(142 days)
The Reprocessed HARMONIC 700, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, urologic, thoracic procedures, and sealing and transection of lymphatic vessels. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand control button.
The reprocessed HARMONIC 700 with Advanced Hemostasis are designed for soft tissue incisions requiring bleeding control and minimal thermal injury. The instruments serve as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in various procedures, including general, pediatric, gynecologic, urologic, and thoracic surgeries, as well as in the sealing and transection of lymphatic vessels. They enable the coagulation of vessels up to 7 mm in diameter using the Advanced Hemostasis hand control button.
The instruments are available in three (3) shaft lengths: 23cm, 36cm, and 45cm lengths (HAR723, HAR736, and HAR745 respectively). Each shaft length has a diameter of 5 mm. The following features are essential to the control and performance of the device:
- An actuating trigger that closes and releases the clamp arm, securing tissue against the scalpel rod.
- MIN/MAX control buttons that adjust energy levels between minimum and maximum modes on the generator, enabling vessel sealing up to 5 mm.
- An Advanced Hemostasis button that allows the clinician to activate an additional energy mode, enabling vessel sealing up to 7 mm.
- A rotation knob to rotate the shaft 360° unless energy is being delivered.
- A torque wrench, a sterile, single-use component, used to apply the correct amount of torque when attaching the Hand Piece to the device.
The instruments connect to a generator and hand piece, which are essential for the device's functionality but are outside the scope of this submission.
The hand piece is a reusable component that attaches to the device and plugs into the generator, allowing the device to interface with the generator. This component contains the transducer, which converts electrical power to ultrasonic mechanical energy.
The generator is a reusable component that generates the electrical signal. Colored light indicators on the front panel of the generator visually communicate device status information to the user.
This document is a 510(k) premarket notification for reprocessed medical devices, not an AI medical device. Therefore, the questions related to AI device performance, such as MRMC studies, training and test sets, ground truth establishment, and expert adjudication, are not applicable to the content provided.
However, I can extract the acceptance criteria and the study that proves the device meets those criteria from the provided text, focusing on the reprocessed medical device context.
Here's the information based on the provided FDA 510(k) letter for the Reprocessed HARMONIC 700 Shears:
1. A table of acceptance criteria and the reported device performance:
The document describes functional performance tests conducted to demonstrate safety and effectiveness. While explicit numerical acceptance criteria values are not provided, the general categories of testing imply the criteria for performance equivalence to the predicate device. The reported performance is that the device meets these criteria and is at least as safe and effective as the predicate.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Validation of Reprocessing | Demonstrated to be effective. |
| Electrical Safety and Electromagnetic Compatibility | Tested in accordance with IEC 60601-1 and IEC 60601-1-2; results deemed acceptable. |
| Functional Performance Tests: | |
| Jaw Clamp Force | Tested and found acceptable for intended function. |
| Tissue Retention Force | Tested and found acceptable for intended function. |
| Burst Pressure (for vessel sealing) | Tested and found acceptable for sealing vessels up to 7mm. |
| Maximum Jaw and Shaft Temperature | Tested and found acceptable. |
| Device Reliability | Demonstrated to be reliable. |
| ATT Functionality and Transection Time | Tested and found acceptable for intended function. |
| Biocompatibility | Previously identified and cleared materials and reprocessing methods were maintained, demonstrating continued biocompatibility. |
| Sterilization/Shelf-Life | Validated to a 10-6 sterility assurance level (SAL) through an EO sterilization process in accordance with ISO 11135. Shelf-life not explicitly detailed but implied as validated. |
| Preclinical Laboratory Evaluations (Animal Model): | |
| Thermal Spread | Tested and found acceptable. |
| Ability to achieve Hemostasis of Vessels | Tested and found acceptable for sealing vessels up to 7mm. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes (number of devices or tests) for each bench and laboratory test.
- Data Provenance: The studies were conducted as part of the manufacturer's premarket notification submission to the FDA. They are internal validation studies performed by Stryker Sustainability Solutions. The document does not specify country of origin for the data or whether it was retrospective or prospective, but these studies for 510(k) submissions are typically prospective and specifically designed for the submission.
- For the preclinical laboratory evaluations, an "animal model" was used.
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 information is not applicable to traditional reprocessing medical device submissions. Ground truth in this context is established through engineering specifications, material science, and performance testing against established standards and predicate device performance, not expert consensus on medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 refer to human expert review processes for AI model output or image interpretation, which is not relevant for this type of device submission. Device performance is determined through standardized engineering and biological tests.
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:
Not applicable. This device is a reprocessed surgical instrument, not an AI-assisted diagnostic or therapeutic device. MRMC studies are specific to evaluating human reader performance with and without AI assistance in diagnostic imaging.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm. Its performance is inherent to its physical properties and functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established by:
- Engineering specifications and design requirements: The device must meet predefined physical, mechanical, and electrical parameters.
- Performance of the original (new) predicate device: The reprocessed device must demonstrate substantial equivalence in performance to the original, legally marketed predicate device.
- Established industry standards: Compliance with standards like ISO 10993-1 (Biocompatibility) and ISO 11135 (EO Sterilization) serves as a ground truth for safety aspects.
- Preclinical (animal) studies: In vivo performance (e.g., thermal spread, hemostasis) in animal models serves as a proxy for clinical performance.
8. The sample size for the training set:
Not applicable. There is no "training set" in the context of a reprocessed medical device. The device itself is manufactured and reprocessed, not "trained" like a machine learning model.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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