(564 days)
The DEX device laparoscopic instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, suturing, transection and electro-cauterization of tissues.
The DEX Device consists of an electro-mechanical system designed for surgeon to perform minimal invasive surgeries: laparoscopic surgery. The surgeon will use the system in a similar way than any laparoscopic instruments and remains in contact with the patient. The surgeon will positioned himself like in any classic laparoscopic procedure, standing in the sterile field close to the patient: Same installation, trocars, endoscopic camera, suction, ESU for monopolar, needles, operating table, instruments, procedure. The device consists of a Control handle and different Arms (instruments); and accessories. The Console hosts the software and the power unit. The control handle is comprised of an ergonomic hand piece that can turn on its own axis thanks to the comfort joint. The control handle has command buttons that activate the different degrees of freedom or the Arm. Different arms can be connected on the control handle. Arms consists in a distal articulation that allows the tip (scissors, needle holder, forceps or Hook) to tilt, rotate and open-close. The arms and the control handle are reusable and autoclavable. The scissors, the dissector (Maryland) and the hook supports electrocautery monopolar energy after connecting the standard monopolar cable between DEX device and an ESU compliant with IEC 60601-2-2; After installed the neutral electrode; The user can control the cautery effect by pressing on the foot pedal switch provided with the ESU. Associated acessories includes : sleeves
Here's a breakdown of the acceptance criteria and study information for the DEX Device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria / Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1, 10993 series, FDA Guidance (2016) | Tests Conducted: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenecity. Outcome: Device is considered biologically safe. Materials chosen from stainless material standards for surgical instrumentation: ASTM F138, ASTM F1058, ASTM F899-12b, ISO 7153-1: Surgical instruments -- Materials -- Part 1: Metals. |
| Electrical Safety & EMC | IEC 60601-1:2012, IEC 60601-2-2:2017 (Electrical Safety) | Outcome: Tested and validated by an independent laboratory as compliant. |
| IEC 60601-1-2 Ed4.0 (2014) (EMC) | Outcome: Tested and validated by an independent laboratory as compliant. | |
| Bench Testing | Needle Holder reliability evaluation | Outcome: Contributed to demonstration of durability and safety in real/simulated conditions. |
| Scissor reliability evaluation | Outcome: Contributed to demonstration of durability and safety in real/simulated conditions. | |
| Grasper reliability evaluation | Outcome: Contributed to demonstration of durability and safety in real/simulated conditions. | |
| Control handle and motors reliability evaluation | Outcome: Contributed to demonstration of durability and safety in real/simulated conditions. | |
| Sleeves reliability evaluation | Outcome: Contributed to demonstration of durability and safety in real/simulated conditions. | |
| Shaft Insulation | Outcome: Contributed to demonstration of durability and safety in real/simulated conditions. | |
| System testing: monopolar energy (animal test) | Outcome: Contributed to demonstration of durability and safety in real/simulated conditions. | |
| Thermal spread of Dex device vs Predicate device | Outcome: DEX device thermal effect in monopolar mode shown to be equivalent to the predicate device. Histomorphometric analysis on fresh tissues demonstrated same characteristics of thermal spread in monopolar mode (CUT and COAG) with usual/identical settings when used with a legally marketed ESU. | |
| Transport and packaging testing | Outcome: Contributed to demonstration of durability and safety in real/simulated conditions. | |
| Cleaning & Sterilization | ISO 17664, ISO 17665, AAMI TIR 12 (Sterilization) | Outcome: Tested and validated by an independent laboratory as compliant. |
| AAMI TIR12, AAMI TIR30 (Cleaning) | Outcome: Tested and validated by an independent laboratory as compliant. | |
| Software Validation | FDA Guidance (2005), IEC 62304:2006 + A1:2015 | Outcome: Software validation activities performed in accordance with guidance and standards. |
| Usability | IEC 60601-1-6:2010 + A1:2013, EN 60601-1-6:2010 + A1:2015 | Outcome: Assessed and found to be safe and effective for intended uses by intended users in its intended use environment. |
| Simulated Use (Durability) | 40 simulated uses including fresh tissues interactions, cauterization, cleaning, lubrication and autoclave for each cycle. | Outcome: DEX device monopolar arms successfully passed 40 simulated uses. No damage, cracks, corrosion, or associated risks identified after 40 tested cycles. |
2. Sample Size Used for the Test Set and Data Provenance:
- Biocompatibility: Not explicitly stated as a separate "test set" sample size. The testing involves materials of the device.
- Electrical Safety & EMC: Not explicitly stated as a numerical sample size of devices. Implies testing performed on "DEX device."
- Bench Test (Reliability): Not explicitly stated as a numerical sample size per specific test (e.g., how many needle holders were evaluated).
- Thermal Spread: Not explicitly stated as a numerical sample size. Mentions "different types of tissues" and "fresh tissues."
- Simulated Use: 40 simulated uses for DEX invasive parts.
- Data Provenance: Not explicitly stated (e.g., country of origin) for each test. Most tests were conducted by independent laboratories. The "System testing: monopolar energy (animal test)" clearly indicates animal data. "Thermal spread... Histomorphometric analysis on fresh tissues" also implies animal or cadaveric tissue. Overall, the studies are likely prospective for the specific device testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. The studies listed are primarily engineering, laboratory, and animal-based performance tests, not clinical studies involving expert interpretation of patient data.
4. Adjudication Method for the Test Set:
- This information is not applicable/provided. The studies focus on device performance parameters rather than diagnostic accuracy or clinical outcomes requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- No, an MRMC comparative effectiveness study was not done.
- The DEX Device is an electromechanical surgical instrument, not an AI-powered diagnostic or assistive tool for human readers/interpreters in the context of radiology or pathology. Therefore, this type of study is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- This concept is not applicable to the DEX Device as it is a physical surgical instrument, not a software algorithm providing standalone diagnostic or assistive output. While it contains software, the relevant "performance" is the instrument's function in the hands of a surgeon.
7. The Type of Ground Truth Used:
- Biocompatibility: Standardized biological test results (e.g., cytotoxicity assays, irritation indices).
- Electrical Safety & EMC: Compliance with international safety standards (e.g., IEC 60601 series).
- Bench Testing (Reliability): Engineering specifications and performance metrics for mechanical function and durability (e.g., number of cycles without failure, functional operation).
- Thermal Spread: Histomorphometric analysis on fresh tissues, comparing lesion characteristics to a predicate device. This is a scientific measurement based on tissue effects.
- Cleaning & Sterilization: Microbiological test results (e.g., sterility assurance level) and validated cleaning efficacy against contaminants, measured against ISO and AAMI standards.
- Software Validation: Adherence to software development lifecycle processes and requirements as outlined in FDA guidance and IEC standards.
- Usability: Assessment against usability standards and guidelines (IEC 60601-1-6, EN 60601-1-6) suggesting an evaluation of user interface and interaction.
- Simulated Use: Physical inspection for damage, cracks, corrosion after repeated operational cycles.
8. The Sample Size for the Training Set:
- This information is not applicable/provided. The DEX Device is a physical medical device, not a machine learning model that requires a "training set" in the conventional sense. The "training" for such a device occurs during its design, development, and engineering validation processes, which are informed by scientific principles and engineering best practices, not a dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable/provided for the same reasons as in item 8.
§ 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.