(79 days)
Not Found
No
The summary describes a basic electrical muscle stimulator with no mention of AI or ML capabilities, data processing, or complex algorithms.
No.
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Not intended for use in any therapy or for the treatment of any medical conditions or diseases."
No
The device description explicitly states, "Not intended for use in any therapy or for the treatment of any medical conditions or diseases," and its intended use is for "improvement of muscle tone and firmness, for strengthening muscles." These functions are not diagnostic but rather for physical conditioning.
No
The device description explicitly states that the device comprises an "electronic stimulator module" and "electrodes," which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an Electrical Muscle Stimulator (EMS) that works by applying electrical signals through the skin to improve muscle tone, firmness, and strength. It does not involve testing samples taken from the body.
- Intended Use: The intended use is for muscle improvement and strengthening, not for diagnosing or treating medical conditions or diseases.
Therefore, this device falls under the category of a physical therapy or fitness device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NGX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arms, abdomen, thighs and buttocks areas.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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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3
Section 6
510(k) Summary
4
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 |
5
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.
6
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 | Substantial
equivalence
determination | |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Device name | HIVOX Spopad
EMS | HIVOX Spopad
EMS | 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 Muscle
Stimulator | Powered Muscle
Stimulator | Identical | |
| Regulation number | 21 CFR 890.5850 | 21 CFR 890.5850 | Identical | |
| Indication for use | 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. | 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 | Electrical Muscle
Stimulation | Electrical Muscle
Stimulation | Identical | |
| Size (L x W x H, inch) | 8.15 × 4.06 × | 9.41 × 2.76 × | Different but | |
| | 0.51 | 0.45 | does not
adversely
impact safety
and
effectiveness of
subject device | |
| Weight (g) | 24.2 | 35.8 | Different but
does not
adversely
impact safety
and
effectiveness of
subject device | |
| Power source | 3 V battery × 1 | 3 V battery × 1 | Identical | |
| 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 – | No | No | Identical | |
| Low battery? | | | | |
| Indicator display –
Voltage / Current level | No | No | Identical | |
| Timer range (minutes) | 20 | 20 | 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 | |
| Compliance with 21 CFR 898? | Yes | Yes | Identical | |
| Housing material and construction | Silicone | Silicone | Identical | |
| 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 | |
| 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 not
adversely
impact safety
and
effectiveness of
subject device |
| Maximum average power density
at 500 Ω (W/cm²) | | 0.0869 | 0.0617 | Different but
does not
adversely
impact safety
and
effectiveness of
subject device |
| | | | | |
| Burst
mode | 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 |
7
8
9
5.10.2 Comparison between SP-920 and SP-921
| Item | Subject device | Predicate device | Substantial
equivalence
determination | |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------|
| Device name | HIVOX Spopad
EMS | HIVOX Spopad
EMS | N/A | |
| Model name | SP-921 | SP-920 | | |
| 510(k) number | K192264 | K141921 | | |
| Product code | NGX | NGX | Identical | |
| Classification name | Powered Muscle
Stimulator | Powered Muscle
Stimulator | Identical | |
| Regulation number | 21 CFR 890.5850 | 21 CFR 890.5850 | Identical | |
| Indication for use | Indicated for the
improvement of
muscle tone and
firmness, for
strengthening | Indicated for the
improvement of
muscle tone and
firmness, for
strengthening | Identical | |
| | | | | |
| | 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. | 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. | | |
| Technology | Electrical Muscle
Stimulation | Electrical Muscle
Stimulation | Identical | |
| | | | Different but
does not
adversely
impact safety
and
effectiveness of
subject device | |
| Size (L × W × H, inch) | $7.17 × 6.81 ×0.51$ | $6.69 × 6.69 ×0.51$ | | |
| | | | Different but
does not
adversely
impact safety
and
effectiveness of
subject 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 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 | 0 | 0 | Identical | |
| electrodes when device is on but
no pulses are being applied (μΑ) | | | | |
| 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 | |
| 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 | |
| Compliance with 21 CFR 898? | Yes | Yes | Identical | |
| Housing material and construction | Silicone | Silicone | Identical | |
| 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 | |
| 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 500
Ω (mA/cm²) | 1.057 | 1.057 | Identical |
| | Maximum average power density
at 500 Ω (W/cm²) | 0.0617 | 0.0617 | Identical |
| Burst
mode | 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 |
10
11
12
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 the | |
| fundamental scientific technology of subject device. | |
| Appearance | Changed for the sake of product segmentation. |
| However, it does not affect the intended use or alter the | |
| fundamental scientific technology of subject device. |
| (1) Comparison of SP-910 and SP-911 | ||
|---|---|---|
| ------------------------------------- | -- | -- |
13
| Conductive surface area | Compared with predicate device (SP-910), the calculated
power density value of the subject device (SP-911) is
raised from 0.0617 W/cm² to 0.0869 W/cm² due to the
smaller size of gel pad. However, we believe that the
product safety will not be affected because the power
density is still far below than the acceptance criterion (0.25
W/cm²) based on the recommendation of Class II Special
Control Guidance Document: Powered Muscle Stimulator
for Rehabilitation issued on April 5, 2010.
Certainly, the intended use and the fundamental scientific
technology of subject device will not be affected and
altered by this difference. |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Weight | Difference because of different design of product
appearance.
However, it does not affect the intended use or later the
fundamental 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 the | |
| fundamental scientific technology of subject device. | |
| Appearance | Changed for the sake of product segmentation. |
| However, it does not affect the intended use or alter the | |
| fundamental scientific technology of subject device. | |
| Weight | Difference because of different design of product |
| appearance. | |
| However, it does not affect the intended use or alter the | |
| fundamental 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
14
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.