(148 days)
A. TENS: The device is intended to be used 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 and/ or norrmal non-commercial household work activities.
B. NMS: The device is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
The "XINIXWAVE" is a portable combined TENS and NMS dual channel device for OTC use. Housed in sturly but lightweight cabinet, the device is battery powered. The same circuitry is used to for both TENS and NMS.
The provided text does not contain detailed acceptance criteria or a study that precisely describes how the device meets those criteria with specific performance metrics. It mainly focuses on the device's substantial equivalence to a predicate device and its indications for use.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not include a table of acceptance criteria or specific performance metrics like sensitivity, specificity, accuracy, or any quantitative measures.
Instead, the "Performance Studies" section (Section 5.0) vaguely states: "Performance testing was conducted on the "XINIXWAVE" combined TENS & NMS device to demonstrate the integrity, suitability and substantial equivalence of the device." This implies that the 'acceptance criteria' were likely functional and safety benchmarks inherent in demonstrating substantial equivalence, rather than specific performance targets for, e.g., pain relief efficacy or muscle stimulation improvement through objective measures.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not mention any specific sample size for a test set. It refers to "Performance testing," but provides no details on the study design, number of participants, or the origin of any data (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention any experts used to establish ground truth or their qualifications. Given the nature of the device (TENS and NMS for OTC use) and the focus on substantial equivalence based on technical characteristics rather than clinical performance (in terms of disease diagnosis or treatment efficacy studies with human subjects), it's highly unlikely that "ground truth experts" in the typical sense (e.g., radiologists, pathologists) were involved in evaluating a test set of data.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method. This is consistent with the lack of a defined test set and expert evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document does not describe any study involving human readers or the AI-assisted improvement effect. The "XINIXWAVE" is a physical medical device (Transcutaneous Nerve Stimulator combined with Neuromuscular Stimulator), not an AI algorithm for interpreting medical images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone (algorithm-only) performance study was not done. This device is not an AI algorithm.
7. The Type of Ground Truth Used:
The concept of "ground truth" as typically used in AI/diagnostic device evaluation (e.g., pathology, expert consensus, outcome data) is not applicable here in the same way. The performance studies mentioned were likely focused on:
- Bench testing: Verifying electrical safety, output parameters (frequency, intensity, pulse width), battery life, durability, etc.
- Comparison to predicate device: Ensuring similar physiological effects and safety profile, likely through technical specifications rather than specific clinical outcomes in a trial.
The "ground truth" for showing "integrity, suitability and substantial equivalence" would be compliance with recognized standards for electromedical devices and verification that its technical specifications align with those of the predicate device for its intended use.
8. The Sample Size for the Training Set:
The concept of a "training set" is not applicable as the "XINIXWAVE" is a hardware medical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as above; there is no training set for this type of device.
Summary of what the document does indicate about "performance studies":
The document uses the term "Performance Studies" to refer to testing that demonstrated the integrity, suitability, and substantial equivalence of the "XINIXWAVE" device to its predicate, the Endurance Therapeutics' T-1040 (K-060846).
- Substantial Equivalence: The primary "performance" aspect highlighted is that the device is "simply 'two products in one' as is the cited predicate device," offering choices of programs for both TENS and NMS, similar to the predicate. It also notes that the device comes with a garment belt for electrode pads, similar to the predicate.
- Integrity and Suitability: These terms generally imply tests for electrical safety, biocompatibility (if applicable to materials in contact with skin), mechanical durability, and verification that the device functions according to its technical specifications within safe limits. These types of tests are typically conducted in a laboratory setting, not on human test sets with "ground truth" in the diagnostic sense.
In conclusion, the K100441 submission for the "XINIXWAVE" does not present performance data in the typical format of acceptance criteria, test set, ground truth, and expert evaluation as would be expected for a diagnostic AI device. Instead, it relies on demonstrating substantial equivalence through technical characteristics and basic safety/functional performance testing to an already approved predicate device.
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SECTION 5.0 ਟ I
International Trade Group, Incorporated 4663 Katie Lane Oxford, OH 45056 USA Tel: 614-568-7000
JUL 1 5 2010
510(k) Summary
General Information 1.
Trade Name of Device:
Common/Usual Name:
"XINIXWAVE"
Transcutaneous Nerve Stimulator combined with Neuromuscular Stimulator
Classification Group:
Classification Name:
Classification regulation:
Submitter's Name: Submitter's Address:
Manufacturer's Name: Manufacturer's Address:
Manufacturer's FDA Reg. No:
ర్లు
NGX, NUH
Stimulator, Nerve, Transcutaneous or Pain Relief, Over-the-Counter Combined with Powered Muscle Stimulator, Overthe-Counter.
21CFR 882.5890 OTC & 890.5850 OTC
International Trade Group, Incorporated 4663 Katie Lane Oxford, OH 45056 USA
Mantra International (HK) Ltd. 1504 Vigor Industrial Bldg. Block B, 14-20 Cheung Tat Road Tsing Yi, Hong Kong, China 3003741750
Device Description 2.
Device Description
The "XINIXWAVE" is a portable combined TENS and NMS dual channel device for OTC use. Housed in sturly but lightweight cabinet, the device is battery powered. The same circuitry is used to for both TENS and NMS.
Indications for Use 3.
Indications for Use
A. TENS: The device is intended to be used for the temporary relief of pain A. TENS: The doviee is intelleg muscles in the lower back, upper extremities associated with betwer extremities (legs) due to strain from exercise and/ or normal non-commercial household work activities.
B. NMS: The device is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
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K10044)
4. Substantial Equivalence
This product is substantially equivalent to the Endurance Therapeutics' T-1040 (K-060846). The device comes with a garment belt that is used to hold the electrode pads to treat the lower back muscles as does the predicate device. The device offers the user a choice of programs for both TENS and NMS as does the predicate device. The user can select either TENS or NMS modalities. In this way it is simply "two products in one" as is the cited predicate device.
5. Performance Studies
Performance testing was conducted on the "XINIXWAVE" combined TENS & NMS device to demonstrate the integrity, suitability and substantial equivalence of the device.
6. Conclusion
Based upon the Indications for use and performance studies the "XINIXWAVE" is shown to be substantially equivalent for its intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and a wavy line representing its tail feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
International Trade Group, Inc. c/o Mr. Brent Reider President 4663 Katie Lane Oxford, Ohio 45056
JUL 1 5 2010
Re: K100441
Trade/Device Name: Xiniwave, Model XW-18 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NUH Dated: June 3, 2010 Received: June 17, 2010
Dear Mr. 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.
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Page 2 - Mr. Brent Reider
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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
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 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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Lesia Alexander
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Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
K 100 44
Device Name: XINIWAVE (Combined TENS & NMS device)
Indications For Use:
A. TENS: The device is intended to be used 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 and/ or norrmal non-commercial household work activities.
B. NMS: The device is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Prescription Use AND/OR Over-The-Counter Use X X (21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Daryl Kaufman
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K100441
page I of
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).