(24 days)
The ERBE BiClamp™ Open and Laparoscopic Instruments are intended for use in general surgery, laparoscopic, gynecologic, urological, and thoracic procedures where fusion of vessels or tissues is desired. The devices can be used on vessels up to 7 mm and bundles as large as will fit in the jaws of the instrument. A vessel fusion is created by the application of bipolar electrosurgical RF energy (coagulation) to the vessels placed between the jaws of the instrument.
The ERBE BiClamp™ Open and Laparoscopic Instruments are designed for use with an ERBE VIO Electrosurgical Generator (ESU) System having an Optional Bipolar Mode/ BiClamp™ upgrade and the multi-function receptacle. Not recommended for use with other manufacturer's generators.
The indications for use with Open Instruments include: general surgery, gynecologic, urological, and thoracic procedures where fusion of vessels and tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.
The indications for use with Laparoscopic Instruments include: all laparoscopic procedures (including gynecologic, general, urological, and thoracic surgery) where fusion of vessels or tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholecystectomies (gall bladder procedures), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.
CAUTION: Vessel fusion can be affected by patient factors such as age, elasticity of vessels, thickness of vessel walls, etc .; therefore, the physician should review each vessel fusion for seal integrity. This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.
The ERBE BiClamp™ Open and Laparoscopic Instruments are used with an ERBE VIO Electrosurgical Generator (ESU) System having the Optional Bipolar Mode/ BiClamp™ upgrade. High Frequency (HF) energy from the ESU is delivered through the jaws of the ERBE BiClamp™ instruments. The instruments are made of stainless steel with plastic and ceramic insulation except at the jaw surfaces (which isolates the energy to only the jaw surfaces). The ERBE BiClamp™ Open Instruments are 200 mm (7.9 Inches) to 210 mm (10.0 Inches) in length with bent jaws that have a smooth surface. The ERBE BiClamp™ Laparoscopic Instruments are made of metals and plastics with a 5 mm outside diameter (O.D.) and a 0 to 450 mm (0 to 17.7 Inches) working length. They have various jaw types, which are standard in the industry. The Instruments are provided non-sterile (The cleaning and sterilization processes have been validated and are provided in the Notes on Use to the customer.).
The provided text is a 510(k) summary for the ERBE BiClamp™ Open and Laparoscopic Instruments. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria through a clinical study. Therefore, most of the detailed information requested regarding clinical study design, sample sizes, expert involvement, and ground truth establishment is not present in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the 510(k) summary. A 510(k) submission for substantial equivalence generally focuses on comparing the new device's characteristics (design, materials, intended use, technological principles) to a legally marketed predicate device, rather than setting and meeting specific performance acceptance criteria from a pre-defined study. The document explicitly states: "The ERBE BiClamp™ Open and Laparoscopic Instruments have the same intended use, principle of operation, and technological characteristics as the predicate devices that were previously cleared for market in a 510(k)." The difference highlighted is a ceramic coating for durability, which was "verified or validated in design control by ERBE Elektromedizin GmbH" but no specific performance metrics or acceptance criteria are given for this.
2. Sample Sizes and Data Provenance:
- Test Set Sample Size: Not applicable/not provided. This document describes a comparison to predicate devices and design verification/validation, not a clinical trial with a defined test set sample.
- Data Provenance: Not applicable/not provided for clinical study data. The 'provenance' of the device itself is ERBE USA, Inc.
3. Number of Experts and Qualifications:
- Number of Experts: Not applicable/not provided. No expert panel was used to establish ground truth in the context of a performance study as described.
- Qualifications of Experts: Not applicable/not provided.
4. Adjudication Method:
- Adjudication Method: Not applicable/not provided. No clinical study requiring adjudication of results is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not done or at least not described in this 510(k) summary. The document focuses on device characteristics and intended use comparison.
- Effect Size: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only) Performance Study:
- Standalone Performance Study: No, this is an electrosurgical instrument, not an AI algorithm. Therefore, a "standalone algorithm only" performance study is not applicable and not described.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable for a clinical performance study. The "ground truth" in this context is the safety and effectiveness of the predicate devices to which the new device is compared. The claim is that the new device is substantially equivalent to these already-cleared devices. The design changes (ceramic coating) were verified/validated through design control activities, which would typically involve engineering tests and simulations, not clinical ground truth in the usual sense.
8. Sample Size for the Training Set:
- Training Set Sample Size: Not applicable/not provided. This document does not describe the development or training of an AI algorithm or a study with a training set.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set: Not applicable/not provided, as there is no mention of a training set or an AI algorithm.
Summary of what the document DOES provide:
- Device Description: ERBE BiClamp™ Open and Laparoscopic Instruments, bipolar electrosurgical devices for vessel and tissue fusion using HF energy.
- Intended Use: General, laparoscopic, gynecologic, urological, and thoracic procedures for fusing vessels up to 7mm and tissue bundles. Designed for use with ERBE VIO ESU System.
- Predicate Devices: Valleylab Inc. LigaSure™ Open and Laparoscopic Instruments (K033421) and ERBE BiClamp™ Open and Laparoscopic Instruments (K981916).
- Substantial Equivalence Claim: The ERBE BiClamp™ Open and Laparoscopic Instruments are substantially equivalent to the predicate devices in intended use, principle of operation, and technological characteristics.
- Key Difference: The ERBE BiClamp™ Open Instruments have a new sealed ceramic coating around the outside jaw area for greater resistance to cleaning and sterilization (durability). This change was "verified or validated in design control."
- Conclusion: No new safety or efficacy issues are raised compared to the predicate devices.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.