(89 days)
No
The summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The device appears to be a standard electrical stimulator.
Yes
The device is indicated for symptomatic relief of various types of pain and delivers peripheral nerve stimulation therapy.
No
The device is described as a "Peripheral Nerve Stimulation (PNS) System" that "delivers stimulation therapy to the percutaneous electrode" to "relieve pain." Its intended use is for "symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain," which are therapeutic applications, not diagnostic ones.
No
The device description explicitly states it is comprised of a percutaneous electrode and a wearable external stimulator, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Smartpatch PNS System Function: The Smartpatch PNS System is a device that delivers electrical stimulation to peripheral nerves through a percutaneous electrode to relieve pain. It is a therapeutic device, not a diagnostic one.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples. The device interacts directly with the patient's body to deliver therapy.
Therefore, the Smartpatch Peripheral Nerve Stimulation (PNS) System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
NHI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back and/or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) for use in clinical environment and patient home environment.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K052289, K061166, K072123, K152437
Reference Device(s)
K011702, K022241, K991784, K000852
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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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
1
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
2
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
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
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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 Stimulator
K061166
(Predicate device) | Vertis PNT
K011702
K022241
(Reference device) |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indications for Use | | | |
| 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 Deepwave Percutaneous
Neuromodulation Pain Therapy
System is comprised of a
percutaneous electrode array
and the Deepwave
Neuromodulation Pain Therapy
Device. The Deepwave
Neuromodulation Pain Therapy
System is indicated 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. | Percutaneous
Neuromodulation Therapy
(PNT) is indicated for the
symptomatic relief and
management of chronic or
intractable pain and/or as an
adjunctive treatment in the
management of post-surgical
pain and post-trauma pain.
The PNT Control Unit is to be
used with PNT Lumbar
Safeguides for low back pain
or PNT Cervical Safeguides
for neck and/or upper back
pain. |
| Prescription
(Rx) device | Yes | Yes | Yes |
| Intended for use
in clinical
environment | Yes | Yes | Yes |
| Intended for use
in patient home
environment | Yes | Yes (BiowaveHOME) | No |
| Single use
electrodes | Yes | Yes | Yes |
| Patient exposure
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 | Smartpatch
percutaneous
electrode | BiowavePENS
percutaneous electrode
K061166
(Predicate device) | Vertis PNT
K011702
K022241
(Reference device) |
|----------------------------------------|-----------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------|
| Introduction method | Percutaneous | Percutaneous | Percutaneous |
| Tissue contact | Skin/tissue | Skin/tissue | Skin/tissue |
| Electrode type | Percutaneous fine
wire | Percutaneous fine
needle | Percutaneous fine
needle |
| Stimulating electrode
material | 316L Stainless Steel | 316L Stainless Steel | Stainless Steel |
| Maximum charge
density at electrode | $0.4µC/mm^2$ | UNK | $0.2µC/mm^2$ |
| Stimulating electrode
shape | 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 | Smartpatch
percutaneous
electrode | BiowavePENS
percutaneous electrode
K061166
(Predicate device) | Vertis PNT
K011702
K022241
(Reference device) |
|------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Electrode
configuration | 1 pair
(1 percutaneous
electrode and 1
surface electrode) | 1 pair
(1 percutaneous set of
1014 electrodes and 1
surface electrode) | 5 pairs
(each pair consists of
two percutaneous
electrodes) |
| Diameter of
percutaneous
extension | 635μm (0.025 inches
(outer diameter of
coiled wire) | UNK | 250μm |
| Electrode length | 15.2mm
(lead is either 20cm
or 40cm with 10cm
introducer 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.