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

Device Description

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.

AI/ML Overview

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.

Summary

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K071431

510(k) Summary for Globus Genesy Electro-Stimulator

SEP 2 1 2007

1. SPONSOR

Domino S.r.l. Via San Felice, 4 31020 San Vendemiano (TV) Italy

Contact Person: Giovanni Ciriani 860-539-1309 Telephone:

Date Prepared: Sep 01, 2007

2. DEVICE NAME

Proprietary Name:	Globus Genesy Electro-Stimulator
Common/Usual Name:	Electric Muscle Stimulator
Classification Name:	Powered Muscle Stimulator, Transcutaneous ElectricalNerve Stimulator (TENS), and Interferential CurrentTherapy Stimulator (IFC)

3. PREDICATE DEVICES

Chattanooga Vectra GENiSYS Stimulator Device K031077

4. DEVICE DESCRIPTION

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ಸ. INTENDED USE

The Globus Genesy Stimulator is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. It is intended to be used for therapy that adopts NMES, Russian, TENS, Premodulated Currents (IFC), and Microcurrent, waveforms.

The Globus Genesy is not intended to be used as an over-the-counter (OTC) device.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Domino S.r.l. Globus Genesy device and the Chattanooga Vectra GENiSYS Stimulator are similar in design and function. Both devices offer:

· biphasic waveforms, rectangular, symmetrical,
· asymmetric rectangular waveforms, compensated,
· monophasic rectangular waveforms.
· premodulated waveforms,
· Russian currents,
· Microcurrents,

Both the Globus and predicate devices are software-driven, electro-stimulator units that provide licensed practitioners with a variety of treatment currents for therapy.

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The Globus Genesy and the Chattanooga Vectra GENiSYS devices are similar in technical characteristics and performance. The Globus Genesy device maximum current output and its maximum electric charge are very similar to the predicate device.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.

Public Health Service

OCT 2 5 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Globus Sport and Health Technologies % Mr. Giovanni Ciriani Managing Partner 18 Eustace Dr. West Hartford, CT 06110

K071431 Re: Trade Name: Globus Genesy 1100 Electro-Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Codes: IPF, GZJ, and LIH Dated: August 31, 2007 Received: September 05, 2007

Dear Mr. Ciriani:

This letter corrects our substantially equivalent letter of September 25, 2007.

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 (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.

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.

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

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Page 2 - Mr. Giovanni Ciriani

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-3474. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K071431

Device Name: Globus Genesy 1100 Stimulator

Indications For Use:

· 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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Marls N. Millu

Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number K071431

Regulation Number and Section

§ 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).