Search Results
Found 2 results
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.
Ask a specific question about this device
(224 days)
HET BIPOLAR LIGATOR SYSTEM
The HET™ Bipolar Electrocautery Forceps and Monitor are 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 accessory monitor provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET Bipolar Electrocautery Forceps and Monitor may be used with the CONMED HYFRECATOR® 2000 or VALLEYLAB SURGISTAT II RF energy generators.
The HET™ Bipolar Electrocautery System is comprised of the HET™ Bipolar Forceps and the HET™ Monitor.
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.
When connected to the HET™ Monitor, the HET™ Bipolar Forceps has an integrated tissue illumination feature and a temperature probe. The HET™ Monitor is an accessory that can be used only with the HET™ Bipolar Forceps when used in conjunction with the CONMED HYFRECATOR® 2000 or the VALLEYLAB SURGISTAT II RF generators. The monitor displays the temperature at the forceps-tissue interface. The HET™ Monitor does not generate RF energy.
The provided 510(k) summary for the HET™ Bipolar Electrocautery Forceps and Monitor (K121085) does not explicitly detail acceptance criteria in a quantitative table or the specific performance metrics used in the human clinical evaluations. The information focuses on establishing substantial equivalence to predicate devices rather than proving a set of pre-defined acceptance criteria with specific performance values.
However, based on the description, we can infer the intent of the acceptance criteria was to demonstrate clinical performance "substantially equivalent to clinical outcomes reported in the literature for the predicate IRC device" for the treatment of symptomatic Grade I and Grade II internal hemorrhoids, and general grasping, manipulating, and coagulating soft tissue.
Below is an attempt to structure the requested information based on the available text, with caveats regarding the missing specifics:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Inferred from substantial equivalence) | Reported Device Performance |
|---|---|---|
| Clinical Efficacy for Symptomatic Grade I & II Internal Hemorrhoids | Clinical outcomes demonstrating similar efficacy to the Redfield Infrared Coagulator (K950836) as reported in literature. | The two human clinical evaluations "demonstrated outcomes substantially equivalent to clinical outcomes reported in the literature for the predicate IRC device." |
| Tissue Coagulation (General Surgery) | Effective grasping, manipulating, and coagulating soft tissue during general surgery. | This is stated as an intended use, implicitly confirmed by substantial equivalence. |
| Safety (Biocompatibility, Electrical Safety) | Meeting established standards for biocompatibility and electrical safety. | "Biocompatibility studies, software validations, and electrical safety studies were conducted and reported in the 510(k) Notice for the predicate HET Systems device [K110143]. Because the two devices are essentially the same, the information reported for the predicate HET device is applicable." |
| In Vivo Performance | Performance comparable to the predicate device in an animal model. | "A study (in an animal model) was conducted to evaluate the in vivo performance and histological effects of the device as compared to the predicate device [K110143]." |
2. Sample Size Used for the Test Set and Data Provenance
- Human Clinical Evaluations: Two human clinical evaluations were conducted. The specific sample size for these studies is not provided in the summary.
- Data Provenance: The origin of the data (country of origin, retrospective or prospective) for the human clinical evaluations is not specified.
- Animal Model Study: One animal model study was conducted. The specific sample size (number of animals) is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. The context of "substantially equivalent to clinical outcomes reported in the literature" suggests a comparison to published data, but it doesn't detail how ground truth for the specific clinical evaluations conducted was established or by whom.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary. Given the focus on substantial equivalence to literature outcomes, a formal adjudication process for the conducted human studies is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This review is for an electrosurgical device, not an AI-powered diagnostic or imaging interpretation device. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance was not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is an electrosurgical device with a monitor displaying temperature. It is not an algorithm-only device, and standalone algorithm performance is not applicable. The device is intended for human-in-the-loop operation.
7. Type of Ground Truth Used
- Clinical Efficacy (Human Clinical Evaluations): The ground truth for the human clinical evaluations appears to be clinical outcomes observed in patients and compared to published literature on the predicate IRC device.
- In Vivo Performance: The ground truth for the animal study involved evaluating "in vivo performance and histological effects."
8. Sample Size for the Training Set
This is an electrosurgical device, not a machine learning or AI algorithm in the context of device approval. Therefore, the concept of a "training set" for an algorithm is not applicable. The device's design and manufacturing rely on engineering principles, material science, and established medical device testing, not data-driven machine learning models.
9. How the Ground Truth for the Training Set was Established
As explained above, the concept of a "training set" and its associated ground truth is not applicable to this type of medical device for regulatory approval.
Ask a specific question about this device
Page 1 of 1