VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX

K011702 · Vertis Neuroscience, Inc. · NHI · Dec 21, 2001 · Neurology

Device Facts

• Record ID: K011702
• Device Name: VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX
• Applicant: Vertis Neuroscience, Inc.
• Product Code: NHI · Neurology
• Decision Date: Dec 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Vertis PNT System delivers percutaneous electrical stimulation for pain management. System components: software-driven, 5-channel, AC-powered control unit; sterile needle electrodes (Safeguides); patient cable. Used in clinical environments by physicians (e.g., physical medicine and rehabilitation) or by physical therapists under physician order; not for patient self-use. Control unit generates electrical stimulus delivered via needle electrodes to target nerves. Output allows clinicians to manage chronic/intractable low back pain. Benefits include symptomatic relief and adjunctive treatment for post-surgical/post-trauma pain.

Clinical Evidence

Prospective clinical study conducted under IDE. Trial duration: November 2000 to March 2001. Study involved 215 PNT therapy sessions with 2150 total electrode placements. Results demonstrated safety and effectiveness of the therapy for the indicated pain management.

Technological Characteristics

5-channel, AC-powered nerve stimulator. Includes sterile needle electrodes and patient cable. Conforms to ANSI/AAMI NS4, ES1, NS15; IEC 60601-1, 60601-1-2, 60601-1-4, 60601-2-10; EN 1441. Sterilization via radiation (ANSI/AAMI/ISO 11137). Software-driven control unit.

Indications for Use

Indicated for patients with chronic or intractable low back pain, including post-surgical and post-trauma low back pain, requiring symptomatic relief or adjunctive management.

Regulatory Classification

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.

Predicate Devices

• EPIX Tens Device System Model EPIX VT (K970203)
• EPIX Tens Device System Model EPIX XL (K951903)
• SMP-PlusTM Model 4930 (K982410)
• Intelect ® Legend Stim Model IFC2 (K924666)
• Mattrix® Neurostimulation System Receiver model 3272 (K982902)
• Mattrix® Neurostimulation System Transmitter model 3210 (K982902)
• TECA Disposable Monopolar Needles 902-DMFxx-TP series (K973442)
• TECA Disposable Monopolar Needles 892-DMGxx-TP series (K973442)
• DMNTM Disposable Monopolar Needle Electrodes DMFxx series (K950314)
• DMNTM Disposable Monopolar Needle Electrodes DMNxx series (K950314)
• Resume II Lead Model 3587a (K915540)

Submission Summary (Full Text)

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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

K011702

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.<br>St. Paul, MN | EPIX Tens Device System<br>Model EPIX VT<br>Model EPIX XL | K970203<br>K951903 |
| Rehabilicare, Inc.<br>New Brighton, MN | SMP-PlusTM<br>Model 4930 | K982410 |
| Chattanooga Group, Inc.<br>Hixson, TN | Intelect ® Legend Stim<br>Model IFC2 (catalog #INT002) | K924666 |
| Medtronic, Inc<br>Minneapolis, MN | Mattrix® Neurostimulation System<br>Receiver model: 3272<br>Transmitter model: 3210 | K982902 |
| TECA Corporation<br>Pleasantville, NY | TECA Disposable Monopolar Needles<br>902-DMFxx-TP series<br>892-DMGxx-TP series | K973442 |
| Medtronic, Inc.<br>Minneapolis, MN | DMNTM Disposable Monopolar Needle<br>Electrodes<br>DMFxx series<br>DMNxx series | K950314 |
| Medtronic, Inc.<br>Minneapolis, MN | Resume II Lead<br>Model 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 [phone]. 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 [phone] or [phone] or at its Internet address [phone] 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