(352 days)
PMS (Mode 1) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 2) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Low-frequency Multi-function Physiotherapy Instrument is a household multifunctional device. it can stimulate healthy muscles in order to improve and facilitate muscle performance, and to relief the pain associated with sore and aching muscles in the waist, upper and lower back, back of the neck, upper extremities (shoulder, arm and hand), lower extremities (hip, knee, ankle, leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. Low-frequency Multi-function Physiotherapy Instrument has 2 operation modes and two channels, which can give certain electrical pulse through 2 pairs of electrode pads on the skin to help users to enjoy body massage and sole massage. The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity Modification keys and time selection keys. The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode. The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.
The provided document is a 510(k) summary for a Low Frequency Multi-Function Physiotherapy Instrument. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with an AI device. Therefore, much of the requested information (like sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, and MRMC studies) is not applicable or not detailed in this document.
However, I can extract information regarding the device's technical specifications and how its performance was evaluated against standards for safety and effectiveness.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" in the typical sense of a clinical performance study with thresholds for metrics like sensitivity or specificity. Instead, it demonstrates compliance with recognized medical device standards and compares the technical specifications of the new device (Subject Device) with a legally marketed predicate device. The "Verdict" column in the comparison table essentially serves as the "reported device performance" against the implicitly accepted performance of the predicate and compliance with standards.
| Elements of Comparison | Subject Device Performance | Predicate Device Performance | Verdict |
|---|---|---|---|
| Company | Shenzhen OSTO Technology Co., Ltd | Shenzhen OSTO Technology Co., Ltd | -- |
| Trade Name | Low-frequency Multi-functional physiotherapy instrument | Health Expert Electronic Stimulator | -- |
| Classification Name | Stimulator, Nerve, Transcutaneous, Over-The-Counter; Stimulator, Muscle, Powered, For Muscle Conditioning | Stimulator, Nerve, Transcutaneous, Over-The-Counter; Stimulator, Muscle, Powered, For Muscle Conditioning | -- |
| 510(k) Number | K172834 | K133929 | -- |
| Product Code | NUH, NGX | NUH, NGX | SE |
| Intended Use / Indications for Use | PMS (Mode 1): Stimulate healthy muscles to improve/facilitate muscle performance. TENS (Mode 2): Temporary relief of pain due to strain from exercise or normal household activities by stimulating nerves. | PMS (Mode 1 | SE |
| Power Source | Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A | Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A | SE |
| Method of Line Current Isolation | Type BF Applied Part |
| Type BF Applied Part | SE |
| Patient Leakage Current | NC: AC: 54.5µA, DC: 0.5µA; SFC: AC:120.0µA, DC: 0.6µA | NC: AC: 54.5µA, DC: 0.5µA; SFC: AC:120.0µA, DC: 0.6µA | SE |
| Main Unit Weight | 115 g | 2 kg | SE (Note 1) |
| Main Unit Dimension | 128.6 x 69.8 x 25 mm | 428 x 428.8 x 185mm | SE (Note 1) |
| Number of Output Channels | 2 | 2 | SE |
| Number of Output Modes | 2 | 25 | SE (Note 2) |
| Output Intensity Level | 99 | 99 | SE |
| Synchronous or Alternating? | Synchronous | Synchronous | SE |
| Regulated Current or Regulated Voltage? | Yes | Yes | SE |
| Software/Firmware/Microprocessor Control? | Yes | Yes | SE |
| Automatic Shut Off | Yes | Yes | SE |
| Indicator Display | On/Off Status, Voltage/Current Level | Yes (On/Off Status, Voltage/Current Level) | SE |
| Indicator Display (Low Battery) | Yes | No | SE |
| Timer Range | 5-60 min | 25 min | SE (Note 2) |
| Waveform | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | SE |
| Shape | Rectangular, with interphase interval | Rectangular, with interphase interval | SE |
| Maximum Output Voltage | 44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ | 44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ | SE |
| Maximum Output Current | 88mA±10% @ 500Ω; 40mA±10% @ 2KΩ; 11.2mA±10% @ 10KΩ | 88mA±10% @ 500Ω; 40mA±10% @ 2KΩ; 11.2mA±10% @ 10KΩ | SE |
| Pulse Duration | 120μs | 120μs | SE |
| Pulse frequency | 77.3Hz | 77.3Hz | SE |
| Charge density | 0.21µC/ cm² @ 500Ω | 0.21µC/ cm² @ 500Ω | SE |
| Power density | 16.37μW/cm² @ 500Ω | 16.37μW/cm² @ 500Ω | SE |
| Active surface area | 50.04cm² | 50.04cm² | SE |
| Environment for operation | Temperature: 5 ~ 45°C; Humidity: 15% - 90%; Atmospheric pressure range of 700 hPa to 1 060 hPa | Temperature: 5 ~ 45° C; Humidity: 20 ~ 65% RH | SE |
| Environment for storage | Device: -25 - +70°C, up to 90% humidity, 700-1060 hPa; Pads: 10-20°C, up to 90% humidity, 700-1060 hPa | Device: 0 ~ 45° C, 10 ~ 90% RH; Electrode Pad: 10~20° C | SE |
Note 1 (Weight, Dimension): The differences in weight and dimensions are deemed substantially equivalent as they "won't affect the safety and effectiveness of the device."
Note 2 (Number of Output Modes, Time Range): The differences are justified as the design meets requirements in the energy aspect due to adjustable levels and default treatment time.
The study that proves the device meets the acceptance criteria:
The "study" here refers to a series of laboratory bench tests and comparisons against a predicate device, rather than a clinical trial for an AI algorithm. The device demonstrated substantial equivalence through:
- Electrical safety test: According to 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 FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Waveform test: Conducted to verify output specifications 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."
- Comparison to a predicate device (K133929): The detailed comparison table shows that the subject device shares technological characteristics, features, specifications, materials, mode of operation, and intended use with the predicate, with differences not raising new questions of safety or effectiveness.
Regarding the specific questions about AI/Software-as-a-Medical-Device (SaMD) studies:
This device is a physical medical instrument (Transcutaneous Electrical Nerve Stimulator/Powered Muscle Stimulator) and not an AI/SaMD. Therefore, many of the questions related to AI device evaluation are not applicable.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (N/A): This is a hardware device, and the evaluation involved bench testing and comparison to technical specifications, not a clinical test set for an algorithm.
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)
- N/A: No expert-established ground truth for a test set in the context of diagnostic or interpretive AI performance was required or provided. The "ground truth" for this device's evaluation was based on engineering standards and the established performance of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A: No adjudication method was used as there was no test set requiring interpretation by multiple experts.
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
- N/A: Not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in concept: The "standalone" performance of the device was evaluated through the bench tests mentioned above (electrical safety, EMC, biocompatibility, usability, software verification, waveform tests) and direct comparison of its technical specifications to the predicate device. This is the device's inherent performance without human interpretation "in-the-loop" in a diagnostic sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Technical Specifications and Regulatory Standards: The "ground truth" for this submission refers to the established safety limits and performance parameters defined by international medical device standards (e.g., IEC 60601 series, ISO 10993) and the documented performance of the legally marketed predicate device (K133929).
8. The sample size for the training set
- N/A: Not an AI device; no training set in the context of machine learning.
9. How the ground truth for the training set was established
- N/A: Not an AI device; no training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 6, 2018
Shenzhen OSTO Technology Co., Ltd. % Cecilia Ceng Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, Guangdong 510006 Cn
Re: K172834
Trade/Device Name: Low Frequency Multi Function Physiotherapy Instrument, Models AST-603, AST-2012A, AST-2010B Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: July 25, 2018 Received: August 6, 2018
Dear Cecilia Ceng:
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.
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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 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) K172834
Device Name
Low Frequency Multi-Function Physiotherapy Instrument
Indications for Use (Describe) PMS (Mode 1) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 2)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
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
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: regulatory@glomed-info.com
2. Subject Device Information
Trade Name: Low-frequency Multi-function physiotherapy instrument Common Name: Electronic Stimulator Classification name:
-
- Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH)
- Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) Review Panel: Neurology Product Code: NUH, NGX Regulation Class: II Regulation Number: 21 CFR 882.5890, 890.5850
3. Predicate Device Information
Sponser: 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 Requlation Class: II
4. Device Description
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Low-frequency Multi-function Physiotherapy Instrument is a household multifunctional device. it can stimulate healthy muscles in order to improve and facilitate muscle performance, and to relief the pain associated with sore and aching muscles in the waist, upper and lower back, back of the neck, upper extremities (shoulder, arm and hand), lower extremities (hip, knee, ankle, leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Low-frequency Multi-function Physiotherapy Instrument has 2 operation modes and two channels, which can give certain electrical pulse through 2 pairs of electrode pads on the skin to help users to enjoy body massage and sole massage.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity Modification keys and time selection keys.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.
The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.
5. Intended Use / Indications for Use
PMS (Mode 1)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 2)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
6. Test Summary
Low-frequency Multi-function physiotherapy instrument, Model: AST-603, AST-2012B has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to 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
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 of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device | Verdict | |
|---|---|---|---|---|
| Company | Shenzhen OSTOTechnology Co., Ltd | Shenzhen OSTOTechnology Co., Ltd | -- | |
| Elements ofComparison | Subject Device | Predicate Device | Verdict | |
| Trade Name | Low-frequency Multi-functional physiotherapyinstrument | Health Expert ElectronicStimulator | -- | |
| Classification Name | Stimulator, Nerve,Transcutaneous, Over-The-Counter | Stimulator, Nerve,Transcutaneous, Over-The-Counter | -- | |
| 510(k) Number | K172834 | K133929 | -- | |
| Product Code | NUH, NGX | NUH, NGX | SE | |
| Intended Use /Indications for Use | PMS (Mode 1)It is intended tostimulate healthymuscles in order toimprove and facilitatemuscle performance.TENS (Mode 2)To be used fortemporary relief of painassociated with soreand aching muscles inthe shoulder, waist,back, back of the neck,arm, leg, and foot due tostrain from exercise ornormal household workactivitiesby applying current tostimulate nerve. | PMS (Mode 1 | SE | |
| Power Source | Adaptor Input: 100-240Vac, 50-60Hz, 0.1AOutput: 5Vdc, 1AUnit Input: 5Vdc, 1A | Adaptor Input: 100-240Vac, 50-60Hz, 0.1AOutput: 5Vdc, 1AUnit Input: 5Vdc, 1A | SE | |
| -Method of LineCurrent Isolation | Type BF Applied Part | Type BF Applied Part | SE | |
| PatientLeakageCurrent | NC:AC: 54.5µA, DC: 0.5µASFC:AC:120.0µA, DC: 0.6µA | NC:AC: 54.5µA, DC: 0.5µASFC:AC:120.0µA, DC: 0.6µA | SE | |
| Main Unit Weight | 115 g | 2 kg | SENote 1 | |
| Main Unit Dimension | 128.6 x 69.8 x 25 mm | 428 x 428.8x 185mm | SENote 1 | |
| Number ofOutput Channels: | 2 | 2 | SE | |
| Number of OutputModes | 2 | 25 | SENote 2 | |
| Output IntensityLevel | 99 | 99 | SE | |
| Elements ofComparison | Subject Device | Predicate Device | Verdict | |
| Synchronous orAlternating? | Synchronous | Synchronous | SE | |
| Regulated Currentor RegulatedVoltage? | Yes | Yes | SE | |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | SE | |
| Automatic ShutOff | Yes | Yes | SE | |
| IndicatorDisplay | On/OffStatus | Yes | Yes | SE |
| LowBattery | No | No | ||
| Voltage/CurrentLevel | Yes | Yes | ||
| Timer Range | 5-60 min | 25 min | SENote2 | |
| Waveform | Pulsed, symmetric,biphasic | Pulsed, symmetric,biphasic | SE | |
| Shape | Rectangular, withinterphase interval | Rectangular, withinterphase interval | SE | |
| Maximum OutputVoltage | 44V±10% @ 500Ω | 44V±10% @ 500Ω | SE | |
| 80V±10% @ 2KΩ | 80V±10% @ 2KΩ | |||
| 112V±10% @ 10KΩ | 112V±10% @ 10KΩ | |||
| Maximum OutputCurrent | 88mA±10% @ 500Ω | 88mA±10% @ 500Ω | SE | |
| 40mA±10% @ 2KΩ | 40mA±10% @ 2KΩ | |||
| 11.2mA±10% @ 10KΩ | 11.2mA±10% @ 10KΩ | |||
| Pulse Duration | 120μs | 120μs | SE | |
| Pulse frequency | 77.3Hz | 77.3Hz | SE | |
| Charge density | 0.21µC/ cm² @ 500Ω | 0.21µC/ cm² @ 500Ω | SE | |
| Power density | 16.37μW/cm² @ 500Ω | 16.37μW/cm² @ 500Ω | SE | |
| Active surface area | 50.04cm² | 50.04cm² | SE | |
| Additional Features | ||||
| Environment foroperation | Temperature: 5 ~ 45Humidity: 15% - 90%Atmospheric pressure | Temperature: 5 ~ 45° CHumidity: 20 ~ 65% RH | SE | |
| Elements ofComparison | Subject Device | Predicate Device | Verdict | |
| range of 700 hPa to 1 060hPa | ||||
| Environment forstorage | Temperature: -25 - +70°CHumidity: up to 90%Atmospheric pressurerange of 700 hPa to 1 060hPa | Temperature: 0 ~ 45° C,Humidity: 10 ~ 90% RHElectrode Pad: 10~20°C | SE | |
| For pads:Temperature:10~20°CHumidity: up to 90%Atmospheric pressurerange of 700 hPa to 1060hPa | For pads:Temperature:10~20°CHumidity: up to 90%Atmospheric pressurerange of 700 hPa to 1060 hPa | SE |
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Comparison in Detail(s):
Note 1 (Weight, Dimension):
These data would be different for different devices because the internal circuit design and components choosing are different, which make them have similar difference on weight, dimensions. But weight and dimensions won't affect the safety and effectiveness of the device so it can deemed as the substantially equivalence.
Note 2 (Number of Output Modes, Time Range):
The design of the time range 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.
Final Conclusion:
The subject device "Low-frequency Multi-function physiotherapy instrument" is Substantial Equivalent to the predicate devices.
8. Date of the summary prepared: July 25, 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).