(130 days)
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No
The document does not mention AI, ML, or related terms, and the device description focuses on traditional electrical stimulation technology.
Yes.
The device description explicitly states it "provides peripheral nerve stimulation (PNS) therapy to relieve pain." Its intended use is for "symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain." These uses clearly define it as providing therapy for medical conditions.
No
The device is described as providing "peripheral nerve stimulation (PNS) therapy to relieve pain," indicating it is a therapeutic device, not a diagnostic one. Its intended use is for "symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain," which are treatment goals, not diagnostic aims.
No
The device description explicitly states the system is comprised of percutaneous electrodes, introducer needles, and a wearable external Pulse Generator, all of which are hardware components. The summary also mentions nonclinical testing including electrical testing, system performance testing, and sterile package integrity testing, further indicating the presence of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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." This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a "Peripheral Nerve Stimulation (PNS) System" that delivers electrical stimulation to nerves to relieve pain. This is a treatment modality, not a method for examining specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a disease or condition
- Using reagents or assays
Therefore, the SPRINT Peripheral Nerve Stimulation (PNS) System is a therapeutic medical device, not an In Vitro Diagnostic device.
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 (comma separated list FDA assigned to the subject device)
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
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Input Imaging Modality
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Anatomical Site
back and/or extremities. Not intended to treat pain in the craniofacial region.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
January 22, 2021
SPR Therapeutics, Inc. Kathryn Stager Director of Regulatory Affairs and Quality Systems 22901 Millcreek Blvd. Suite 110 Cleveland, Ohio 44122
Re: K202660
Trade/Device Name: SPRINT 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: December 22, 2020 Received: December 23, 2020
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/cfpmr/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.
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
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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 (OS) 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 mediation-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,
Pamela Scott 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)
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) | |
|---|---|
| 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 is a logo for Sprint PNS System. The word "SPRINT" is in large, white, bold letters on the top line. Below that, "PNS SYSTEM" is in smaller, white letters. The background is a solid green color.
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 & Quality Systems Telephone: 216-378-9067
Date Prepared: September 10, 2020
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 (K181422)
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.
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ട. 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 K181422.
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:
- The frequency range is being expanded and finer adjustment of duty cycle and session duration will be permitted by the clinician.
- Two new cables are being introduced to simplify the MicroLead placement ● procedure.
- The shelf life for sterile components is being extended from 12 months to 24 months. ●
- An additional hydrogel formulation for the Mounting Pad is being made available for ● patients with skin sensitivity.
None of these changes alters the fundamental delivery of peripheral nerve stimulation to the target nerve(s) through the identical MicroLead electrode, 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.
September 2020 0153-PMN-003[01]