(61 days)
Not Found
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies. The device is described as a standard electrical stimulator.
Yes
The device is indicated for symptomatic relief of various types of pain (chronic, post-surgical, post-traumatic), and provides peripheral nerve stimulation therapy to achieve this relief. This direct therapeutic action classifies it as a therapeutic device.
No
The device description and intended use clearly state that the SPRINT PNS System provides "symptomatic relief" of pain through stimulation therapy, rather than diagnosing a condition.
No
The device description explicitly states the system is comprised of a percutaneous electrode and a wearable external Pulse Generator, 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 (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description: The SPRINT Peripheral Nerve Stimulation (PNS) System is described as a system that uses a percutaneous electrode and an external pulse generator to deliver electrical stimulation to peripheral nerves. This is a therapeutic device that directly interacts with the body to relieve pain.
- Intended Use: The intended use is for symptomatic relief of pain in the back and/or extremities. This is a treatment indication, not a diagnostic one.
The device description and intended use clearly indicate that this is a therapeutic device for pain management, not a device used for testing samples outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
NHI
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 Pulse Generator (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 (MicroLead) is a sterile, coiled, stainless steel wire designed to be percutaneously inserted via an introducer needle 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, stimulator programming by the clinician, and stimulator use by the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back and/or extremities, not craniofacial region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician (for programming) and Patient (for operation)
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), software verification and validation, system performance testing, human factors/usability testing, and sterile package integrity testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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July 31, 2018
SPR Therapeutics, Inc. Kathryn Stager Director of Regulatory Affairs and Ouality Systems 22901 Millcreek Blvd, Suite 110 Cleveland, Ohio 44122
Re: K181422
Trade/Device Name: SPRINT Peripheral Nerve Stimulation System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NHI Dated: Mav 29, 2018 Received: May 31, 2018
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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Pamela D. Scott -S
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)
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, Inc 22901 Millcreek Boulevard, Suite 110 Cleveland, OH 44122
216-378-9108 (phone) 216-674-2303 (fax)
Contact Person: Kathryn Stager, MS, RAC, Director of Regulatory Affairs and Quality Systems Telephone: 216-378-9067
Date Prepared: May 29, 2018
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
SPRINT PNS System (K170902)
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 Pulse Generator (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 (MicroLead) is a sterile, coiled, stainless steel wire designed to be percutaneously inserted via an introducer needle and remain
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Image /page/4/Picture/0 description: The image contains the logo for SPR Therapeutics. The logo has the letters "SPR" in large, green font. Below the letters is the text "SPR Therapeutics" in a smaller, gray font. The logo also has a gray swoosh design above the letters.
indwelling for the duration of the therapy (up to 60 days). The Pulse Generator and accessory components provide tools for percutaneous MicroLead placement, stimulator programming by the clinician, and stimulator use by the patient.
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:
The indication for use statement is identical to that cleared in K170902.
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 proposed modifications include the following:
- Minor changes have been made to parameter ranges and adjustment of . stimulus intensity.
- The Pulse Generator is now capable of delivering 2 channels of stimulation.
- . The Pulse Generator is now powered by a rechargeable battery pack that connects directly to it, rather than having the battery embedded in the disposable return current Pads.
- A Hand-Held Remote has been added to the system to enable the patient to . operate the stimulator (via Bluetooth communication) without having to press buttons and read a display on the skin-mounted stimulator. The clinician can also program stimulation parameters using the Hand-Held Remote.
- . A Clinical Programmer tablet computer has been added to the system and can be used to program the Pulse Generator (via Bluetooth) as an alternative to the
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Hand-Held Remote for the clinician.
- . The OnePass Introducer System has been added to the system to enhance placement of the MicroLead through its Introducer. Echogenic markings have been added to the Percutaneous Sleeve, Stimulating Probe, and Introducer to enhance visibility under ultrasound.
- . Changes have been made to cables and accessories to simplify use.
None of these changes alters the fundamental delivery of the same range of stimulation parameters to the target nerve through the identical MicroLead, using the identical stimulus waveform, limited by the identical charge delivery, for the identical indications for use.
7. PERFORMANCE DATA
Nonclinical testing of this device includes biocompatibility testing, electrical testing (safety and electromagnetic compatibility), software verification and validation, system performance testing, human factors/usability testing, and sterile package integrity testing.
8. CONCLUSIONS
The Sprint PNS System has been shown to be substantially equivalent to the identified predicate device.