LogoFDA 510(k) Search
K Number
K030507
Device Name
T.E.A.R. TECH3 MODEL #44TT03
Manufacturer
VISION QUEST INDUSTRIES, INC.
Date Cleared
2003-05-20

(90 days)

Product Code
IPF
Regulation Number
890.5850
Type
Traditional
Panel
PM
Reference & Predicate Devices
K982388,K931781
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The High Volt Pulsed Current Stimulator and Neuromuscular Electrical Stimulators share the same indications for use as listed below:

  • Relaxation of muscle spasms .
  • Prevention or retardation of disuse atrophy ●
  • Increases local blood circulation ●
  • . Promotes muscle re-education and range of motion
  • . Maintaining and increasing range of motion
  • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis .

Interferential Stimulators have one additional indication for use:

  • Provides symptomatic relief and management of post surgical, acute, or chronic . pain
    The target population for this device is patients with chronic, acute pain syndrome, and/or recovering from orthopedic related surgery.
Device Description

The T.E.A.R. Tech3 IF/Muscle Stimulator is a combination device combining the functionality of Interferential (IF) / Neuromuscular (NMES) and High Volt Pulsed Current (HVPC) stimulators in one device which produces a mild electrical current that is transmitted via leads to electrodes placed on the skin in areas predetermined by the clinician. The device, a set of electrodes with leads, a battery pack (lithium ion rechargeable and alkaline), carrying case, and instructions for use make up the T.E.A.R. Tech3 stimulation system.

AI/ML Overview

This submission does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.

Instead, the submission, K030507 for the T.E.A.R. Tech3, is a 510(k) Premarket Notification, which demonstrates substantial equivalence to legally marketed predicate devices. This type of submission relies on showing that the new device has the same intended use and technological characteristics as existing, approved devices, and does not raise new questions of safety or effectiveness. It does not typically involve extensive clinical trials or the establishment of new performance acceptance criteria as would be seen for novel devices.

Therefore, most of the requested information cannot be extracted from this document as it pertains to a different type of regulatory submission (e.g., a PMA or De Novo classification) that would present new performance data.

Here's what can be stated based on the provided text:

  1. Table of Acceptance Criteria and Reported Device Performance: Not applicable. The submission asserts substantial equivalence based on technological characteristics and intended use being similar to predicate devices, rather than presenting a performance study against specific acceptance criteria.

  2. Sample size used for the test set and the data provenance: Not applicable. No test set data or provenance is mentioned.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is mentioned.

  4. Adjudication method for the test set: Not applicable. No test set needing adjudication is mentioned.

  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrical stimulator, not an AI-assisted diagnostic tool involving human readers.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth data is presented.

  8. The sample size for the training set: Not applicable. This is not a machine learning device, so there is no training set mentioned.

  9. How the ground truth for the training set was established: Not applicable.

Summary of the K030507 Submission:

  • Acceptance Criteria and Study: The submission does not define specific acceptance criteria or present a study to demonstrate performance against such criteria. Instead, it argues for substantial equivalence to predicate devices.
  • Basis for Substantial Equivalence: The T.E.A.R. Tech3 is deemed substantially equivalent to the predicate devices (Surgi Stim K982388 and Jace Tri-Stim K931781) because it has the "same intended use and technological characteristics" and "no new questions of safety or effectiveness have been raised."
  • Technological Characteristics: The device is a combination of Interferential (IF) / Neuromuscular (NMES) and High Volt Pulsed Current (HVPC) stimulators.
  • Indications for Use: The shared indications include relaxation of muscle spasms, prevention of disuse atrophy, increased local blood circulation, promotion of muscle re-education and range of motion, maintaining/increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. The Interferential Stimulator has an additional indication for symptomatic relief and management of post-surgical, acute, or chronic pain.
  • Target Population: Patients with chronic/acute pain syndrome, and/or recovering from orthopedic-related surgery.

§ 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).