(168 days)
ETG 255 Combo Stimulator,
For TENS mode
Symptomatic relief of chronic intractable pain, relief of acute post-surgical and posttraumatic pain.
For EMS mode
- Relaxation of muscle spasm.
- Increase of local blood flow circulation
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
TEN 260 Stimulator
Symptomatic relief of chronic intractable pain, relief of acute post-surgical and posttraumatic pain.
ETG 255 Combo Stimulator, TEN 260 Combo Stimulator are non-invasive devices. The devices contain the following main parts: TENS stimulation unit, Support Belt, electrode, and snap cable. The electrode is permanently sewn up in the support belt. Each belt is flexible, and is available in range of sizes to ensure good patient contact. A male snap connector is placed within the electrode and is connected via the female snap connector to a short lead wire. The lead wire has a female pin connection at the distal end which accepts the lead wire connection from the stimulator. The device can be worn on the low back part of user so as to place the electrode on the treatment location of low back.
The provided text describes a 510(k) summary for the "Care back pain relief stimulator" (models TENS 7000 and LT3074). This submission is to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy through acceptance criteria and a study.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, and ground truth information) are not applicable or cannot be extracted directly from this type of premarket notification for a Class II medical device claiming substantial equivalence.
Here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the context of a clinical study or performance goals. Instead, the approach is to demonstrate substantial equivalence to a predicate device based on similar intended use and technological characteristics. The performance is reported in terms of various electrical output parameters.
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (TENS 7000) | Reported Device Performance (LT3074) |
|---|---|---|---|
| Indications for use | Temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. | Temporary relief of pain associated with sore and aching muscles in the lower back due to strain form exercise or normal household and working activities. | Temporary relief of pain associated with sore and aching muscles in the lower back due to strain form exercise or normal household and working activities. |
| Power Source | 9V Battery | 9V Battery | 4.5V Battery |
| Max Output Voltage (V) @500Ω | 40.0V | 40.0V | 45.0V |
| Max Output Voltage (V) @2kΩ | 120.0V | 100.0V | 50.0V |
| Max Output Voltage (V) @10kΩ | 150.0V | 110.0V | 60.0V |
| Max Output Current (mA) @500Ω | 80.0 mA | 80.0mA | 90.0mA |
| Max Output Current (mA) @2kΩ | 60.0 mA | 50.0mA | 25.0mA |
| Max Output Current (mA) @10kΩ | 15.0 mA | 11.0mA | 6.0mA |
| Pulse Width Range (us) | 150-260 us | 50-300us | 50-250us |
| Frequency (Hz) | 2-120Hz | 2-150Hz | 2-110Hz |
| Timer Range (minutes) | 15min, 30min, 60min and continuous | 5 - 60 minutes or Continuous | 30 minutes |
| Maximum Average Current @500Ω | 2.5mA | 3.6mA | 2.5mA |
| RMS current | 20.0 mA.r.m.s | 17.0 mA.r.m.s | 14.2 mA.r.m.s |
| Maximum Current Density @500Ω | $0.56mArms/cm^2$ | $0.56mArms/cm^2$ | $0.14mArms/cm^2$ |
| Maximum Power Density @500Ω | $3.3mWrms/cm^2$ | $4.8mWrms/cm^2$ | $1.0mWrms/cm^2$ |
| Compliance with Voluntary Standards? | IEC60601-1, IEC60601-1-2, IEC60601-2-10 | IEC60601-1, IEC60601-1-2, IEC60601-2-10 | IEC60601-1, IEC60601-1-2, IEC60601-2-10 |
| Compliance with 21 CFR 898? | Yes | Yes | Yes |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states: "Care back pain relief stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence." Therefore, there is no test set or related data provenance for a clinical study.
- The comparison is based on technical specifications and non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no clinical test set was used to establish substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical test set was used to establish substantial equivalence.
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
- Not applicable. This device is a TENS stimulator, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a TENS stimulator, not an algorithm. The performance evaluation was based on its electrical output characteristics and compliance with standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of clinical ground truth. The "ground truth" for demonstrating substantial equivalence relied on comparing the technical specifications and safety standards compliance of the proposed device against those of the legally marketed predicate device.
8. The sample size for the training set
- Not applicable as no machine learning algorithm was involved, and no clinical training set was used.
9. How the ground truth for the training set was established
- Not applicable as no machine learning algorithm was involved, and no clinical training set was used.
Summary of the Study (Demonstration of Substantial Equivalence):
The "study" presented is a 510(k) premarket notification to the FDA, where Shenzhen Dongdixin Technology Co., Ltd. sought to demonstrate that their "Care back pain relief stimulator" (Models TENS 7000 and LT3074) is substantially equivalent to a legally marketed predicate device, the "Low Back Pain Relief System" (K060222) by Gemore Technology Co.,Ltd.
The basis for demonstrating substantial equivalence was:
- Identical Intended Use: Both devices are intended for the temporary relief of pain associated with sore and aching muscles in the lower back.
- Similar Technological Characteristics: A side-by-side comparison of electrical output parameters (voltage, current, pulse width, frequency, timer, etc.), power source, physical dimensions, and materials was provided (as detailed in the table above). While there are some differences in specific values (e.g., pulse width range, frequency), the manufacturer asserts these differences do not affect the fundamental scientific technology or safety and effectiveness.
- Non-Clinical Bench Testing & Standards Compliance: The manufacturer submitted test reports certifying compliance with voluntary standards, including IEC60601, IEC60601-1-2, IEC60601-2-10, ISO 10993 (biocompatibility, implying the electrode materials are safe for skin contact, though not explicitly an "acceptance criterion" in the table), and ISO14971 (risk management). Software verification was also carried out according to FDA guidance.
Conclusion: The manufacturer concluded that the proposed device maintains the same safety and effectiveness as the predicate device, despite minor engineering differences, therefore establishing substantial equivalence. The FDA concurred with this assessment in their letter.
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File No: WMI-04-OTCT -FDA-05 Version: 1.3
JUL 2 9 2011
)
510(k) SUMMARY
Care back pain relief stimulator, K (
07/27/2011 Date of Submission: Shenzhen Dongdixin Technology Co., Ltd. 510(k) Submitter's Name: No.3bldg. xiliyangguang industrial Estae xilixiaobaimang Nanshan district Shenzhen, China Address: 518108 +86(755) 27652471 Telephone: Fax: +86(755) 27652674 510(k) Correspondent Kang Jian Ping contact: microcong@gmail.com E-mail:
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1. Proposed Device:
| Trade Name: | Care back pain relief stimulator |
|---|---|
| Model: | TENS 7000,LT3074 |
| Classification Name: | Stimulator, Nerve, Transcutaneous. |
| Over-The-Counter | |
| Regulation Number: | 21CRF 882.5890 |
| Product Code: | NUH |
| Device Class: | II |
2. Predicate Device:
| Predicate Device: | Low Back Pain Relief System |
|---|---|
| 510(k) Number: | K060222 |
| Manufacturer: | Gemore Technology Co.,Ltd |
3. Description of Proposed Device:
Care back pain relief stimulator, which includes models TENS 7000 and LT3074 are non-invasive devices which are tented for over the counter use in temporary relief of pain associated with sore and aching muscles in the lower back due to strain form exercise or normal household and working activities.
The devices contain the following main parts: TENS stimulation unit, Support Belt, electrode, and snap cable.
The electrode is permanently sewn up in the support belt. Each belt is flexible, and is available in range of sizes to ensure good patient contact. A male snap connector is placed within the electrode and is connected via the female snap connector to a short lead wire. The lead wire has a female pin connection at the distal end which accepts the lead wire connection from the stimulator.
The device can be worn on the low back part of user so as to place the electrode on the treatment location of low back.
4. Proposed Device Intended Use Statement:
Care back pain relief stimulator is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain form exercise or
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normal household and working activities.
Technological Characteristics: 5.
Both the stimulator and the Predicate device stimulator have the same intended use and fundamental technology. A side-by-side comparison of the technological characteristics of the care back pain relief and the cited predicate devices is included in the 510(k) submission.
| Parameter | Care back pain relief stimulatorModel: TENS7000,LT3074 | Low Back Pain ReliefSystem, modelGM320PP |
|---|---|---|
| Indications for use | Care back pain relief stimulator isintended for temporary relief ofpain associated with sore andaching muscles in the lower backdue to strain form exercise ornormal household and workingactivities. | The model GM320PP isintended for temporaryrelief of pain associatedwith sore and achingmuscles in the lower backdue to strain from exerciseor normal household andwork activities. |
| Power Source | 9V Battery for TENS70004.5V Battery for LT3074 | 9V Battery |
| Max Output Voltage (V)±20% | 40.0V@500Ω for TENS 7000 | 40.0V@500Ω |
| 45.0V@500Ω for LT3074 | ||
| 100.0V@2kΩ for TENS 7000 | 120.0V@2kΩ | |
| 50.0V@2kΩ for LT3074 | ||
| 110.0V@10kΩ for TENS 7000 | 150.0V@10kΩ | |
| 60.0V@10kΩ for LT3074 | ||
| Max Output Current (mA)±20% | 80.0mA @500Ω for TENS 7000 | 80.0 mA @500Ω |
| 90.0mA @500Ω for LT3074 | ||
| 50.0mA @2kΩ for TENS 7000 | 60.0 mA @2kΩ | |
| 25.0mA @2kΩ for LT3074 | ||
| 11.0mA @10kΩfor TENS 7000 | 15.0 mA @10kΩ | |
| 6.0mA @2kΩ for LT3074 | ||
| Pulse Width Range | 50-300us for TENS 700050-250us for LT3074 | 150-260 us |
| Frequency | 2-150Hz for TENS 70002-110Hz for LT3074 | 2-120Hz |
| Timer Range (minutes) | 5 - 60 minutes or Continuous foTENS700030 minutes for LT3074 | 15min, 30min, 60minand continuous |
| Maximum Average Current(average absolute value),mA (refer to the remark 1) | 3.6mA,500Ω, for TENS 70002.5mA,500Ω, for LT3074 | 2.5mA,500Ω |
| RMS current (refer to the remark 1) | 17.0 mA.r.m.s for TENS 7000 | 20.0 mA.r.m.s |
| 14.2 mA.r.m.s for LT3074 | ||
| Maximum Current Density(refer to the remark 1) | $0.56mArms/cm^2,500Ω$ for TENS7000$0.14mArms/cm^2,500Ω$ for LT3074 | $0.56mArms/cm^2,500Ω$ |
| Maximum Power Density(refer to the remark 1) | $4.8mWrms/cm^2,500Ω$ for TENS7000$1.0mWrms/cm2,500Ω$ for LT3074 | $3.3mWrms/cm^2,500Ω$ |
| Compliance with VoluntarStandards? | IEC60601-1, IEC60601-1-2IEC60601-2-10 | IEC60601-1, IEC60601-1-2IEC60601-2-10 |
| Compliance with 21 CFR898? | Yes | Yes |
| Weight (grams.) | 150 grams with battery forTENS700080 grams with battery for LT3074 | 140 grams with battery |
| Dimensions (mm.) H x W x T | 1016124.5cm for TENS7000857230cm for LT3074 | 10861.525 |
| Housing Materials &Construction | Enclosure: ABS,94V-1,80°C,ULApproved | Enclosure:ABS,94V-1,80°C,ULApproved |
| Materials of electrodes: | Rubber or fabric | Gel |
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File No: WMI-04-OTCT -FDA-05 Version: 1.3
Non-Clinical Tests Performed: 6.
Care back pain relief stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Care back pain relief stimulator has received test reports certifying that the Care back pain relief stimulator was tested and found to be in conformity with voluntary standards includes IEC60601, IEC60601-1-2, IEC60601-2-10, ISO 10993 and ISO14971. The software verification has been carried out according to the FDA Guidance of the content of Premarket submissions for the software contained in Medical Devices. This test reports have provided as part of this premarket notification.
7. Conclusions:
The Care back pain relief Stimulator, which includes models TENS 7000 and LT3074, has the same intended use and technological characteristics as the cited predicate device. Moreover, bench testing, safety report and Risk Analysis Report documentation supplied in this submission demonstrates that the difference in the submitted models could maintain the same safety and effectiveness as that of the cited predicate device. In the other words, those engineering difference do not affect the intended use or alter the fundamental scientific technology of the device. Thus, the care back pain relief stimulator is substantially equivalent to the predicate device.
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File No: WMI-04-OTCT -FDA-05 Version: 1.3
Remark 1
TENS 7000 sample calculations:
Maximum Average Current=I maxpulse ratepulse width=80mA150Hz300us*$10^{-6}$=3.6mA
300us * 80mA = 17.0mA.r.m.s Ir.m.s = 150 Hz * 1000000 17.0mArm.s Ir.m.s Maximum Current Density = = 0.56mA.r.m.s/$cm^2$ 30cm2 S 300us Vr.m.s * 40V = 8.5V r.m.s 150Hz 10000000 8.5Vr.m.s Vr.m.s Maximum Voltage Density = = 0.28V r.m.s/$cm^2$ 30cm2 S Vr.m.s * Ir.m.s 8.5Vr.m.s * 17mAr.m.s Maximum Power Density = = 4.8mW r.m.s / cm2 S 30cm2
LT3074 sample calculations:
Maximum Average Current=I maxpulse ratepulse width=90mA100Hz250us*10-6=2.5mA
$$Ir.m.s = \sqrt{\frac{5}{5} * 100 Hz * \frac{250us}{1000000}} * 90mA = 14.2mAr.m.s$$
$$Maximum Current Density = \frac{Ir.m.s}{S} = \frac{14.2mAr.m.s}{100cm^{2}} = 0.14mAr.m.s/cm^{2}$$
$$Vr.m.s = \sqrt{\frac{5}{5} * 100Hz * \frac{250us}{1000000}} * 45V = 7.1Vr.m.s$$
$$Maximum Voltage Density = \frac{Vr.m.s}{S} = \frac{7.1Vr.m.s}{100cm^{2}} = 0.07Vr.m.s/cm^{2}$$
$$Maximum Power Density = \frac{Vr.m.s * Ir.m.s}{S} = \frac{7.1Vr.m.s * 14.2mAr.m.s}{100cm^{2}} = 1.0mWr.m.s/cm^{2}$$
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Handelhaus Dittman GMBH Shenzen Dongdixin Technology Co. LTD. c/o Mr. Kang Jiang Ping R.A. Director No. 3 Building Xiliyiangguang Industrial Estate Xillixaobaim Shenzen China 518108
JUL 2 9 2011
Re: K110390
Trade/Device Name: ETG 255 Combo Stimulator, TEN 260 Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Codes: GZJ, IPF Dated: November 30, 2011 Received: February 11, 2011
Dear Mr. Jiang Ping:
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.
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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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Keria Alexander
Malvina B. Eydelman, M.D. Director
Division of Ophthalmic, Neurological, Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number ( ):
Device Name:
ETG 255 Combo Stimulator, TEN 260 Combo Stimulator
Indications for Use:
ETG 255 Combo Stimulator,
For TENS mode
Symptomatic relief of chronic intractable pain, relief of acute post-surgical and posttraumatic pain.
For EMS mode
-
- Relaxation of muscle spasm.
- Increase of local blood flow circulation 2.
- Prevention or retardation of disuse atrophy 3.
- Muscle re-education 4.
- Maintaining or increasing range of motion. 5.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis 6.
TEN 260 Stimulator
Symptomatic relief of chronic intractable pain, relief of acute post-surgical and posttraumatic pain.
Prescription Use V V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110390
§ 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).