(592 days)
The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The POTENZA is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis. The POTENZA generates radiofrequency (RF) energy by means of high RF at IMHz or 2MHz. The 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. The POTENZA has two operating modes: monopolar mode and bipolar mode.
The provided text is a 510(k) Summary for the POTENZA device, which is an electrosurgical cutting and coagulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (also named POTENZA, K201685) rather than presenting a study to prove acceptance criteria for a new device.
The "acceptance criteria and reported device performance" in this context refer to the performance standards and test results that show the modified device is substantially equivalent to the previously cleared predicate device.
Here's an analysis of the provided information, framed to address your request as best as the document allows:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study. Instead, it details various tests performed to demonstrate that the changes made to the device (new electrode tips) do not raise new questions of safety or effectiveness and that the device continues to conform to applicable standards. The "reported device performance" are the results of these tests, which consistently show "Pass."
| Test Type | Standard / Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing (for new electrode tips) | ||
| Cytotoxicity | ISO 10993-05:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (Implied acceptance: pass cytotoxicity assessment) | Pass |
| Sensitization: Guinea Pig Maximization Test | ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (Implied acceptance: no sensitization) | Pass |
| Irritation or Intracutaneous Reactivity | ISO 10993-23: Biological Evaluation of Medical Devices: Test for irritation, 2021 (Implied acceptance: no irritation/reactivity) | Pass |
| Acute Systemic Toxicity | ISO 10993- 11: Biological Evaluation of Medical Devices- Part 11: Tests for Systemic Toxicity, 2017 (Implied acceptance: no acute systemic toxicity) | Pass |
| Material Mediated Pyrogen Test | ISO 10993- 11: Biological Evaluation of Medical Devices- Part 11: Tests for Systemic Toxicity, 2017 (Implied acceptance: no pyrogenic response) | Pass |
| In-vitro Hemolysis Test direct contact method | ISO 10993-04: Biological Evaluation of Medical Devices - Part 04, Selection of Tests for Interactions with Blood, 2017/ ASTM F 756-17 (Standard Practice for the Assessment of Hemolytic Properties of Materials) (Implied acceptance: no hemolysis) | Pass |
| In-vitro Hemolysis Test Indirect Method | ISO 10993-04: Biological Evaluation of Medical Devices - Part 04, Selection of Tests for Interactions with Blood, 2017/ ASTM F 756-17 (Implied acceptance: no hemolysis) | Pass |
| Electrical Safety and Electromagnetic Compatibility (EMC) | ||
| Electrical Safety | IEC 60601-2-2:2017 (Implied acceptance: conformance to standard) | Conforms |
| EMC | IEC 60601-1-2:2014 (Implied acceptance: conformance to standard) | Conforms |
| Bench Testing | ||
| Output accuracy (Monopolar at 1MHz and 2 MHz) | Predefined design specifications (Implied acceptance: within specified accuracy range) | Conforms |
| Output accuracy (Bipolar at 1MHz and 2MHz) | Predefined design specifications (Implied acceptance: within specified accuracy range) | Conforms |
| Frequency: manual and standard | Predefined design specifications (Implied acceptance: correct frequency output) | Conforms |
| Power fluctuation characteristics | Predefined design specifications (Implied acceptance: stable power output) | Conforms |
| Negative output protection | Predefined design specifications (Implied acceptance: protection functions correctly) | Conforms |
| Impedance measurement accuracy and range | Predefined design specifications (Implied acceptance: accurate measurement within range) | Conforms |
| HO count accuracy | Predefined design specifications (Implied acceptance: accurate count) | Conforms |
| Safety test of various warnings / failsafe mechanisms | Predefined design specifications (Implied acceptance: warnings/failsafes function correctly) | Conforms |
| Needle depth | Predefined design specifications (Implied acceptance: accurate needle depth) | Conforms |
| Motor speed level | Predefined design specifications (Implied acceptance: correct motor speed) | Conforms |
| Ex Vivo testing (Thermal testing) | Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, August 15, 2014 (Implied acceptance: consistent thermal effects for electrocoagulation/hemostasis) | Conforms |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify exact sample sizes for each test (e.g., number of devices tested for electrical safety, number of tissue samples for ex vivo testing). For biocompatibility, it states "four newly added electrode tips" were tested, but not the number of samples for each biological test. For ex-vivo testing, it mentions "three types of tissue Liver, Kidney and Muscle," but not the quantity of each.
- Data Provenance: The tests were conducted by Jeisys Medical Inc., the manufacturer. The data is retrospective in the sense that it was generated for this regulatory submission. Country of origin for the data is implied to be South Korea, where Jeisys Medical Inc. is based. The tests were laboratory (bench) and ex-vivo animal tissue tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission relies on performance against recognized standards and technical specifications for electrosurgical devices, rather than human expert-established ground truth for a diagnostic AI algorithm. The device is a physical instrument, not an AI or diagnostic software.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often in diagnostic contexts. The tests described are objective, physical, electrical, and biological performance tests against defined standards.
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. This device is an electrosurgical tool, not an AI-assisted diagnostic or interpretation system. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. Its performance is evaluated through bench testing and ex-vivo studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed consists of:
- Specified limits/ranges within recognized consensus standards (e.g., ISO 10993 series, IEC 60601 series).
- The device's own predefined design specifications for parameters like output accuracy, frequency, power, impedance, needle depth, motor speed, etc.
- The expected biological responses for biocompatibility (e.g., no cytotoxicity, no sensitization).
- Expected thermal effects consistent with electrocoagulation and hemostasis in ex-vivo tissue.
8. The sample size for the training set
Not applicable. No AI/machine learning model is described, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, the establishment of its ground truth is not relevant.
§ 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.