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K Number
K062641
Device Name
BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1
Manufacturer
AVAZZIA, INC.
Date Cleared
2007-04-30

(236 days)

Product Code
GZJ
Regulation Number
882.5890
Type
Traditional
Panel
NE
Reference & Predicate Devices
K042912
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and posttraumatic pain.

Device Description

The four Avazzia Biofeedback Electro-Stimulation Technology (BEST) devices are biofeedback, micro-current transcutaneous electro-stimulation devices for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain. They are easy-to-use, handheld, AA battery-operated portable devices for use in the home or clinic.

AI/ML Overview

The provided text is a 510(k) Summary for TENS devices (Body-Stim™, Biomodulator™, BEST-RSI™, BEST-Pro1TM). It states that the technological characteristics of these devices are the same as their predicate device, InterX5000 (K042912). The summary highlights software verification according to FDA guidance and conformity with IEC 60601-1 and EMC:IEC 60601-1-2 international safety standards. It also mentions a CE Mark for the devices.

However, the 510(k) summary does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria.

Here's why and what's missing:

  • Acceptance Criteria and Reported Device Performance: This type of document, a 510(k) Summary, primarily focuses on demonstrating substantial equivalence to a predicate device. It typically does not include a table of detailed performance acceptance criteria and their corresponding reported values from a specific clinical or technical study. Instead, it relies on demonstrating that the new device's technological characteristics are equivalent to the predicate, and safety standards are met.
  • Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document refers to "verification and validation tests" but provides no details about them. It does not describe:
    • The sample size of any test set.
    • The provenance of any data (e.g., country of origin, retrospective/prospective).
    • The number or qualifications of experts used for ground truth.
    • Any adjudication methods.
    • Whether an MRMC or standalone study was performed, or any effect sizes.
    • The type of ground truth used (e.g., pathology, outcomes data).
    • The sample size of a training set or how its ground truth was established.

Conclusion:

Based on the provided 510(k) summary, it is not possible to complete the requested table or answer the specific questions regarding acceptance criteria and the details of a study proving the device meets those criteria. The document states that "verification and validation tests contained in this submission demonstrate that the submitted models are equivalent to the safety and effectiveness as that of the cleared devices," but it does not present the data or methodology of those tests in this summary.

To obtain this information, one would typically need to review the full 510(k) submission, not just the summary.

§ 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).