(172 days)
Rhytec Portrait PSR (K)060948
No
The 510(k) summary describes a standard electro-surgical device with no mention of AI, ML, image processing, or any related concepts. The performance studies are limited to bench testing of basic device parameters.
Yes
The device is used for electrocoagulation and hemostasis in surgical procedures, which are therapeutic interventions. Its effect—heating the skin to cause non-viability of the epidermis and controlled damage to the dermis—is also a direct physical treatment, characteristic of a therapeutic device.
No
The device is described as an electro-surgical device for electrocoagulation and hemostasis, which are therapeutic procedures. It is used to heat the skin for controlled damage, not to diagnose a condition.
No
The device description explicitly lists hardware components: a system console, footswitch, handpiece, and tip.
Based on the provided information, the PlaDuo device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis." This describes a device used on the patient's body during a procedure, not a device used to test samples outside the body.
- Device Description: The description details how the device works by heating the skin, which is a direct interaction with the patient's tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The PlaDuo's function is therapeutic (electrocoagulation and hemostasis) and involves direct interaction with the patient's skin.
N/A
Intended Use / Indications for Use
The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The ShenB Co Ltd PlaDuo is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin so that part or all of the epidermis becomes non-viable and there is controlled damage to the underlying dermis.
The PlaDuo system consists of a system console, footswitch, handpiece, and tip with 3 interchangeable guides.
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)
Bench Testing
ShenB conducted bench testing to assure that the PlaDuo operates safely and within the predefined design specifications. Tested parameters included: Output Energy, Durability of the tip, Thermal testing in accordance with FDA's “Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery”
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.
Potenza (K)192545
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.
Rhytec Portrait PSR (K)060948
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 14, 2020
ShenB Co. Ltd. % Connie Hoy Consultant Hoy and Associates 3916 N. Potsdam Ave #4676 Sioux Falls, South Dakota 57104
Re: K201735
Trade/Device Name: PlaDuo System Regulation Number: 21 CFR 878,4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: November 29, 2020 Received: December 1, 2020
Dear Connie Hoy:
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 Actinclude 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.
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
1
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-devices/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 (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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201735
Device Name
PlaDuo System
Indications for Use (Describe)
The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
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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510k SUMMARY
A summary of 510k safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
K201735
| 807.92(a)(1) - Submitter Information | |
|---|---|
| Name | ShenB Co Ltd. |
| Address | Shenb Bldg 148 |
| Seongsui-ro | |
| Seongdong-Gu, Seoul , KR 04796 | |
| Phone number | 82 70.4912.2702 |
| oskar@shenb.com | |
| Establishment Registration Number | 3010226575 |
| Name of contact person | Mr. Oskar Lee |
| Date prepared | June 15, 2020 |
| 807.92(a)(2) - Name of device | |
| Trade or proprietary name | PlaDuo System |
| Common or usual name | Electrosurgical, cutting and coagulation device and accessories |
| Classification name | Electrosurgical, cutting and coagulation device and accessories |
| Classification panel | General and Plastic Surgery |
| Regulation | 21 CFR 878.4400 |
| Product Code(s) | GEI |
| Regulatory Class | Class II Prescription Use |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | |
| Predicate device | Potenza (K)192545 |
| Reference device | Rhytec Portrait PSR (K)060948 |
| 807.92(a)(4) - Device description | |
| The ShenB Co Ltd PlaDuo is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin so that part or all of the epidermis becomes non-viable and there is controlled damage to the underlying dermis. |
The PlaDuo system consists of a system console, footswitch, handpiece, and tip with 3 interchangeable guides. |
| | 807.92(a)(5) Intended use of the device |
| Indications for use | The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis |
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| 807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate | |||
|---|---|---|---|
| Characteristic | Proposed Device | ||
| PlaDuo System | Predicate Device | ||
| Potenza (K)192545 | Reference Device | ||
| Rhytec Portrait PSR3 | |||
| (K)060948 | |||
| Mode of Operation | Nitrogen Gas | Radio Frequency | Nitrogen Gas |
| Principal of | |||
| Operation | Plasma energy is delivered to the | ||
| skin and energy is rapidly | |||
| transferred to the skin surface. | |||
| As the plasma energy passes | |||
| through the tissue it generates an | |||
| electrothermal reaction which is | |||
| capable of coagulating tissue. | RF energy is delivered through | ||
| the skin into the target tissue via | |||
| a handpiece equipped with an | |||
| electrode tip. As the RF energy | |||
| passes through the tissue, it | |||
| generates an electrothermal | |||
| reaction which is capable of | |||
| coagulating the tissue. | Plasma energy is delivered to the | ||
| skin and energy is rapidly | |||
| transferred to the skin surface. | |||
| As the plasma energy passes | |||
| through the tissue it generates an | |||
| electrothermal reaction which is | |||
| capable of coagulating tissue. | |||
| Frequency | 2.45Ghz | 1mHz and 2mHz | 2.45Ghz |
| Max Power (w) | 100W | 50W | 100W |
| Output Energy | 0.5 – 4J | Up to 2J | 1 – 4J |
| Repetition Rate | 1 – 3 Hz | N/A | 1 – 4 Hz |
| Emitting Time | 5 – 40ms | N/A | 5 – 40ms |
| Depth of thermal | |||
| effect | up to 400 microns | Up to 4mm | Unknown |
| Gas Requirement | Medical Grade Nitrogen | N/A | Medical Grade Nitrogen |
| Electrical Voltage | AC 100-230V/ 50/60Hz | AC 100-230V/ 50/60Hz | AC 100-240V/ 50/60Hz |
| 807.92(b)(1) NONCLINICAL TESTS SUBMITTED | |||
| Discussion of | |||
| nonclinical tests: | Biocompatibility | ||
| ShenB performed biocompatibility testing for the electrode tips according to 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. Of the PlaDuo components, only the handpiece guide |
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| table below: | ||
|---|---|---|
| Test Type | Standard | Results |
| Cytotoxicity | ISO 10993-05:2009, Biological | |
| evaluation of medical devices |
- Part 5: Tests for in vitro
cytotoxicity | Pass |
| Sensitization: Guinea Pig
Maximization Test (GPMT) | ISO 10993-10:2010, Biological
evaluation of medical devices - Part 10: Tests for irritation
and skin sensitization | Pass |
| Irritation or Intracutaneous
Reactivity [Animal
Intracutaneous (Intradermal)
Reactivity Test | ISO 10993-10:2010, Biological
evaluation of medical devices - Part 10: Tests for irritation
and skin sensitization | Pass |
Electrical Safety and electromagnetic compatibility (EMC)
Electrical safety, EMC and device-related electrical safety for high frequency were conducted on the PlaDuo system according to the following consensus standards:
- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2-12, . Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance
- IEC 60101-2-2:2017, 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 60601-1-2:2014, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances - Requirements and Tests
Software Verification and Validation Testing
Software verification and validation testing was conducted for the subject device, and documentation was provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005, commensurate with a moderate level of concern.
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| | Bench Testing
ShenB conducted bench testing to assure that the PlaDuo operates safely and within the
predefined design specifications. Tested parameters included:
• Output Energy
• Durability of the tip
• Thermal testing in accordance with FDA's “Guidance for Industry and FDA Staff:
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General
Surgery” |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 807.92(b)(2) CLINICAL TESTS SUBMITTED | |
| | No Clinical study was conducted as part of this submission. |
| 807.92(b)(3) Conclusion | |
| | The substantial equivalence of the PlaDuo is demonstrated through performance testing.
The PlaDuo has equivalent intended use, indication for use and thermal characteristics to the predicate device. |
No new questions of safety and/or effectiveness are raised as a result of the differences when compared to predicate device based on the data provided in the submission. Therefore, the PlaDuo is substantially equivalent to the legally marketed predicate device.