(88 days)
GM322IF(K032719)
Not Found
No
The document describes a standard electrical stimulator and does not mention any AI or ML capabilities. The performance studies focus on compliance with electrical safety standards and software verification, not AI/ML performance metrics.
Yes
The device is described as an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain, which directly relates to treating a medical condition.
No
The device is described as an interferential stimulator used for pain relief and management, not for diagnosing conditions.
No
The device description explicitly states it is a "stimulator" that "generates the small true-sine pulses of electrical current" and delivers it through "cable and electrode placed on skin," indicating it is a hardware device. While software verification is mentioned, it is in the context of verifying the software component of a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is used for "symptomatic relief and management of chronic intractable pain" by applying electrical stimulation to the patient's skin and nerves. This is a therapeutic use, not a diagnostic one.
- Device Description: The device generates electrical pulses and delivers them to the patient's body. This is consistent with a physical therapy or pain management device, not a device that analyzes samples from the body (which is what IVDs do).
- No mention of analyzing samples: There is no indication that this device collects or analyzes any biological samples (like blood, urine, tissue, etc.). IVDs are specifically designed to perform tests on such samples.
In summary, the device's function and intended use clearly fall outside the definition of an In Vitro Diagnostic device. It is a therapeutic device used for pain management.
N/A
Intended Use / Indications for Use
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
Product codes (comma separated list FDA assigned to the subject device)
LIH
Device Description
The Gemore IF series True sine interferential stimulator / Model: GM3A00IF/GM3A10IF/GM3A20IF/GM3A50IF are the device which generates the small true-sine 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
GM322IF(K032719)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510(K) Summarv
DEC 2 1 2012
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 on August 30, 2012.
The assigned 510(k) number is: _ K122944
- Submitter 's Identifications:
| Company Name : | GEMORE TECHNOLOGY CO., LTD. |
|---|---|
| Contact person: | Boden S.P. Lai |
| Address : | 11FL., NO. 29-5, Sec. 2, Chung Cheng E. RD., Tan Shui, Taipei Hsien, Taiwan |
| TEL No. : | 886-2-8809-1799 |
| Fax No. : | 886-2-8809-1781 |
| E-mail address : | boden001@gmail.com |
-
- Name of the Device:
Trade/Device Name: Gemore IF True Sine Interferential Stimulator Model GM3A001F/GM3A10IF/GM3A20IF/GM3A50IF Regulation Number: Unclassified Regulation Name: Interferential Stimulator Requlatory Class: II Product Code: LIH
- Name of the Device:
-
- Information of the 510(k) Cleared Device (Predicate Device):
Gemore IF TENS/Model: GM322IF(K032719).
- Information of the 510(k) Cleared Device (Predicate Device):
4. Dev ice Description:
The Gemore IF series True sine interferential stimulator / Model: GM3A00IF/GM3A10IF/ GM3A20IF/GM3A50IF are the device which generates the small true-sine 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.
-
- Intended Use:
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
- Intended Use:
In addition, the standard format for the statement of indications and contraindication for use are provided hereafter.
1
6. Subst antial Equivalence Comparison
The Gemore IF series True sine interferential stimulator / Model: GM3A00IF/GM3A10IF/ GM3A20IF/GM3A501F have output characteristics and controls that are identical to those of the predicate device. The new devices were modified different from the predicate device with the following different features:
- 1> The new device housing was designed and constructed for each model.
- 2> The firmware, software and operation interface were change so as to change the operation type from digital to analog.
- 3.> The maximum intensity adjustment range was changed from 60mA to 70 mA.
- 4> The operation modes was reduced from 9 modes into 4 modes,
7. 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 IEC 60601-1, and IEC 60601-1-2 requirement.
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software quidance.
8. Conclusions_
The Gemore IF true sine interferential stimulator. model GM3A00IF/GM3A10IF/GM3A20IF /GM3A50IF, has the same intended use and technological characteristics as the cleared device of GM322IF(K032719). Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.
In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of 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 fashion around the symbol.
Public Health Service
December 21, 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Gemore Technology Company, Ltd. % Mr. Boden S. P. Lai General Manager 11 Fl, No. 29-5, Sec 2 Chung Cheng E. Rd Tan Shui, Taipei Hsien China (Taiwan) 25 1
Re: K122944
Trade/Device Name: Gemore IF series True sine interferential stimulator/Model GM3A00IF/GM3A10IF/GM3A20IF/GM3A50IF
Regulation Number: Unclassified Regulation Name: Interferential Stimulator Regulatory Class: Class II Product Code: LIH Dated: September 21, 2012 Received: September 24, 2012
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
Page 2 - Mr. Lai
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 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 yours,
Victor Krauthamer -S
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page_ 1 of
次1229444 510(k) Number (if known):_
Device Name: Gemore IF series True sine interferential stimulator Model: GM3A00IF/GM3A10IF/GM3A20IF/GM3A50IF
Indications For Use:
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V OR
(Division Sign-Off)
Division of Neurological and Physical
Division of Neurological and Physical Medicine Devices 510(k) Number
Over-The-Counter Use
(Optional Format 1-2-96)