(507 days)
No
The description focuses on electro-coagulation using high-frequency current and does not mention any AI or ML components or functionalities.
Yes
The device is intended for use in dermatologic and general surgical procedures for electro-coagulation, which involves treating or managing a medical condition.
No
The device description states its use is for "electro-coagulation" and "tissue coagulation by means of high-frequency current," which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly lists multiple hardware components including a main unit, handpieces, cables, foot switch, LCD touchscreen, ground pad, and power cable.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electro-coagulation in dermatologic and general surgical procedures." This describes a therapeutic or surgical intervention performed directly on the patient's tissue, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details an instrument that uses high-frequency current for tissue coagulation. This is a physical process applied to the body, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue biopsies, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to alter tissue through electro-coagulation, which is a surgical procedure.
N/A
Intended Use / Indications for Use
This device is intended for use in dermatologic and general surgical procedures for electro-coagulation.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, Four handpieces, GP Cable, foot switch, LCD touchscreen, ground pad and power cable.
The SILKRO has two operating modes: monopolar mode and bipolar mode. In the monopolar mode, RF energy flows from the main unit and a patient loop is formed by pairing the active electrode tip with the neutral electrode pad. Heat is not generated in the neutral electrode pad due to its low contact resistance, but heat is generated in the active electrode tip which has higher contact resistance. The higher contact resistance heats up the tissue resulting in coagulation. In the bipolar mode, RF energy is delivered between adjacent needles in the electrode tip without use of the neutral electrode pad. The user can select the mode and adjust parameters through the touch screen user interface of the electrosurgical device.
RF(HF) energy is delivered to the target tissue using a handpiece (RM, RN, RC, RV) and electrode tip, the tip being placed in light contact with the epidermis and the handpiece being held at right anqles to the tarqet tissue. As the HF energy passes through the skin, it generates an electro RF reaction, which is capable of coaqulating the tissue.
- Electrosurgical Unit Main body
- Four different handpieces (motor )
- Neutral electrode pad and neutral electrode pad cable, cleared under K092761
- Handpiece stands
- Foot switch
- Power cord
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
- Basic safety and essential performance of the SILKRO is evaluated in accordance with IEC 60601-1:2012.
- Effect to the device by electromagnetic disturbances is evaluated in accordance with the FDArecognized consensus standard, IEC 60601-1-2:2014.
- Medical electrical equipment Part 2 -2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories, IEC 60601-2-2.
- General Requirements for Basic Safety and Essential Performance Collateral Standard: Usability is evaluated in accordance with the FDA-recognized consensus standard, IEC 60601-1-6:2013.
- Risk management is recorded in the reference of ISO 14971:2007.
- The software for SILKRO is verified and validated in accordance with its moderate level of concern. Software life cycle processes are evaluated according to the FDA-recognized consensus standard, IEC 62304:2006.
- Application of usability engineering to medical devices is evaluated in accordance with IEC 62366:2007.
- ex vivo animal testing using models was also conducted to obtain histological data of values for depth and zone of coagulation and thermal damage immediately post treatment; 10 days post treatment. The treatment was performed at the intensity(power) low, mid, high. Based on this animal test, it was confirmed through mechanical and histological evaluation that RM, RV, RC handpieces can affect tissue by thermal effect of each output condition.
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.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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.
June 3, 2022
Hironic Co., Ltd % Sang Hwa Myung Regulatory Affair Consultant E&M D-1474, 230, Simin-daero, Dongan-gu Anyang-si, Gyeonggi-do 14067 Republic of Korea
Re: K210084
Trade/Device Name: SILKRO Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 7, 2022 Received: January 10, 2022
Dear Sang Hwa Myung:
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/cdrl/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 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.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
Food and Drug Administration Indications for Use
510(k) Number (if known) K210084
Device Name SILKRO
Indications for Use (Describe)
This device is intended for use in dermatologic and general surgical procedures for electro-coagulation.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/0 description: The image shows the logo for HIRONIC. The logo consists of a red square with a white arrow pointing to the right, followed by the word "HIRONIC" in black, sans-serif letters. The logo is simple and modern, and the red and black colors give it a bold and professional look.
510(k) Summary
This summary of 510(k) Safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
K210084
- Submitter Information - 807.92(a)(1)
| Applicant | Hironic Co., Ltd. |
|---|---|
| Address | 19F, 767, Sinsu-Ro, Suji-Gu, Yongin-Si, Gyeonggi-do, 16827, |
| Republic of Korea | |
| Phone Number | +82-31-525-7000 |
| Fax Number | +82-31-525-7010 |
| Contact Person | Sang Hwa, Myung |
| Contact Information | D-1474, 230, Simin-daero, Dongan-gu, Anyang-si, Gyeonggi-do, |
| 14067, Republic of Korea | |
| m. +82-10-4952-6638, e. mshenmc@gmail.com, f. 031-388-9263 | |
| Preparation Date | Jan 07, 2022 |
Date 510(k) summary prepared: June 01, 2022
2. Device Name and Code - 807.92(a)(2)
| Trade/Device Name | SILKRO |
|---|---|
| Common Name | Electrosurgical System |
| Classification Name | Electrosurgical cutting and coagulation device and accessories |
| Product Code | GEI |
| Regulation Number | 21 CFR 878.4400 |
| Regulatory Class | II |
| Review Panel | General & Plastic Surgery (ODE) |
- Legally marketed device(s) to which equivalence is claimed - 807.92(a)(3)
| Predicate Devices | K170325 |
|---|---|
| Applicant: ILOODA CO., LTD | |
| Trade/Device Name: Secret RF | |
| Regulation Number: 21 CFR 878.4400 | |
| Regulation Name: Electrosurgical Cutting and Coagulation Device | |
| and Accessories | |
| Regulatory Class: Class II | |
| Product Code: GEI, OUH | |
| Reference Devices 1 | K182355 |
| Applicant: ILOODA CO., LTD | |
| Trade/Device Name: Secret RF Smartcure Applicator | |
| Regulation Number: 21 CFR 878.4400 | |
| Regulation Name: Electrosurgical Cutting and Coagulation Device | |
| and Accessories | |
| Regulatory Class: Class II | |
| Product Code: GEI, OUH | |
| Reference Device 2 | K201685 |
| Applicant: Jeisys Medical Inc. | |
| Trade/Device Name: Potenza | |
| Regulation Number: 21 CFR 878.4400 | |
| Regulation Name: Electrosurgical Cutting and Coagulation Device | |
| and Accessories | |
| Regulatory Class: Class II | |
| Product Code: GEI |
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Image /page/4/Picture/0 description: The image shows the logo for Hironic. The logo consists of a red square with a white stylized "H" inside, followed by the word "HIRONIC" in black, sans-serif capital letters. The logo is simple and modern, with a focus on the company name.
4. Device Description - 807.92(a)(4)
This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, Four handpieces, GP Cable, foot switch, LCD touchscreen, ground pad and power cable.
The SILKRO has two operating modes: monopolar mode and bipolar mode. In the monopolar mode, RF energy flows from the main unit and a patient loop is formed by pairing the active electrode tip with the neutral electrode pad. Heat is not generated in the neutral electrode pad due to its low contact resistance, but heat is generated in the active electrode tip which has higher contact resistance. The higher contact resistance heats up the tissue resulting in coagulation. In the bipolar mode, RF energy is delivered between adjacent needles in the electrode tip without use of the neutral electrode pad. The user can select the mode and adjust parameters through the touch screen user interface of the electrosurgical device.
RF(HF) energy is delivered to the target tissue using a handpiece (RM, RN, RC, RV) and electrode tip, the tip being placed in light contact with the epidermis and the handpiece being held at right anqles to the tarqet tissue. As the HF energy passes through the skin, it generates an electro RF reaction, which is capable of coaqulating the tissue.
- Electrosurgical Unit Main body
- Four different handpieces (motor )
- Neutral electrode pad and neutral electrode pad cable, cleared under K092761
- Handpiece stands
- Foot switch
- Power cord
5. Indication for use - 807.92(a)(5)
This device is intended for use in dermatologic and general surgical procedures for electrocoagulation.
- Summary of the Technological Characteristics of the Device Compared to the Predicate - 807.92(a)(6) (1) Predicate device
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) Number | Pending | K170325 |
| Manufacturer | Hironic Co., Ltd. | ILOODA CO., LTD |
| Trade/Device Name | SILKRO | Secret RF |
| Classification Name | Electrosurgical cutting and | |
| coagulation device and | ||
| accessories | Electrosurgical cutting and | |
| coagulation device and accessories | ||
| Indication for use | This device is intended for use in | |
| dermatologic and general | ||
| surgical procedures for electro- | ||
| coagulation. | Secret RF is intended for use in | |
| dermatologic and general surgical | ||
| procedures for electro-coagulation | ||
| and hemostasis. | ||
| Output energy type | Radio Frequency | Radio Frequency |
| User interface | Color Touch Panel | Color Touch Panel |
| Operating Frequency | 2MHz | 2MHz |
| Rated Input | 100-240VAC, 50/60Hz | 100-240VAC, 50/60Hz |
| Max Power | 25W ± 20%, 500Ω | 25W ± 20%, 500Ω |
| RF Intensity | 1 ~ 10 Level | 1 ~ 10 Level |
| RF Duration | 50 ms ~ 950 ms | 50 ms ~ 950 ms |
| Treatment Time | 5 ~ 15 min | 10 ~ 15 min |
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Image /page/5/Picture/0 description: The image shows the logo for Hironic. The logo consists of a red square with a white shape inside, followed by the word "HIRONIC" in black, block letters. The letters are stylized and have a modern, technological look.
| (Recommended) | (Recommended) | |
|---|---|---|
| Needle insert depth | 0.5 ~ 3.5 mm(0.1 step) | 0.5 ~ 3.5mm (0.1 step) |
| Repetition | 0.2/0.5/0.8/1.0/2.0 sec/Single | 0.2 / 0.5 / 1 / 2 sec / Single |
| Mode of operation | Bipolar type | Bipolar type |
| Electrode(Needle) type | RF Micro needle 25pin, 49pin | RF Micro needle 25pin, 49pin |
| Sterilization | EO Gas | EO Gas |
Information provided in these 510(k) submissions shows that SILKRO are substantially equivalent to the predicate device(K170325) in terms of indication for use, performance that related with technological characteristics. SILKRO Treatment time is recommendation between 5 to 15 min and it is within range of predicate device(K17025)'s treatment time.
| Proposed Device | Reference Device 1 | |
|---|---|---|
| 510(k) Number | Pending | K182355 |
| Manufacturer | Hironic Co., Ltd. | ILOODA CO., LTD |
| Trade/Device Name | SILKRO | Secret RF Smartcure Applicator |
| Classification Name | Electrosurgical cutting and | |
| coagulation device and | ||
| accessories | Electrosurgical cutting and | |
| coagulation device and accessories | ||
| Indication for use | This device is intended for use in | |
| dermatologic and general | ||
| surgical procedures for electro- | ||
| coagulation. | Secret RF Smartcure Applicator is | |
| intended for use in dermatologic and | ||
| general surgical procedures for | ||
| electro-coagulation and hemostasis | ||
| Output energy type | Radio Frequency | Radio Frequency |
| User interface | Color Touch Panel | Color Touch Panel |
| Operating Frequency | 2MHz | 2MHz |
| Rated Input | 100-240VAC, 50/60Hz | 100-240VAC, 50/60Hz |
| Power output | 7.5 W±20%, 500Ω | 45W±20%, 500Ω |
| RF Duration | 100 ms ~ 1000 ms | 100 ms ~ 3000 ms |
| Treatment Time | 10~ 15 minutes | 10~ 15 minutes |
| Needle insert depth | 1.2, 1.5, 1.8 mm | 0.8/1.25/1.5/ 2.0 mm |
| Mode of operation | Monopolar | Monopolar |
| Electrode(Needle) | ||
| type | 1 pin type | 1 pin Type |
| Single Use | Single Use | Single Use |
| Sterilization | EO Gas | EO Gas |
(2) Reference Device 1
Information provided in these 510(k) submissions shows that SILKRO electrosurgical system's RN handpiece is substantially equivalent to the Reference device 1(K182355) in terms of indication for use, and performance that related with technological characteristics. RF duration is not exact same values but our duration is within in range of reference device's duration value.
(3) Reference Device 2
| Proposed Device | Reference Device 2 | |
|---|---|---|
| 510(k) Number | Pending | K201685 |
| Manufacturer | Hironic Co., Ltd. | Jeisys Medical Inc |
| Trade/Device Name | SILKRO | Potenza |
| Classification Name | Electrosurgical cutting and | |
| coagulation device and | ||
| accessories | Electrosurgical cutting and | |
| coagulation device and accessories |
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Image /page/6/Picture/0 description: The image shows the word "HIRONIC" in black letters with a red symbol to the left. The symbol is a stylized letter "H" with a curved top and a flat bottom. The word "HIRONIC" is in all caps and has a bold, sans-serif font. The letters are evenly spaced and the word is centered in the image.
| Indication for use | This device is intended for use in
dermatologic and general
surgical procedures for electro-
coagulation. | Potenza is intended for use in
dermatologic and general surgical
procedures for electro-coagulation
and hemostasis. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Output energy type | Radio Frequency | Radio Frequency |
| Operating Frequency | 2MHz | 2MHz |
| Power output | Maximum 40 W ±20%, | Maximum 50W±20%, |
| Treatment Time | 10 ~ 15 min | 10 ~ 15 min |
| Treatment
Activation | Touch screen, Foot switch,
Neutral electrode pad and neutral
electrode pad cable, cleared
under K092761. | Touch screen, Foot switch, Neutral
electrode pad and neutral electrode
pad cable, cleared under K092761. |
| Mode of operation | Monopolar | Monopolar |
Information provide in these 510(k) submissions shows that SILKRO electrosurgical system's Electrosurgical Unit part, Bipolar and monopolar operating mode, output frequency of 2MHz, same as for the reference device. Also, treatment time, treatment activation with operation mode, same as for the reference device.
7. Non-clinical tests submitted - 807.92(b)(1)
-
-. Basic safety and essential performance of the SILKRO is evaluated in accordance with IEC 60601-1:2012.
-
-. Effect to the device by electromagnetic disturbances is evaluated in accordance with the FDArecognized consensus standard, IEC 60601-1-2:2014.
-
-. Medical electrical equipment Part 2 -2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories, IEC 60601-2-2,
-
-. General Requirements for Basic Safety and Essential Performance Collateral Standard: Usability is evaluated in accordance with the FDA-recognized consensus standard, IEC 60601-1-6:2013.
-
-. Risk management is recorded in the reference of ISO 14971:2007.
-
-. The software for SILKRO is verified and validated in accordance with its moderate level of concern. Software life cycle processes are evaluated according to the FDA-recognized consensus standard, IEC 62304:2006.
-
-. Application of usability engineering to medical devices is evaluated in accordance with IEC 62366:2007.
-
ex vivo animal testing using models was also conducted to obtain histological data of values for depth and zone of coagulation and thermal damage immediately post treatment; 10 days post treatment. The treatment was performed at the intensity(power) low, mid, high. Based on this animal test, it was confirmed through mechanical and histological evaluation that RM, RV, RC handpieces can affect tissue by thermal effect of each output condition.
8. Biocompatibility
Hironic Co., Ltd performed biocompatibility testing for the contact part of each of handpiece's tips. FDA's "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process", June 6, 2016.
SILKRO skin contact materials (Applied part that touched patients' skin permanently within 24 hours) were evaluated according to ISO 10993-1. The results of this test confirmed that materials met the biocompatibility requirements. Biocompatibility testing including cytotoxicity, sensitization, oral
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Image /page/7/Picture/0 description: The image shows the word "HIRONIC" in a stylized font. The first letter "H" is a red square with a white arrow pointing to the right. The rest of the letters are black and in a bold, sans-serif font. The letters are slightly rounded and have a modern look.
mucosal irritation was completed according to the following standards: ISO 10993-1 Biological Evaluation of Medical Devices –Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process ISO 10993-5 Biological Evaluation of Medical Devices – Part 5 Cytotoxicity ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization ISO 10993-12 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials.
Each tip are external communicating devices which come into contact with tissue for a limited period of time, i.e., less than 24 hours.
9. Sterilization and shelf life
-. Sterilization
The RM Micro Needle tips (RMT-125, RMT-149, RMT-N49) and RN Needle tips are subject to Ethylene Oxide (EO) sterilization.
EO sterilization residual testing for the RM Micro Needle tips (RMT-125, RMT-149, RMT-N49) and RN Needle tips according to ISO 10993-7:2008, Biological Evaluation of Medical Devices -Part 7: Ethylene Oxide Sterilization Residuals to acceptance criteria as specified in the standard. According to ISO 11135:2014. Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices, the sterility assurance level (SAL) is 10-6,
-. Shelf life
Hironic Co., Ltd performed shelf-life testing to establish three years shelf-life based on 97-days accelerated aging in accordance with the following standards to the acceptance criteria as specified in the standard:
-
ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices - Accelerated Aging
-
ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration - Packaging Test
-
ASTM F88/F88M: Standard Test Method for Seal Strength of Flexible Barrier Materials
-. Packaging
RMT-149 is packed in PET+Steril Paper. To keeping the sterility of the product is important for this shelf life study. The test based on ASTM F1980-16, Accelerated aging theory.
11. Conclusions drawn from clinical and non-clinical tests submitted
SILKRO device has same indications for use and similar design and technological characteristics as the predicate device. The differences between the subject devices and the predicate device do not raise new questions of safety or efficacy. Results of performance testing demonstrated substantial equivalence of the subject device to the predicate. Therefore, the subject device is as safe and effective as previously cleared predicate device for the proposed intended use.