Stimulation for Pain Relief" in an even smaller red font.

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: Susan Alpert, PhD, MD, Consultant Telephone: 612-202-7019

Date Prepared: June 24, 2016

2. DEVICE

Trade/Proprietary Name:	Smartpatch PNS System
Common/Usual Name:	Peripheral Nerve Stimulator
Classification Name:	Percutaneous Electrical Nerve Stimulation (PENS)devices (21 CFR 882.5890)
Regulatory Class:	II
Product Codes:	NHI

3. PREDICATE DEVICE

BiowavePENS System (K052289, K061166, K072123, K152437)

Reference devices: Vertis Percutaneous Neuromodulation Therapy (PNT) (K011702, K022241), St. Jude/ANS Quattrode Lead (K991784, K000852)

4. DEVICE DESCRIPTION

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Image /page/4/Picture/0 description: The image is a logo for SPR Therapeutics. The logo has the letters "SPR" in large, bold, blue font. Below the letters, the words "SPR Therapeutics" are written in a smaller, blue font. Below that, the words "Stimulation for Pain Relief" are written in a smaller, blue, italicized font. Above the letters "PR" is a yellow arc.

provided in two lengths (20cm, 40cm) with a maximum placement depth of approximately 10cm.

ട്. INDICATIONS FOR USE

The Smartpatch Peripheral Nerve Stimulation (PNS) System is indicated for up to 30 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 Smartpatch PNS System is not intended to treat pain in the craniofacial region.

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The determination of substantial equivalence is based on comparison of the indications for use, operational characteristics, and fundamental technological characteristics of the BiowavePENS System and the Smartpatch PNS System. The Smartpatch PNS System has equivalent indications for use and technical characteristics to the BiowavePENS System and other Class II Percutaneous Electrical Nerve Stimulation (PENS) Devices. Another similar device is the Vertis Percutaneous Neuromodulation Therapy (PNT) (K011702, K022241), which is included as a reference device. These devices consist of electrodes placed percutaneously in proximity to a painful area, an external stimulator, and associated tools and accessories intended to deliver peripheral nerve stimulation for the symptomatic relief of pain.

A side-by-side comparison of the characteristics of the Smartpatch PNS System, the cited predicate device (BiowavePENS and BiowaveHOME), and the reference device (Vertis Percutaneous Neuromodulation Therapy) is provided in Tables 1 and 2 and discussed below.

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Image /page/5/Picture/0 description: The image shows the logo for SPR Therapeutics. The logo has the letters "SPR" in large, blue, bold font. Below the letters, the words "SPR Therapeutics" are written in a smaller, blue font. Below that, the words "Stimulation for Pain Relief" are written in a smaller, blue font with the trademark symbol.

Table 1 Side-by-Side Comparison: Smartpatch PNS Stimulator vs. BiowavePENS Stimulator (cited predicate) vs. Vertis PNT (reference device)

Feature/Characteristic	Smartpatch PNS Stimulator	BiowavePENS StimulatorK061166(Predicate device)	Vertis PNTK011702 K022241(Reference device)
Intended Use/Indications for Use
Indications forUse	The Smartpatch PeripheralNerve Stimulation (PNS)System is indicated for up to30 days in the back and/orextremities for:• Symptomatic relief ofchronic, intractable pain,post surgical and post-traumatic acute pain;• Symptomatic relief ofpost-traumatic pain;• Symptomatic relief ofpost-operative pain.	The Deepwave PercutaneousNeuromodulation Pain TherapySystem is comprised of apercutaneous electrode arrayand the DeepwaveNeuromodulation Pain TherapyDevice. The DeepwaveNeuromodulation Pain TherapySystem is indicated for:• Symptomatic relief ofchronic, intractable pain,post surgical and post-traumatic acute pain;• Symptomatic relief of post-traumatic pain;• Symptomatic relief of post-operative pain.	PercutaneousNeuromodulation Therapy(PNT) is indicated for thesymptomatic relief andmanagement of chronic orintractable pain and/or as anadjunctive treatment in themanagement of post-surgicalpain and post-trauma pain.The PNT Control Unit is to beused with PNT LumbarSafeguides for low back painor PNT Cervical Safeguidesfor neck and/or upper backpain.
Prescription(Rx) device	Yes	Yes	Yes
Intended for usein clinicalenvironment	Yes	Yes	Yes
Intended for usein patient homeenvironment	Yes	Yes (BiowaveHOME)	No
Single useelectrodes	Yes	Yes	Yes
Patient exposure<30 days (Non-implant)	Yes	Yes	Yes
Portable/body-worncomponents	Yes	Yes	No
Stimulation
Feature/Characteristic	Smartpatch PNS Stimulator	BiowavePENS StimulatorK061166(Predicate device)	Vertis PNTK011702 K022241(Reference device)
Amplituderange,mAvolts p-p	0.2-200-30	UNK0-27.5 rms	0-151UNK
Stimulatingphase,maximumduration, usec	200	130 (feed frequency)	200
Frequency, Hz	5-100	122 (beat frequency)	4-50
Duty cycle, %	50 or 100	100	UNK
Stimulationbetweenseparatelyplaced cathode& anode	Yes	Yes	Yes
Waveform	Biphasic rectangular with apositive and negative phasethat is charge balanced	Biphasic sine waves with apositive and negative phasethat is charge balanced	Biphasic rectangular with apositive and negative phasethat is charge balanced
Pulse Generator
Software/Firmware/MicroprocessorControl	Yes	Yes	Yes
Weight	.024 kg	.45 kg	3.18kg
Size	Hand-held	Hand-held	Desktop
Number ofchannels	1	1	5
Location	External	External	External
Software-driven	Yes	Yes	Yes
Power Source	Battery Powered ExternalStimulator w/replaceablebatteries	Battery Powered ExternalStimulator w/rechargeablebatteries	Line Power
Feature/Characteristic	Smartpatch PNS Stimulator	BiowavePENS StimulatorK061166(Predicate device)	Vertis PNTK011702 K022241(Reference device)
Patient isolated	Yes	Yes	Yes
Features
On/offactivation	Button	Button	Button
Text prompts	On LCD screen	On LCD screen	On LCD screen
Intensity control	Plus and minus buttons usedto increase therapy to strongbut comfortable level	Plus and minus buttons used toincrease therapy to strong butcomfortable level	Knob and buttons used toincrease therapy to strong butcomfortable level
Data recording	Yes (e.g. usage time,parameters, error codes)	Yes (e.g. usage time,parameters, error codes)	UNK

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Image /page/6/Picture/0 description: The image shows the logo for SPR Therapeutics. The logo is primarily blue and features the letters "SPR" in a large, bold font. Below the letters, the words "SPR Therapeutics" are written in a smaller font. Underneath that, the phrase "Stimulation for Pain Relief" is written in an even smaller font. A yellow arc is positioned above the letters "SPR", and the trademark symbol is located in the upper right corner of the logo.

1 Percutaneous electrical nerve stimulation has also been delivered at 25mA. 1. Rozen, D. and G.W. Grass, Intradiscal electrothermal coagulation and percutaneous neuromodulation therapy in the treatment of discogenic low back pain. Pain practice : the official journal of World Institute of Pain, 2005. 5(3): p. 228-43.

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Image /page/7/Picture/0 description: The image shows the logo for SPR Therapeutics. The logo features the letters "SPR" in large, bold, blue font. Below the letters, the words "SPR Therapeutics" are written in a smaller, blue font. Underneath that, the phrase "Stimulation for Pain Relief" is written in a smaller, italicized, blue font. A yellow arc is above the letters "SPR".

UNK = Not able to determine from publicly available materials. FDA may have access to information in cleared 510(k)s.

Table 2 Side-by-Side Comparison: Smartpatch percutaneous electrode vs. BiowavePENS percutaneous electrode (cited predicate) vs. Vertis PNT (reference device)

Feature/ Characteristic	Smartpatchpercutaneouselectrode	BiowavePENSpercutaneous electrodeK061166(Predicate device)	Vertis PNTK011702 K022241(Reference device)
Introduction method	Percutaneous	Percutaneous	Percutaneous
Tissue contact	Skin/tissue	Skin/tissue	Skin/tissue
Electrode type	Percutaneous finewire	Percutaneous fineneedle	Percutaneous fineneedle
Stimulating electrodematerial	316L Stainless Steel	316L Stainless Steel	Stainless Steel
Maximum chargedensity at electrode	$0.4µC/mm^2$	UNK	$0.2µC/mm^2$
Stimulating electrodeshape	Straight with tine	Straight	Straight

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Image /page/8/Picture/0 description: The image contains the logo for SPR Therapeutics. The logo features the letters "SPR" in large, bold, blue font. Below the letters, the words "SPR Therapeutics" are written in a smaller, blue font. Underneath that, the phrase "Stimulation for Pain Relief" is written in a smaller, italicized, blue font. A yellow arc is positioned above the letters "SPR".

Feature/ Characteristic	Smartpatchpercutaneouselectrode	BiowavePENSpercutaneous electrodeK061166(Predicate device)	Vertis PNTK011702 K022241(Reference device)
Electrodeconfiguration	1 pair(1 percutaneouselectrode and 1surface electrode)	1 pair(1 percutaneous set of1014 electrodes and 1surface electrode)	5 pairs(each pair consists oftwo percutaneouselectrodes)
Diameter ofpercutaneousextension	635μm (0.025 inches(outer diameter ofcoiled wire)	UNK	250μm
Electrode length	15.2mm(lead is either 20cmor 40cm with 10cmintroducer needle)	0.74mm	UNK(surface area 16mm²)
Supplied sterile	Yes	Yes	Yes

UNK = Not able to determine from publicly available materials. FDA may have access to information in cleared 510(k)s.

The Smartpatch PNS System uses the same fundamental technologies as the BiowavePENS System and other Class II PENS devices such as the reference Vertis PNT device. Like the BiowavePENS System and Vertis PNT, the Smartpatch PNS System is intended to be a prescription (Rx) device for use by or on the order of a licensed healthcare practitioner. In all three Systems, low levels of electrical current are delivered by an external stimulator through electrodes that are placed percutaneously in proximity to a target peripheral nerve associated with a painful area. In all three devices, short-term electrical stimulation therapy is delivered for symptomatic relief and management of pain.

There are two minor technological differences; the electrode configuration and the stimulation waveform. The BiowavePENS percutaneous needle array electrodes are used for a single 30-minute treatment and then discarded, with a new set of needles inserted for each treatment session. The flexible Smartpatch percutaneous electrode design enables the electrode to be percutaneously placed once and left in place to deliver therapy at home as prescribed, and discarded at the end of the therapy. This minor difference in electrode configuration does not raise any new types of questions of safety and effectiveness, as both designs pass through the skin, dwell in place for the treatment sessions, and safely deliver electrical stimulation for the desired short-term treatment period. Of note, the Vertis PNT percutaneous electrodes are straight needles passing through the skin to a depth of approximately 2-4cm, consistent with the placement of the Smartpatch percutaneous electrodes.

The Biowave, Vertis and Smartpatch external stimulators deliver biphasic

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Image /page/9/Picture/0 description: The image is a logo for SPR Therapeutics. The logo features the letters "SPR" in large, bold, blue font. Below the letters, the words "SPR Therapeutics" are written in a smaller, blue font. Underneath that, the phrase "Stimulation for Pain Relief" is written in a smaller, italicized, blue font. A yellow arc is above the letters "SPR".

electrical stimulation waveforms with a positive and negative phase that is charge balanced between an active percutaneous electrode and a return surface electrode to activate peripheral nerves and relieve pain. The Vertis PNT and Smartpatch PNS Systems deliver rectangular waveforms with an adjustable frequency, pulse duration, and intensity. The BiowavePENS delivers sine waveforms also with an adjustable intensity. The intensity of the Vertis PNT and Smartpatch PNS System stimulation waveforms is adjusted by changing current intensity, while the intensity of the BiowavePENS stimulation waveform is adjusted by changing voltage intensity. These minor differences do not raise new questions of safety and effectiveness.

Based on the information available for these devices, on thorough verification and validation testing, and on support of safety from clinical studies, SPR has established the substantial equivalence of the Smartpatch PNS System to the cited predicate device. SPR has demonstrated that the Smartpatch PNS System has substantially equivalent technical characteristics to the BiowavePENS device. Further, the minor technological differences between the devices do not raise new questions regarding safety and effectiveness, and evaluation of the effect of the technological differences supports the finding of substantial equivalence.

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.

Although no effectiveness data are required to demonstrate substantial equivalence, clinical testing 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.

8. CONCLUSIONS

The Smartpatch PNS System has been shown through comparison to be substantially equivalent to the identified predicate device.

Regulation Number and Section

§ 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).