XiniWave II Model ECS322P

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a family. July 10, 2017 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 International Trade Group, Inc. Brent Reider President & Secretary of International Trade Group, Inc. 4663 Katie Lane Oxford, Ohio 45056 Re: K171092 Trade/Device Name: XiniWave II Model ECS322P Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH Dated: February 2, 2017 Received: April 12, 2017 Dear Brent Reider: 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 II (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 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 {1}------------------------------------------------ related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Industry and Consumer Education 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, # Michael J. Hoffmann -S for Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K171092 Device Name XiniWave II Model ECS322P #### Indications for Use (Describe) TENS: The device is intended for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from exercise and/or normal household and work activities. NMS: The device is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. | Type of Use (Select one or both, as applicable) | |---------------------------------------------------| | \[x] Prescription Use (Part 21 CFR 801 Subpart D) | | \[x] Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary | General Information | As Required by 21 CFR 807.92(c) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant Date: | 26 April 2017 | | Applicant & Spec. Dev. Name:<br>Applicant & Spec. Dev. Address:<br>Applicant & Spec. Dev. Tele .:<br>Applicant & Spec. Dev. FAX:<br>Applicant & Spec. Dev. Contact:<br>Applicant & Spec. Dev. e-mail: | International Trade Group, Incorporated<br>4663 Katie Lane, Suite "O"<br>Oxford, OH 45056 USA<br>614-568-7000<br>614-568-7001<br>Brent C. Reider, President<br>brent.reider@yarlap.com | | Device Trade Name and Model: | XiniWave II Model ECS322P | | 510(k): | K171092 | | Common/Usual Name: | Stimulator, Nerve, Transcutaneous for Pain Relief<br>Over-the-Counter Combined with<br>Powered Muscle Stimulator, Over-the-Counter. | | Classification Group: | NGX & NUH | | Classification Name: | Stimulator, Nerve, Transcutaneous for Pain Relief<br>Over-the-Counter Combined with<br>Powered Muscle Stimulator, Over-the-Counter. | | Classification regulations: | 21CFR 882.5890 OTC: Stimulator, Nerve,<br>Transcutaneous for Pain Relief | ## Applicant Device Description The Applicant device, XiniWave II Model ECS322P, is a precision Class II device housed in a sturdy lightweight cabinet. The keypad controls and the circuit for the Applicant device are identical to the Predicate. For a maturing user constituency, the cabinet of the Applicant device is larger than the Predicate with a bigger white paper Liquid Crystal Display (LCD), yet the weight of the device is virtually equivalent. The Applicant device is powered by 3 x 1.5V AAA alkaline batteries. The Applicant device offers the user a choice of eight (8) pre-set Transcutaneous Electro Neuro Stimulation (TENS) programs for the temporary relief of pain (80 mA Max.) and one pre-set Neuro-Muscular Electrical Stimulation (NMES) program for muscle conditioning (90 mA Max.). In the NMES mode of operation the user is able to select work/rest stimulation with pulse rates between 2-100Hz and pulse widths between 50-450uS rate may be selected. The mode of action for the Applicant device in TENS or NMES mode is identical to the mode of action to the Predicate. {4}------------------------------------------------ The Applicant device is supplied with skin electrodes (electrode surface minimum of 25cm -), to stimulate the patient. The skin electrodes (extant for the industry) are the same ones as supplied with the Predicate and delineated in the User's Manual. The Applicant device control unit connects directly to the skin electrode by cable and plug (extant for the industry). Sold as a kit, the XiniWave II Model ECS322P kit consists of: One (1) Battery Powered Stimulator (Control Unit) One (1) set of Four (4) skin electrodes Three (3x1.5V) AAA Batteries One (1) User's Manual One (1) case Individual components that may be lost (e.g., battery compartment door) or which must be replaced throughout normal usage (e.g., battery and electrode(s) can be re-ordered individually, see User's Manual). #### Predicate Device: Per 21 CFR 807.92(a)(3), the cited Predicate device is: | Predicate Trade Name and Model: XiniWave, Model XW-18 | | |-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Predicate 519(k): | K100441 | | Predicate 510(k) Holder: | International Trade Group, Inc.<br>(Applicant of XiniWave II Model ECS322P) | | Predicate Product Code: | NGX & NUH | | Predicate Common/Usual Name: | Stimulator, Nerve, Transcutaneous for Pain<br>Relief Over-the-Counter Combined with<br>Powered Muscle Stimulator, Over-the-<br>Counter. | | Predicate Classification Name: | Stimulator, Nerve, Transcutaneous for Pain<br>Relief Over-the-Counter Combined with<br>Powered Muscle Stimulator, Over-the-<br>Counter. | | Predicate Classification Reg .: | 21CFR 882.5890 OTC: Stimulator, Nerve,<br>Transcutaneous for Pain Relief<br>21CFR 890.5850 OTC: Powered Muscle<br>Stimulator | | Predicate Indications for Use: | Unchanged to Applicant Device | | Predicate Essential Technology: | Unchanged to Applicant Device | {5}------------------------------------------------ ## Indications for Use The indications for use of the Applicant device, see Section 5.0 table 1 below, are consistent with the uses described under 21CFR 882.5890 OTC: Stimulator, Nerve, Transcutaneous for Pain Relief and 21CFR 890.5850 OTC: Powered Muscle Stimulator. #### Applicant & Predicate (K100441) Indications for Use (Unchanged) Section 5.0 Table 1 TENS: The device is intended for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from exercise and/or normal household and work activities. NMS: The device is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. #### Indications for Use Discussion The indications for use of the Applicant device and the Predicate are unchanged and consistent with the uses described under 21CFR 882.5890 OTC: Stimulator, Nerve, Transcutaneous for Pain Relief and 21CFR 890.5850 OTC: Powered Muscle Stimulator. #### Device Modifications The device modifications listed in Section 5.0, Table 2, do not affect the intended use of the device or alter the fundamental scientific technology of the device. | Device Modifications | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Section 5.0, Table 2 | | | | Modification | Predicate Device (K100441) | Applicant Device (TBA) | | Energy<br>Type: | 1 X 9 Volt Alkaline Battery<br>(standard 800mAh)<br>See Tables 3 & 4 later in this Section and Section 12.0, Tables 3 & 4 for Power Density details. | 3 X 1.5 Volt Alkaline Batteries<br>(standard 1,000mAh) | | Ergonomics: | Paper White LCD - 35 X 17 mm<br>Weight: 0.09 kg. without battery,<br>0.1 kg. with battery. | Paper White LCD - 45 X 35 mm<br>Weight: 0.12 kg. without battery,<br>0.16 kg. with battery. | | | Channel Outlet/Connectors on Cabinet Top<br>Electrode Positioning Belt for Lower Back | Channel Outlet/Connectors at Cabinet Base<br>No Electrode Positioning Belt for Lower Back | | Dimensions: | 108 X 62 X 23 mm. without clip | 128 x 67 x 25 mm. without clip | | Software+: | TENS: All 7 Programs are Pre-set<br>NMES: All 6 Programs are Pre-set | TENS: All 8 Programs, Pre-set<br>NMES: 1 Program, User Select<br>In NMES Mode user is able to select work/rest stimulation with<br>rates between 2-100Hz & width between 50-450μS | | | Program Run Times are Pre-set | Program Run Times Pre-Set Incremental to Max.<br>Program Lock Feature to set and record 1 program | | Manual: | English | English & Spanish | | + The Applicant and Predicate devices are programmed exactly the same way, by hardwire connection to the Circuit Board using<br>identical secure proprietary software codes. Neither the Applicant nor the Predicate device can be programmed by remote radio<br>frequency signals. Electro Magnetic Certification of the device is presented in Section 17.1 of this Application | | | ## Device Substantial Equivalence and Safety The device modifications do not alter the fundamental scientific technology of the device under 21CFR 882.5890 OTC: Stimulator, Nerve, Transcutaneous for Pain Relief and 21CFR 890.5850 OTC: Powered Muscle Stimulator. The Applicant device uses Traditional 510(k): Notification of a New Device: XiniWave II Model ECS322P ProCode: NGX & NUH Document Completion Date: 10 July 2017 Submission: S007 Per 21 CFR 807.92(a)(3)(4)(5)(6)(b(1)(2)(3)(c)(d) Page 3 of 7 {6}------------------------------------------------ ## SECTION 5.0 510(k) Summary Substantially Equivalent programs as the Predicate device (per 21CFR 882.5890 OTC and 21CFR 890.5850 OTC). Program comparisons for the Applicant and Predicate are demonstrated in Section 5.0, Table 3 below: | Device Substantial Equivalence and Safety of the Applicant and Predicate Programs<br>Section 5.0, Table 3 | | | | | | | | | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-----------|------------|-------------|---------------|--------------|--------------|-------------|---------------------|----------------------| | Utility | Program Description | | Rate<br>Hz | Pulse<br>μS | Work<br>Sec. | Rest<br>Sec. | Time<br>Min. | Max. mW/cm² | | | | | Predicate<br>K100441 | Applicant | | | | | | 80mA | Max. mW/cm²<br>90mA | Ave. mW/cm²<br>45 mA | | Applicant Device has 8 TENS Programs (3 are HAN/TENS) – The Predicate Device has 7 TENS Programs<br>Electrode Surface Min. of 25cm²<br>Assumes 500 Ohm Load | | | | | | | | | | | | TENS | Program 1 | | 80 | 200 | n/a | n/a | 60 | 2.0 | n/a | 0.6 | | HAN | | Program 1 | 2/70 | 260/150 | n/a | n/a | 30 | 1.3 | n/a | 0.4 | | Predicate & Applicant are similar | | | | | | | | | | | | TENS | Program 2 | | 50 | 100 | n/a | n/a | 60 | 0.6 | n/a | 0.2 | | HAN | | Program 2 | 2/15 | 260/180 | n/a | n/a | 30 | 0.3 | n/a | 0.1 | | Predicate & Applicant are similar | | | | | | | | | | | | TENS | Program 3 | | 10 | 175 | n/a | n/a | 60 | 0.2 | n/a | 0.1 | | HAN | | Program 3 | 2/100 | 260/130 | n/a | n/a | 30 | 1.7 | n/a | 0.5 | | Predicate & Applicant are similar | | | | | | | | | | | | TENS | Program 4 | | 150 | 200 | n/a | n/a | 60 | 3.8 | n/a | 1.2 | | | | Program 4 | 2/200 | 50/300 | n/a | n/a | 60 | 7.7 | n/a | 2.4 | | Predicate & Applicant are different | | | | | | | | | | | | TENS | Program 5 | | 150 | 175 | n/a | n/a | 60 | 3.4 | n/a | 1.1 | | | | Program 5 | 150 | 200 | n/a | n/a | 60 | 3.8 | n/a | 1.2 | | Predicate & Applicant are similar | | | | | | | | | | | | TENS | Program 6 | | 100/65 | 200/100 | n/a | n/a | 60 | 2.6 | n/a | 0.8 | | | | Program 6 | 100 | 120 | n/a | n/a | 60 | 1.5 | n/a | 0.8 | | Predicate & Applicant are similar | | | | | | | | | | | | TENS | Program 7 | | 65/10 | 200/100 | n/a | n/a | 60 | 1.7 | n/a | 0.5 | | | | Program 7 | 35 | 200 | n/a | n/a | 60 | 0.9 | n/a | 0.3 | | Predicate & Applicant are similar | | | | | | | | | | | | TENS | Program 8 | | 10/15 | 150/250 | n/a | n/a | 55 | 0.5 | n/a | 0.2 | | Applicant Device has only 1 NMES Program – The Predicate Device has 6 NMES Programs | | | | | | | | | | | | MNES | Program 9 | | 35 | 250 | 8 | 8 | 15 | n/a | 1.4 | 0.4 | | | | Program 9 | 2/90 | 50/450 | User Variable | | 15 | n/a | 6.5 | 1.6 | While the identified program output differences appear evocative, the output of the applicant are within extant mode of clinical effectiveness and devices cleared in 21CFR 882.5890 OTC: Stimulator, Nerve, Transcutaneous for Pain Relief and 21CFR 890.5850 OTC: Powered Muscle Stimulator. Additional information has been included in the manual for the user to better understand and optimally managing the fundamental scientific technology of the device. In this way a lay-person seeking pain management therapy and muscle conditioning can derive maximum benefit from the output potential of the device. The Applicant and Predicate devices are programmed by hardwire connection to the Circuit Board only. Neither the Applicant nor the Predicate device can be programmed {7}------------------------------------------------ by remote radio frequency signals. The product firmware is written in a secure (proprietary) code. The skin electrode in the Applicant device is identical to the Predicate device. The Applicant device control unit connects directly to the skin electrode by cable and plug (design extant for the industry). Water-resistance is designed into the unit for EU mandated performance requirements per IEC 60601-2-11:2013 only. To the Applicants knowledge, it is not the custom to use any device of this type in wet areas. The Applicant is in complete agreement with FDA guidance not to use the device in wet areas. Hence, the Applicant device will not be promoted as water-resistant nor labelled as such per this 510(k) submission. The manual of the Applicant and Predicate devices are printed in English. The Applicant device is available in Spanish test is available on request. The languages used in the Applicant device have been selected based on the predominant languages spoken in the United States and Commonwealth of Puerto Rico and then cross-referenced with the cumulative immigration data selecting the three largest languages spoken by immigrant populations to enter theses United States over the past 50 years (1965 to 2015). As such the device labelling complies with or exceeds 21 CFR 801.15(a)(6)(3)(c)(1)(2)& (3). The Risk Assessment prepared by an independent firm and reviewed by independent commentators, in accordance with the Quality System Regulation (including documentation of design inputs. risk analysis, design output, test procedures, verification and validation procedures, and documentation of formal design reviews) demonstrate that the product modifications are as safe, and effective, and that the Applicant device performs as well as the Predicate device [21 CFR 807.92(b)(3)]. The Applicant device uses the identical pre-set NMES programs as the Predicate device and such, the out-put, in the applicable NMES programs is substantially equivalent as demonstrated in Section 5.0 Table 4 below. | Device Substantial Equivalence and Safety<br>Applicant and Predicate Out-put by NMES Program<br>Section 5.0 Table 4 | | | |---------------------------------------------------------------------------------------------------------------------|-----------------------------------|----------------------------------------| | Basic Unit Characteristics | Applicant Device<br>XiniWave | Applicant Device<br>XiniWave II | | 510(k) | K100441 | To Be Advised | | Maximum Output Current pulse<br>peak @ 500 Ohms | 80mA +0/- 8% | TENS 80mA +0/- 8%<br>NMES 90mA +0/- 8% | | Maximum Output Current pulse<br>peak @ 2K Ohms | 50mA +/-10% | 50mA +/-10% | | Maximum Output Current pulse<br>peak @ 10K Ohms | 19mA +/-10%<br>And thus shuts off | 19mA +/-10%<br>And thus shuts off | Traditional 510(k): Notification of a New Device: XiniWave II Model ECS322P ProCode: NGX & NUH Document Completion Date: 10 July 2017 Submission: S007 Per 21 CFR 807.92(a)(3)(4)(5)(6)(b(1)(2)(3)(c)(d) Page 5 of 7 {8}------------------------------------------------ | Pulse Width (μS) | 175 μS – 250 μS,<br>program dependent | 50 μS – 250 μS,<br>program dependent | |-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Frequency (Hz) | 12 Hz - 150Hz,<br>program dependent | 2 Hz - 100Hz,<br>program dependent | | Net Charge @ 500 ohms (μC<br>per pulse)<br>(If zero, state method of<br>achieving zero net charge.) | Zero- positive pulse is equal and<br>opposite to negative pulse.<br>Asymmetrical DC zero<br>(Transformer output) | Zero- positive pulse is equal andSymmetrical DC zero<br>(Transformer output) | | Maximum (Peak) Phase Charge,<br>(μC) at 500 ohms | $80mA x 250μS = 20 μC$<br>This corresponds to the longest<br>pulse at the highest current. | $90mA x 450 μS = 40 μC$<br>This corresponds to the longest<br>pulse at the highest current. | | Maximum (peak) Current<br>Density, (mA/cm²) 2 X 2 | $3.2 mA/cm²$<br>Surface = 25 cm² (2X2) | $4.3 mA/cm²$<br>Surface = 25 cm² (2X2) | | Maximum Power Density,<br>(W/cm²)<br>at 500 ohms | $3.8mW/cm²$<br>At maximum frequency of<br>150Hz pulse width 200µS and<br>current of 80mA. | $7.7 mW/cm²$<br>At maximum frequency of<br>100Hz pulse width 450µS and<br>current of 90mA.<br>TENS Program 04 | Therefore, since the device modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device concordant with the uses described under 21CFR 882.5890 OTC and for muscle conditioning as described under 21CFR 890.5850 OTC: Powered Muscle Stimulator (i.e., Indications for Use unchanged from the Predicate) and the Quality Assurance paradigm, including Risk, demonstrates that the product modifications are as safe, and effective, and performs as well as or better than the Predicate device. As such the Applicant device and does not raise new questions about safety or effectiveness and demonstrates with reasonable assurance based on established controls that the device is at least as safe and effective as a legally marketed device. ## Conclusion - . The Applicant device is substantially equivalent to the predicate because it has the same intended therapeutic use as the Predicate described under 21CFR 882.5890 OTC: Stimulator, Nerve, Transcutaneous for Pain Relief and 21CFR 890.5850 OTC: Powered Muscle Stimulator: - The Applicant device has the similar technological characteristics as the Predicate and that any differences do not adversely impact the safety or effectiveness of the Applicant device; - The therapeutic labelling of the Applicant device is concordant with the Predicate and - The information submitted to the FDA for the Applicant device does not raise new questions about safety or effectiveness and demonstrates with reasonable assurance based on established controls that the device is at least as safe and effective as the Predicate, a legally marketed device. {9}------------------------------------------------ Hence, the XiniWave II Model ECS322P device meets the FDA's definition of Substantial Equivalency under the relationships cited above (21 U.S.C. §§ 360(n), 360c(t)(1) & 360c(i); 21 CFR 807.92(a)(3) and suggest when obtained over-the-counter and used by a layperson without oversight by a healthcare practitioner in a non-clinical environment, the applicant device can be used correctly, safely and in a manner that produces temporary pain relief consistent with the uses described under 21CFR 882.5890 OTC and for muscle conditioning as described under 21CFR 890.5850 OTC: Powered Muscle Stimulator.