(372 days)
Secret RF Smartcure applicator is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
Secret RF's High Frequency(=Radio Frequency) includes the system main body, a handpices with singleuse micro-needle type electrodes, footswitch and an LCD touch screen control panel.
The HF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the HF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the Secret RF system creates heat within the target dermal tissue via micro-needles inserted from the tip.
The Secret RF is consists of ;
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- Secret RF main unit (FDA cleared K170325)
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- Bipolar type handpieces with Bipolar type micro-needle electrodes (FDA cleared K170325)
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- Secret RF Smartcure applicator
The Secret RF Smartcure Applicator consists of :
- Smartcure handpiece
- Monopolar type micro-needle electrodes (MTR-AC-01 , MTR-AC-04, MTR-AC-27G, K3i)
The provided text describes a 510(k) premarket notification for the "Secret RF Smartcure Applicator" and details its substantial equivalence to predicate devices, but it does not contain information on acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or effectiveness data (e.g., sensitivity, specificity, accuracy).
The document focuses on:
- Regulatory Clearance: Affirming that the device is substantially equivalent to legally marketed predicate devices for dermatologic and general surgical procedures for electro-coagulation and hemostasis.
- Technical Specifications: Comparing the proposed device's technical characteristics (e.g., frequency, max power, RF duration, electrode type) with a predicate device (SecretRF K170325) and two reference devices (AGNES K160469, EVRF K112334).
- Performance Data (Non-Clinical/Pre-Clinical): Listing performed tests, which are primarily related to safety, electrical compatibility, and basic functionality:
- Biocompatibility testing (ISO10993-1;2009)
- Electrical safety and essential performance (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2: 2009)
- Animal testing (micropig models for histological data on ablation and thermal damage depth and zone at various post-treatment intervals and intensities).
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to clinical outcomes or diagnostic accuracy, as this information is not present. The "performance data" listed refers to design verification and validation testing for safety and basic function, not clinical efficacy or diagnostic performance metrics.
- Sample size used for the test set and data provenance: Not mentioned, as no clinical effectiveness study is described.
- Number of experts and their qualifications for ground truth: Not applicable, as no ground truth for labeling or diagnosing clinical conditions is discussed.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported. The document explicitly states the device's substantial equivalence is based on similarities to predicate devices and performance testing related to safety and functionality.
- Standalone performance (algorithm only): Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable in the context of clinical performance data. The animal study used histological data as an endpoint for depth and zone of ablation/thermal damage.
- Sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How ground truth for the training set was established: Not applicable.
However, based on the provided text, I can infer a type of "acceptance criteria" related to regulatory compliance and safety, and report the "performance" in terms of meeting these standards.
Inferred Acceptance Criteria and Reported Performance (based on regulatory and safety compliance):
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance / Compliance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2009 | Patient contact components and materials are tested and validated. |
| Electrical Safety & Performance | Compliance with IEC 60601-1 (General Requirements for basic safety and essential performance) | Requirements of specified standards were fulfilled. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 (General Requirements for basic safety and essential performance - collateral standards: electromagnetic compatibility) | Requirements of specified standards were fulfilled. |
| High Frequency Surgical Equipment Safety | Compliance with IEC 60601-2-2: 2009 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories) | Requirements of specified standards were fulfilled. |
| Functional Equivalence | Demonstrating similar intended use, indications for use, and technological characteristics to predicate devices. | Device has the same intended use and similar indications as predicate devices. The technology of the predicate devices is also the same. Minimal differences do not raise new safety/effectiveness issues. |
| Histological Response | Evaluation of depth and zone of ablation and thermal damage in vivo. | In vivo animal testing using micropig models conducted to obtain histological data immediately, 7 days, and 14 days post-treatment at low, mid, and high intensity. (Specific results not detailed in this summary, only that the testing was performed). |
Study Description (as reported in the document):
The document references several types of studies performed as part of the 510(k) submission, primarily for demonstrating safety and substantial equivalence, rather than clinical efficacy or diagnostic performance.
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Biocompatibility Testing:
- Description: Testing of patient contact components and materials.
- Standard: ISO 10993-1:2009.
- Data Provenance: Not specified, but generally performed in a lab setting.
- Sample Size: Not specified (refers to materials, not patients).
- Ground Truth: Adherence to the ISO standard.
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Non-Clinical (Engineering/Safety) Testing:
- Description: Evaluation of the device's electrical safety, essential performance, and electromagnetic compatibility.
- Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2: 2009.
- Data Provenance: Not specified, but generally performed in a lab setting.
- Sample Size: Not specified (typically tests on a device unit).
- Ground Truth: Compliance with the respective IEC standards.
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Animal Testing:
- Description: In vivo study to obtain histological data on depth and zone of ablation and thermal damage.
- Species: Micropig models.
- Purpose: To assess immediate, 7-day, and 14-day post-treatment effects.
- Data Provenance: Animal study. Country of origin not specified.
- Sample Size: Not specified (number of micropigs or treatment sites).
- Ground Truth: Histological analysis of tissue samples.
- Experts: Not specified, but typically includes pathologists.
- Adjudication: Not specified.
Missing Information:
Crucially, the document explicitly states this is a substantial equivalence determination for a medical device. For such submissions, extensive clinical efficacy studies with predefined acceptance criteria for patient outcomes (like those you’d expect for an AI diagnostic device's sensitivity/specificity or a pharmaceutical drug's effectiveness) are often NOT required if the device is sufficiently similar to legally marketed predicate devices. The focus is on ensuring basic safety and functional equivalence.
Therefore, the requested details related to clinical performance metrics, ground truth establishment for a diagnostic output, training sets, or human-AI comparative effectiveness studies are not present in this regulatory summary because they were likely not part of the 510(k) submission for this type of 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.