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510(k) Data Aggregation
(107 days)
HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM
The HET™ Bipolar Electrocautery Forceps and Monitor is intended to be used for grasping, manipulating and coagulating soft tissue during general surgery.
The HET™ Bipolar Electrocautery Forceps and Monitor may 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 provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET Systems HET™ Bipolar Electrocautery Forceps and Monitor may be used with any Bipolar Electrosurgical generator in the coagulation mode with an output power set at 10 W and a maximum voltage of 1250v.
The monitor displays the temperature at the forceps-tissue interface. The HET" Monitor does not generate RF energy.
The provided document describes the HET™ Bipolar Electrocautery Forceps and Monitor (K140422). However, it is a 510(k) summary for a submission aiming to demonstrate substantial equivalence to a predicate device (K121085). This document primarily discusses performance testing related to equivalence with the predicate and does not detail specific acceptance criteria or an independent study to "prove the device meets acceptance criteria" for a novel device approval.
Instead, the submission focuses on demonstrating that the new device, when used with various electrosurgical generators, performs comparably to the predicate device.
Here's an analysis based on the information provided, highlighting what is (and isn't) present:
1. Table of acceptance criteria and reported device performance:
The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it refers to performance testing done to show equivalence to the predicate device. The key performance evaluations were:
| Performance Aspect | Reported Device Performance |
|---|---|
| Zone of thermal injury | Studies were conducted in an ex vivo tissue model to evaluate the zone of thermal injury. The implication is that the results were comparable to the predicate device to support substantial equivalence. (No specific numerical values or acceptance ranges are provided). |
| Treatment time | Studies in an ex vivo tissue model confirmed that the treatment time was "acceptable to allow safe treatment." (No specific numerical values or acceptance ranges are provided). |
| Biocompatibility | Previously conducted and reported in the 510(k) Notice for the predicate (K121085). Because the devices are the same, the information is applicable. Included cytotoxicity, intracutaneous irritation, sensitization, acute systemic toxicity, and hemocompatibility, all conducted in accordance with ISO 10993 and GLP requirements. The implication is that these met acceptance criteria at the time of the predicate's clearance. |
| Software Validation | Previously conducted and reported for the predicate (K121085). Applicable to the current device due to identicality. |
| Electrical Safety | Previously conducted and reported for the predicate (K121085). Applicable to the current device due to identicality. |
| Clinical Performance (Predicate Device) | Human clinical evaluations for the predicate device (K121085) demonstrated outcomes substantially equivalent to clinical outcomes reported in the literature for an additional predicate device. This is referenced as supporting the predicate device's clinical performance, which the current device is equivalent to. |
Since this is a 510(k) for substantial equivalence of an unchanged device but with an expanded compatibility claim (use with any bipolar electrosurgical generator), the "study that proves the device meets the acceptance criteria" is implicitly the suite of tests performed to show that the device performs equivalently to the already cleared predicate device across various compatible generators.
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not specified. The document states "a series of studies (in an ex vivo tissue model)" but does not provide details on the number of samples or repetitions.
- Data provenance: Ex vivo tissue model. No country of origin is specified for the ex vivo studies. It's a combination of "retrospective" (referencing prior predicate studies) and "prospective" (new ex vivo studies specifically for this submission to test compatibility with various generators). The human clinical data mentioned refers to the predicate device and is therefore also retrospective for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable / not specified. The studies cited are primarily engineering/performance tests on ex vivo tissue models (thermal injury, treatment time) and biocompatibility tests. These types of tests do not typically involve human experts establishing a "ground truth" in the way clinical studies or diagnostic AI studies do. The clinical outcomes mentioned refer to the predicate device and are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable / not specified. Adjudication methods are relevant for subjective assessments, typically in clinical or diagnostic studies. The performance tests described (thermal injury, treatment time, biocompatibility, electrical safety) are objective measurements.
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 a surgical tool, not a diagnostic AI system with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the ex vivo performance testing (thermal injury, treatment time): The "ground truth" is based on direct physical measurements (e.g., assessing tissue damage, timing procedures).
- For biocompatibility, software, and electrical safety: These are based on established standards (ISO 10993 for biocompatibility) and engineering validation.
- For clinical performance (referenced for the predicate device): The ground truth was clinical outcomes, compared to literature.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, this is not an AI/machine learning device.
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