(88 days)
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.
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.
The provided text describes the InterX Sterile Self-Adhesive Dual Electrode (ISSDE) and its performance against acceptance criteria, primarily through comparison to predicate devices, in the context of a 510(k) submission.
Here's an analysis of the acceptance criteria and study information:
1. Table of acceptance criteria and the reported device performance
The document presents a "Substantial Equivalence Table" comparing the ISSDE to three predicate devices for various characteristics, which effectively serves as the acceptance criteria and the reported performance. The "acceptance criteria" for the ISSDE are implicitly defined by its substantial equivalence to the predicate devices and compliance with relevant standards.
| Substantial Equivalence Item | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (ISSDE) |
|---|---|---|
| Sterile | Predicate 1: NO, Predicate 2: YES, Predicate 3: NO | YES |
| Intended Use | Varied (Non-sterile, reusable, stimulating electrode; Sterile, post-operative, stimulating electrode) | Sterile, post-operative, reusable, self-adhesive, stimulating electrode (single patient) |
| Indications for Use | Similar wording across predicates, emphasizing conductive interface for TENS/NMES/FES. | Provides conductive interface between InterX stimulation device and patient's skin. Latex-free, reusable (single patient only), sterile for single patient use. |
| Hydrogel Volume Resistivity | 2500 ohm-cm (max) for all predicates | 1500 ohm-cm (max) |
| Electrode Area (surface area) | Varied (50.23 cm², 57.64 cm², 47.47 cm²) | 67.58 cm² |
| Hydrogel Biocompatibility (ISO 10993) | Passed Cytotoxicity, Delayed Contact Hypersensitivity, Primary Skin Irritation Tests | Passed Cytotoxicity, Delayed Contact Hypersensitivity, Primary Skin Irritation Tests |
| Hydrogel Stainless Steel Adhesion (180° peel) | Varied (136 grams minimum, 180 grams minimum) | 136 grams minimum |
| Conductive Electrode Element | Varied (Carbon film with silver flood coated over entire surface, or gradient pattern) | Carbon film with silver flood coated over entire surface |
| Electrode Top Cover | Varied (Non-Conductive White Tricot, Non-Conductive White Polyethylene Foam, 31.25 mils thick) | Non-Conductive White Polyethylene Foam, 31.25 mils thick |
| Sterilization Method | Predicate 1: N/A, Predicate 2: Gamma Sterilized, Predicate 3: N/A | Gamma Sterilized |
| Storage Liner | Varied (Polyester with silicone release, Silicone coated bulk paper) | Polyester with silicone release |
| Electrode Lead Wire | Single conductor 24 AWG tinned copper with PVC jacket | 2-conductor cable, 24 AWG tinned copper with PVC jacket |
| Electrode Packaging | Sealed Pouch | Sealed Pouch |
| Number per Package | Varied (4, 2, 4) | 1 |
| Electrode Permanence | Disposable | Disposable |
| Patient Preparation | Clean Dry Skin | Clean Dry Skin |
| Electrode Placement | On Patient Skin In Intended Treatment Area | On Patient Skin In Intended Treatment Area |
| Latex Content | Latex Free / Not made with natural rubber latex | Not made with natural rubber latex |
| Electrode Impedance @ 1000 Hz | Less than 50 ohms | Less than 50 ohms |
| Wire Attachment Integrity (force to remove lead wire from electrode) | Varied (More than 10 lbs. force, More than 15 lbs. force) | More than 25 lbs. force |
| Connector Disengagement Force | Varied (More than 2 lbs. force, More than 1.75 lbs. force) | More than 2 lbs. force |
| Connector Design | Varied (Overmolded .080" single pole socket, .080" single pole socket with heat shrink) | Overmolded keyed connector with 2-pole 1.0 mm sockets, touch-proof |
| 21 CFR 898 Compatible? | 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 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "samples per electrode type" for impedance testing, but it does not specify the exact sample size number used for the test set for any of the performance tests (impedance, energy distribution, biocompatibility, adhesion, etc.).
The data provenance is from bench testing conducted by the manufacturer (Neuro Resource Group, Inc.) in the context of a 510(k) submission, confirming design verification. There is no mention of country of origin of the data or whether it was retrospective or prospective in the clinical sense, as the testing is purely on the device's physical and electrical characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and study. The "ground truth" here is objective physical and electrical measurements of the device's performance, compared against established engineering standards and predicate device performance. It does not involve expert interpretation or clinical assessment by medical professionals like radiologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) where consensus among multiple reviewers is needed to establish ground truth. The tests described are objective measurements (e.g., impedance, adhesive strength) that do not require human adjudication to determine a "truth."
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable as the device is a cutaneous electrode, not an AI-assisted diagnostic tool or an imaging modality that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a passive electrode and does not contain an algorithm. The "performance" described is the electrode's physical and electrical properties, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used for this device is based on:
- Established engineering standards: e.g., ISO standards (ISO 10993 for biocompatibility, ISO 11137 for sterilization) and FDA guidance for cutaneous electrodes.
- Physical and electrical measurements: Directly measuring properties like impedance, adhesion, and energy distribution.
- Performance of legally marketed predicate devices: The ISSDE's performance is compared against the pre-established characteristics of three predicate electrodes for "substantial equivalence."
8. The sample size for the training set
This question is not applicable. The device is a passive medical device (an electrode), not a machine learning or AI model that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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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: 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:
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- Device Name: Superior StarBurst TENS/NMES/FES Stimulating Electrodes Manufacturer: Covidien, LP 510(k) Reference: K083350
-
- Device Name: Sterile Post Operative Electrodes Self-Adhering Manufacturer: Covidien 510(k) Reference: K900997 (510(k) holder: Katecho, Inc.)
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- 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 beused with medical device labels, | None |
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| labeling, and information to be | |||
|---|---|---|---|
| supplied - Part 1: General | |||
| requirements | |||
| 2 | ISO 10993-1:1997 | Biological evaluation of medicaldevices - Part 1: Evaluation &Testing | None |
| 3 | ISO 10993-5:1999 | Biological evaluation of medicaldevices - Part 5: Tests for In VitroCytotoxicity | None |
| 4 | ISO 10993-10:1996 | Biological evaluation of medicaldevices - Part 10: Tests for Irritationand Delayed-type Hypersensitivity | None |
| 5 | ISO 11607-1:2006 (R) 2010 | Packaging for terminally sterilizedmedical device- Part 1:Requirements for materials, sterilebarrier systems and packagingsystems | None |
| 6 | ANSI/AAMI/ISO 11137-1:2006/(R)2010 | Sterilization of health care products- Radiation -Part 1: Requirementsfor development, validation, androutine control of a sterilizationprocess for medical devices | None |
| 7 | ANSI/AAMI/ISO 11137-2:2012 | Sterilization of health care products- Radiation -Part 2: Establishing thesterilization 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:
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| SubstantialEquivalenceItem | InterX SterileSelf-AdhesiveDual Electrode(ISSDE)(New Device) | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3 |
|---|---|---|---|---|
| Sterile | YES | NO | YES | NO |
| Intended Use | Sterile, post-operative,reusable, self-adhesive,stimulating electrode (singlepatient) | Non-sterile, reusable, self-adhesive, stimulatingelectrode (single patient) | Sterile, post-operative, self-adhesive, stimulatingelectrode (single patient) | Non-sterile, reusable, self-adhesive, stimulating andrecording electrode(single patient) |
| Indications forUse | ISSDE isindicated for usewith InterXTranscutaneousElectrical NerveStimulator. TheISSDE providesthe conductiveinterfacebetween theInterXstimulationdevice and thepatient's skin.The ISSDE isnot made withnatural rubberlatex, is reusable(single patientonly), and isprovidedpackaged andlabeled as asterile device,for single patientuse. | The SuperiorStarburstReusable Self-adheringTENS/NMES/FES StimulatingElectrodes areindicated for usewithtranscutaneouselectricalstimulationdevices as non-sterile, Latexfree, reusabledevice for singlepatient use only.The electrodesprovide theconductiveinterfacebetween thestimulationdevice and thepatient's skin. | The Sterile PostOp Self-adhering TENSStimulatingElectrodes areindicated for usewithtranscutaneouselectricalstimulationdevices assterile, Latexfree for singlepatient use only.The electrodesprovide theconductiveinterfacebetween thestimulationdevice and thepatient's skin. | The ClassicReusable Self-adheringTENS/NMES/FES StimulatingElectrodes areindicated for usewithtranscutaneouselectricalstimulationdevices as non-sterile, Latexfree, reusabledevice for singlepatient use only.The electrodesprovide theconductiveinterfacebetween thestimulationdevice and thepatient's skin. |
| HydrogelVolumeResistivity | 1500 ohm-cm(max) | 2500 ohm-cm(max) | 2500 ohm-cm(max) | 2500 ohm-cm(max) |
| Electrode Area(surface area incontact withskin) | 67.58 cm2 | 50.23 cm2 | 57.64 cm2 | 47.47 cm2 |
| SubstantialEquivalenceItem | InterX SterileSelf-AdhesiveDual Electrode(ISSDE)(New Device) | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3 |
| HydrogelBiocompatibilityISO 10993-1 | CytotoxicityTest - PassedDelayed ContactHypersensitivityTest - PassedPrimary SkinIrritation Test -Passed | CytotoxicityTest - PassedDelayed ContactHypersensitivityTest - PassedPrimary SkinIrritation Test -Passed | CytotoxicityTest - PassedDelayed ContactHypersensitivityTest - PassedPrimary SkinIrritation Test -Passed | CytotoxicityTest - PassedDelayed ContactHypersensitivityTest - PassedPrimary SkinIrritation Test -Passed |
| Primary SkinIrritation Test -Passed | Primary SkinIrritation Test -Passed | Primary SkinIrritation Test -Passed | Primary SkinIrritation Test -Passed | |
| HydrogelStainless SteelAdhesion (180°peel) | 136 gramsminimum | 136 gramsminimum | 180 gramsminimum | 136 gramsminimum |
| ConductiveElectrodeElement | Carbon filmwith silver floodcoated overentire surface | Carbon filmwith silver floodcoated gradientpattern | Carbon filmwith silver floodcoated overentire surface | Carbon filmwith silver floodcoated overentire surface |
| Electrode TopCover | Non-ConductiveWhitePolyethyleneFoam, 31.25mils thick | Non-ConductiveWhite Tricot | Non-ConductiveWhitePolyethyleneFoam, 31.25mils thick | Non-ConductiveWhitePolyethyleneFoam, 31.25mils thick |
| SterilizationMethod | GammaSterilized | N/A | GammaSterilized | N/A |
| Storage Liner | Polyester withsilicone release | Polyester withsilicone release | Silicone coatedbulk paper | Polyester withsilicone release |
| Electrode LeadWire | 2-conductorcable, 24 AWGtinned copperconductors withPVC jacket | Single conductor24 AWG tinnedcopper withPVC jacket | Single conductor24 AWG tinnedcopper withPVC jacket | Single conductor24 AWG tinnedcopper withPVC jacket |
| ElectrodePackaging | Sealed Pouch | Sealed Pouch | Sealed Pouch | Sealed Pouch |
| Number perPackage | 1 | 4 | 2 | 4 |
| ElectrodePermanence | Disposable | Disposable | Disposable | Disposable |
| PatientPreparation | Clean Dry Skin | Clean Dry Skin | Clean Dry Skin | Clean Dry Skin |
| ElectrodePlacement | On Patient SkinIn IntendedTreatment Area | On Patient SkinIn IntendedTreatment Area | On Patient SkinIn IntendedTreatment Area | On Patient SkinIn IntendedTreatment Area |
| Latex Content | Not made withnatural rubberlatex | Latex Free | Latex Free | Latex Free |
| SubstantialEquivalenceItem | InterX SterileSelf-AdhesiveDual Electrode(ISSDE)(New Device) | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3 |
| ElectrodeImpedance @1000 Hz | Less than 50ohms | Less than 50ohms | Less than 50ohms | Less than 50ohms |
| WireAttachmentIntegrity (forceto remove leadwire fromelectrode) | More than 25lbs. force | More than 10lbs. force | More than 10lbs. force | More than 15lbs. force |
| ConnectorDisengagementForce | More than 2 lbs.force | More than 2 lbs.force | More than 1.75lbs. force | More than 2 lbs.force |
| ConnectorDesign | Overmoldedkeyed connectorwith 2-pole 1.0mm sockets,touch-proof | Overmolded.080" single polesocket, touch-proof | .080" single polesocket with heatshrink covering,touch-proof | Overmolded.080" single polesocket, touch-proof |
| 21 CFR 898Compatible? | Yes | Yes | Yes | Yes |
| Lead Wire toElectrodeAttachmentMethod | Cyanoacrylateadhesivebetween wireinsulation andsilver film,tinned copperwire in contact | Cyanoacrylateadhesivebetween wireinsulation andsilver film,tinned copperwire in contact | Cyanoacrylateadhesivebetween wireinsulation andsilver film,tinned copperwire in contact | Cyanoacrylateadhesivebetween wireinsulation andsilver film,tinned copperwire 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
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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
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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
§ 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).