(54 days)
CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps and CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps are intended for use in electrosurgery for coagulation of tissue.
The CODMAN VersaTru Disposable Non-Stick Bipolar Forceps (VersaTru Bipolar Forceps) are single use, disposable, sterile electrosurgical devices, for use in electrosurgery for the coagulation of tissue. The forceps are part of an electrosurgical system consisting of an electrosurgical bipolar generator and bipolar cord attached to the proximal end of the forceps, to provide power and deliver electrical current from the generator to the distal tips of the forceps.
This document is a 510(k) Summary for the "CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps" and "CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps". It describes the device, its intended use, a comparison to a predicate device, and performance data used to establish substantial equivalence.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a separate table with quantified values. Instead, it presents various test categories and states that the device "Pass"ed each one. The acceptance criteria are implicitly defined by the standards and internal requirements referenced for each test.
| Test Category | Specific Test | Reported Device Performance | Implicit Acceptance Criteria (based on referenced standards/guidance) |
|---|---|---|---|
| Bench Testing | Lesion Size | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements |
| Resistivity | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Weight Test | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Non-Stick Test | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Thermal Effects Lesion Study | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Mechanical Test | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Dimensional Verification | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Physical Characterization | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Functional Testing (after transit) | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Ergonomics Validation | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Electromagnetic Compatibility/ Electrical Safety Testing | All tests in accordance with: IEC 60601-1-2:2014, IEC 60601-1:2005/A1:2012, IEC 60601-2-2:2009/C1:2014 | Pass | Compliance with referenced IEC standards |
| Sterilization | Sterility Assurance Level (SAL) | 10^-6 | SAL of 10^-6 in accordance with ISO 11137-1:2006/Amd1:2013 and ISO 11137-2:2013 |
| Shelf-Life Testing | Accelerated aging studies | Pass | Device and packaging remain functional and maintain sterility for up to 1 year, in accordance with FDA guidance (August 15, 2016) and internal requirements |
| Biocompatibility Testing | Cytotoxicity Study | PASS (Non-cytotoxic) | Compliance with ISO 10993-5 and FDA guidance |
| Guinea Pig Maximization Sensitization Test | PASS (Non-sensitizing) | Compliance with ISO 10993-10 and FDA guidance | |
| Intracutaneous Study | PASS (Non-irritating) | Compliance with ISO 10993-10 and FDA guidance | |
| Systemic Toxicity Study | PASS (Non-toxic) | Compliance with ISO 10993-11 and FDA guidance | |
| USP Rabbit Pyrogen Study | PASS (Non-pyrogenic) | Compliance with ISO 10993-11, USP , and FDA guidance | |
| ASTM Hemolysis Study | PASS (Non-hemolytic) | Compliance with ISO 10993-4, ASTM F756, and FDA guidance | |
| Chemical Characterization of Extractables | PASS | Compliance with ISO 10993-18 and FDA guidance | |
| Toxicology Risk Assessment | PASS | Compliance with ISO 10993-17 and FDA guidance |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes (number of devices) used for each individual bench test, electrical safety test, sterilization validation, shelf-life test, or biocompatibility test. It generally states that "All testing was performed on final sterile devices" and refers to applicable standards. For example, for sterilization validation, ISO standards typically dictate minimum sample sizes based on the chosen method and desired SAL.
- Data Provenance: The data provenance is described as being generated from "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" guidance, internal requirements, and international standards (IEC, ISO, ASTM). This indicates that the tests were conducted specifically for the purpose of this 510(k) submission, likely in a controlled laboratory environment. The country of origin of the data is not explicitly stated but is implicitly tied to the submitter (Medos International SARL in Switzerland) and the manufacturer testing facilities. The studies are prospective in nature, as they are part of the premarket submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable to the presented document. The document describes testing of a physical medical device (bipolar forceps) against engineering and biological performance standards, not an AI or diagnostic device that requires expert ground truth labeling. The "ground truth" for these tests is defined by the physical and chemical properties measured and compared against established engineering, electrical, and biological safety standards.
4. Adjudication method for the test set:
Not applicable, as no expert adjudication was required for the types of tests described. The results are objective measurements against defined acceptance criteria (standards).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This document pertains to the 510(k) clearance for bipolar forceps, which is a physical surgical instrument, not an AI-assisted diagnostic tool. No MRMC studies were conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document is for a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the various tests conducted (bench, electrical, sterilization, biocompatibility, shelf-life) is established by:
- Physical/Chemical Measurements: Direct measurements of device dimensions, electrical properties, material composition, etc.
- Biological Endpoints: Observing cellular responses (cytotoxicity), immunological reactions (sensitization), tissue irritation, systemic toxicity, pyrogenicity, and hemolysis in in vitro or in vivo (animal) models.
- Functional Performance: Testing the device's ability to perform its intended function (e.g., coagulation, non-stick properties) under simulated conditions.
- Compliance with Standards: The ultimate ground truth is compliance with the referenced international standards (IEC, ISO, ASTM) and FDA guidance documents, which set the safety and performance benchmarks.
8. The sample size for the training set:
Not applicable. There is no "training set" in the context of physical medical device clearance. This question is relevant to AI/machine learning models.
9. How the ground truth for the training set was established:
Not applicable. As there were no AI algorithms involved, there was no training set or ground truth for such a set.
§ 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.