(102 days)
The reprocessed vessel sealer/dividers are intended for use in general and gynecological laparoscopic surgical procedures where ligation and division of vessels and lymph is desired.
Indications for use include general laparoscopic procedures including urologic, vascular, thoracoscopic, and gynecologic procedures where ligation of the vessels is performed. These procedures include laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectory, 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 to 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 laparoscopic general surgical procedures (as indicated) using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting.
The provided text describes a 510(k) premarket notification for a reprocessed vessel sealer, focusing on its substantial equivalence to a predicate device. The information details functional and safety testing to support this claim, rather than a clinical study evaluating AI performance or human reader improvements. Therefore, some of the requested information regarding AI-specific assessments (like MRMC studies, standalone AI performance, or training set details) will not be present in this document.
Here's an breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of "acceptance criteria" alongside specific "reported device performance" values for each criterion in a quantitative format as one might expect for a typical diagnostic device study. Instead, it lists the types of tests performed and generally states that the device performs "as originally intended."
| Acceptance Criteria Category (Derived) | Stated Performance / Testing Focus |
|---|---|
| Cleaning & Sterilization | Process validation performed to validate cleaning and sterilization procedures. |
| Specific tests: Cleaning validation, Sterilization validation (ISO 11135, USP ), Ethylene oxide residual testing (ISO 10993-7). | |
| Packaging & Shelf-life | Process validation performed for device packaging. |
| Specific tests: Packaging validation (ASTM D4169, ASTM F88, ASTM F2096), Shelf-life validation (ASTM 1980-07). | |
| Functional Performance | Functional testing performed through simulated use, visual inspection, and fatigue testing. Manufacturing process includes visual and validated functional testing of all products. |
| Specific tests: Electrical Safety (IEC 60601-2-2), Device Functionality, Vessel Seal Burst (Static and Burst Pressure), Vessel Seal Thermal Spread, Mold Stress, Drop, Spillage, Push. | |
| Reported Outcome: "Performance testing shows the reprocessed vessel sealers to perform as originally intended." and "The reprocessed vessel sealer has the same technological and performance characteristics as the predicate, K130744." | |
| Biocompatibility | Ethylene oxide residual testing (ISO 10993-7) implies compliance with biocompatibility standards related to sterilization residuals. (No explicit statement of full biocompatibility testing beyond residual testing from what is provided). |
2. Sample size used for the test set and the data provenance
The document states: "Representative samples of reprocessed devices were tested to demonstrate appropriate functional characteristics." It does not specify the exact sample size for any of the test sets (e.g., number of devices used for burst pressure, thermal spread, or fatigue testing).
The data provenance is from non-clinical tests performed by SterilMed, Inc. (and Libra Medical Inc. for contact purposes). This is a manufacturer's submission for regulatory approval, implying the data was generated internally for this purpose. The country of origin for the testing would presumably be the country of the manufacturing/testing facility, which is stated as "11400 73rd Avenue North Maple Grove, MN 55369" (USA). The testing is retrospective in the sense that it's performed on batches of reprocessed devices to demonstrate consistent quality and performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The "ground truth" for this type of device (a reprocessed surgical instrument) is established through engineering and scientific performance testing against defined physical and electrical standards, not through expert clinical consensus as would be common for diagnostic or AI-driven devices.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads) where experts may disagree, requiring a method to reach a consensus "ground truth." For engineering performance tests, the results are quantitative and objective, not subject to expert disagreement requiring adjudication in this context.
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
No, an MRMC comparative effectiveness study was not done. This submission is for a reprocessed electrosurgical device, not an AI-based diagnostic tool or system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This device does not involve an algorithm or AI.
7. The type of ground truth used
The ground truth used for this device is based on engineering standards, physical measurements, and compliance with predicate device performance characteristics. This includes:
- Pre-defined physical and electrical specifications (e.g., IEC 60601-2-2 for electrical safety).
- Validation against established protocols for cleaning, sterilization, packaging, and shelf-life (e.g., ISO 11135, USP , ISO 10993-7, ASTM D4169, ASTM F88, ASTM F2096, ASTM 1980-07).
- Functional performance benchmarks, such as vessel seal burst pressure, thermal spread, and mechanical integrity, designed to demonstrate equivalence to the original (predicate) device's intended performance.
8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reason as point 8.
§ 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.