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The TivaMed Cooled RF System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

TivaMed Cooled RF System uses radiofrequency (RF) energy to selectively heat a given volume of tissue beneath the surface, while cryogen is delivered to the inside of the treatment tip to cool and protect the surface tissue.

The provided text describes the TivaMed Cooled RF System, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria.

Here's a breakdown of what is and is not present in relation to your request:

1. A table of acceptance criteria and the reported device performance:

• Not present. The document mentions "functional and performance requirements" were met, but it does not specify these requirements as acceptance criteria or provide quantitative performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not present. The document states "representative samples of the device underwent biocompatibility, electrical, and mechanical testing," but it does not specify the sample size for these tests or the data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable/Not present. As there's no clinical performance study described, there's no mention of ground truth established by experts. The testing described (biocompatibility, electrical, mechanical) are engineering/bench tests, not clinical evaluations requiring expert interpretation of results in a diagnostic context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not present. No clinical test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable/Not present. This device is an electrosurgical unit, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study and AI performance improvement are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable/Not present. This is hardware, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable/Not present. For the functional and safety testing, "ground truth" would be established by adherence to the specified engineering standards (e.g., IEC 60601-1, ISO 10993-1). There is no clinical "ground truth" mentioned.

8. The sample size for the training set:

• Not applicable/Not present. This is not a machine learning or AI device that would have a training set.

9. How the ground truth for the training set was established:

• Not applicable/Not present. See point 8.

Summary of available information regarding testing:

The device underwent:

• Functional and Safety Testing:
  • Biocompatibility testing
  • Electrical testing
  • Mechanical testing
• Standards Adhered to:
  • IEC 60601-1: Medical Electrical Equipment - General Requirements for Safety
  • IEC 60601-1-2 (Likely electromagnetic compatibility)
  • IEC 60601-1-4: Medical Electrical Equipment - General Requirements for Safety - Programmable Electrical Medical Systems (though the device itself doesn't appear to be "programmable" in a complex sense, this standard covers certain aspects)
  • IEC 60601-2-2: Medical Electrical Equipment - Particular Requirements for the Safety of High Frequency Surgical Equipment
  • AAMI/ANSI/ISO 11135-1:2007: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
  • Federal Register, Volume 43, No. 122, 1978 (likely for regulatory context or specific test methods)
  • FDA "ETO, ECH, and EG Proposed Maximum Residue Limits and Maximum Limits of Exposure" (for sterilization by-products)

The conclusion is based on the device's "similarities in principles of operation, technology, materials, and indications for use" to its predicate devices, suggesting that the compliance with these standards and functional tests provides the basis for substantial equivalence, rather than a specific clinical performance study against acceptance criteria.

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The ThermaCool IIA System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The device consists of the same four principal components as the ThermaCool and The ThemaCool II as reviewed under the referenced earlier premarket notifications. The four principal components are:
The Thermage ThermaCool IIA RF Generator
The Thermage ThermaCool IIA Handpiece Connection Module
The Thermage ThermaCool IIA RF Cooling Module
The Thermage ThermaCool IIA RF Handpiece Assembly
The device generates radio frequency (RF) energy and operates in either monopolar or bipolar mode as selected by the user. The device continuously monitors output energy, treatment duration, and measured impedance. When used in monopolar mode, a commercially available dispersive patient return electrode is implemented. When used in bipolar mode, current flows via the handpiece insert tip and no dispersive electrode is needed. The handpiece attaches to the unit via an industry standard BNC type connector. As before, the intended use of the device is for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The system has been modified and now includes a heating element and a new cryogen metering valve within the handpiece. The effect of the change is improving cryogen flow characteristics in the clinical setting.

The provided text is a 510(k) premarket notification for the ThermaCool IIA device, which is an electrosurgical cutting and coagulation device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a formal clinical study with performance metrics as one might find for a novel device or software.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone).

The submission states:

• "There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation device and accessories."
• "However, voluntary standards such as in-house Standard Operating Procedures and device and accessories. Trowerer, velazary of and utilized in the production of the device."

This indicates that the manufacturer relies on internal, voluntary standards rather than externally defined performance criteria for this specific type of device in this context. The core of the 510(k) submission is to demonstrate that the ThermaCool IIA is substantially equivalent to the previously cleared ThermaCool II (K000944 & K003183), especially regarding a modification related to a heating element and cryogen metering valve to improve cryogen flow characteristics.

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