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510(k) Data Aggregation
(160 days)
REPROCESSED HAND ACTIVATE SEALER/DIVIDER
The Reprocessed Hand Activated Sealer/Divider can be used during open procedures to seal vessels up to and including 7mm, lymphatics and tissue bundles. The Hand Activated Sealer/Divider can also be used to seal pulmonary vasculature but only when used with the ForceTriad™ energy platform.
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 Hand Activated Sealer/Divider is an instrument that works exclusively with the ForceTriad™ energy platform (not within the scope of this submission) to seal vessels up to and including 7 mm. seal pulmonary vasculature, lymphatics and tissue bundles. The instrument's shaft diameter is 13.5 mm (oval), length is 18 cm and shaft rotation is 180 degrees.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Reprocessed Hand Activated Sealer/Divider:
Summary of Acceptance Criteria and Study Findings for Reprocessed Hand Activated Sealer/Divider
This submission is for a reprocessed device, thus the "acceptance criteria" and "device performance" are primarily focused on demonstrating that the reprocessed device performs identically to its predicate device and original intent, and that the reprocessing itself is safe and effective.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Conducted | Reported Device Performance |
|---|---|---|
| Equivalence to Predicate | Design, materials, intended use, mechanism of action, claims, clinical applications, patient population, performance specifications, method of operation. | "The design, materials, and intended use of the Reprocessed Hand Activated Sealer/Divider are identical to the predicate device." |
| "The mechanism of action... is identical to the predicate device in that the same standard mechanical design, size, and materials are utilized." | ||
| "There are no changes to the claims, intended use. clinical applications. patient population, performance specifications, or method of operation." | ||
| Reprocessing Effectiveness | Removal of adherent visible soil and decontamination. | "Ascent Healthcare Solutions' reprocessing of the Hand Activated Sealer/Divider includes removal of adherent visible soil and decontamination." |
| Functionality Testing | Appropriate function of components. | "Each individual Hand Activated Sealer/Divider is tested for appropriate function of its components prior to packaging and labeling operations." |
| Performance (Safety & Effectiveness Demonstration) | Bench and laboratory testing covering: |
- Biocompatibility
- Validation of reprocessing
- Sterilization Validation
- Function test(s)
- Packaging Validation | "Performance testing demonstrates that Reprocessed Hand Activated Sealer/Divider perform as originally intended."
"Conclusion: Ascent Healthcare Solutions concludes that the Reprocessed Hand Activated Sealer/Divider are safe, effective, and substantially equivalent to the predicate device as described herein." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific numerical sample size for the "test set" in terms of how many reprocessed devices were tested for each performance criterion.
- Sample Size: Not explicitly stated as a numerical value (e.g., "N=X devices"). The text mentions "Each individual Hand Activated Sealer/Divider is tested for appropriate function," suggesting every unit undergoes some functional testing. For other tests like biocompatibility or sterilization, it's implied that a sufficient, representative sample was used according to regulatory standards for validation, but the exact number is not provided.
- Data Provenance: The studies were conducted as "Bench and laboratory testing" by Ascent Healthcare Solutions. There is no mention of country of origin for the data or whether it was retrospective or prospective in the sense of clinical studies. Given it's a reprocessed device and the tests are focused on material, functional, and reprocessing validation, these are typical laboratory-based studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This type of submission (510(k) for a reprocessed electrosurgical device) focuses on engineering and material science testing, rather than interpretation of medical images or clinical outcomes by medical experts to establish a "ground truth." The "ground truth" here is adherence to engineering specifications and performance within established safety and effectiveness parameters, which would be assessed by engineers, quality control specialists, and possibly microbiologists. The document does not describe the use of medical experts for establishing ground truth for these tests.
4. Adjudication Method for the Test Set
N/A. As with point 3, this is not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation tasks (e.g., radiology reads) where there's subjectivity and potential disagreement. The performance tests described (biocompatibility, sterilization, function, etc.) are typically objective, pass/fail criteria and do not involve human adjudication in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is completely irrelevant for this device and type of submission. MRMC studies are used to evaluate the diagnostic performance of imaging devices or algorithms where multiple readers interpret cases. This submission is for a reprocessed surgical instrument.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
N/A. This is not an AI algorithm or a diagnostic device. It's a reprocessed surgical instrument. The device itself operates as designed (without "human-in-the-loop" once it's in use, other than being operated by the surgeon) and its performance is assessed against its original specifications and the predicate device.
7. The Type of Ground Truth Used
The "ground truth" for this submission is multifaceted, rooted in engineering specifications, established regulatory standards, and the performance characteristics of the original (predicate) device.
- Predicate Device Performance: The primary ground truth is that the reprocessed device must perform "identically" and "as originally intended" compared to the new, predicate device.
- Safety Standards: Ground truth for biocompatibility relates to accepted material safety standards.
- Sterilization Standards: Ground truth for sterilization validation relates to established industry and regulatory standards for achieving sterility (e.g., sterilization assurance level, SAL).
- Functional Specifications: Ground truth for function tests would be the original engineering specifications for force, sealing ability (e.g., vessel seal strength), electrical integrity, etc., of the new device.
8. The Sample Size for the Training Set
N/A. There is no "training set" in the context of this device. A training set is used for machine learning models. This submission describes the testing and validation of a reprocessed medical device through traditional engineering and quality control methods.
9. How the Ground Truth for the Training Set Was Established
N/A. As mentioned in point 8, there is no training set for this device.
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