(79 days)
These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
EMS, Electrical Muscle Stimulator, which improves, tones, firms & strengthens muscle and relaxes stiff muscle through the skin. It is recognized as a clinically proven, effective, non-medication method of training muscle from certain causes. It manages muscle strengthen, toning and firming. It is also free from side effects when used properly, and can also be used as a simple means of self-training.
HIVOX Spopad EMS SP series, SP-911 and SP-921 are the proposed devices for the 510(k) submission. These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in therapy or for the treatment of any medical conditions or diseases.
SP-911 and SP-921 are 1-channel battery-operated-user-friendly muscle stimulation system specifically designed to exercise the muscles. Each device comprises namely an electronic stimulator module which generates the required stimulation signals. SP-911 comprises 2 electrodes, which connects the signals from the stimulator to the skin. SP-921 comprises 4 electrodes, which connect the signals from the stimulator to the skin. Power is supplied from one battery, CR2032, located in a compartment protected by a removable battery cover. The user cannot access the wiring or connectors.
The provided text is a 510(k) Summary for the HIVOX Spopad EMS SP-911 and SP-921. It details the safety and performance testing conducted to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study for a new, complex algorithm or AI.
The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." (Section 5.9). This means there was no clinical study conducted where the device's performance was measured against established acceptance criteria using human data, adjudicated ground truth, or expert readers.
Instead, the submission relies on non-clinical testing to demonstrate performance and safety, specifically for a "Powered Muscle Stimulator." The acceptance criteria referenced are for electrical and physical performance characteristics of the device itself, rather than diagnostic accuracy or clinical effectiveness in the context of AI.
Therefore, many of the requested details regarding sample size, data provenance, expert qualifications, ground truth, MRMC studies, or standalone algorithm performance are not applicable to this type of device clearance and the information provided.
I can, however, extract the acceptance criteria for the non-clinical tests that were performed, as implied by the statement "All the test result demonstrate HIVOX Spopad EMS SP-911 and SP-921 meet the requirement of its pre-defined acceptance criteria and intended use". The document also implicitly defines acceptance criteria by noting when differences do not adversely impact safety and effectiveness, and by comparing the subject device's performance against the predicate and relevant standards.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a clean "acceptance criteria" table with "reported performance" directly. Instead, it compares the subject device's performance characteristics to those of its predicate device, and implicitly (though not explicitly numerically) against relevant international standards. The determination of "Identical" implies meeting the same performance characteristics as the cleared predicate, which serves as the de facto acceptance benchmark for substantial equivalence in many parameters. For parameters that are "Different but does not adversely impact safety and effectiveness," the standard or a justified value serves as the acceptance criteria.
| Feature / Acceptance Criteria (Implied) | Subject Device Performance (SP-911 / SP-921) | Predicate Device Performance (SP-910 / SP-920) | Substantial Equivalence Determination / Justification of Acceptance |
|---|---|---|---|
| General | |||
| Intended Use | Identical to Predicate | Indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. | Identical. |
| Technology/Principle of Operation | Electrical Muscle Stimulation | Electrical Muscle Stimulation | Identical. |
| Compliance with Voluntary Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 | Identical (SP-911/921 also comply with IEC 60601-1-11, which extends compliance). |
| Compliance with 21 CFR 898 | Yes | Yes | Identical. |
| Housing material and construction | Silicone | Silicone | Identical. |
| Electrical / Output Characteristics | |||
| Output waveform | Symmetrical biphasic | Symmetrical biphasic | Identical. |
| Shape | Rectangular | Rectangular | Identical. |
| Duration of primary (depolarizing) phase | 0 | 0 | Identical. |
| Pulse duration (μs) | 400 | 400 | Identical. |
| Max Output Voltage (V, ±10%) at 500 Ω | SP-911: 52 / SP-921: 58.4 | SP-910: 52 / SP-920: 58.4 | Identical. |
| Max Output Voltage (V, ±10%) at 2k Ω | SP-911: 102 / SP-921: 106 | SP-910: 102 / SP-920: 106 | Identical. |
| Max Output Voltage (V, ±10%) at 10k Ω | SP-911: 150 / SP-921: 154 | SP-910: 150 / SP-920: 154 | Identical. |
| Max Output Current (mA, ±10%) at 500 Ω | SP-911: 104 / SP-921: 117 | SP-910: 104 / SP-920: 117 | Identical. |
| Max Output Current (mA, ±10%) at 2k Ω | SP-911: 51 / SP-921: 53 | SP-910: 51 / SP-920: 53 | Identical. |
| Max Output Current (mA, ±10%) at 10k Ω | SP-911: 15 / SP-921: 15.4 | SP-910: 15 / SP-920: 15.4 | Identical. |
| Frequency (Hz) | SP-911: 3/4/5 / SP-921: 2/4/25 | SP-910: 3/4/5 / SP-920: 2/4/25 | Identical. |
| Net charge per pulse at 500 Ω (μC) | SP-911: 0.416 / SP-921: 0.468 | SP-910: 0.416 / SP-920: 0.468 | Identical. |
| Maximum charge at 500 Ω (μC) | SP-911: 41.6 / SP-921: 46.8 | SP-910: 41.6 / SP-920: 46.8 | Identical. |
| Maximum current density at 500 Ω (mA/cm²) | SP-911: 1.672 / SP-921: 1.057 | SP-910: 1.187 / SP-920: 1.057 | SP-911: Different (higher) but does not adversely impact safety and effectiveness. Justified against 0.25 W/cm² acceptance criterion for power density. SP-921: Identical. |
| Maximum average power density at 500 Ω (W/cm²) | SP-911: 0.0869 / SP-921: 0.0617 | SP-910: 0.0617 / SP-920: 0.0617 | SP-911: Different (higher) but does not adversely impact safety and effectiveness. Still below the acceptance criterion of 0.25 W/cm² from the Class II Special Control Guidance Document. SP-921: Identical. |
| Safety Features | |||
| Shelf-Life testing | Met requirements | N/A (implied by predicate clearance) | Met pre-defined acceptance criteria. |
| Performance verification | Met requirements | N/A (implied by predicate clearance) | Met pre-defined acceptance criteria. |
| Usability validation | Met requirements | N/A (implied by predicate clearance) | Met pre-defined acceptance criteria. |
| Method of Line Current Isolation | Battery supply | Battery supply | Identical. |
| Patient Leakage Current Normal Condition (μΑ) | 2.0 | 2.0 | Identical. |
| Patient Leakage Current Single Fault Condition (μΑ) | 2.1 | 2.1 | Identical. |
| Method of channel isolation | Single channel | Single channel | Identical. |
| Average DC current through electrodes when device is on but no pulses are being applied (μΑ) | 0 | 0 | Identical. |
| Number of output modes | 1 | 1 | Identical. |
| Regulated current or regulated voltage? | Voltage | Voltage | 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 overrides control? | Yes | Yes | Identical. |
| Indicator display – On / Off Status | No | No | Identical. |
| Indicator display – Low battery? | No | No | Identical. |
| Indicator display – Voltage / Current level | No | No | Identical. |
| Timer range (minutes) | 20 | 20 | Identical. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The testing was non-clinical (shelf-life, performance verification, usability validation) and involves device samples, not patient data or clinical subjects. The document does not specify the number of devices tested for these non-clinical assessments.
- Data Provenance: The testing was conducted by HIVOX Biotek Inc., based in New Taipei City, Taiwan, R.O.C. (as per "Submitter Address" in Section 5.3). The data is from the manufacturer's internal testing as part of their 510(k) submission. It is not retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this was a non-clinical submission, there was no "ground truth" derived from expert consensus on medical images or clinical outcomes. The "ground truth" for the device's electrical and physical parameters would be defined by engineering specifications and international standards, measured using appropriate test equipment and procedures.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for the reasons stated above.
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 powered muscle stimulator, not an AI-enabled diagnostic or assistive tool. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" implicitly refers to engineering specifications, regulatory requirements (e.g., 21 CFR 898), and international standards (e.g., IEC 60601 series). Performance verification would involve measuring parameters against these defined acceptable ranges. Usability validation typically involves testing by representative users against predefined usability criteria.
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable for the reasons stated above.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 8, 2019
Hivox Biotek Inc. Marx Lee Regulatory Affairs Representative 5F., No. 123, Xinde Rd. Sanchong Dist. New Taipei City, TW 24158
Re: K192264
Trade/Device Name: HIVOX Spopad EMS SP-911, SP-921 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 7, 2019 Received: October 9, 2019
Dear Marx 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.
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for: Vivek Pinto, Ph.D. Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192264
Device Name HIVOX Spopad EMS SP-911, SP-921
Indications for Use (Describe)
These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 6
510(k) Summary
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510(k) SUMMARY
| 5.1 Type of Submission | Special |
|---|---|
| 5.2 Date of Summary | November 8, 2019 |
| 5.3 Submitter | HIVOX BIOTEK INC. |
| Address: | 5F., No. 123, Xingde Rd., Sanchong Dist., New Taipei City 24158, Taiwan, R.O.C. |
| Phone: | +886-2-8511-2668 |
| Fax: | +886-2-8511-2669 |
| Contact: | Marx Lee |
| (Marx.Lee@hivox-biotek.com) |
5.4 Identification of the Subject Device
| Proprietary/Trade name: | HIVOX Spopad EMS |
|---|---|
| Models: | SP-911, SP-921 |
| Classification product code: | NGX |
| Regulation number: | 890.5850 |
| Regulation description: | Power muscle stimulator |
| Review panel: | Physical Medicine |
| Device class: | II |
5.5 Identification of the Predicate Device
| Proprietary/Trade name: | HIVOX Spopad EMS |
|---|---|
| Models: | SP-910, SP-920 |
| 510(k) number: | K141921 |
| Classification product code: | NGX |
| Regulation number: | 890.5850 |
| Regulation description: | Power muscle stimulator |
| Review panel: | Physical Medicine |
| Device class: | II |
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5.6 Intended Use / Indication for Use of the Device
These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
5.7 Description of the Device
EMS, Electrical Muscle Stimulator, which improves, tones, firms & strengthens muscle and relaxes stiff muscle through the skin. It is recognized as a clinically proven, effective, non-medication method of training muscle from certain causes. It manages muscle strengthen, toning and firming. It is also free from side effects when used properly, and can also be used as a simple means of self-training.
HIVOX Spopad EMS SP series, SP-911 and SP-921 are the proposed devices for the 510(k) submission. These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in therapy or for the treatment of any medical conditions or diseases.
SP-911 and SP-921 are 1-channel battery-operated-user-friendly muscle stimulation system specifically designed to exercise the muscles. Each device comprises namely an electronic stimulator module which generates the required stimulation signals. SP-911 comprises 2 electrodes, which connects the signals from the stimulator to the skin. SP-921 comprises 4 electrodes, which connect the signals from the stimulator to the skin. Power is supplied from one battery, CR2032, located in a compartment protected by a removable battery cover. The user cannot access the wiring or connectors.
5.8 Non-clinical Testing
A series of safety and performance tests were conducted on the subject device, HIVOX Spopad EMS SP-911 and SP-921.
- Shelf-Life testing
- Performance verification
- Usability validation
All the test result demonstrate HIVOX Spopad EMS SP-911 and SP-921 meet the requirement of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
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5.9 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
5.10 Comparison of Differences and Substantial Equivalence Determination 5.10.1 Comparison between SP-910 and SP-911
| Item | Subject device | Predicate device | Substantialequivalencedetermination | |
|---|---|---|---|---|
| Device name | HIVOX SpopadEMS | HIVOX SpopadEMS | N/A | |
| Model name | SP-911 | SP-910 | N/A | |
| 510(k) number | K192264 | K141921 | N/A | |
| Product code | NGX | NGX | Identical | |
| Classification name | Powered MuscleStimulator | Powered MuscleStimulator | Identical | |
| Regulation number | 21 CFR 890.5850 | 21 CFR 890.5850 | Identical | |
| Indication for use | Indicated for theimprovement ofmuscle tone andfirmness, forstrengtheningmuscles in arms,abdomen, thighs,and buttocksareas.Not intended foruse in anytherapy or for thetreatment of anymedicalconditions ordiseases. | Indicated for theimprovement ofmuscle tone andfirmness, forstrengtheningmuscles in arms,abdomen, thighs,and buttocksareas.Not intended foruse in anytherapy or for thetreatment of anymedicalconditions ordiseases. | Identical | |
| Technology | Electrical MuscleStimulation | Electrical MuscleStimulation | Identical | |
| Size (L x W x H, inch) | 8.15 × 4.06 × | 9.41 × 2.76 × | Different but | |
| 0.51 | 0.45 | does notadverselyimpact safetyandeffectiveness ofsubject device | ||
| Weight (g) | 24.2 | 35.8 | Different butdoes notadverselyimpact safetyandeffectiveness ofsubject device | |
| Power source | 3 V battery × 1 | 3 V battery × 1 | Identical | |
| Method of Line Current Isolation | Battery supply | Battery supply | Identical | |
| Patient Leakage CurrentNormal Condition (μΑ) | 2.0 | 2.0 | Identical | |
| Patient Leakage CurrentSingle Fault Condition (μΑ) | 2.1 | 2.1 | Identical | |
| Method of channel isolation | Single channel | Single channel | Identical | |
| Average DC current throughelectrodes when device is on butno pulses are being applied (μΑ) | 0 | 0 | Identical | |
| Number of output modes | 1 | 1 | Identical | |
| Regulated current or regulatedvoltage? | Voltage | Voltage | 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 overrides control? | Yes | Yes | Identical | |
| Indicator display –On / Off Status | No | No | Identical | |
| Indicator display – | No | No | Identical | |
| Low battery? | ||||
| Indicator display –Voltage / Current level | No | No | Identical | |
| Timer range (minutes) | 20 | 20 | Identical | |
| Compliance with voluntarystandards? | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | Identical | |
| Compliance with 21 CFR 898? | Yes | Yes | Identical | |
| Housing material and construction | Silicone | Silicone | Identical | |
| Output waveform | Symmetricalbiphasic | Symmetricalbiphasic | Identical | |
| Shape | Rectangular | Rectangular | Identical | |
| Duration of primary(depolarizing) phase | 0 | 0 | Identical | |
| Pulse duration (μs) | 400 | 400 | Identical | |
| Maximum output voltage(V, ±10%) at 500 Ω | 52 | 52 | Identical | |
| Maximum output voltage(V, ±10%) at 2k Ω | 102 | 102 | Identical | |
| Maximum output voltage(V, ±10%) at 10k Ω | 150 | 150 | Identical | |
| Maximum output current(mA, ±10%) at 500 Ω | 104 | 104 | Identical | |
| Maximum output current(mA, ±10%) at 2k Ω | 51 | 51 | Identical | |
| Maximum output current(mA, ±10%) at 10k Ω | 15 | 15 | Identical | |
| Frequency (Hz) | 3/4/5 | 3/4/5 | Identical | |
| Net charge per pulse at 500 Ω(μC) | 0.416 | 0.416 | Identical | |
| Maximum charge at 500 Ω (μC) | 41.6 | 41.6 | Identical | |
| Conductive surface area (cm²) | 62.20(Two electrodes) | 87.58(Two electrodes) | Identical | |
| Maximum current density at 500 | 1.672 | 1.187 | Different but | |
| Ω (mA/cm²) | does notadverselyimpact safetyandeffectiveness ofsubject device | |||
| Maximum average power densityat 500 Ω (W/cm²) | 0.0869 | 0.0617 | Different butdoes notadverselyimpact safetyandeffectiveness ofsubject device | |
| Burstmode | A. Pulse per burst | N/A | N/A | Identical |
| B. Burst per second | N/A | N/A | Identical | |
| C. Burst duration (sec) | N/A | N/A | Identical | |
| D. Duty cycle | N/A | N/A | Identical |
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5.10.2 Comparison between SP-920 and SP-921
| Item | Subject device | Predicate device | Substantialequivalencedetermination | |
|---|---|---|---|---|
| Device name | HIVOX SpopadEMS | HIVOX SpopadEMS | N/A | |
| Model name | SP-921 | SP-920 | ||
| 510(k) number | K192264 | K141921 | ||
| Product code | NGX | NGX | Identical | |
| Classification name | Powered MuscleStimulator | Powered MuscleStimulator | Identical | |
| Regulation number | 21 CFR 890.5850 | 21 CFR 890.5850 | Identical | |
| Indication for use | Indicated for theimprovement ofmuscle tone andfirmness, forstrengthening | Indicated for theimprovement ofmuscle tone andfirmness, forstrengthening | Identical | |
| muscles in arms,abdomen, thighs,and buttocksareas.Not intended foruse in anytherapy or for thetreatment of anymedicalconditions ordiseases. | muscles in arms,abdomen, thighs,and buttocksareas.Not intended foruse in anytherapy or for thetreatment of anymedicalconditions ordiseases. | |||
| Technology | Electrical MuscleStimulation | Electrical MuscleStimulation | Identical | |
| Different butdoes notadverselyimpact safetyandeffectiveness ofsubject device | ||||
| Size (L × W × H, inch) | $7.17 × 6.81 ×0.51$ | $6.69 × 6.69 ×0.51$ | ||
| Different butdoes notadverselyimpact safetyandeffectiveness ofsubject device | ||||
| Weight (g) | 48.3 | 52.6 | ||
| Power source | 3 V battery × 1 | 3 V battery × 1 | Identical | |
| Method of Line Current Isolation | Battery supply | Battery supply | Identical | |
| Patient Leakage CurrentNormal Condition (μΑ) | 2.0 | 2.0 | Identical | |
| Patient Leakage CurrentSingle Fault Condition (μΑ) | 2.1 | 2.1 | Identical | |
| Method of channel isolation | Single channel | Single channel | Identical | |
| Average DC current through | 0 | 0 | Identical | |
| electrodes when device is on butno pulses are being applied (μΑ) | ||||
| Number of output modes | 1 | 1 | Identical | |
| Regulated current or regulatedvoltage? | Voltage | Voltage | 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 overrides control? | Yes | Yes | Identical | |
| Indicator display –On / Off Status | No | No | Identical | |
| Indicator display –Low battery? | No | No | Identical | |
| Indicator display –Voltage / Current level | No | No | Identical | |
| Timer range (minutes) | 20 | 20 | Identical | |
| Compliance with voluntarystandards? | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | Identical | |
| Compliance with 21 CFR 898? | Yes | Yes | Identical | |
| Housing material and construction | Silicone | Silicone | Identical | |
| Output waveform | Symmetricalbiphasic | Symmetricalbiphasic | Identical | |
| Shape | Rectangular | Rectangular | Identical | |
| Duration of primary(depolarizing) phase | 0 | 0 | Identical | |
| Pulse duration (μs) | 400 | 400 | Identical | |
| Maximum output voltage(V, ±10%) at 500 Ω | 58.4 | 58.4 | Identical | |
| Maximum output voltage(V, ±10%) at 2k Ω | 106 | 106 | Identical | |
| Maximum output voltage | 154 | 154 | Identical | |
| (V, ±10%) at 10k Ω | ||||
| Maximum output current(mA, ±10%) at 500 Ω | 117 | 117 | Identical | |
| Maximum output current(mA, ±10%) at 2k Ω | 53 | 53 | Identical | |
| Maximum output current(mA, ±10%) at 10k Ω | 15.4 | 15.4 | Identical | |
| Frequency (Hz) | 2/4/25 | 2/4/25 | Identical | |
| Net charge per pulse at 500 Ω(μC) | 0.468 | 0.468 | Identical | |
| Maximum charge at 500 Ω (μC) | 46.8 | 46.8 | Identical | |
| Conductive surface area (cm²) | 110.68(four electrodes) | 110.68(four electrodes) | Identical | |
| Maximum current density at 500Ω (mA/cm²) | 1.057 | 1.057 | Identical | |
| Maximum average power densityat 500 Ω (W/cm²) | 0.0617 | 0.0617 | Identical | |
| Burstmode | E. Pulse per burst | 25 | 25 | Identical |
| F. Burst per second | 1 | 1 | Identical | |
| G. Burst duration (sec) | 20 | 20 | Identical | |
| H. Duty cycle | 20 | 20 | Identical |
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The HIVOX Spopad EMS SP-911 and SP-921 submitted in this 510(k) file are substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared HIVOX Spopad EMS SP-910 and SP-920 (K141921) respectively. Differences between the devices cited in the following do not raise any new issue of substantially equivalence.
| Feature | Substantial equivalence justification |
|---|---|
| Labeling | Different in product model.However, it does not affect the intended use or alter thefundamental scientific technology of subject device. |
| Appearance | Changed for the sake of product segmentation.However, it does not affect the intended use or alter thefundamental scientific technology of subject device. |
| (1) Comparison of SP-910 and SP-911 | ||
|---|---|---|
| ------------------------------------- | -- | -- |
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| Conductive surface area | Compared with predicate device (SP-910), the calculatedpower density value of the subject device (SP-911) israised from 0.0617 W/cm² to 0.0869 W/cm² due to thesmaller size of gel pad. However, we believe that theproduct safety will not be affected because the powerdensity is still far below than the acceptance criterion (0.25W/cm²) based on the recommendation of Class II SpecialControl Guidance Document: Powered Muscle Stimulatorfor Rehabilitation issued on April 5, 2010.Certainly, the intended use and the fundamental scientifictechnology of subject device will not be affected andaltered by this difference. |
|---|---|
| Weight | Difference because of different design of productappearance.However, it does not affect the intended use or later thefundamental scientific technology of subject device. |
(2) Comparison of SP-920 and SP-921:
| Feature | Substantial equivalence justification |
|---|---|
| Labeling | Different in product model.However, it does not affect the intended use or alter thefundamental scientific technology of subject device. |
| Appearance | Changed for the sake of product segmentation.However, it does not affect the intended use or alter thefundamental scientific technology of subject device. |
| Weight | Difference because of different design of productappearance.However, it does not affect the intended use or alter thefundamental scientific technology of subject device. |
5.11 Discussion
The HIVOX Spopad EMS SP-911 and SP-921 have been compared with HIVOX Spopad EMS SP-910 and SP-920 respectively. The subject devices have the same intended use, principle of operation and technological characters as the predicate device. We have completed the design control process and the validation tests to confirm the safety and performance of subject device. Although there are some specifications that are different between the subject devices and
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predicate devices, the test results complied with the test requests, and this demonstrates that the differences between these parameters would not impact the safety and effectiveness of the subject device. Therefore, the difference between the subject devices and predicate devices did not raise any problem of substantial equivalence. The subject devices are substantially equivalent to the predicate devices intended use, safety and performance claims.
5.12 Conclusion
After analyzing non-clinical studies and related testing data, it can be concluded that the HIVOX Spopad EMS SP-911 and SP-921 are substantially equivalent to the predicated devices.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).