(62 days)
No
The summary describes a software-driven electrical stimulator for pain management, but there is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated for "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," which aligns with the definition of a therapeutic device.
No.
The device is described as a nerve stimulator designed for delivering percutaneous electrical stimulation for pain management, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists hardware components: the Vertis PNT Control Unit (a nerve stimulator), sterile Safeguides (needle electrodes), and a Patient Cable. While the Control Unit is described as "software-driven," the system as a whole includes physical hardware that delivers the therapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Vertis PNT System is a device for delivering percutaneous electrical stimulation to manage pain. It involves needle electrodes inserted into the body and a control unit to generate electrical stimulus.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is to deliver a physical therapy (electrical stimulation) directly to the body.
- Intended Use: The intended use is for the symptomatic relief and management of pain, not for diagnosing a condition based on sample analysis.
While the device description mentions the use of MRI/CT imaging data, this data is likely used for guiding the placement of the electrodes or assessing the patient's anatomy, not for performing a diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
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.
Product codes
NHI, GXZ
Device Description
The Vertis PNT System is designed for delivering percutaneous electrical stimulation (termed: Percutaneous Neuromodulation Therapy -PNT ). The Vertis PNT System is intended to be used in pain management by a physician (e.g., anesthesiologists or physical medicine and rehabilitation physicians) or on the order of a physician (e.g., by a physical therapist) in a clinic environment. The device system includes 3 major components:
- the Vertis PNT Control Unit a software-driven, ● five channel, AC powered nerve stimulator which generates the electrical stimulus;
- the sterile Safeguides which are sterile, needle electrodes; ●
- the Patient Cable - which interconnects the PNT Control Unit to the electrodes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
low back, neck, upper back
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician (e.g., anesthesiologists or physical medicine and rehabilitation physicians) or on the order of a physician (e.g., by a physical therapist) in a clinic 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
Bench data: electrode performance and dimensional data
Human data: human magnetic resonance images (MRI)/ computerized tomography . (CT) imaging data, published human clinical trial data for cervical pain management, post-market data for the Vertis PNT System.
Data demonstrated acceptable results for the device and therapy.
Key Metrics
Not Found
Predicate Device(s)
K011702, K970203, K951903, K982410
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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SEP 1 1 2002
1:2
Appendix 13 510(k) Summary of Safety and Effectiveness
Vertis Neuroscience, Inc. Percutaneous Neuromodulation Therapy (PNT) ™ Control Unit and Accessories
General Information
| Classification | Class II |
|---|---|
| Trade Name | Percutaneous Neuromodulation Therapy |
| (PNT) Nerve Stimulation System | |
| Submitter | Vertis Neuroscience, Inc. |
| 2101 Fourth Avenue, Suite 200 | |
| Seattle, Washington, USA 98121 | |
| Contact | Lori Glastetter |
| Vice President, Regulatory Affairs/ | |
| Quality Assurance |
Nature of this 510(k)
The Vertis Percutaneous Neuromodulation Therapy (PNT) System (nerve stimulator and accessories) was cleared for marketing under 510(k) Notification K011702. This submission was filed to request clearance to market a new cervical electrode kit and cable and modify the existing PNT labeling to accommodate these new accessories.
Device Description
The Vertis PNT System is designed for delivering percutaneous electrical stimulation (termed: Percutaneous Neuromodulation Therapy -PNT ). The Vertis PNT System is intended to be used in pain management by a physician (e.g., anesthesiologists or physical medicine and rehabilitation physicians) or on the order of a physician (e.g., by a physical therapist) in a clinic environment. The device system includes 3 major components:
- the Vertis PNT Control Unit a software-driven, ● five channel, AC powered nerve stimulator which generates the electrical stimulus;
- the sterile Safeguides which are sterile, needle electrodes; ●
- the Patient Cable - which interconnects the PNT Control Unit to the electrodes
1
K022241
205-2
Indications for use
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.
Substantially Equivalent Devices
| Manufacturer | Substantially Equivalent devices | 510(k) |
|---|---|---|
| Vertis Neuroscience, | ||
| Inc. | Vertis Percutaneous Neuromodulation | |
| Therapy (PNT) Stimulation System (Vertis | ||
| PNT Control Unit and Accessories) | ||
| Model CU 100 and SG 101-xxx | K011702 | |
| Empi, Inc. | ||
| St. Paul, MN | EPIX Tens Device System | |
| Model EPIX VT | ||
| Model EPIX XL | K970203 | |
| K951903 | ||
| Rehabilicare, Inc. | ||
| New Brighton, MN | SMP-PlusTM | |
| Model 4930 | K982410 |
Safety and Effectiveness - Testing
Extensive data were provided that evaluated the use of PNT cervical electrodes and cervical percutaneous electrical stimulation. These data included the following. Data demonstrated acceptable results for the device and therapy.
- electrode performance and dimensional (bench) data ●
- human magnetic resonance images (MRI)/ computerized tomography . (CT) imaging data
- published human clinical trial data for cervical pain management ●
- . post-market data for the Vertis PNT System
Summary of Substantial Equivalence
Based on the information provided in this Notification, we believe the described modification to the legally marketed predicate Vertis PNTTM Control Unit and Accessories has been shown to be substantially equivalent to devices in commercial distribution prior to May 28, 1976.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
SEP 1 1 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lori J. Glastetter Vice President, Regulatory Affairs/Quality Assurance Vertis Neuroscience, Inc. 2101 Fourth Avenue, Suite 200 Seattle, Washington 98121
Re: K022241
Trade/Device Name: Vertis Percutaneous Neuromodulation Therapy (PNT) Nerve Stimulation System (Vertis PNT Control Unit, Vertis PNT Lumbar Safeguides and Vertis PNT Cervical Safeguides) Regulation Number: 21 CFR 882.5890 and 21 CFR 882.1350 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief and Needle Electrode Regulatory Class: Class II Product Code: NHI and GXZ Dated: July 10, 2002 Received: July 11, 2002
Dear Ms. Glastetter:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
3
Page 2 - Ms. Lori Glastetter
CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K 0222 4 |
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
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 a
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 pair.
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Mark N. Milliken
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number -