(115 days)
The reprocessed vessel sealers are indicated for use in general and gynecological, laparoscopic surgical prooedures where ligation of vasculature is desired. The reprocessed vessel sealers can be used to seal to seal to seal to seal and including 7 imm, lymphatics, and tissue bundles. The reprocessed vessel scalers can also be used to seal pulmonary vasculature when used with the ForceTriad™ energy platform.
The vessel sealers are electrosurgical instruments for use with the ForceTriad™ energy platform when performing laparoscopic procedures. The vessel sealers are capable of sealing vessels and lymphatics, grasping tissue and dissection. The vessel sealers have a 5 mm shaft diameter, 37 cm shaft length and a shaft rotation of 159 degrees. The distal end mechanism may have a blunt or dolphin nose tip.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Reprocessed Vessel Sealers:
Based on the provided information, this submission focuses on the substantial equivalence of a reprocessed medical device to its original predicate devices, rather than a novel device requiring a typical clinical study with acceptance criteria for efficacy. The "acceptance criteria" here therefore refers to demonstrating that the reprocessed device performs identically to the predicate device and meets established safety and functional standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Performance identical to predicate devices in design, materials, clinical applications, patient population, performance specifications, and method of operation. | "The reprocessed vessel sealers are identical to the predicate devices in design, materials of construction, and intended use. There are no changes to the clinical applications, patient population, performance specifications, or method of operation." |
| "Performance testing shows the reprocessed vessel sealers to perform as originally intended." | ||
| Cleaning Validation | Validation of cleaning procedures. | "Process validation testing was performed to validate the cleaning... procedures." Specific details of acceptance metrics for cleaning are not provided, but it's stated as validated. |
| Sterilization Validation | Validation of sterilization procedures (ISO 11135, USP ). | "Process validation testing was performed to validate the ... sterilization procedures." Adherence to ISO 11135 and USP implies meeting their respective sterility assurance level (SAL) requirements. |
| Biocompatibility | Assurance of biocompatibility (ISO 10993). | "Biocompatibility testing (ISO 10993)" was performed. Adherence to ISO 10993 implies meeting its requirements for biological safety. |
| Ethylene Oxide Residuals | Testing for ethylene oxide residuals (ISO 10993-7). | "Ethylene oxide residual testing (ISO 10993-7)" was performed. Adherence to ISO 10993-7 implies meeting its requirements for acceptable residual levels. |
| Packaging Validation | Validation of packaging (ASTM D.4169, ASTM F 88, ASTM F 2096). | "Packaging validation (ASTM D.4169, ASTM F 88, ASTM F 2096)" was performed. Adherence to these ASTM standards implies meeting requirements for package integrity and sterile barrier maintenance. |
| Shelf Life Validation | Validation of shelf life (ASTM 1980-07). | "Shelf life validation (ASTM 1980-07)" was performed. Adherence to ASTM 1980-07 implies meeting requirements for maintaining sterility and functionality over the declared shelf life. |
| Functional Performance | Demonstrated appropriate functional characteristics; bench testing through simulated use, visual inspection, fatigue testing, and function testing. | "Representative samples of reprocessed vessel sealers were tested to demonstrate appropriate functional characteristics." |
| "validation of functional performance (bench testing) was performed through simulated use, visual inspection, fatigue testing, and function testing." This indicates the device met pre-defined functional requirements, though specific metrics are not detailed. | ||
| Manufacturing Process | Includes visual and validated functional testing of all products produced. | "the manufacturing process includes visual and validated functional testing of all products produced." This is an ongoing quality control measure to ensure individual units meet standards. |
2. Sample Size and Data Provenance
The document does not explicitly state specific sample sizes for each non-clinical test (e.g., how many reprocessed devices were tested for cleaning validation). It refers to "Representative samples" for functional testing.
- Test Set Sample Size: Not explicitly stated for specific tests, but general reference to "representative samples."
- Data Provenance: The studies are described as internal non-clinical tests performed by Sterilmed, Inc. (submitter). The country of origin for the data is implicitly the USA, where Sterilmed is located and where the submission was made to the FDA. The data is prospective in the sense that these tests were conducted by Sterilmed for the purpose of this 510(k) submission to demonstrate equivalence.
3. Number of Experts and Qualifications for Ground Truth
This type of submission (reprocessed device) primarily relies on engineering and laboratory test standards rather than expert interpretation of clinical data or images. Therefore, the concept of "ground truth established by experts" as seen in diagnostic AI is not directly applicable here. The "experts" would be the engineers, microbiologists, and other technical specialists who conducted and validated the non-clinical tests according to established international and national standards (e.g., ISO, ASTM, USP). Their qualifications would be expertise in those particular testing methodologies and standards.
4. Adjudication Method
Not applicable. This is not a study involving human reader interpretation or clinical outcomes requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a submission for a reprocessed medical device demonstrating equivalence through non-clinical testing. It does not involve AI, human reader performance, or clinical comparative effectiveness studies in the traditional sense of a novel diagnostic or therapeutic device.
6. Standalone Performance Study
Yes, in a sense. The "standalone performance" is demonstrated through the various non-clinical tests (cleaning, sterilization, biocompatibility, functional performance, etc.) where the reprocessed device is tested in isolation against defined criteria and regulatory standards. The purpose is to show the device performs on its own, as originally intended, after reprocessing.
7. Type of Ground Truth Used
The ground truth used in this context is predominantly:
- Engineering/Performance Standards: Adherence to established performance specifications (e.g., sealing capability, fatigue resistance, visual inspection criteria, shaft rotation).
- Regulatory/Industry Standards: Compliance with international and national standards for sterility (ISO 11135, USP ), biocompatibility (ISO 10993), packaging (ASTM D.4169, ASTM F 88, ASTM F 2096), shelf life (ASTM 1980-07), and residual chemicals (ISO 10993-7).
- Predicate Device Performance: The original functional specifications and performance of the predicate Covidien LigaSure™ Laparoscopic Instruments serve as the benchmark for "as originally intended" performance.
8. Sample Size for the Training Set
Not applicable. This is a reprocessed device submission based on non-clinical testing, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model in this submission.
§ 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.