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K Number
K042711
Device Name
MODEL BMLS03-7
Manufacturer
BIOMEDICAL LIFE SYSTEMS, INC.
Date Cleared
2005-03-14

(165 days)

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

(TENS) Transcutaneous Electrical Nerve Stimulator Mode: Transcutaneous Electrical Nerve Stimulation (TENS) is used for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems. Muscle Stimulator Mode: External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: relaxation of muscle spasm; muscle reeducation; prevention of disuse atrophy; maintaining and increasing the range of motion; and as immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. Interferential Mode: Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain. High Volt Pulsed Current Stimulator Mode: High Voltage Pulsed Stimulation is indicated as therapeutic adjunct for: prevention of muscle of disuse atrophy, relaxation of muscle spasm, muscle reeducation, maintaining and increasing the range of motion, and as immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Device Description

Combination Transcutaneous Electrical Nerve Stimulator for Pain Relief, Powered Electrical Muscle Stimulator, Interferential Muscle Stimulator, and High Volt Pulsed Stimulator Model BMLS03-7

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, granting clearance for a medical device. It does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria in the format requested.

The document states that the device, a "Combination Transcutaneous Electrical Nerve Stimulator for Pain Relief, Powered Electrical Muscle Stimulator, Interferential Muscle Stimulator, and High Volt Pulsed Stimulator Model BMLS03-7," has been determined to be "substantially equivalent" to legally marketed predicate devices. This means the FDA found that the device is as safe and effective as a legally marketed device that does not require premarket approval.

Here's why the requested information cannot be extracted from this document:

  1. Acceptance Criteria and Device Performance Table: The document does not define specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or present performance data for the device against such criteria. Substantial equivalence is a regulatory standard, not a performance metric defined by specific statistical outcomes.
  2. Sample Size and Data Provenance for Test Set: This information is not part of a 510(k) clearance letter. The substantial equivalence determination is based on a comparison to predicate devices, which may or may not involve a new clinical study. If a study was performed, its details are not included here.
  3. Number and Qualifications of Experts: Not applicable or provided. The determination is made by FDA reviewers based on the submission from the manufacturer, not a consensus of external experts establishing a ground truth for a test set.
  4. Adjudication Method: Not applicable or provided.
  5. MRMC Comparative Effectiveness Study: Not mentioned or implied. A 510(k) clearance typically does not require a comparative effectiveness study showing human reader improvement with AI assistance, as this is not an AI device.
  6. Standalone Performance Study: The document does not detail any standalone performance study. The focus is on substantial equivalence to existing devices.
  7. Type of Ground Truth: Not applicable or provided in the context of a performance study.
  8. Training Set Sample Size: Not applicable. This device is not an AI/ML device that requires training.
  9. Ground Truth for Training Set Establishment: Not applicable.

In summary, this document is an FDA clearance letter for a device, confirming its substantial equivalence to other devices already on the market. It does not provide the detailed study information (acceptance criteria, performance data, clinical study specifics) typically associated with a clinical trial or performance evaluation designed to establish new performance claims.

§ 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).