(103 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 a sterile, single patient use device used for dissection, grasping, coagulation, and cutting between the blade and clamp arm. It 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 closure. 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 blade used in the HARMONIC HD 1000i Shears has a slightly different blade design than that of the predicate device, the HARMONIC ACE+Shears with Advanced Hemostasis (cleared under K132612 on October 17, 2013), and is also slightly longer and more tapered than the predicate device. Additionally, two dashes have been added to the device which are intended to represent relative vessel size. The distal/front Energy button is indicated for vessels up to 5 mm in diameter. The Energy with Advanced Hemostasis button (the Green button), which is found on the side of the device handle, is designed for larger vessels and is indicated for vessels up to 7 mm in diameter. The device utilizes Adaptive Tissue Technology (the technological characteristics of which were first cleared under K120729 on May 17, 2012). This technology provides the generator with the ability to identify and monitor the instrument during use. The HARMONIC HD 1000i Shears are designed for use exclusively with the Ethicon Generator 11 (GEN11).
The provided text describes the HARMONIC HD 1000i Shears. Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance & Adjudication method
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes various tests performed and states that the "Data generated from the bench testing met the predetermined acceptance criteria" and that "the results of the acute/survival studies demonstrated that the tissue effects were not different than the predicate device."
Here's an attempt to structure the information into a table format based on the descriptions:
| Test / Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance | Adjudication Method |
|---|---|---|---|
| Sterilization | Sterilized to the same sterility assurance level as the predicate device. | Both the subject and predicate devices are sterilized via ethylene oxide and to the same sterility assurance level. | Not explicitly stated, but implicitly a pass/fail against established sterility assurance level. |
| Biocompatibility | No new materials introduced, therefore no new biocompatibility concerns. | Biocompatibility testing was not required as no new materials were introduced. | Not applicable (no test performed). |
| Electrical Safety | Compliance with IEC 60601-1:2005. | The system was shown to comply with IEC 60601-1:2005 for electrical safety. | Not explicitly stated, but typically involves objective measurement against standard thresholds. |
| EMC | Compliance with IEC 60601-1-2:2007. | The system was shown to comply with IEC 60601-1-2:2007 for electromagnetic compatibility. | Not explicitly stated, but typically involves objective measurement against standard thresholds. |
| Bench Testing | Predetermined acceptance criteria (specific values not provided in text). | Data generated from the bench testing (tissue pad life, tissue pad removal force, instrument grasping force, sealed vessel burst test) met the predetermined acceptance criteria. | Not explicitly stated, but implies a comparison against pre-defined numerical limits or ranges for each metric. |
| Acute Animal Testing | Tissue effects not different from the predicate device (for hemostatic transection, lateral thermal damage, tissue dissection, back cutting). | The results of the acute studies demonstrated that the tissue effects were not different than the predicate device for hemostatic transection of vessel pedicles ( |
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