INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)

• K Number: K130816
• Device Name: INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)
• Manufacturer: NEURO RESOURCE GROUP, INC.
• Date Cleared: 2013-06-21 ( 88 days)
• Product Code: GXY
• Regulation Number: 882.1320

Intended 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. 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 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 which is then sealed, gamma sterilized and boxed for shipment. The Proposed ISSDE is designed for single-patient/multiple application use.

Predicate Devices

K083350, K900997, K900519

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states that the electrodes do not contain active electronics, software, or firmware, and there is no mention of AI or ML in the summary.

Therapeutic

No
The device described, ISSDE, is an electrode that provides a conductive interface for an electrical nerve stimulator (InterX Transcutaneous Electrical Nerve Stimulator). It does not, by itself, provide therapy; rather, it is an accessory to a therapeutic device.

Diagnostic

No
The ISSDE is a conductive interface for an electrical nerve stimulator, providing the electrical connection to the patient's skin. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the electrodes do not contain active electronics, software, or firmware. It is a physical component (electrode and cable) that connects to a separate stimulation device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is a "conductive interface between the InterX stimulation device and the patient's skin." This describes a device that facilitates the delivery of electrical stimulation to the body, not a device that tests samples from the body to diagnose a condition.
• Device Description: The description details the physical components of an electrode designed for electrical conductivity and adhesion to the skin. It explicitly states the electrodes "do not contain active electronics, software or firmware," which is typical of a passive component used in conjunction with an active medical device (the InterX stimulator).
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.

The device is an accessory to a Transcutaneous Electrical Nerve Stimulator (TENS) device, which is a therapeutic device, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

GXY

Device 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 which is then sealed, gamma sterilized and boxed for shipment. The Proposed ISSDE is designed for single-patient/multiple application use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's skin

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Sterile post-operative healthcare setting (for first application)

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Hydrogel Volume Resistivity: 1500 ohm-cm (max)
Electrode Area (surface area in contact with skin): 67.58 cm2
Hydrogel Biocompatibility ISO 10993-1: Cytotoxicity Test - Passed, Delayed Contact Hypersensitivity Test - Passed, Primary Skin Irritation Test - Passed
Hydrogel Stainless Steel Adhesion (180° peel): 136 grams minimum
Electrode Impedance @ 1000 Hz: Less than 50 ohms
Wire Attachment Integrity (force to remove lead wire from electrode): More than 25 lbs. force
Connector Disengagement Force: More than 2 lbs. force

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.

K083350, K900997, K900519

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

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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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: [phone] X 223 Fax: [phone]

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

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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.

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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 |

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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