(441 days)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg, due to strain from exercise or normal household and work activities.
- Neck Pad is used in back of neck.
- Meridian Pad is used in shoulder, waist, back, and arm.
This instrument is a new generation of household multifunctional device based on physics, modern microelectronics and clinical practices, it uses low frequency electrotherapy, and circular traction vibration to temporarily alleviate the pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg. The Neck Pad is used in for back of neck and it accord with human body cervical physiological curvature of streamlined ring design accord with human body cervical physiological curvature of streamlined ring design. The Meridian Pad is used in shoulder, waist, back, and arm. The device has one operation modes which has 2 modes and 50 output Intensity Level, so the device can give certain electrical pulse through 2 pairs of electrode pads or the Neck Pad on the skin to help users to enjoy body massage and sole massage.
The remote control of this device is user-friendly controlled because it has the operating elements of ON/OFF knob, left or right button and increase or decrease button.
The device is equipped with accessories of electrode pads and an electrode wire is used to connect the pads to the main unit.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.
The device can be successfully opened only when switch button of the remote control and Neck Pad turned on at the same time.
The remote control is the only controller to select the pulse intensity and adjust the treatment time.
The provided text is a 510(k) Summary for a medical device (Neck Care Therapy, Model: SYK-509B) and does not contain a study that proves the device meets acceptance criteria in the manner described by your request (e.g., a clinical trial with a test set, ground truth established by experts, MRMC studies, or standalone performance evaluation).
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Health Expert Electronic Stimulator, K133929) primarily through bench testing for safety and performance specifications, and a comparison of technical characteristics and intended use.
Here's an analysis based on the information provided, highlighting what is and is not present:
Key Takeaways from the document:
- This device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, intended for Over-The-Counter Use.
- The primary method of demonstrating equivalence is through engineering bench tests of electrical safety, EMC, biocompatibility, usability, software verification, and waveform output.
- There is no mention of a clinical study involving human subjects or expert readers to evaluate the device's therapeutic effectiveness for pain relief, nor is there a direct assessment of its performance against a predefined "acceptance criteria" for clinical outcomes. The "acceptance criteria" in this context are primarily related to meeting safety standards and having comparable technical specifications to the predicate device.
Detailed Breakdown based on your Request (with notations on missing information):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (What was needed to pass) | Reported Device Performance (How the device performed) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-10 standards. | "Comply with IEC 60601-1 and 60601-2-10" |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 standard. | "Comply with IEC 60601-1-2" |
| Biocompatibility | Compliance with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization) for user-contacting materials. | "Biocompatibility test according to ISO 10993-5 and ISO 10993-10" (Implies successful compliance) |
| Usability | Compliance with IEC 62366 standard. | "Usability test according to IEC 62366 standard" (Implies successful compliance) |
| Software Verification & Validation | Compliance with FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | "Software verification and validation test according to the requirements..." (Implies successful compliance) |
| Waveform Output Specifications | Compliance with "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning" for output current, voltage, pulse duration, frequency, net charge, phase charge, AVG current, etc. | "The waveform test has also been conducted to verify the output specifications..." (Detailed comparison table with predicate shows identical/similar values for key output parameters) |
| Leakage Current | Comparable to predicate device (NC AC: 54.5uA, DC: 0.5uA; SFC AC: 120uA, DC: 0.6uA). | Identical to predicate device values. |
| Average Current (no pulses) | <0.01uA. | <0.01uA. |
| Primary Goal | Demonstrate substantial equivalence to the predicate device, showing no new issues of safety or effectiveness. | Concluded that the device is "Substantially Equivalent (SE) to the predicate device." |
2. Sample size(s) used for the test set and the data provenance:
- Test Set: Not applicable in the context of a clinical performance study. The "test set" here refers to samples of the device undergoing engineering and bench testing. The document does not specify the number of units tested for each engineering test.
- Data Provenance: The tests were conducted by the manufacturer, Shenzhen OSTO Technology Co., Ltd., and/or their contracted labs as part of the 510(k) submission process for market clearance. This is not clinical data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically understood in AI/clinical studies (e.g., diagnostic labels) was not established. The "ground truth" here is compliance with engineering standards and performance specifications, verified by testing against established international and FDA guidelines.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical adjudication panel or similar process described. Compliance was assessed against technical standards.
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 comparative effectiveness study was not done. This device is a direct-to-consumer TENS unit, not an AI-assisted diagnostic or therapeutic tool that would involve human "readers" or image interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the AI context. The device is a standalone TENS unit. Its "standalone performance" was evaluated through the various engineering and bench tests for safety and electrical characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is the technical specifications and safety standards defined by international standards (IEC, ISO) and FDA guidance for TENS devices. The device's performance was compared against these established technical benchmarks and the specifications of an already cleared predicate device. There is no clinical "ground truth" (e.g., pain reduction measured by a clinical scale, confirmed by expert consensus, or pathology) indicated in this submission.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm.
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December 7, 2018
Shenzhen OSTO Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, 510006 China
Re: K172897
Trade/Device Name: Neck Care Therapy, Model: SYK-509B Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: November 2, 2018 Received: November 8, 2018
Dear Cassie Lee:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Pamela D. Scott -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172897
Device Name Neck Care Therapy (model: 905B)
Indications for Use (Describe)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
- -Neck Pad is used in back of neck.
- Meridian Pad is used in shoulder, waist, back, and arm. -
Type of Use (Select one or both, as applicable)
| Research Use Only (RUO) unless Subject to Other Claims | |
|---|---|
| In-Vitro Diagnostic Use (IVD) unless Subject to Other Claims |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K172897
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: Shenzhen OSTO Technology Co., Ltd. Establishment Registration Number: Applying Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street Longgang District, Shenzhen City Guangdong Province, CHINA Tel: +86-755-29769546 Fax: +86-755-29769540 Contact Person: Li Yang (General Manager) Email: annaosto@163.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: +86-20-61099984 Email: requlatory@glomed-info.com
2. Subject Device Information
Trade Name: Neck Care Therapy Common Name: Electronic Stimulator Classification name: Transcutaneous electrical nerve stimulator for pain relief, Transcutaneous Electrical Nerve Stimulator, Muscle, Powered, For Muscle Conditioning Review Panel: Neurology Product Code: NUH, NGX Regulation Class: II Regulation Number: 21 CFR 882.5890, 890.5850
3. Predicate Device Information
Sponsor: Shenzhen OSTO Technology Company Limited Trade Name: Health Expert Electronic Stimulator Common Name: Electronic Stimulator Classification name: Stimulator, Nerve, Transcutaneous, Muscle, Powered, For Muscle Conditioning, Over-The-Counter 510(k)number: K133929 Review Panel: Neurology, Physical Medicine Product Code: NUH, NGX Regulation Number: 882.5890, 890.5850 Regulation Class: II
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4. Device Description
This instrument is a new generation of household multifunctional device based on physics, modern microelectronics and clinical practices, it uses low frequency electrotherapy, and circular traction vibration to temporarily alleviate the pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg. The Neck Pad is used in for back of neck and it accord with human body cervical physiological curvature of streamlined ring design accord with human body cervical physiological curvature of streamlined ring design. The Meridian Pad is used in shoulder, waist, back, and arm. The device has one operation modes which has 2 modes and 50 output Intensity Level, so the device can give certain electrical pulse through 2 pairs of electrode pads or the Neck Pad on the skin to help users to enjoy body massage and sole massage.
The remote control of this device is user-friendly controlled because it has the operating elements of ON/OFF knob, left or right button and increase or decrease button.
The device is equipped with accessories of electrode pads and an electrode wire is used to connect the pads to the main unit.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.
The device can be successfully opened only when switch button of the remote control and Neck Pad turned on at the same time.
The remote control is the only controller to select the pulse intensity and adjust the treatment time.
5. Intended Use / Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg, due to strain from exercise or normal household and work activities.
- Neck Pad is used in back of neck. ।
- -Meridian Pad is used in shoulder, waist, back, and arm.
6. Test Summary
Neck Care Therapy, Model: AST-905B has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 standards �
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10
- � Usability test according to IEC 62366 standard
- � Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- � The waveform test has also been conducted to verify the output specifications of the device according to "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning".
7. Comparison to predicate device and conclusion
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The technological characteristics, features, specifications, materials, mode of operation, and intended use of Electronic Muscle Stimulator is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of comparison | SubjectK172897 | device | PredicateK133929 | device | Remark |
|---|---|---|---|---|---|
| Device name and model | AST-905B200B | Neck Care Therapyor SYK- | Health | ExpertElectronic Stimulator | |
| Intended Use & Indications forUse | temporarysoremusclesfrom------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | To be used forreliefofpain associated withandachingintheshoulder, waist, backof neck, back, arm,and leg, due to strainexerciseornormal household andwork activities.— Neck Pad isused in back of neck.Meridian Pad isused in shoulder,waist, back, and arm | stimulate9~25)Tosoremusclesnormalwork | PMS (Mode 1~8)It is intended tohealthymuscles in order toimprove and facilitatemuscle performance.TENS(Modebeusedfortemporary reliefofpain associated withand achingintheshoulder, waist, back,back of the neck, arm,leg, and foot due tostrain from exercise orhouseholdactivitiesbyapplying currenttostimulate nerve. | Similar intendeduse and IFU |
| Power Source(s) | C, | Main Unit:Power Adaptor:Input:100~240Va50/60Hz, 0.2A;Output: 5Vdc, 1A | 100-0.1A | AdaptorInput:240Vac, 50-60Hz,Output: 5Vdc, 1AUnit Input: 5Vdc, 1A | Similar |
| 500mAh | Battery:3.7Vdc, | 500mAh | Battery:3.7Vdc, | Identical | |
| AAA x 21 A | Remote Control:Battery:3Vdc,Unit Input: 5Vdc, | AAA x 21 A | Remote Control:Battery:3Vdc,Unit Input: 5Vdc, | Identical | |
| CurrentMethodofLineIsolation | Part | Type BF Applied | Part | Type BF Applied | Identical |
| Patient Leakage Current | NCSFC | AC: 54.5uADC: 0.5uAAC: 120uA | NCSFC | AC: 54.5uADC: 0.5uAAC: 120.0uA | Identical |
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| DC: 0.6uA | DC: 0.6uA | DC: 0.6uA | |
|---|---|---|---|
| Average current throughelectrodes when device is on butno pulses are being applied | <0.01uA | <0.01uA | Identical |
| Number of Output Modes | 2 | 25 | Doesn't affectsafety andeffectiveness*See note 1 |
| Output Intensity Level | 50 steps | 99 steps | Doesn't affectsafety andeffectiveness*See note 1 |
| Synchronous or Alternating? | Synchronous | Synchronous | Identical |
| Method of Channel Isolation | VoltageTransformIsolation | VoltageTransformIsolation | Identical |
| Regulated Current orRegulated Voltage? | Voltage Control | Voltage Control | Identical |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Identical |
| Automatic Overload Trip | No | No | Identical |
| Automatic No-Load Trip | No | No | Identical |
| Automatic Shut Off | Yes | Yes | Identical |
| User Override Control | Yes | Yes | Identical |
| Timer Range | 5-30 min | 25 min | Similar*See note 1 |
| Weight | Main Unit:AST-905B: 222gElectrode:Patch Electrode: 44g | 2kg (Withoutaccessories) | Doesn't affectsafety andeffectiveness |
| Dimensions | Main Unit:AST-905B:187.216967.3 mmElectrode:Patch Electrode: 8.9 cm*5.8 cm | 428mm x 428.8mmx185mmElectrode:Patch Electrode: 8.9 cm*5.8 cm | Identicalelectrode area |
| Electrode pads | Electrode Pads:White silica gel, Blackconductive silicone,Transparent conductiveadhesive silicone, TransparentPET silicone | Electrode Pads:White silica gel, Blackconductive silicone,Transparent conductiveadhesive silicone, TransparentPET silicone | Identical |
| Stickymetalsheet: Stainless steel | PP conductive plastic | Complies with IEC10993-5and10993-10. | |
| Housing unit | ABS plastic | ABS plastic | Identical |
| Waveform | Pulsed.symmetric,biphasic | Pulsed,symmetric,biphasic | Identical |
| Shape | Rectangular, withinterphase interval | Rectangular, withinterphase interval | Identical |
| Maximum Output Voltage | 44V±10%ರಿ500Ω80V±10% @ 2KΩ112V±10% @ 10KΩ | 44V±10% @ 500Ω80V±10% @ 2KΩ112V±10% @ 10KΩ | Identical |
| Maximum Output Current | 88mA±10%ರಿ500Ω40mA±10%ರಿ2KQ11.2mA±10% @ 10KΩ | 88mA±10%ರಿ500Ωത40mA±10%2KΩ11.2mA±10% @ 10KΩ | Identical |
| Pulse Duration (us) | 120us | 120us | Identical |
| Pulse frequency | 77.3Hz | 77.3Hz | Identical |
| Net Charge (per pulse) | 0µC @ 500ΩMethod:Balancedwaveform | 0µC @ 500ΩMethod:Balancedwaveform | Identical |
| PhaseChargeMaximum(a)500Ω | 12.78μC | 12.78μC | Identical |
| MaximumAverageCurrent@500Ω | 0.968 mA | 0.968 mA | Identical |
| MaximumCurrentDensity(r.m.s) @ 500Ω | 0.235 mA/cm² | 0.235 mA/cm² | Identical |
| MaximumAveragePowerDensity @ 500Ω | 1.38 mW/cm² | 1.38 mW/cm² | ldentical |
| Operating Environment | Temperature:5~40°CHumidity: 15%90%RHAtmosphericPressure: 700 hPa to1060 hPa | Temperature: 5 ~45°CHumidity: 20 ~ 65% RH | Similar |
| Storage Environment | Temperature:-25+70°CHumidity:<90%RH,AtmosphericPressure: 700 hPa to1 060 hPa | Temperature: 0-45°C,Humidity:10ﮧ90% RHElectrodePad:10~20°C | Similar |
| Biocompatibility | Biocompatibilitytestaccordingાકભtoાકભ10993-5and10993-10 | Alldirectlyusercontacting materials arecompliancewithISO10993-5andISO10993-10requirements. | Identical |
| Electrical Safety | ComplywithIEC60601-1IECand60601-2-10 | ComplywithIECIEC60601-1and60601-2-10 | Identical |
| EMC | ComplywithIEC60601-1-2 | ComplywithIEC60601-1-2 | Identical |
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Comparison in Detail(s):
Note 1 (Time Range, Number of Output Modes, Output Intensity Level):
The design of the time range, Number of Output Modes and Output Intensity Level is basing on the intended use. And according to the output specification comparing with the predicated devices, we set the default treatment time is 15min and the user could adjust the levels which could meet the requirements in the energy aspect. Thus, the subject device is actually the same as predicated ones.
Finial Conclusion:
Based on the above analysis and tests performed, it can be concluded that Neck Care Therapy device is effective, and it is Substantially Equivalent (SE) to the predicate device.
8. Date of the summary prepared: December 7, 2018
§ 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).