(89 days)
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.
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.
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
This document is a 510(k) premarket notification for the XiniWave II Model ECS322P, a powered muscle stimulator for both TENS and NMES applications. It claims substantial equivalence to a predicate device, XiniWave Model XW-18 (K100441). The document primarily focuses on demonstrating that the new device is as safe and effective as the predicate despite some modifications.
Here's an analysis of the provided text with respect to acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in the sense of predefined numerical performance targets for a clinical study. Instead, the performance evaluation is based on demonstrating substantial equivalence to a predicate device. The "reported device performance" is a comparison of output parameters between the applicant device and the predicate.
Below is a table summarizing the key device characteristics and their comparison, which effectively serves as the "performance" data used to support substantial equivalence.
| Characteristic | Predicate Device (XiniWave, Model XW-18) Performance | Applicant Device (XiniWave II, Model ECS322P) Performance | Acceptance Criteria (Implied by Substantial Equivalence) |
|---|---|---|---|
| Indications for Use | Temporarily relieves pain (TENS) and stimulates healthy muscles (NMS). | Temporarily relieves pain (TENS) and stimulates healthy muscles (NMS). | Unchanged from Predicate. |
| Technology | Identical fundamental scientific technology. | Identical fundamental scientific technology. | Unchanged from Predicate. |
| Max. Output Current (peak @ 500 Ohms): | 80mA +/- 8% | TENS: 80mA +/- 8%; NMES: 90mA +/- 8% | Within extant mode of clinical effectiveness and cleared devices. |
| Max. Output Current (peak @ 2K Ohms): | 50mA +/- 10% | 50mA +/- 10% | Similar to Predicate. |
| Max. Output Current (peak @ 10K Ohms): | 19mA +/- 10% (shuts off) | 19mA +/- 10% (shuts off) | Similar to Predicate. |
| Pulse Width (μS) | 175 μS – 250 μS (program dependent) | 50 μS – 250 μS (program dependent) | Within extant mode of clinical effectiveness. |
| Frequency (Hz) | 12 Hz - 150Hz (program dependent) | 2 Hz - 100Hz (program dependent) | Within extant mode of clinical effectiveness. |
| Net Charge @ 500 ohms (μC per pulse) | Zero (Asymmetrical DC zero, transformer output) | Zero (Symmetrical DC zero, transformer output) | Similar to Predicate. |
| Max. (Peak) Phase Charge (μC) at 500 ohms | 20 μC (80mA x 250μS) | 40 μC (90mA x 450 μS) | Within extant mode of clinical effectiveness. |
| Max. Current Density (mA/cm²) @ 2 X 2 | 3.2 mA/cm² (Surface = 25 cm²) | 4.3 mA/cm² (Surface = 25 cm²) | Within extant mode of clinical effectiveness. |
| Max. Power Density (W/cm²) @ 500 ohms | 3.8mW/cm² | 7.7 mW/cm² | Within extant mode of clinical effectiveness. |
| Ergonomics (LCD Size) | 35 X 17 mm | 45 X 35 mm | Not explicitly an "acceptance criterion" for safety/effectiveness, but a noted change. |
| Ergonomics (Weight) | 0.09 kg (without battery) / 0.1 kg (with battery) | 0.12 kg (without battery) / 0.16 kg (with battery) | Not explicitly an "acceptance criterion." |
| Software (Programs) | TENS: 7 pre-set; NMES: 6 pre-set | TENS: 8 pre-set; NMES: 1 (user selectable work/rest) | Programs are "Substantially Equivalent" to Predicate. |
| Manual Languages | English | English & Spanish | Not an "acceptance criterion" for device performance, but for labeling compliance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe any "test set" in the context of a clinical study with human subjects or a formal algorithm evaluation. The performance comparison is based on comparing the technical specifications and output parameters of the new device against its predicate. This is a technical, engineering-based comparison rather than a clinical one involving patient data.
- Sample Size for Test Set: Not applicable, no human test set or algorithm evaluation based on data is described.
- Data Provenance: Not applicable, no clinical data is presented. The information is derived from technical specifications and design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. No "ground truth" establishment by experts for a test set is described, as the evaluation is based on technical specifications comparison rather than interpretation of data by experts.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document does not describe an MRMC comparative effectiveness study, nor any clinical study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware product, a powered muscle stimulator. It does not involve an "algorithm" in the context of image analysis, diagnostics, or other applications where standalone algorithm performance would be relevant. While it has embedded "programs," these control electrical stimulation output, not information processing or interpretation for which a standalone AI performance would be assessed.
7. The Type of Ground Truth Used
Not applicable. No clinical ground truth (e.g., pathology, outcomes data, expert consensus) is used, as the evaluation is based on engineering and performance specifications.
8. The Sample Size for the Training Set
Not applicable. No "training set" is mentioned or implied, as this is a hardware device with pre-programmed functions, not a machine learning model that requires training data.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth for it.
Summary of the Study:
The "study" described in this 510(k) submission is not a clinical trial or an AI/algorithm validation study. It is a technical and regulatory comparison designed to demonstrate "substantial equivalence" of the XiniWave II Model ECS322P to its predicate device, XiniWave Model XW-18.
The applicant asserts that despite some modifications (battery type, LCD size, physical dimensions, channel connector location, software program specifics, manual languages), the fundamental scientific technology and the intended use remain unchanged. The core of the evidence lies in comparing output parameters (current, pulse width, frequency, charge, power density) to show that the new device's outputs remain within clinically effective ranges and are comparable to or within acceptable variations of the predicate, and thus do not raise new questions of safety or effectiveness. The risk assessment mentioned indicates that product modifications are as safe and effective as the predicate.
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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
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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
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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) |
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510(k) Summary
| General Information | As Required by 21 CFR 807.92(c) |
|---|---|
| Applicant Date: | 26 April 2017 |
| Applicant & Spec. Dev. Name:Applicant & Spec. Dev. Address:Applicant & Spec. Dev. Tele .:Applicant & Spec. Dev. FAX:Applicant & Spec. Dev. Contact:Applicant & Spec. Dev. e-mail: | International Trade Group, Incorporated4663 Katie Lane, Suite "O"Oxford, OH 45056 USA614-568-7000614-568-7001Brent C. Reider, Presidentbrent.reider@yarlap.com |
| Device Trade Name and Model: | XiniWave II Model ECS322P |
| 510(k): | K171092 |
| Common/Usual Name: | Stimulator, Nerve, Transcutaneous for Pain ReliefOver-the-Counter Combined withPowered Muscle Stimulator, Over-the-Counter. |
| Classification Group: | NGX & NUH |
| Classification Name: | Stimulator, Nerve, Transcutaneous for Pain ReliefOver-the-Counter Combined withPowered Muscle Stimulator, Over-the-Counter. |
| Classification regulations: | 21CFR 882.5890 OTC: Stimulator, Nerve,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.
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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.(Applicant of XiniWave II Model ECS322P) |
| Predicate Product Code: | NGX & NUH |
| Predicate Common/Usual Name: | Stimulator, Nerve, Transcutaneous for PainRelief Over-the-Counter Combined withPowered Muscle Stimulator, Over-the-Counter. |
| Predicate Classification Name: | Stimulator, Nerve, Transcutaneous for PainRelief Over-the-Counter Combined withPowered Muscle Stimulator, Over-the-Counter. |
| Predicate Classification Reg .: | 21CFR 882.5890 OTC: Stimulator, Nerve,Transcutaneous for Pain Relief21CFR 890.5850 OTC: Powered MuscleStimulator |
| Predicate Indications for Use: | Unchanged to Applicant Device |
| Predicate Essential Technology: | Unchanged to Applicant Device |
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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) |
| EnergyType: | 1 X 9 Volt Alkaline Battery(standard 800mAh)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(standard 1,000mAh) |
| Ergonomics: | Paper White LCD - 35 X 17 mmWeight: 0.09 kg. without battery,0.1 kg. with battery. | Paper White LCD - 45 X 35 mmWeight: 0.12 kg. without battery,0.16 kg. with battery. |
| Channel Outlet/Connectors on Cabinet TopElectrode Positioning Belt for Lower Back | Channel Outlet/Connectors at Cabinet BaseNo 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-setNMES: All 6 Programs are Pre-set | TENS: All 8 Programs, Pre-setNMES: 1 Program, User SelectIn NMES Mode user is able to select work/rest stimulation withrates between 2-100Hz & width between 50-450μS |
| Program Run Times are Pre-set | Program Run Times Pre-Set Incremental to Max.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 usingidentical secure proprietary software codes. Neither the Applicant nor the Predicate device can be programmed by remote radiofrequency 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
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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 ProgramsSection 5.0, Table 3 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Utility | Program Description | RateHz | PulseμS | WorkSec. | RestSec. | TimeMin. | Max. mW/cm² | |||
| PredicateK100441 | Applicant | 80mA | Max. mW/cm²90mA | Ave. mW/cm²45 mA | ||||||
| Applicant Device has 8 TENS Programs (3 are HAN/TENS) – The Predicate Device has 7 TENS ProgramsElectrode Surface Min. of 25cm²Assumes 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
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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 SafetyApplicant and Predicate Out-put by NMES ProgramSection 5.0 Table 4 | ||
|---|---|---|
| Basic Unit Characteristics | Applicant DeviceXiniWave | Applicant DeviceXiniWave II |
| 510(k) | K100441 | To Be Advised |
| Maximum Output Current pulsepeak @ 500 Ohms | 80mA +0/- 8% | TENS 80mA +0/- 8%NMES 90mA +0/- 8% |
| Maximum Output Current pulsepeak @ 2K Ohms | 50mA +/-10% | 50mA +/-10% |
| Maximum Output Current pulsepeak @ 10K Ohms | 19mA +/-10%And thus shuts off | 19mA +/-10%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
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| Pulse Width (μS) | 175 μS – 250 μS,program dependent | 50 μS – 250 μS,program dependent |
|---|---|---|
| Frequency (Hz) | 12 Hz - 150Hz,program dependent | 2 Hz - 100Hz,program dependent |
| Net Charge @ 500 ohms (μCper pulse)(If zero, state method ofachieving zero net charge.) | Zero- positive pulse is equal andopposite to negative pulse.Asymmetrical DC zero(Transformer output) | Zero- positive pulse is equal andSymmetrical DC zero(Transformer output) |
| Maximum (Peak) Phase Charge,(μC) at 500 ohms | $80mA x 250μS = 20 μC$This corresponds to the longestpulse at the highest current. | $90mA x 450 μS = 40 μC$This corresponds to the longestpulse at the highest current. |
| Maximum (peak) CurrentDensity, (mA/cm²) 2 X 2 | $3.2 mA/cm²$Surface = 25 cm² (2X2) | $4.3 mA/cm²$Surface = 25 cm² (2X2) |
| Maximum Power Density,(W/cm²)at 500 ohms | $3.8mW/cm²$At maximum frequency of150Hz pulse width 200µS andcurrent of 80mA. | $7.7 mW/cm²$At maximum frequency of100Hz pulse width 450µS andcurrent of 90mA.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.
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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.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).