Search Results

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.

Ask a specific question about this device

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. High Frequency (HF) energy from the ESU is delivered through the jaws of the ERBE BiClamp" Instruments to coagulate/desiccate tissue. The ERBE BiClamp™ Open Instruments are made of stainless steel with plastic insulation except at the jaw surfaces (which isolates the energy to only the jaw surfaces). The ERBE BiClamp'™ Laparoscopic Instruments are made of metals and plastics with the electrical energy isolated to the jaws. They have various jaw types, which are standard in the industry. The ERBE BiClamp™ Open Instruments range in size from 200 mm (7.9 inches) to 270 mm (10.6 inches) in length with bent jaws that have a smooth surface. The ERBE BiClamp™ Laparoscopic Instruments have a 5 mm outside diameter (O.D.) and a 340 mm (13.4 inches) working length. The Instruments are provided non-sterile and are reusable (Note: The cleaning and sterilization processes have been validated and are provided in the Notes on Use to the customer.).

This document is a 510(k) summary for the ERBE BiClamp™ Open and Laparoscopic Instruments. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study results with acceptance criteria.

Therefore, the requested information regarding acceptance criteria and performance studies cannot be fully extracted from the provided text for this specific device. The document mostly discusses similarities and differences with a predicate device and states that "all the instrument designs have been verified or validated in design control by ERBE Elektromedizin GmbH." This suggests that design control activities were performed, but the details of those validations are not included in this summary.

Based on the information provided in the K033421 510(k) Summary, here's what can be gathered, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific quantitative acceptance criteria or reported device performance metrics (e.g., success rates, failure rates, or specific measurements) are provided in this document. The submission relies on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data against defined criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. The document does not describe a clinical test set in the way a clinical trial would. It refers to design verification and validation, but details on sample size, country of origin, or retrospective/prospective nature are not included for a specific performance evaluation test set within this summary.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

Not applicable. The document does not describe a process for establishing ground truth using experts for device performance evaluation. The "truth" in this context is based on the predicate device's established safety and efficacy.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set requiring adjudication is described.

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

No MRMC study is mentioned or implied. This device is an electrosurgical instrument, not an AI-based diagnostic tool, so such a study would not be relevant.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a medical device, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this 510(k) submission is the established safety and efficacy of the predicate device (Valleylab Inc. LigaSure™ Open and Laparoscopic Instruments K981916). The submission argues that the ERBE BiClamp™ is substantially equivalent to this predicate.

8. Sample Size for the Training Set:

Not applicable. This device does not involve a training set in the context of machine learning or AI.

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

Not applicable, as there is no training set for this type of device.

Summary of what is available and missing:

• Available:

  • Device Description: Detailed information about the ERBE BiClamp™ instruments, their materials, sizes, and compatibility with the ERBE VIO Electrosurgical Generator.
  • Intended Use and Indications for Use: Clear statements on how and where the device is intended to be used, including specific surgical procedures and vessel sizes.
  • Predicate Device: Clearly identifies the legally marketed predicate device (Valleylab Inc. LigaSure™ Open and Laparoscopic Instruments, K981916).
  • Similarities and Differences to Predicate: Highlights shared characteristics (physical, dimensional, technological, intended use) and differences (reusability, lack of closure mechanism).
  • Verification/Validation Statement: It states that "all the instrument designs have been verified or validated in design control by ERBE Elektromedizin GmbH." This implies that internal testing was conducted to ensure the device met its design specifications and user needs.

• Missing from this document (and typically not found in a 510(k) summary unless the device is novel or has substantial differences requiring new clinical data):

  • Specific quantitative acceptance criteria (e.g., tensile strength of seals, burst pressure, seal integrity rates).
  • Detailed results of the design verification and validation studies (e.g., number of vessels tested, types of tissue, success rates).
  • Any clinical trial data with specific sample sizes, ground truth establishment, or expert reviews.
  • Any comparative effectiveness data against the predicate device in a clinical setting.

In essence, this 510(k) relies on the premise that because the ERBE BiClamp™ has very similar intended use, principles of operation, and technological characteristics to an already cleared device, and the identified differences (reusability, no closure mechanism) do not raise new safety or efficacy issues, it is substantially equivalent. The "study" referenced is the design control process, whose detailed reports are not part of this public summary.

Ask a specific question about this device