(203 days)
Percutaneous Neuromodulation Therapy (PNT) is indicated for the symptomatic relief and management of chronic or intractable low back pain and/or as an adjunctive treatment in the management of post-surgical low back pain and post-trauma low back pain.
The PNT Control Unit is to be used with a PNT Safeguide Kit - Lumbar.
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., I NT Uystein is intendousical medicine and rehabilitation physicians) or on the order of a physician (e.g., by a physical therapist) in a clinic environment. It is not intended for patient use. 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, and ●
- the Patient Cable which interconnects the PNT Control Unit to the . electrodes
The provided text describes the Vertis Neuroscience, Inc. Percutaneous Neuromodulation Therapy (PNT)™ Control Unit and Accessories, its intended use, and the studies conducted to demonstrate its safety and effectiveness.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) for device performance as would typically be seen in AI/diagnostic device submissions. Instead, acceptance is framed around adherence to electrical safety, quality management, and biocompatibility standards, and demonstrating overall safety and effectiveness through a clinical trial.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bench/Animal Testing | Conformance to various electrical safety, performance, and biocompatibility standards (e.g., AAMI NS4, ES1, NS15; IEC 60601 series, ISO 11137, ISO 10993-1). Software validation per recognized techniques. | "All testing of the products yielded acceptable results prior to commercial distribution." |
| Clinical Testing | Demonstration of safety and effectiveness of percutaneous neuromodulation therapy for its intended use. | "The clinical trial demonstrated the safety and effectiveness of the percutaneous neuromodulation therapy." |
| Substantial Equivalence | Similarity of design features, materials, test results, clinical results, and indicated use to predicate devices, raising no new safety or effectiveness issues. | Vertis believes the device "does not raise any new safety or effectiveness issues and is substantially equivalent to currently available nerve stimulators, electrodes and accessories." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Test Set: 215 patients.
- Data Provenance: The clinical trial was a prospective study conducted at "multiple United States clinical sites."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not specify the number or qualifications of experts involved in establishing ground truth for the clinical trial. It only states that the system is intended for use by a physician (e.g., physical medicine and rehabilitation physicians) or on the order of a physician (e.g., physical therapist). The clinical trial "demonstrated the safety and effectiveness," but the method of assessing patient outcomes or 'ground truth' for effectiveness (e.g., pain reduction scales, functional improvement) is not detailed.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the clinical test set. It mentions the trial was "reviewed and approved in November 2000" and that Vertis "conducted a prospective clinical study evaluating the safety and effectiveness."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not indicated in the provided text. The device is a nerve stimulation system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases with and without AI assistance. This study focused on the safety and effectiveness of the therapy itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the typical sense for this device. The PNT System is a physical device (control unit, electrodes, patient cable) that delivers electrical stimulation. It is not an algorithm that performs a diagnostic task in a standalone manner. Its "performance" is in generating the electrical stimulus and the clinical outcome from that stimulation, which is inherently human-in-the-loop (physician application to the patient). The software component was validated, but this likely refers to its control functions, not independent diagnostic performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of "ground truth" for the clinical effectiveness. Given the nature of a therapy for pain management, it is highly probable that the effectiveness was assessed using patient-reported outcomes data (e.g., pain scales, functional questionnaires) and clinician observations, rather than pathology or expert consensus on a diagnostic finding. The safety aspect would be based on adverse event reporting.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as the device is not an AI/machine learning model in the sense that it learns from a dataset. It is a therapy delivery system. The clinical trial data (215 patients) would be considered the "test set" for validating its performance in a clinical setting.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" for an AI model described for this device.
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Appendix 25 - revised 510(k) Summary of Safety and Effectiveness
Class II
DEC 2 1 2001
Vertis Neuroscience, Inc. Percutaneous Neuromodulation Therapy (PNT) ™ Control Unit and Accessories
General Information
Classification
Trade Name
Percutaneous Neuromodulation Therapy (PNT) Nerve Stimulation System
Submitter
Contact
Vertis Neuroscience, Inc. 2101 Fourth Avenue, Suite 200 Seattle, Washington, USA 98121
Lori Glastetter Vice President, Regulatory Affairs/ Quality Assurance
Substantially Equivalent Devices
| Manufacturer | Substantially Equivalent devices | 510(k) |
|---|---|---|
| Empi, Inc.St. Paul, MN | EPIX Tens Device SystemModel EPIX VTModel EPIX XL | K970203K951903 |
| Rehabilicare, Inc.New Brighton, MN | SMP-PlusTMModel 4930 | K982410 |
| Chattanooga Group, Inc.Hixson, TN | Intelect ® Legend StimModel IFC2 (catalog #INT002) | K924666 |
| Medtronic, IncMinneapolis, MN | Mattrix® Neurostimulation SystemReceiver model: 3272Transmitter model: 3210 | K982902 |
| TECA CorporationPleasantville, NY | TECA Disposable Monopolar Needles902-DMFxx-TP series892-DMGxx-TP series | K973442 |
| Medtronic, Inc.Minneapolis, MN | DMNTM Disposable Monopolar NeedleElectrodesDMFxx seriesDMNxx series | K950314 |
| Medtronic, Inc.Minneapolis, MN | Resume II LeadModel 3587a | K915540 |
Intended use
Percutaneous Neuromodulation Therapy (PNT) is indicated for the symptomatic relief and management of chronic or intractable low back pain and/or as an adjunctive treatment in the management of post-surgical low back pain and post-trauma low back pain.
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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., I NT Uystein is intendousical medicine and rehabilitation physicians) or on the order of a physician (e.g., by a physical therapist) in a clinic environment. It is not intended for patient use. 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, and ●
- the Patient Cable which interconnects the PNT Control Unit to the . electrodes
Bench/Animal Testing
Extensive bench and animal was conducted on the Vertis PNT System and included performance and safety testing. The Vertis PNT System conforms to applicable performanted on the technical references and FDA-recognized consensus standards noted below. Additionally, the PNT Control Unit software was validated per recognized validation techniques.
Results: All testing of the products yielded acceptable results prior to commercial distribution.
ANSI/AAMI NS4-1985 Transcutaneous Electrical Nerve Stimulators, approved 5-20-86. ANSI/AAMI ES1 1993 - Safe Current Limits for Electromedical Apparatus, approved 12-2-93 ANSI/AMI NS15-1995 Implantable Peripheral Nerve Stimulators, approved 2-1-95 IEC60601-1:1993 Medical Electrical Equipment, Part 1: General Requirements for Safety and Amendments A1:1991, A2:1995. IEC 60601-1-2 First Edition 1993-4 Medical Electrical Equipment, - Part 1: General Requirements for Safety: Electromagnetic Compatibility -Requirements and Tests (tested in accordance to the IEC 61000 series). IEC 60601-1-4:1996 Medical Electrical Equipment, Part 1: General Requirements for Safety, Part 2: Collateral Standard: Programmable electrical medical systems. IEC 60601-2-10:1987 Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of Nerve and Muscle Stimulators. EN (CEN) 1441:1997 Medical Devices - Risk Analysis.
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ANSI/AAMI/ISO 15223: 2000 Medical Devices - Symbols to be used with Medical Device Labels, Labeling and Information to be Supplied, approved 3-13-00.
IEC 60601-2-10:1987 Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of Nerve and Muscle Stimulators.
ANSI/AAMI/ISO 11137: 1994 Sterilization of Health Care Products -Requirements for Validation and Routine Control -Radiation Sterilization; using Method 1 as described per AAMI/ISO TIR No. 13409: 1996 Sterilization of Health care Products - Radiation Sterilization -Substantiation of 25kGy as a Sterilization Dose for Small or Infrequent Production Batches.
ANSI/AAMI/ISO 10993-1:1997, Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing.
Clinical Testing
Under the auspices of an Investigational Device Exemption, Vertis conducted a prospective clinical study evaluating the safety and effectiveness of percutaneous neuromodulation therapy.
The Vertis clinical trial was reviewed and approved in November 2000. The trial commenced shortly thereafter at multiple United States clinical sites. The trial was completed in March 2001. During the multi-week investigational protocol, there were a total of 2150 electrode placements in 215 PNT therapy sessions with patients.
Results: The clinical trial demonstrated the safety and effectiveness of the percutaneous neuromodulation therapy.
Summary of Substantial Equivalence
Therefore, due to the similarity of design features, materials, test results, clinical results and indicated use to other predicate devices, Vertis believes the Vertis PNT System does not raise any new safety or effectiveness issues and is substantially equivalent to currently available nerve stimulators, electrodes and accessories that have been determined to be substantially equivalent to devices in commercial distribution prior to May 28, 1976.
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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol of three curved lines that resemble a person. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2001
Lori J. Glastetter Vice President, Regulatory Affairs/Quality Assurance Vertis Neuroscience, Inc. 2101 Fourth Avenue, Suite 200 Seattle, Washington 98121
Re: K011702/S1
rever router System (Vertis PNT Control Unit and Vertis PNT Lumbar Safeguard Kit)
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: September 24, 2001 Received: September 25, 2001
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 commence 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
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Page 2 – Ms. Lori Glastetter
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setting CHK Part 807); labeling (21 CFR Part 001); good rate 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 5 10(k) I his letter will anow you to ought manteaning of substantial equivalence of your device your device premarket notification. The PDA miding of baction 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 If you desire specific advice for your acvice disenostic devices), please contact the Office of additionally 21 CFN Fall 607.10 for in the e.for suestions on the promotion and advertising of Compliance at (301) 594 4657. Thursday, Jim 1594-4639. Also, please note the your device, piease comace the Ories of eeee on premarket notification" (21CFF Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification" (21CFF) regulation entitied, "Misorananing of responsibilities under the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address (600) 050 2017 01 (501) - 1 (501) - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - -
Sipeerely gours,
Celia M. Witten, P Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): Koll 7-02
Device Name: Vertis PNT System
Indications For Use:
Percutaneous Neuromodulation Therapy (PNT) is indicated for the symptomatic relief and management of chronic or intractable low back pain and/or as an adjunctive treatment in the management of post-surgical low back pain and post-trauma low back pain.
The PNT Control Unit is to be used with a PNT Safeguide Kit - Lumbar.
(Please Do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
(Optional Format 3-10-98)
510(k) Number KD11702
§ 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).