(82 days)
The device is an high voltage TENS device with TENS indications used for symptomatic relief and management of chronic intractable pain.
The GM3X3HV is the device which generates twin high voltage pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.
The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of regulatory submission historically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not typically found in these summaries.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The document primarily indicates compliance with recognized standards. It does not define specific performance acceptance criteria in terms of clinical outcomes or statistical measures like sensitivity, specificity, or accuracy. The acceptance is implied by meeting the regulatory requirements for substantial equivalence.
Reported Device Performance: No quantitative performance data for the device (GEM-HV TENS) is presented in this summary. The "performance" is implicitly deemed equivalent to the predicate device through compliance with standards and a lack of significant differences in technological characteristics.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Compliance with ANSI/AAMI NS4-1985 | Met |
| Compliance with EN 60601-1 | Met |
| Compliance with EN 60601-1-1 | Met |
| Compliance with EN 60601-1-2 | Met |
| Software Verification (FDA guidance) | Carried out |
| Maintain same safety and effectiveness as predicate device (K946299) | Demonstrated through technological characterization and engineering differences not affecting intended use or fundamental scientific technology. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This summary does not describe a test set with human subjects or a dataset for performance evaluation in the way requested for AI/diagnostic devices. The "test set" here refers to the device itself being tested for compliance with engineering and safety standards, rather than a clinical trial.
- Data Provenance: Not applicable. The "data" refers to engineering specifications, testing reports for compliance, and software verification reports, not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth establishment by experts is not described, as this summary focuses on engineering and regulatory equivalence, not clinical performance evaluation against a gold standard.
4. Adjudication Method for the Test Set
Not applicable. No adjudication method is mentioned, as there is no human-based expert review or clinical outcome assessment described for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary. This type of study is relevant for evaluating the impact of a new diagnostic or interpretative device on human reader performance, which is not the focus of this TENS device submission.
6. Standalone Performance Study (Algorithm Only)
No. A standalone performance study for an algorithm is not relevant or described. The device in question is a hardware medical device (TENS) that generates electrical pulses, not an AI algorithm.
7. Type of Ground Truth Used
Not applicable. The concept of "ground truth" (e.g., pathology, expert consensus, outcomes data) as it applies to diagnostic or prognostic devices is not relevant to this TENS device's 510(k) submission. The "truth" being established here is that the device meets safety and performance standards for its specified function and is substantially equivalent to a predicate device.
8. Sample Size for the Training Set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, the establishment of its "ground truth" is also not applicable.
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________
DEC 1 6 2003
Submitter's Identifications: 1. GEMORE TECHNOLOGY CO., LTD. 11FL., NO. 29-5, Sec. 2, Chung Cheng E. RD., Tan Shui, Taipei Hsien, Taiwan
Contact: Boden S.P. Lai General Manager
Date of Summary Preparation: September 15, 2003.
2. Name of the Device:
GEM-HV TENS (Also known as GEM-PGS TENS), High Voltage TENS Device / Model; GM3X3HV, where X is the parameter for different housing.
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- Information of the 510(k) Cleared Device (Predicate Device):
PGS123 (K946299).
- Information of the 510(k) Cleared Device (Predicate Device):
4. Device Description:
The GM3X3HV is the device which generates twin high voltage pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.
5. Intended Use:
The device is an high voltage TENS device with TENS indications used for symptomatic relief and management of chronic intractable pain.
In addition, the standard format for the statement of indications and contraindication for use are provided hereafter.
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510(K) SUMMARY
6. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement.
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.
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- Conclusions
The high voltage TENS device, model GM3X3HV, has the same intended use and i ne filgh voltage TENS donos, model end device of Skylark PGS123 (K946299). Moreover, technological characteried as the circular this submission demonstrate that the difference in vellifed demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.
- Conclusions
In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 2003
Mr. Boden S.P. Lai General Manager Gemore Technology Co., Ltd. 11FL., No. 29-5, Sec. 2, Chung Cheng E. RD., Tan Shui, Taipei Hsien, Taiwan
Re: K032994
Trade/Device Name: GM3 Series HV TENS Model GM3X3HV Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: September 23, 2003 Received: September 29, 2003
Dear Mr. Lai:
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 such 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); 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.
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Page 2 - Mr. Boden S.P. Lai
This letter will allow you to begin 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark N Millasson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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GEMORE TECHNOLOGY CO., LTD.
510(K) SUMMARY
Page of 1
510(k) Number (if known):
Device Name: GEM-HV TENS (Also known as GEM-PGS TENS), High Voltage TENS Device / Model: GM3X3HV, where X is the parameter for different housing with range from 0 to 5.
Indications For Use:
The device is an high voltage TENS device with TENS indications used for symptomatic relief and management of chronic intractable pain.
Prescription Use _ V (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)
Marli N Milkerson
11103-6330 00081 Wision of Coneral, Restorative and Neurological Devices
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§ 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).