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K Number
K213612
Device Name
SYLFIRM X
Manufacturer
VIOL Co., Ltd.
Date Cleared
2022-06-23

(220 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K200185
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SYLFIRM X™ is intended for use in dermatologic procedures for electrocoagulation and hemostasis.

Device Description

The SYLFIRM X™ includes a system main device, a hand-piece equitable with a bi-polar electrode, and a foot switch. The RF signal is generated from the main device which is then delivered to the handpiece and then to bi-polar electrode. The RF signal is delivered to the target tissue using penetrating needle electrodes in the consumable tip. The bi-polar electrode is placed in light contact with the epidermis while the hand-piece is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, SYLFIRM X™ creates heat within the target skin tissue via needle electrodes from the bi-polar electrode.

AI/ML Overview

The provided text describes the Sylfirm X, an electrosurgical cutting and coagulation device. The document is a 510(k) summary submitted to the FDA for market clearance. It doesn't contain information about AI or machine learning algorithms, so there are no acceptance criteria, performance metrics, or study details related to such technologies.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (also Sylfirm X, K200185) for its intended use in dermatologic procedures for electrocoagulation and hemostasis.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert ground truth, or MRMC studies because the provided text is for a medical device that does not involve AI/ML.

However, I can extract information regarding the device's performance testing for general safety and efficacy:

Device Performance Testing (Preclinical):

  • Study Design: The study evaluated the safety and effectiveness of SYLFIRM X™ as a radiofrequency (RF) heating device to treat dermal conditions and hemostasis.
  • Sample Size: Three (3) Yucatan Mini-pigs were used.
  • Observation Periods:
    • Animal G1: Euthanized 3 hours after treatment on Day 1.
    • Animal G2: Euthanized on Day 5.
    • Animal G3: Euthanized on Day 22.
  • Findings:
    • Gross Observations: No erythema or edema formation observed within 1-hour post-treatment or at any other scheduled time points on any animals.
    • Microscopic Findings:
      • Animals euthanized on Days 1 and 5: Minimal to moderate, multifocal deep dermal collagen necrosis.
      • Animal euthanized on Day 22: Minimal to mild multifocal deep dermal fibrosis.
  • Conclusion: Test results, including histology data, demonstrated that the subject device is substantially equivalent to the predicate devices in the market for its intended use.

Additional Tests Conducted to support substantial equivalence (not AI/ML related):

  1. Sterilization Validation Test: Verified sterility assurance level (10-6) for EO sterilization using the biological indicator (BI) overkill method, in accordance with ISO 11135-1, ISO 10993-1, ISO 10993-7, ISO 11138-1, ISO 11138-2, ISO 11737-1, ISO 11737-2, AAMI TIR 15, and ISO 13485:2016.
  2. Shelf-life Validation Test: Conducted using the accelerated aging method in accordance with ASTM F1980-07 (2011) and referenced standards ISO 11607-1, ISO 11607-2, ISO 11737-2, ASTM F1929, ASTM F 88, and USPNF.
  3. Biocompatibility Test: Performed on the patient-contacting component (J25BM) in accordance with ISO 10993-5, ISO 10993-10, ISO 10993-11, and USP 38 .
  4. Software Validation Test: Performed for the device's firmware, which was determined to have a "moderate" level of concern.
  5. EMC & Electrical Safety Test: Evaluated according to IEC 60601-1:2005, IEC 60601-1:2012, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-2-2:2017, CISPR 11:2009/AMD1:2010, and IEC 60601-1-2:2014.
  6. Verification (for new accessories): Performance tests were done to confirm the same performance for added bi-polar tips (J25BM, J25BS, J18BS).

Note: The document only lists the types of tests performed and their general conclusions (e.g., "demonstrated that the subject device is substantially equivalent"). It does not provide specific numerical acceptance criteria (e.g., "sensitivity must be >X%") or quantitative results. The standard for a 510(k) clearance is to demonstrate substantial equivalence to a predicate device, not necessarily to meet specific quantitative performance benchmarks as would be expected for a novel AI/ML device.

§ 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.