(121 days)
The Globus Genesy 1100 Electro-stimulator should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. It is intended to be used for therapies employing NMES, Russian, and Premodulated Currents (IFC) to obtain the following:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Additional Indications for Microcurrent, Premodulated Currents (IFC), NMES and TENS waveforms:
- Management of chronic, intractable pain
- Post-traumatic acute pain
- Post-surgical acute pain
The Globus Genesy Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimulators, Transcutaneous Electrical Nerve Stimulator. Premodulated Current Therapy Stimulator, and Microcurrent Therapy Stimulator.
Each device in the family comes with a menu to select different stimulation The Stimulation Programs have been subdivided in menus and programs. submenus to facilitate use for various types of uses. The user can create and store protocols in the device for subsequent recall, and can store them and manipulate them in a PC for labeling and stimulation parameter changes.
The Globus Genesy electrical impulses trigger excitations that are transmitted to the muscle fibers, where they generate mechanical responses that result in muscle work. This work is used for muscle and range-of-motion rehabilitation therapies.
They also interact with the mechanism of pain generation and transmission in the nerve fibers; other stimulation currents interact directly with the affected body part to obtain the effect desired by the physician or licensed practitioner.
The core of the Globus Genesy device is a constant-current generator; a transformer guarantees insulation between outlet current utilized for the battery charger, and the circuits utilized for stimulation current. A micro-processor elaborates the menu selections and drives the constant-current generator that originates the electrical impulses for the electrostimulation. This is accomplished according to the parameters stored for that particular program. The user can regulate the current continuously from 0-120 mA.
The provided text is a 510(k) summary for the Globus Genesy Electro-Stimulator. It outlines the device's description, intended use, and claims of substantial equivalence to a predicate device. However, it does not describe any specific studies conducted by the applicant (Domino S.r.l.) to prove the device meets acceptance criteria.
The document focuses on demonstrating substantial equivalence based on similarity in design, function, and technical characteristics to the predicate device (Chattanooga Vectra GENiSYS Stimulator K031077), rather than presenting independent performance data from the Globus Genesy device itself.
Therefore, many of the requested sections about acceptance criteria, study details, and performance data cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
- Cannot be provided: The document does not define specific acceptance criteria (e.g., performance metrics, thresholds) for the Globus Genesy Electro-Stimulator, nor does it report any direct performance data for the device. It only states that its "maximum current output and its maximum electric charge are very similar to the predicate device."
2. Sample size used for the test set and the data provenance
- Cannot be provided: The document does not describe any specific test set or clinical study conducted with the Globus Genesy device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot be provided: There is no mention of a test set or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided: No test set or adjudication method 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
- Cannot be provided: This device is an electro-stimulator, not an AI-powered diagnostic device involving human readers. Therefore, an MRMC study is not applicable, nor is AI assistance relevant to this device type described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided: Not applicable for this device type. The device operates under medical supervision, inherently involving a human in the loop for application and therapy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided: No ground truth is established or discussed for the Globus Genesy device's performance.
8. The sample size for the training set
- Cannot be provided: This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Cannot be provided: Not applicable.
Summary based on the provided text:
The 510(k) submission for the Globus Genesy Electro-Stimulator relies on demonstrating substantial equivalence to an existing legally marketed device (Chattanooga Vectra GENiSYS Stimulator K031077). This means that instead of conducting new clinical trials or extensive performance studies with the Globus Genesy device itself, the manufacturer asserts that its device is as safe and effective as the predicate device because of its similar design, functionality, and technological characteristics.
The key arguments for substantial equivalence are:
- Similar Design and Function: Both devices are software-driven electro-stimulators offering a variety of treatment currents (biphasic, monophasic, premodulated waveforms, Russian currents, Microcurrents).
- Similar Technical Characteristics: The Globus Genesy device's "maximum current output and its maximum electric charge are very similar to the predicate device."
- Similar Intended Use: Both are intended for adjunctive therapy under medical supervision, addressing conditions like muscle spasms, disuse atrophy, pain management, and increasing range of motion using various waveforms (NMES, Russian, TENS, Premodulated Currents (IFC), and Microcurrents).
The FDA's letter confirms that they have reviewed the submission and determined the device is substantially equivalent, allowing it to be marketed. This determination implies that the FDA found sufficient evidence in the comparison to the predicate device to conclude that the Globus Genesy meets the safety and effectiveness requirements without requiring new clinical performance studies to define and meet specific acceptance criteria.
§ 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).