(134 days)
No
The description focuses on standard TENS device features like channels, programs, output strength, and display, with no mention of AI or ML.
Yes
The device is intended for the "temporary relief of pain associated with sore and aching muscles," which is a therapeutic purpose. It is also described as a "Transcutaneous Electrical Nerve Stimulator stimulation system."
No
The device description indicates that it is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for temporary pain relief. There is no mention of it being used to identify, measure, or monitor medical conditions, which are characteristics of a diagnostic device.
No
The device description explicitly states it is a "portable single-channel, battery operated Transcutaneous Electrical Nerve Stimulator stimulation system" and mentions hardware components like batteries, an LCD display, and adjustable output strength, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Tyece OTC TENS Device is a Transcutaneous Electrical Nerve Stimulator. It applies electrical stimulation to the skin to relieve pain. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for "temporary relief of pain associated with sore and aching muscles." This is a therapeutic function, not a diagnostic one.
Therefore, the Tyece OTC TENS Device is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Tyece OTC TENS Device EM26 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the shoulder and neck due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM27 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM28 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM29 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.
Product codes
NUH
Device Description
The Tyece OTC TENS Device EM26, EM27, EM28 and EM29 powered by 4.5V (3 x 1.5V AAA /Alkaline batteries), is similar to the predicate device, LT3060 (K130802), with the following features:
- a. It is a portable single-channel, battery operated Transcutaneous Electrical Nerve Stimulator stimulation system. The predicate is a dual-channel TENS device.
- b. It contains 4 programs, similar to the predicate device which has 12 programs
- The output strength is adjustable from 0-110mA, similar to the predicate device at 0-96mA, via regulated voltage.
- d. The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low indication.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, neck, lower extremities (leg), upper extremities (arm)
Indicated Patient Age Range
Healthy adults
Intended User / Care Setting
Not Found
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)
Non-clinical testing was performed in order to validate the design according to the company's specified design requirements, and to assure conformance with the following voluntary design standards. The device passes all testing performed below:
- -IEC 60601-1: 2005 + AM1 (2012) Medical Devices Part 1: General Requirement for Safety Report
- -IEC 60601-1-2:2014 Medical Devices Part 2: General Requirements for Safety – Harmonized Standards: Electromagnetic Compatibility -Test and Requirement Report
- -IEC 60601-1-11 Medical Electrical Equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Report
- -IEC 60601-2-10 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators Report
- -Software Validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
August 12, 2020
Tyece Limited % Maria Griffin Senior Consultant mdi Consultants, Inc. 55 Northern Blvd, Ste 200 Great Neck. New York 11021
Re: K200838
Trade/Device Name: Tyece OTC TENS Device EM26, EM27, EM28, and EM29 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: May 27, 2020 Received: June 1, 2020
Dear Maria Griffin:
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 (OS) 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 medical devices and radiation-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.
Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200838
Device Name
Tyece TENS Device Models: EM26, EM27, EM28, EM29
Indications for Use (Describe)
The Tyece OTC TENS Device EM26 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the shoulder and neck due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM27 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM28 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM29 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the logo for TYECE, a company focused on beauty, health, and fitness. The word "TYECE" is written in large, bold, maroon letters. Below the company name, the words "Beauty . Health . Fitness" are written in a smaller, lighter font.
Unit 803, Block A. Po Lung Centre 11 Wang Chiu Road, Kowloon Bay, Hong Kong Tel: (852) 2349 7456 . Fax (852) 2349 9166 www.tvece.com
510k Summary
The assigned 510(k) number is: K200838
-
- Submitter's identifications:
Tyece Limited Unit 803, Block A, Po Lung Centre, 11 wang Chiu Road, Kowloon Bay, Hong Kong Contact: Parshid Falahati Telephone: +852 23497456 Email: parshid@tyece.com
- Submitter's identifications:
Date of Summary Preparation: July 28, 2020
-
- Device:
Trade Name: Tyece OTC TENS Device EM26, EM27, EM28 and EM29
- Device:
Common Name: TENS Device Classification Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Product code: NUH Regulation class: II Regulation Number: 21 CFR 882.5890
-
- Predicate Device
Trade/Device Name: LT3060 510(k) Number: K130802
- Predicate Device
-
- Reference Device
Trade/Device Name: Savia OTC TENS Model EM-38 510(k) Number: K113321
- Reference Device
5. Device Description:
The Tyece OTC TENS Device EM26 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the shoulder and neck due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM27 is intended for use by healthy adults for temporary relief of
4
pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM28 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM29 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM26, EM27, EM28 and EM29 powered by 4.5V (3 x 1.5V AAA /Alkaline batteries), is similar to the predicate device, LT3060 (K130802), with the following features:
- a. It is a portable single-channel, battery operated Transcutaneous Electrical Nerve Stimulator stimulation system. The predicate is a dual-channel TENS device.
- b. It contains 4 programs, similar to the predicate device which has 12 programs
- The output strength is adjustable from 0-110mA, similar to the predicate device at 0-C. 96mA, via regulated voltage.
- d. The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low indication.
6. Intended Use:
The Tyece OTC TENS Device EM26 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the shoulder and neck due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM27 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM28 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM29 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.
7. Technological Comparison to Predicate Devices:
Tyece OTC TENS Device EM26, EM27, EM28 and EM29 has similar technological characteristics to the predicate device in product design, material, energy source type, main program modes and the main output waveform etc. Through detailed calculation comparison
5
of stimulation output energy, we found that the output levels for the subject device and the predicate device are very similar and within acceptable ranges as specified in the FDA guidance. We believe that the differences between the two devices do not affect the determination of substantial equivalence.
8. Discussion of Non-clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Non-clinical testing was performed in order to validate the design according to the company's specified design requirements, and to assure conformance with the following voluntary design standards. The device passes all testing performed below:
- -IEC 60601-1: 2005 + AM1 (2012) Medical Devices Part 1: General Requirement for Safety Report
- -IEC 60601-1-2:2014 Medical Devices Part 2: General Requirements for Safety – Harmonized Standards: Electromagnetic Compatibility -Test and Requirement Report
- -IEC 60601-1-11 Medical Electrical Equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Report
- -IEC 60601-2-10 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators Report
- -Software Validation
The Tyece OTC TENS Device, Models EM26, EM27, EM28 and EM29, by applying the same stimulus parameters has the same intended use as the cleared predicate device, LT3060 (K130802).
A summary of the technological characteristics of Models EM26, EM27, EM28 and EM29 compared to the predicate device is given below:
Basic Unit Characteristics:
| Item | Subject Device | Predicate Device | Discussion of differences |
|---|---|---|---|
| 510(k) Number | K200838 | K130802 | Similar |
| Device Name, Model | Tyece OTC TENS | ||
| Device EM26, EM27, | |||
| EM28 and EM29 | LT3060 | Similar | |
| Manufacturer | Savia | ||
| Electronics | |||
| (Shenzhen) Co. | |||
| Ltd. | Shenzhen | ||
| Dongdixin | |||
| Technology | |||
| Co., Ltd | Different but does not | ||
| adversely impact | |||
| safety and | |||
| effectiveness of | |||
| subject device | |||
| Intended Use | The Tyece OTC TENS | ||
| Device EM26 is | |||
| intended for use by | |||
| healthy adults for | |||
| temporary relief of | |||
| pain associated with | |||
| sore and aching | |||
| muscles in the | |||
| shoulder and neck | |||
| due to strain from | |||
| exercise or normal | |||
| household and work | |||
| activities. | |||
| The Tyece OTC TENS | |||
| Device EM27 is | |||
| intended for use by | |||
| healthy adults for | |||
| temporary relief of | |||
| pain associated with | |||
| sore and aching | |||
| muscles in the lower | |||
| extremities (leg) due | |||
| to strain from exercise | |||
| or normal household | |||
| and work activities. | |||
| The Tyece OTC TENS | |||
| Device EM28 is | |||
| intended for use by | |||
| healthy adults for | |||
| temporary relief of | |||
| pain associated with | |||
| sore and aching | |||
| muscles in the upper | |||
| extremities (arm) due | |||
| to strain from exercise | |||
| or normal household | |||
| and work activities. | |||
| The Tyece OTC TENS | |||
| Device EM29 is | |||
| intended for use by | |||
| healthy adults for | LT3060 OTC TENS | ||
| Device: | |||
| The device is | |||
| designed to be used | |||
| for temporary relief | |||
| of pain associated | |||
| with sore and | |||
| aching muscles in | |||
| the shoulder, waist, | |||
| back, neck, upper | |||
| extremities (arm), | |||
| and lower | |||
| extremities (leg) due | |||
| to strain from | |||
| exercise or normal | |||
| household work | |||
| activities. | Same | ||
| Prescription or OTC | OTC | OTC | Same |
| Power Source | 4.5V (3 x 1.5V AAA, | ||
| type | |||
| LR03 Alkaline | |||
| batteries) | Battery | ||
| powered, d.c. | |||
| 9.0V, one 6F22 | |||
| battery | Different but does not | ||
| adversely impact safety | |||
| and effectiveness of | |||
| subject device | |||
| -Method of Line Current Isolation | No line connection | ||
| possible when | |||
| connected to body | No line connection | ||
| possible when | |||
| connected to body | Same | ||
| -Patient Leakage Current |
- Normal condition
- Single fault condition | Not applicable, no
line connection, no
AC charger
connection or
operation.
Connection method
does
not allow AC
charger
connection to
patient | 0.61uA
0.68uA | Different but does not
adversely impact safety and
effectiveness of subject
device |
| Average DC current through
electrodes when device is on
but no pulses are being applied | 0μΑ | 0μΑ | Same |
| Number of Output Models | TENS | TENS | Same |
| Number of Output Channels | 1 | 2 | Different but does not
adversely impact safety and
effectiveness of subject
device |
| -Synchronous or Alternating? | Synchronous | Alternating | Different but does not
adversely impact safety and
effectiveness of subject
device |
| -Method of Channel Isolation | Single Channel | Dual Channel | Different but does not
adversely impact safety and
effectiveness of subject
device |
| Regulated Current or Regulated | Constant Voltage | Constant Voltage | Same |
| Software/Firmware/Micropr
ocessor Control? | YES | YES | Same |
| Automatic Overload Trip? | YES | YES | Same |
| Automatic No-Load Trip? | YES | YES | Same |
| Automatic Shut Off? | YES | YES | Same |
| Patient Override Control? | YES | YES | Same |
| Indicator Display:
On/Off Status?
Low Battery?
Voltage/Current Level?
- | YES
YES
YES (Voltage) | YES
YES
YES (Voltage) | Same |
| Timer Range (minutes) | 30 mins - Program A,
25 mins - Programs B,
C, D | 1 - 60 mins | Different but does not
adversely impact safety and
effectiveness of subject
device |
| Compliance with Voluntary Standards? | 60601-1 & 60601-1-2 | 60601-1 & 60601-1-
2 | Same |
| Compliance with 21 CFR 898? | YES | YES | Same |
| Weight (lbs., oz.) | EM26 - Approx.
0.6 lb (280g) with
batteries EM27 -
Approx. 0.34 lb
(155g) with
batteries EM28 -
Approx. 0.39 lb
(175g) with
batteries
EM29 - Approx.
0.46 lb (210g)
with batteries | Approx. 0.28
lb with
batteries | Different but does not
adversely impact
safety and
effectiveness of
subject device |
| Dimensions (in.) [W x H x D] | 3.4 x 1.4 x 2.3 in | 4.5 x 2.55 x 0.9 in | Different but does not
adversely impact safety and
effectiveness of subject
device |
| Housing Materials and Construction | ABS | ABS | Same |
| Electrode Cable Length | 1.2m | 1.2m | Same |
6
7
8
Output Specifications
| Attribute | | Subject Device:
Tyece OTC TENS
Device, Models
EM26, EM27, EM28
and EM29 | Predicate Device:
LT3060 (K130802) | Discussion of Difference |
|---------------------------------------------|-------|-------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------------------------------------------------------------|
| Waveform | | Symmetrical
biphasic | Symmetrical
biphasic | Same |
| Shape | | Rectangular | Rectangular | Same |
| Channels | | Single | Dual | Different but does not
adversely impact safety
and effectiveness of
subject device |
| Maximum Output Voltage
(Volts)
(±20%) | @500Ω | 54.4Vp-p | 48Vp-p | Different but does not
adversely impact safety
and effectiveness of
subject device |
| | @2kΩ | 112Vp-p | 114Vp-p | Different but does not
adversely impact safety
and effectiveness of
subject device |
| | @10Ω | 198Vp-p | 115Vp-p | |
| Maximum Output Current
(mA)
(±20%) | @500Ω | 108.8mAp-p | 96mAp-p | Different but does not
adversely impact safety
and effectiveness of
subject device |
| | @2kΩ | 56mAp-p | 57mAp-p | Different but does not
adversely impact safety
and effectiveness of
subject device |
| | @10Ω | 19.8mAp-p | 11.5mAp-p | |
| Amplitude (mA) | | 0-110 | 0-96 | Different but does not
adversely impact safety
and effectiveness of
subject device |
| Frequency (Hz) | | 4-110 | 1-150 | Different but does not
adversely impact safety
and effectiveness of
subject device |
| Pulse Width (μS) | | 60-220µs per phase | 50-300µs per phase | Different but does not
adversely impact safety
and effectiveness of
subject device |
9
| For multiphasic
waveforms only | Symmetrical phases? | | No multiphasic waveforms | Yes | Different but does not
adversely impact safety and
effectiveness of subject
device. |
|---------------------------------------------------------------------------------------|---------------------|--|--------------------------|----------------|----------------------------------------------------------------------------------------------|
| | Phase Duration | | | 50-300uS | |
| Power ON indicator | | | LCD | LCD | Same |
| Net Charge (μC per pulse) (if zero
state method of achieving zero net
charge) | | | 0.00246 μC@500Ω | 0 μC@500Ω | Different but does not
adversely impact safety
and effectiveness of
subject device |
| Maximum Phase Charge (μC)
@500Ω | | | 0.02398 | 0.0288 | Different but does not
adversely impact safety
and effectiveness of
subject device |
| Maximum Current Density (mA/cm²)
@500Ω | | | 0.52 | 1.15 | |
| Maximum Power Density
(W/ cm²) @500Ω (using smallest
electrode conductive area) | | | 0.033 | 0.373 | |
| RMS Voltage (RMSV)
(±20%) | @500Ω | | 5.5V | 5.2V | Different but does not
adversely impact safety
and effectiveness of
subject device |
| | @2kΩ | | 16.3V | 14.2V | |
| | @10Ω | | 27.2V | 20.2V | |
| RMS Current (RMSA)
(±20%) | @500Ω | | 11mA | 10mA | |
| | @2kΩ | | 7.35mA | 8.85mA | |
| | @10Ω | | 2.02mA | 1.88mA | |
| Burst Mode | | | | | Different but does not
adversely impact safety
and effectiveness of
subject device |
| - Pulses per burst | | | 110 | N/A | |
| - Burst per second | | | 2 | | |
| - Burst duration (seconds) | | | 0.5s | | |
| - Duty cycle: Line (b) x Line (c) | | | 1 | | |
| ON Time (seconds) | | | N/A | N/A | Same |
| OFF Time (seconds) | | | N/A | N/A | |
| Additional Features (specify, if
applicable) | | | Not applicable | Not applicable | Same |
Summary for the technology comparison
The Tyece OTC TENS Device EM26, EM27, EM28 and EM29 has similar technological characteristics to the predicate device in product design, material, energy source type, main program modes and the main output waveform etc. Through detailed calculation comparison of stimulation output energy, we found that the output levels for the subject device and the predicate device are very similar and within acceptable ranges as specified in the FDA guidance. We believe that the differences between the two devices do not affect the determination of substantial equivalence.
10
Conclusion
The Tyece OTC TENS Device EM26, EM27, EM28 and EM29 has the same intended use and similar technological characteristics as the cleared predicate device. Moreover, verification and validation tests demonstrate that the differences in the submitted models maintain the same safety and effectiveness as that of the cleared device. Therefore, we conclude that the subject device is substantially equivalent to the predicate device.