Who is the manufacturer of INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)?

Neuro Resource Group, Inc. filed the 510(k) submission for INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) (K130816).

What is the FDA product code for INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)?

GXY. It is classified under 21 CFR 882.1320 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)?

Superior StarBurst TENS/NMES/FES Stimulating Electrodes (K083350); Sterile Post Operative Electrodes Self-Adhering (K900997); Reusable and Self-Adhering TENS.NMES.FES Stimulating Electrodes (Classic # 2404) (K900519).

Who can help prepare an FDA 510(k) submission like INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)

K130816 · Neuro Resource Group, Inc. · GXY · Jun 21, 2013 · Neurology

Device Facts

Record ID	K130816
Device Name	INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)
Applicant	Neuro Resource Group, Inc.
Product Code	GXY · Neurology
Decision Date	Jun 21, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1320
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

ISSDE is indicated for use with InterX Transcutaneous Electrical Nerve Stimulator, previously cleared by FDA (K042912). The ISSDE provides the conductive interface between the InterX stimulation device and the patient's skin. The ISSDE is not made with natural rubber latex, is reusable (single patient only), and is provided packaged and labeled as a sterile device, for single patient use. As a sterile device, the ISSDE can be applied to patients in a sterile post-operative healthcare setting. NRG only guarantees sterility for the first application, however, ISSDE can be repositioned and reapplied (single patient only) as a non-sterile device for subsequent applications. Refer to the labeling for reuse instructions.

Device Story

ISSDE is a flexible, sterile laminate electrode designed to interface with the InterX Transcutaneous Electrical Nerve Stimulator. It consists of a top cover, reinforcement film, dual conductive members with printed silver, biocompatible conductive hydrogel, and a 2-conductor cable. The device is applied to the patient's skin to deliver electrical stimulation. It is intended for single-patient, multiple-application use; provided sterile for the first application in post-operative settings and can be repositioned for subsequent applications. The electrode does not contain active electronics, software, or firmware. It facilitates the transmission of electrical signals from the stimulator to the patient, potentially aiding in pain management or therapeutic stimulation as determined by the clinician using the InterX system.

Clinical Evidence

Bench testing only. Performance evaluation included impedance testing at 1000 Hz, energy distribution uniformity, and biocompatibility (cytotoxicity, delayed-type hypersensitivity, and primary skin irritation per ISO 10993). Sterilization validation was performed per ANSI/AAMI/ISO 11137. Results confirmed impedance and energy distribution are substantially equivalent to predicate devices.

Technological Characteristics

Flexible laminate electrode; materials include white polyethylene foam top cover, silver-printed conductive members, biocompatible hydrogel, and 24 AWG tinned copper 2-conductor cable. Connectivity via touch-proof keyed connector. Sterilization via gamma radiation. No active electronics, software, or firmware.

Indications for Use

Indicated for use with InterX Transcutaneous Electrical Nerve Stimulator as a conductive interface between the device and patient skin. For single-patient use; latex-free; provided sterile for initial application in post-operative settings.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

Superior StarBurst TENS/NMES/FES Stimulating Electrodes (K083350)
Sterile Post Operative Electrodes Self-Adhering (K900997)
Reusable and Self-Adhering TENS.NMES.FES Stimulating Electrodes (Classic # 2404) (K900519)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for NRG. The logo is in black and white and features the letters "NRG" in a bold, sans-serif font. The letters are enclosed in a rounded rectangle. There is a small dot to the right of the letter G. # Section 5 - 510(k) Summary K1308.16 JUN 2 1 2013 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.87(h) and 21 CFR 807.92. G R O U P Submitter Information: Neuro Resource Group, Inc. 1100 Jupiter Road, Suite 190 Plano, TX 75074 Establishment # 3004786509 Official Contact: Dave Turner, CEO Neuro Resource Group, Inc. 1100 Jupiter Road, Suite 190 Plano. TX 75074 Phone: 972-665-1810 X 223 Fax: 972-665-1814 # Date Summary Prepared: 06/20/13 Product Name & Classification: Trade Name: InterX Sterile Self-Adhesive Dual Electrode (ISSDE) Classification Name: Cutaneous Electrodes Classification Regulation: 21CFR 882.1320 Classification Code: GXY Classification Panel: Neurology #### Predicate Device Information: - 1. Device Name: Superior StarBurst TENS/NMES/FES Stimulating Electrodes Manufacturer: Covidien, LP 510(k) Reference: K083350 - 2. Device Name: Sterile Post Operative Electrodes Self-Adhering Manufacturer: Covidien 510(k) Reference: K900997 (510(k) holder: Katecho, Inc.) - 3. Device Name: Reusable and Self-Adhering TENS.NMES.FES Stimulating Electrodes (Classic # 2404) Manufacturer: Covidien 510(k) Reference: K900519 (510(k) holder: Classic Medical Products, Inc.) #### Product Description: The Proposed ISSDE is a flexible, sterile laminate composed of a top cover, a reinforcement film, dual conductive members with printed silver, biocompatible conductive hydrogel, a release liner which protects the hydrogel before use and during storage and a 2-conductor cable secured between the reinforcement film and the conductive members. The electrodes do not contain active electronics, software or firmware. The cable connects the dual-electrode to the Inter X electrical stimulation device. A single finished dual-electrode is placed into a protective pouch {1}------------------------------------------------ which is then sealed, gamma sterilized and boxed for shipment. The Proposed ISSDE is designed for single-patient/multiple application use. ### Intended Use: ISSDE is indicated for use with InterX Transcutaneous Electrical Nerve Stimulator, previously cleared by FDA (K042912). The ISSDE provides the conductive interface between the InterX stimulation device and the patient's skin. The ISSDE is not made with natural rubber latex, is reusable (single patient only), and is provided packaged and labeled as a sterile device, for single patient use. As a sterile device, the ISSDE can be applied to patients in a sterile post-operative healthcare setting. NRG only guarantees sterility for the first application, however, ISSDE can be repositioned and reapplied (single patient only) as a non-sterile device for subsequent applications. Refer to the labeling for reuse instructions. ### Indications for Use: ISSDE is indicated for use with InterX Transcutaneous Electrical Nerve Stimulator. The ISSDE provides the conductive interface between the InterX stimulation device and the patient's skin. The ISSDE is not made with natural rubber latex, is reusable (single patient only), and is provided packaged and labeled as a sterile device, for single patient use. #### Technological Characteristics: The Proposed ISSDE exhibits identical technological characteristics as compared to the following predicates: - Covidien's Superior StarBurst TENS/NMES/FES Stimulating Electrodes (K083350) - - Covidien's Sterile Post Operative Electrodes Self-Adhering (K900997) " - Covidien's Reusable and Self-Adhering TENS.NMES.FES Stimulating Electrodes . (Classic # 2404) (K900519) The electrode is composed of a top cover, a reinforcement film, dual conductive members with printed silver, biocompatible conductive hydrogel, a release liner which protects the hydrogel before use and during storage and a 2-conductor cable secured between the reinforcement film and the conductive members. # Bench Testing: The InterX Sterile Self-Adhesive Dual Electrode (ISSDE) and the predicate devices were tested per protocol in accordance with the FDA's "Draft Guidance for Industry and Staff: Class II Special Controls Guidance Document: Cutaneous Electrode (April 5, 2010)". ISSDE gel electrodes were sterilized to a very high radiation level (greater than 40 kGy) to create a worst case scenario for gel degradation. Electrical performance of the ISSDE was tested for uniform energy distribution along the length of each electrode. Comparison of energy distribution of the ISSDE electrodes were made to FDA cleared predicate gel electrode devices. Another performance factor of particular interest was impedance, which was measured across the total surface area of each ISSDE gel electrode. The results from the tests performed provide evidence that design verification per 21CFR-820.30(g) was met. ISSDE complies with the applicable requirements of the following standards: | No. | Standard Reference & Revision | Title | Deviations | |-----|-------------------------------|---------------------------------------------------------------------|------------| | 1 | ISO 15223-1(Second Edition) | Medical Devices – Symbols to be used with medical device labels, | None | {2}------------------------------------------------ | | | labeling, and information to be | | |---|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | | | supplied - Part 1: General | | | | | requirements | | | 2 | ISO 10993-1:1997 | Biological evaluation of medical devices - Part 1: Evaluation & Testing | None | | 3 | ISO 10993-5:1999 | Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity | None | | 4 | ISO 10993-10:1996 | Biological evaluation of medical devices - Part 10: Tests for Irritation and Delayed-type Hypersensitivity | None | | 5 | ISO 11607-1:2006 (R) 2010 | Packaging for terminally sterilized medical device- Part 1: Requirements for materials, sterile barrier systems and packaging systems | None | | 6 | ANSI/AAMI/ISO 11137-1:2006/(R) 2010 | Sterilization of health care products - Radiation -Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices | None | | 7 | ANSI/AAMI/ISO 11137-2:2012 | Sterilization of health care products - Radiation -Part 2: Establishing the sterilization dose | None | Guidance Document: The recommendations of the FDA's "Draft Guidance for Industry and Staff: Class II Special Controls Guidance Document: Cutaneous Electrode (April 5, 2010)" were taken into account in preparing this 510(k) submission. ### Performance Data: Design validation of the ISSDE was confirmed and documented. Tests to measure impedance and variation of energy distribution, which determine safety and efficacy, were conducted to compare the ISSDE to three predicate devices. Values of current were calculated from testing each electrode. Impedance values were tabulated for all gel electrodes using samples per electrode type. Impedance values for the ISSDE are confirmed to be substantially equivalent to predicate devices Variation of energy distribution was also determined to be substantially equivalent, which confirms avoidance of hot spots. The results of the impedance and variation of energy distribution tests conducted confirm that the ISSDE design is substantially equivalent to three FDA cleared predicate devices. Performance data for the Proposed ISSDE is compared to that of the predicate devices mentioned above. Results from the biocompatibility study, physical and functional performance evaluation demonstrate that the Proposed ISSDE is substantially equivalent to the legally marketed devices. {3}------------------------------------------------ ______________________________________________________________________________________________________________________________________________________________________________ # Substantial Equivalence Table: : : ה : : | Substantial Equivalence Item | InterX Sterile Self-Adhesive Dual Electrode (ISSDE) (New Device) | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | |-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sterile | YES | NO | YES | NO | | Intended Use | Sterile, post-operative, reusable, self-adhesive, stimulating electrode (single patient) | Non-sterile, reusable, self- adhesive, stimulating electrode (single patient) | Sterile, post-operative, self- adhesive, stimulating electrode (single patient) | Non-sterile, reusable, self- adhesive, stimulating and recording electrode (single patient) | | Indications for Use | ISSDE is indicated for use with InterX Transcutaneous Electrical Nerve Stimulator. The ISSDE provides the conductive interface between the InterX stimulation device and the patient's skin. The ISSDE is not made with natural rubber latex, is reusable (single patient only), and is provided packaged and labeled as a sterile device, for single patient use. | The Superior Starburst Reusable Self- adhering TENS/NMES/F ES Stimulating Electrodes are indicated for use with transcutaneous electrical stimulation devices as non- sterile, Latex free, reusable device for single patient use only. The electrodes provide the conductive interface between the stimulation device and the patient's skin. | The Sterile Post Op Self- adhering TENS Stimulating Electrodes are indicated for use with transcutaneous electrical stimulation devices as sterile, Latex free for single patient use only. The electrodes provide the conductive interface between the stimulation device and the patient's skin. | The Classic Reusable Self- adhering TENS/NMES/F ES Stimulating Electrodes are indicated for use with transcutaneous electrical stimulation devices as non- sterile, Latex free, reusable device for single patient use only. The electrodes provide the conductive interface between the stimulation device and the patient's skin. | | Hydrogel Volume Resistivity | 1500 ohm-cm (max) | 2500 ohm-cm (max) | 2500 ohm-cm (max) | 2500 ohm-cm (max) | | Electrode Area (surface area in contact with skin) | 67.58 cm2 | 50.23 cm2 | 57.64 cm2 | 47.47 cm2 | | Substantial Equivalence Item | InterX Sterile Self-Adhesive Dual Electrode (ISSDE) (New Device) | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | | Hydrogel Biocompatibility ISO 10993-1 | Cytotoxicity Test - Passed Delayed Contact Hypersensitivity Test - Passed Primary Skin Irritation Test - Passed | Cytotoxicity Test - Passed Delayed Contact Hypersensitivity Test - Passed Primary Skin Irritation Test - Passed | Cytotoxicity Test - Passed Delayed Contact Hypersensitivity Test - Passed Primary Skin Irritation Test - Passed | Cytotoxicity Test - Passed Delayed Contact Hypersensitivity Test - Passed Primary Skin Irritation Test - Passed | | | Primary Skin Irritation Test - Passed | Primary Skin Irritation Test - Passed | Primary Skin Irritation Test - Passed | Primary Skin Irritation Test - Passed | | Hydrogel Stainless Steel Adhesion (180° peel) | 136 grams minimum | 136 grams minimum | 180 grams minimum | 136 grams minimum | | Conductive Electrode Element | Carbon film with silver flood coated over entire surface | Carbon film with silver flood coated gradient pattern | Carbon film with silver flood coated over entire surface | Carbon film with silver flood coated over entire surface | | Electrode Top Cover | Non-Conductive White Polyethylene Foam, 31.25 mils thick | Non-Conductive White Tricot | Non-Conductive White Polyethylene Foam, 31.25 mils thick | Non-Conductive White Polyethylene Foam, 31.25 mils thick | | Sterilization Method | Gamma Sterilized | N/A | Gamma Sterilized | N/A | | Storage Liner | Polyester with silicone release | Polyester with silicone release | Silicone coated bulk paper | Polyester with silicone release | | Electrode Lead Wire | 2-conductor cable, 24 AWG tinned copper conductors with PVC jacket | Single conductor 24 AWG tinned copper with PVC jacket | Single conductor 24 AWG tinned copper with PVC jacket | Single conductor 24 AWG tinned copper with PVC jacket | | Electrode Packaging | Sealed Pouch | Sealed Pouch | Sealed Pouch | Sealed Pouch | | Number per Package | 1 | 4 | 2 | 4 | | Electrode Permanence | Disposable | Disposable | Disposable | Disposable | | Patient Preparation | Clean Dry Skin | Clean Dry Skin | Clean Dry Skin | Clean Dry Skin | | Electrode Placement | On Patient Skin In Intended Treatment Area | On Patient Skin In Intended Treatment Area | On Patient Skin In Intended Treatment Area | On Patient Skin In Intended Treatment Area | | Latex Content | Not made with natural rubber latex | Latex Free | Latex Free | Latex Free | | Substantial Equivalence Item | InterX Sterile Self-Adhesive Dual Electrode (ISSDE) (New Device) | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | | Electrode Impedance @ 1000 Hz | Less than 50 ohms | Less than 50 ohms | Less than 50 ohms | Less than 50 ohms | | Wire Attachment Integrity (force to remove lead wire from electrode) | More than 25 lbs. force | More than 10 lbs. force | More than 10 lbs. force | More than 15 lbs. force | | Connector Disengagement Force | More than 2 lbs. force | More than 2 lbs. force | More than 1.75 lbs. force | More than 2 lbs. force | | Connector Design | Overmolded keyed connector with 2-pole 1.0 mm sockets, touch-proof | Overmolded .080" single pole socket, touch- proof | .080" single pole socket with heat shrink covering, touch-proof | Overmolded .080" single pole socket, touch- proof | | 21 CFR 898 Compatible? | Yes | Yes | Yes | Yes | | Lead Wire to Electrode Attachment Method | Cyanoacrylate adhesive between wire insulation and silver film, tinned copper wire in contact | Cyanoacrylate adhesive between wire insulation and silver film, tinned copper wire in contact | Cyanoacrylate adhesive between wire insulation and silver film, tinned copper wire in contact | Cyanoacrylate adhesive between wire insulation and silver film, tinned copper wire in contact | . · · . {4}------------------------------------------------ . . : : · , {5}------------------------------------------------ # Conclusions: The Proposed ISSDE is similar in intended use, functional design, principles of operation, materials, packaging and other technological characteristics to the predicate devices. A fter analyzing the performance and testing, it is concluded that the ISSDE is as safe and effective as the predicate devices and do not raise any new issues of safety and effectiveness. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. # DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 21, 2013 Neuro Resource Group, Inc. c/o David Turner, CEO Neuro Resource Group 1100 Jupiter Road, Ste. 190 Plano, TX 75074 Re: K130816 Trade/Device Name: InterX Sterile Self-Adhesive Dual Electrode (ISSDE) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: March 13, 2013 Received: March 25, 2013 Dear Mr. Turner: 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 11 (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 {7}------------------------------------------------ # Page 2 - David Turner 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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address hup://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to hup://www.fda.gov/MedicalDevices/Safetv/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. # Joyce M. Whang -S Victor Krauthamer, Ph.D. for Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # Indications for Use 510(k) Number (if known): K130816 InterX Sterile Self-Adhesive Dual Electrode (ISSDE) Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: ISSDE is indicated for use with InterX Transcutaneous Electrical Nerve Stimulator. The ISSDE provides the conductive interface between the InterX stimulation device and the patient's skin. The ISSDE is not made with natural rubber latex, is reusable (single patient only), and is provided packaged and labeled as a sterile device, for single patient use. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) # Joyce M. Whang -S (Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD) 510(k) Number K130816 Page 1 of 1

INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps