(168 days)
The reprocessed vessel sealer/dividers are bipolar electrosurgical instruments intended for use with the ForceTriad™ Energy Platform in general, minimally invasive and open surgical procedures where ligation and division of vessels and lymphatics is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymphatics) interposed between the iaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.
Indications for use include general open and minimally invasive procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The reprocessed vessel sealer/dividers can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.
The reprocessed vessel sealer is a sterile, hand-held bipolar RF electrosurgical instrument designed exclusively for use with the ForceTriad™ energy platform (generator) to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during general surgical procedures (as indicated), laparoscopic or open, using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws without having to latch the lever, which includes a clicking mechanism that indicates to the user that the jaws are in the grasping zone, a button (switch) to activate the LigaSureTM mode by closing the handle against the button (switch) for vessel sealing, and a trigger to actuate an independent cutting blade.
This document describes the regulatory clearance for reprocessed vessel sealers (device name: Reprocessed Vessel Sealers, models LF1737 and LF1723) which are electrosurgical instruments. The submission aims to demonstrate substantial equivalence to predicate devices (Covidien LigaSure™ 5 mm, Maryland Jaw Sealer/Dividers, K133338).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance values in the way one might expect for an AI/CADe device. Instead, the acceptance criteria are implicitly defined by a series of non-clinical tests designed to demonstrate that the reprocessed devices perform as intended and are safe and effective, similar to the original predicate devices. The reported device performance is generally stated as achieving compliance with these tests.
However, based on the "Summary of Non-Clinical Tests Conducted" section, we can infer the following:
| Acceptance Criteria (Inferred from Tests) | Reported Device Performance (Summary) |
|---|---|
| Cleaning Validation: | Validated cleaning procedures. |
| Sterilization Verification: | Validated sterilization procedures. |
| Ethylene Oxide Residual Testing: | Compliant with ISO 10993-7. |
| Packaging Validation: | Compliant with ASTM D4169, ASTM F88, ASTM F2096. |
| Shelf-Life Validation: | Compliant with ASTM 1980-07. |
| Visual Inspection: | Part of manufacturing process and bench testing to demonstrate appropriate functional characteristics. |
| Fatigue Testing: | Performed as part of functional performance (bench testing). |
| Electrical Safety: | Testing performed. |
| Device Functionality: | Testing performed. |
| Vessel Seal Burst (Static and Burst Pressure): | Testing performed. Performance shows reprocessed vessel sealers perform as originally intended. |
| Vessel Seal Thermal Spread: | Testing performed. |
| EMC: | Testing performed. |
| Mold Stress: | Testing performed. |
| Drop: | Testing performed. |
| Spillage: | Testing performed. |
| Push: | Testing performed. |
| Biocompatibility: | Testing performed for Cytotoxicity, Pyrogen, Thrombogenicity, Irritation, Acute Toxicity, Immune Response, Hemolysis, Sensitization. |
Overall Conclusion: "Performance testing shows the reprocessed vessel sealers to perform as originally intended." and "Sterilmed concludes that the reprocessed vessel sealers are safe, effective, and substantially equivalent to the predicate devices..."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions that "Representative samples of reprocessed devices were tested" for various functional and safety characteristics. However, specific sample sizes (e.g., number of devices, number of seals, number of tests for each parameter) for each test are not provided.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be bench and laboratory testing performed by the manufacturer/reprocessor (Sterilmed, Inc., located in Minnesota, USA). The nature of these tests (cleaning, sterilization, packaging, functional performance, biocompatibility) indicates they are prospective tests performed on manufactured devices, not retrospective data analysis from clinical cases.
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)
This section is not applicable as the device is a reprocessed surgical instrument, not an AI/CADe device or diagnostic tool that requires expert human interpretation to establish ground truth for a test set. The "ground truth" for this device's performance is established by objective engineering and safety standards (e.g., burst pressure thresholds, sterility levels, biocompatibility profiles) and comparison to the performance of the original device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving human readers or AI outputs. The tests described are objective engineering and laboratory tests where the outcome is determined by adherence to a predefined standard or measurement, not by expert consensus or adjudication.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic performance, especially for AI-assisted image interpretation. The device in question is a reprocessed surgical instrument, and its performance is evaluated through bench testing and safety assessments, not through human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is not an algorithm or AI system. It is a physical medical instrument. Therefore, the concept of "standalone (algorithm only)" performance does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on objective engineering standards, validated laboratory testing protocols, and comparison to the established performance of the original, new device. For example:
- Sterility: Absence of microorganisms, verified by sterilization indicators and microbial testing.
- Ethylene Oxide Residuals: Concentrations below a specified limit (ISO 10993-7).
- Mechanical Functionality: Ability to open, close, grasp, seal, and cut within specified force ranges and dimensions, often compared to the original device's specifications.
- Vessel Seal Burst Strength: Ability to withstand a certain pressure without leaking (e.g., specified kPa or mmHg).
- Electrical Safety: Compliance with electrical safety standards (e.g., leakage current, insulation).
- Biocompatibility: Absence of adverse biological reactions (cytotoxicity, irritation, etc.) validated through in vitro and in vivo tests.
Essentially, the ground truth is established by meeting predefined scientific and engineering thresholds that demonstrate the device is safe and performs identically or equivalently to the original device.
8. The sample size for the training set
This section is not applicable. The device is a physical reprocessed medical instrument, not an AI model. Therefore, there is no "training set" in the context of machine learning. The "training" for the reprocessing procedures involves process validation and adherence to established protocols for cleaning, sterilization, and functional testing.
9. How the ground truth for the training set was established
This section is not applicable as there is no "training set" in the machine learning sense. However, if one were to loosely interpret "training set" as the data that informed the reprocessing procedures and quality checks, then the "ground truth" for establishing these procedures would be derived from:
- Regulatory standards: Follow FDA guidelines and relevant international standards (e.g., ISO for sterilization, biocompatibility).
- Manufacturer's specifications: Understanding the original device's design, materials, and performance requirements.
- Scientific and engineering principles: Applying established methods for cleaning, disinfection, sterilization, and material compatibility.
- Validation studies: Performing rigorous studies to prove that the reprocessing methods consistently achieve the desired outcomes (e.g., sterility, functionality).
The "ground truth" in this context is the successful demonstration that the reprocessed device can consistently meet the same safety and performance characteristics as the new, original device.
§ 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.