Search Results

The 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 HARMONIC 700, 5 mm Diameter Shears with Advanced Hemostasis are intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments are sterile, single-patient-use instruments consisting of an ergonomic grip housing assembly with hand control buttons (MIN for minimum power level, MAX for maximum power level, and Advanced Hemostasis for large vessel sealing). An integrated audible and tactile mechanism in the grip housing indicates full trigger closure. The instruments have a clamp arm and coated curved blade that are 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 instrument shafts can be rotated 360° to facilitate visualization and access to targeted tissue. The three dashes on the instrument are intended to represent relative vessel size. The MAX button is typically used for smaller vessels where cutting speed is the fastest. The MIN button is typically used in slightly larger vessels and has reduced cutting speed. It is indicated for vessels up to 5 mm in size. The Advanced Hemostasis button is designed for larger vessels and is indicated for vessels up to 7 mm in size. In this mode, cutting speed is further reduced and hemostasis is maximized. This design is common to both subject and predicate devices and has been evaluated by FDA in K132612 (predicate device), K160752 (HARMONIC HD1000i), and K200841 (HARMONIC 1100). The instruments utilize Adaptive Tissue Technology. 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 700, 5 mm Diameter Shears with Advanced Hemostasis are designed for use exclusively with the Generator G11 (GEN11) software version 2018-1 or later, last cleared under K200841 on 11 May 2020.

The provided text describes the HARMONIC 700 Shears and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and supporting studies as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set (Preclinical Studies)

• Acute Animal Testing: Performed in three acute porcine studies. The document does not specify the exact number of animals or vessels tested within these studies, but it mentions evaluating "arteries, veins, and pedicles of various sizes."
  • Data Provenance: Porcine (animal) models. This is a form of prospective data collection for preclinical evaluation.
• Chronic Animal Testing: Performed in a survival study. The document does not specify the exact number of animals or vessels tested.
  • Data Provenance: Animal (survival) model. This is a form of prospective data collection for preclinical evaluation.

3. Number of Experts and Qualifications for Ground Truth of Test Set

The document does not mention the use of human experts to establish ground truth for the test set in the context of the preclinical (animal) studies. The evaluation metrics (e.g., vessel burst pressure, thermal spread, intra-operative tissue effects, post-operative performance) are typically measured objectively by research staff or specific equipment.

4. Adjudication Method for Test Set

Not applicable, as ground truth for the preclinical studies was based on objective measurements rather than human reader interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence." The comparison is between the subject device and a predicate device through bench and animal testing.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a surgical instrument, not an AI or algorithm-based diagnostic/screening tool. The "Adaptive Tissue Technology" mentioned gives the generator "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," which is an integrated system feature, not a standalone algorithm being evaluated for performance against a ground truth.

7. Type of Ground Truth Used (for preclinical studies)

The ground truth for the preclinical studies was based on objective biological and mechanical outcomes measured in animal models (porcine).

• Acute Studies: Evaluation of "intra-operative tissues effects," "thermal spread," and the ability to "transected and sealed" vessels and pedicles.
• Chronic Studies: Evaluation of the long-term performance of "transected and sealed" blood vessels and blood vessel pedicles in a survival setting.
• Bench Testing: Direct physical measurements such as Tissue Pad Life, Tissue Pad Removal Force, Instrument Grasping Force, Sealed Vessel Burst Pressure, and objective measurements of thermal spread.

8. Sample Size for the Training Set

Not applicable. This device is a physical surgical instrument and does not involve AI/machine learning models that require a separate "training set" of data in the conventional sense for performance evaluation in this 510(k) submission. The "Adaptive Tissue Technology" is a functional design feature, not a trainable AI model in the context of this submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" as understood in AI/machine learning contexts for this device submission.

Ask a specific question about this device