(198 days)
The Reprocessed Harmonic FOCUS™ Scalpels (hereinafter harmonic scalpel) is indicated to be used for cutting soft tissue and providing hemostasis when control of bleeding and minimal thermal injury is desired. The instrument can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
SterilMed reprocessed harmonic scalpels are used in combination with a hand piece, generator, torque wrench and grip assist and are intended to be used in soft tissue surgery for simultaneous cutting and coagulation of vessels and tissue. The instrument has a scissor handle with hand control capabilities consisting of MIN and MAX buttons. The handle housing has an integrated mechanism for limiting the force that can be applied when closing the distal mechanism. The instrument has a working length of 9 cm, an active blade of 16 mm and utilizes a curved blade and clamp arm. This device allows for the cutting and coagulation of vessels up to and including 5 mm in diameter. Note: Only the harmonic scalpel is the subject of this submission, the reusable hand piece, generator, and any other related equipment are not included in the scope of this submission.
Device Acceptance Criteria and Study Details
1. Acceptance Criteria and Reported Device Performance
The device under review is the "Reprocessed Harmonic Scalpel," and its acceptance criteria are established through a demonstration of substantial equivalence to its predicate device, the Ethicon Harmonic FOCUS™ Curved Shears (510(k) K063192). The study focuses on demonstrating that the reprocessed device performs functionally and safely as intended, aligning with the predicate device.
The acceptance criteria are not explicitly numerical thresholds for performance metrics (e.g., a specific force or cutting speed). Instead, they are defined by successful completion of a battery of non-clinical tests and functional performance evaluations, which collectively attest to the device's ability to maintain the inherent functional design, materials, indications for use, and methods of construction of the original device.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Cleaning Validation | Performed through process validation testing to validate cleaning procedures. |
| Sterilization Validation | Performed through process validation testing to validate sterilization procedures, in accordance with ISO 11135 and USP . |
| Biocompatibility Testing | Conducted in accordance with ISO 10993-1. |
| Ethylene Oxide Residual Testing | Performed in accordance with ISO 10993-7. |
| Packaging Validation | Performed in accordance with ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096. |
| Shelf Life Validation | Performed in accordance with ASTM 1980-07. |
| Functional Performance (Bench Testing) | Performed through simulated use on beef tissue, visual inspection, fatigue testing (including repeated cycling and maximum power testing), and function testing (including system checks). Performance testing shows the Reprocessed Harmonic Scalpels to perform as intended. |
| Manufacturing Process Quality Controls | The manufacturing process includes visual and validated functional testing of all products produced, ensuring appropriate functional characteristics for representative samples. |
| Substantial Equivalence to Predicate Device | Concluded based upon similarities in functional design (principles of operation), materials, indications for use, and methods of construction with the Ethicon Harmonic FOCUS™ Curved Shears (510(k) K063192). The reprocessed harmonic scalpels are substantially equivalent to Ethicon Harmonic FOCUS™ Curved Shears. |
2. Sample Size and Data Provenance (Test Set)
- Sample Size: The document states that "Representative samples of reprocessed harmonic scalpels were tested." However, the exact numerical sample size for each specific test or for the overall test set is not provided in the summary.
- Data Provenance: The study appears to be entirely retrospective in the sense that it relies on bench testing and comparisons to existing standards and predicate devices. The data provenance can be considered manufacturer-generated data (SterilMed, Inc.) as it describes internal testing and validation processes. No mention of geographical origin for the data is made, implying it was conducted in the manufacturer's testing facilities (likely in the US, given the submission to the FDA).
3. Number of Experts and Qualifications (Test Set Ground Truth)
This study does not involve human expert interpretation of medical images or diagnoses, so the concept of "experts establishing ground truth for the test set" in the context of medical image analysis is not applicable. The "ground truth" for this device is established by adherence to engineering specifications, validated test methods, and comparison to the predicate device's known performance and manufacturing standards. The validation involves certified testing against industry standards (e.g., ISO, ASTM, USP) which are developed by expert committees in their respective fields.
4. Adjudication Method (Test Set)
No adjudication method (e.g., 2+1, 3+1) is mentioned or applicable as this is not a study involving human readers making subjective assessments that require reconciliation. The assessment of performance relies on objective, quantifiable tests and adherence to established standards and specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of medical data (like imaging), comparing human reader performance with and without AI assistance. This submission pertains to a reprocessed surgical instrument, not a diagnostic AI device. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not relevant here.
6. Standalone Performance (Algorithm Only)
No, a standalone (algorithm only) performance study was not done. This device is a physical surgical instrument, not a software algorithm. Therefore, "algorithm only" performance is not applicable.
7. Type of Ground Truth Used
The ground truth used for this study is a combination of:
- Established Industry Standards: Compliance with recognized international and national standards for sterilization (ISO 11135, USP ), biocompatibility (ISO 10993-1), ethylene oxide residuals (ISO 10993-7), packaging (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life (ASTM 1980-07).
- Predicate Device Performance: The functional design, materials, indications for use, and methods of construction of the Ethicon Harmonic FOCUS™ Curved Shears (510(k) K063192) serve as the benchmark for substantial equivalence.
- Objective Functional Testing: Verified performance "as intended" through simulated use on beef tissue, visual inspection, fatigue testing, and function testing with system checks.
In essence, the ground truth is defined by the demonstrated ability of the reprocessed device to meet the safety and performance specifications of the original device and comply with relevant regulatory and technical standards.
8. Sample Size for the Training Set
This submission describes the testing and re-processing of a physical medical device. It does not involve machine learning algorithms or AI, and therefore, the concept of a "training set" is not applicable. The 'training' for this device is the established reprocessing protocol itself, and its validation.
9. How the Ground Truth for the Training Set was Established
Since there is no "training set" in the context of machine learning for this device, this question is not applicable. The "ground truth" for the reprocessing protocol itself is established through extensive engineering and scientific validation to ensure that the reprocessed device is safe, sterile, and performs identically to its new counterpart. This includes developing and validating cleaning, sterilization, and inspection methods based on scientific principles and regulatory requirements.
N/A