(111 days)
As prescribed by a physician for the following:
Relaxation of muscle spasm
Increasing local blood circulation
Maintaining or increasing range of motion
Preventing or retarding disuse atrophy
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
The GS 3000 is a High Voltage Pulsed Galvanic Current (HVPGC) Stimulator which delivers stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The device has a twin peak monophasic waveform with a 5 usec fixed duration. The current Amplitude is adjustable from 0-350 Volts (0~190V Max @ 500ohm resistance), with an adjustable pulse frequency range from 2-100 cycles per second.
The GS 3000 is a single channel device, with the option to set the active electrodes (treatment electrode) to either positive or negative polarity in relation to the dispersive electrode (closes patient circuit) and alternating or synchronous treatment mode selection. The device is powered by a 9 volt battery.
It appears this document describes a 510(k) premarket notification for a medical device called the GS 3000, which is a Powered Muscle Stimulator.
However, the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. The "Discussion of performance testing" section specifically refers to:
- IEC 60601-1: General requirements for safety of medical electrical equipment. This covers electrical leakage current, electrode and lead wire safety, output current, and power density.
- IEC 60601-1-2: Collateral standard for electromagnetic compatibility.
These are engineering and safety performance standards, not clinical performance or efficacy studies. The document states that the device "met all applicable requirements" for these standards, indicating successful electrical and EMC testing.
Therefore, I cannot fill in the requested table and sections related to clinical acceptance criteria, study details, sample sizes, ground truth, or MRMC studies because this information is not present in the provided text.
The document primarily focuses on establishing "substantial equivalence" to a predicate device based on technological characteristics (output specifications, device design, waveforms) and safety standards, rather than clinical performance outcomes against defined acceptance criteria.
Based on the provided text, here is what can be extracted, and where limitations exist:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not applicable/provided for clinical performance) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 (electrical leakage current, electrode/lead wire safety, output current, power density) | "met all applicable requirements" |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | "met all applicable requirements" |
| Technological Equivalence | Output specifications, device design, and waveforms comparable to predicate device | "demonstrated the GS 3000 to be substantially equivalent to the predicate device." |
| Clinical Performance/Efficacy | (No specific clinical performance acceptance criteria or results are provided in this document.) | (No clinical performance data is provided in this document.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- No information provided. The performance tests mentioned (IEC 60601-1 and IEC 60601-1-2) are engineering and safety tests, not clinical studies involving patients or a "test set" in the context of diagnostic or clinical outcome performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "test set" and no ground truth established by experts for clinical performance in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" and no adjudication method described.
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
- No. An MRMC study was not done. The device is a "Powered Muscle Stimulator," not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- No. This is not an algorithm-based device. "Standalone performance" in this context would refer to the device's electrical output characteristics and safety, which were tested against IEC standards as mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical performance. For the engineering and safety tests, the "ground truth" would be the specifications and limits defined by the IEC standards themselves.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a "training set."
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102202 NOV 2 3 2010
Section 5: 510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for the GS 3000 510(k) premarket notification for and in accordance with FDA's "Guidance Document for Powered Muscle Stimulator 510(k)s" June 9, 1999.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the GS 3000 is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices.
| Applicant: | EMSI3504 Cragmont Dr. Suite#100Tampa, FL 33619Ph: 813-471-0129Fax: 813-471-0130Registration Number: 3003573572 |
|---|---|
| Contact: | Cherita JamesM Squared Associates, Inc901 King Street, Suite 200Alexandria, VA 22314Phone: 703-562-9800 Ext. 257Facsimile: 703-562-9797 |
| Date of submission: | August 3, 2010 |
| Proprietary Name: | GS 3000 |
| Common Name: | Powered Muscle Stimulator |
| Classification Status: | 21 CFR 890.5850 |
| Product Code: | IPF |
| Panel: | Physical Medicine |
| Predicate Device: | Skylark Device Company PGS 123 K946299 |
Device Description: . The GS 3000 is a High Voltage Pulsed Galvanic Current (HVPGC) Stimulator which delivers stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The device has a twin peak monophasic waveform with a
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5 usec fixed duration. The current Amplitude is adjustable from 0-350 Volts (0~190V Max @ 500ohm resistance), with an adjustable pulse frequency range from 2-100 cycles per second.
The GS 3000 is a single channel device, with the option to set the active electrodes (treatment electrode) to either positive or negative polarity in relation to the dispersive electrode (closes patient circuit) and alternating or synchronous treatment mode selection. The device is powered by a 9 volt battery.
Intended Use: As prescribed by a physician for the following:
Relaxation of muscle spasm
Increasing local blood circulation
Maintaining or increasing range of motion
Preventing or retarding disuse atrophy
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Discussion of performance testing: Testing performed in accordance with the accepted FDA requirements of IEC 60601-1, found the GS 3000 met all applicable requirements. Based on the output measurements, calculations, and safety testing/inspection conducted; the GS 3000 is safe with respect to electrical leakage current, electrode and lead wire safety, as well as output current and power density. Testing performed in accordance with the accepted FDA requirements of IEC 60601-1-2, Medical Electrical Equipment, Part 1: General Requirements for Safety. Collateral Standard: Electromagnetic Compatibility- Requirements and Test, found the GS 3000 met all applicable requirements.
Technological Characteristics and Substantial Equivalence
Output specifications, device design, and waveforms demonstrated the GS 3000 to be substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Electrostim Medical Services, Inc. % M Squared Associates, Inc. Ms. Cherita James 901 King Street, Suite 200 Alexandria, Virginia 22314
Re: K102202
Trade Name: GS 3000 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: October 27, 2010 Received: October 28, 2010
NOV 2 3 2010
Dear Ms. James:
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 application (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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{3}------------------------------------------------
Page 2 - Ms. Cherita James
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Mark A. Millkenna
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use Statement
| 510(k) Number: | To be assigned |
|---|---|
| Device Name: | GS 3000 |
| Indications for Use: | Relaxation of muscle spasm |
| Increasing local blood circulation | |
| Maintaining or increasing range of motion | |
| Preventing or retarding disuse atrophy | |
| Muscle re-education | |
| Immediate post-surgical stimulation of calf muscles to preventvenous thrombosis. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
Page 1 of __ 1_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milliken
(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, Division of Surgh
and Restorative Devices
510(k) Number J
§ 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).