(261 days)
The Harmonic HD 1000i Shears instrument is 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, plastic, pediatric, gynecologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis.
The HARMONIC HD 1000i Shears are sterile, single-patient use devices for the dissection, grasping, coagulation, and cutting of soft tissue between the blade and clamp arm. The device consists of an ergonomic grip housing assembly with two-hand control buttons: 1) Energy button for power levels 1-5, and 2) Energy with Advanced Hemostasis button for large vessel sealing. The device is available in two shaft lengths (20 cm and 36 cm), and both device shafts can be rotated continuously to facilitate visualization and access to targeted tissue. An integrated audible and tactile mechanism in the grip housing indicates full trigger closures. The device has a clamp arm and coated curved blade that is designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The Energy button is indicated for vessels up to 5 mm in diameter. When the Energy button is used, cutting speed is the fastest. The Energy with Advanced Hemostasis button is designed for larger vessels and is indicated for vessels up to 7 mm in diameter. When the Energy with Advanced Hemostasis button is used, cutting speed is reduced and hemostasis is maximized. The device utilizes Adaptive Tissue Technology (the technological characteristics of which were first cleared under K120729 on May 17, 2012 and incorporated into multiple Ethicon devices). This provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output, as well as provide audible feedback to the user as appropriate. The HARMONIC HD 1000i Shears are designed for use exclusively with the Ethicon Generator 11 (GEN 11), last cleared under K160554 on September 9, 2016.
Here's a breakdown of the acceptance criteria and study information for the HARMONIC HD 1000i Shears, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
This document primarily describes a substantial equivalence submission, meaning the acceptance criteria are largely based on demonstrating that the new device (HARMONIC HD 1000i Shears K191555) is as safe and effective as a legally marketed predicate device (HARMONIC HD 1000i Shears K160752). Therefore, "acceptance criteria" here refers to the aspects of the device that need to match or perform equivalently to the predicate. The "reported device performance" is implicitly that the subject device is substantially equivalent across these characteristics.
| Acceptance Criteria (Characteristic/Specification) | Reported Device Performance (Subject Device K191555 vs. Predicate K160752) |
|---|---|
| Product Code | Same |
| Sterility Method | Same |
| Sterility Assurance Level | Same |
| Patient Use | Same |
| Maximum Power | Same |
| Maximum Voltage | Same |
| Maximum Current | Same |
| Blade Frequency | Same |
| Blade Amplitude – HARHD20 | Same |
| Blade Amplitude – HARHD36 | Same |
| Shaft Diameter | Same |
| Active Blade Length | Same |
| Blade Design/Geometry | Same |
| Shaft Lengths | Same |
| Packaging | Same |
| Energy Activation Method | Same |
| Maximum Indicated Vessel Size (up to 7mm) | Same |
| Handle Type | Same |
| Identification | Same |
| Compatible Generator | Same (Ethicon Generator 11) |
| Modality | Same |
| Available Generator Tones | Same |
| Energy Buttons | Same |
| Energy Buttons for Advanced Hemostasis | Same |
The document states: "Minor design modifications have been made to improve device performance. The fundamental technological characteristics (ie, design, material, chemical composition, energy source) of the HARMONIC HD 1000i Shears are equivalent to the predicate." and "Performance Data: Minor design modifications have been made to improve device performance. Verification testing for the design modifications was provided to demonstrate safety and effectiveness."
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a "test set" in the context of an independent performance study with defined metrics. Instead, it refers to "Verification testing for the design modifications" that was provided to demonstrate safety and effectiveness.
- Sample Size: Not explicitly stated for any specific test sets.
- Data Provenance: Not specified, but generally, premarket submissions like this would involve internal company testing. The document does not indicate country of origin or whether data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not mention the use of external experts or the establishment of ground truth by experts for the purpose of a study to evaluate the device's performance against specific clinical outcomes or diagnoses. The submission focuses on demonstrating substantial equivalence based on engineering and performance characteristics compared to a predicate device.
4. Adjudication Method
As there's no mention of a study involving expert review or a "test set" requiring adjudication of results, an adjudication method is not discussed in this document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not mentioned or described in the provided document. The submission is for a surgical instrument, not an AI/imaging diagnostic device where such studies are common.
6. Standalone Performance Study (Algorithm Only)
A standalone performance study (algorithm only) was not mentioned or described. This device is a physical surgical instrument, not a software algorithm.
7. Type of Ground Truth Used
For this 510(k) submission, the "ground truth" implicitly refers to the established performance and safety profile of the predicate device (HARMONIC HD 1000i Shears K160752). The new device is deemed acceptable because it maintains or improves upon these characteristics. The supporting data would be engineering tests and comparative data, rather than expert consensus on clinical findings, pathology, or outcomes data from independent clinical trials.
8. Sample Size for the Training Set
The document does not mention a "training set" as this is not an artificial intelligence/machine learning submission. If "training set" were interpreted as data used during the R&D phase to develop the minor design modifications, that information is not provided.
9. How Ground Truth for the Training Set Was Established
Since a "training set" in the context of AI/ML is not applicable, the method for establishing its ground truth is not discussed in the document.
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