(106 days)
The HET Bipolar System is intended to be used for the treatment of symptomatic grade I and grade II internal hemorrhoids.
The HET™ Bipolar Forceps is a sterile, single-use bipolar forceps having a tapered tubular configuration. The device is connected via an integrated bipolar cable to the bipolar output of an electrosurgical generator. The accessory monitor displays the temperature at the forceps-tissue interface and provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET™ Bipolar Electrocautery Forceps and Monitor do not generate RF energy themselves and may be used with any Bipolar Electrosurgical generator in the coagulation power setting with an output power set at 10 W and a maximum voltage of 1250V.
This document is a 510(k) Pre-Market Notification for the HET™ Bipolar Electrocautery Forceps and Monitor. The submission states that the device is identical to its predicate device (K140422) in terms of design, materials, software, and treatment mechanism. The purpose of this 510(k) is to limit the indications for use to symptomatic grade I and grade II internal hemorrhoids and clarify that the action is tissue ligation. Therefore, the performance data presented refers to the predicate device.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
Since the subject device is identical to the predicate device and the 510(k) is primarily for clarifying indications and the mechanism of action (tissue ligation), there are no new acceptance criteria or device performance results reported for the subject device in this document. The performance data refers to the predicate device (K140422).
Based on the information for the predicate device (K140422) as referenced in this submission:
| Acceptance Criteria (Implied) | Reported Device Performance (for Predicate K140422) |
|---|---|
| Acceptable Zone of Thermal Injury | Performance testing evaluated the zone of thermal injury for the predicate device (K140422) when used with eight FDA-cleared, commercially available bipolar electrosurgical generators. The testing "confirmed that the treatment time was acceptable to allow safe treatment." |
| Acceptable Treatment Time for Safe Treatment | The testing confirmed that the treatment time was acceptable to allow safe treatment. |
| Conformance to Electromedical Safety Standards | Additional testing was provided to support conformance to the latest revision of IEC 60601-1-2:2014. |
| Biocompatibility in accordance with ISO 10993 recommendations | Biocompatibility testing was previously conducted and reported in 510(k) K121085, including cytotoxicity, intracutaneous irritation, sensitization, acute systemic toxicity, and hemocompatibility, performed on the final, finished, gamma-irradiation sterilized device and in accordance with GLP. |
| Sterility Assurance Level (SAL) | The HET™ Bipolar Forceps are sterilized with EtO to a sterility level of 10-6. |
Study Details for Predicate Device (K140422) as referenced:
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Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated in this document. The document mentions "Performance testing was conducted" to characterize the device's performance when used with "eight FDA cleared, commercially available, bipolar electrosurgical generators." The specific number of cases, tissue samples, or treatments is not provided.
- Data provenance: Not specified in this document. It's likely from laboratory or bench testing given the nature of evaluating thermal injury and treatment time. It's not stated whether it's retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the reported performance testing (zone of thermal injury, treatment time) appears to be objective, measurable parameters typically assessed through engineering and scientific methods rather than expert interpretation of images or clinical outcomes in the context of ground truth establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. The performance tests described (thermal injury, treatment time, electrical safety, biocompatibility, sterilization) are objective measurements and engineering assessments, not requiring adjudication in the context of expert case review.
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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:
- No MRMC or AI-assisted study was performed or is relevant to this device. This is a medical device for electrosurgical treatment, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For performance testing related to thermal injury and treatment time, the "ground truth" would be objective measurements (e.g., histological analysis of tissue for thermal damage depth, precise timing measurements).
- For biocompatibility, the ground truth is established by standardized biological assays (e.g., cell viability for cytotoxicity, skin reaction for irritation/sensitization).
- For sterilization, the ground truth is the measured Sterility Assurance Level (SAL).
- For electrical safety, the ground truth is conformance to the specified standard (IEC 60601-1-2:2014).
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The sample size for the training set:
- Not applicable. This is not an AI or machine learning device requiring a training set.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.