(127 days)
The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
The Ultravision 5mm Trocar component also establishes a path of entry for instruments used in laparoscopic surgery.
The Ultravision™ Visual Clearing System removes surgical smoke from the visual field during laparoscopic surgery by means of electrostatic precipitation. The System consists of the Ultravision Generator, the Ionwand Sterile Pack, and the Ionwand 5mm Trocar. The Ionwand is connected to the energy source and is then introduced into the body cavity near the smoke generating electrosurgical device. The Ultravision™ 5mm Trocar is a new accessory device intended for use only with the Ultravision™ Visual Field Clearing System to introduce the Ionwand while providing a pathway for laparoscopic instruments through one 5 mm trocar incision. The Ultravision™ 5mm Trocar provides an alternative to the currently available Ultravision™ Visual Field Clearing System Ionwand™ Sterile Pack for introduction of the Ionwand. The Ultravision™ 5mm Trocar is a standard dilating laparoscopic trocar compatible for use with 5mm instruments. The trocar design includes a discrete lumen that is positioned separate from the main trocar channel and which accepts the Ionwand component of the system. The trocar design allows the distal tip of the Ionwand to exit the trocar some 12mm from its distal point and at an angle to the trocar body that positions the Ionwand at a point close to but not interfering with the 5mm energy instruments that are intended to be accommodated by the trocar. The Ultravision™ 5mm trocar and Ionwand are provided packaged together in the same sterile barrier packaging. The trocar may be used with or without the Ionwand component of the system.
The provided text describes the regulatory clearance (510(k) submission) for the Ultravision™ Visual Field Clearing System, specifically focusing on the new 5mm Trocar component. It details the device's function, comparison to predicate devices, and the nonclinical testing performed to demonstrate substantial equivalence.
Based on the provided information, the device is not an AI/ML medical device. It's a surgical device for clearing smoke during laparoscopic surgery. Therefore, many of the typical acceptance criteria and study components associated with AI/ML devices (like MRMC studies, expert consensus for ground truth on training data, etc.) are not applicable here.
However, I can extract the acceptance criteria and the study (nonclinical testing) that proves the device meets them from the provided text, interpreting them in the context of a physical medical device.
Here's the information as requested, with "N/A" for sections not applicable to this type of device or not explicitly mentioned in the document:
Acceptance Criteria and Device Performance for Ultravision™ Visual Field Clearing System (K170178)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the successful results of the specified nonclinical tests, demonstrating equivalence to predicate devices. The reported device performance is that it "Pass"-ed all these tests and was found "Equivalent" to the predicate.
| Acceptance Criteria (Test) | Description of Test | Reported Device Performance (Result) |
|---|---|---|
| Performance of the system to clear the visual field of smoke and particulate matter | Performance comparison to the predicate device under simulated use conditions | Equivalent to predicate - Pass |
| Usability | Complexity of use compared to the predicate and reference device | Equivalent to predicate and reference - Pass |
| Ionwand removal and reinsertion | Repeated insertions/removals performed and forces both quantitative and qualitative evaluations performed | Equivalent to predicate and reference - Pass |
| Leak resistance and sealing, maintenance of pneumoperitoneum during use | Pressure tests under high and low pressures with and without instruments or Ionwand inserted, including multiple cycles of use | Equivalent to predicate or reference - Pass |
| Strength, resistance to bending | Tensile or pressure forces applied to shaft, trocar, and connections | Equivalent to predicate or reference - Pass |
| Dimensional Verification | Confirmation of dimensional characteristics by dimensional evaluation | Pass |
| Luer fitting | Confirmation of compliance with industry standard luer fitting | Pass |
| Electrical Safety | Dielectric breakdown, radio-frequency applied parts, capacitive coupling | Pass |
| Biocompatibility per ISO 10993 | Appropriate biocompatibility based on tissue contact and duration | Pass |
| Sterilization and shelf life studies | Validated sterilization cycle according to industry standard, shelf life studies on accelerated aging conditions including product and package evaluations | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- The document does not explicitly state the numerical sample sizes for each nonclinical test (e.g., how many units were tested for strength, how many cycles for reinsertion). It describes the type of tests performed.
- Data Provenance:
- Country of Origin: Not specified, but the applicant (Alesi Surgical Ltd) is based in Cardiff, GB (United Kingdom). The tests were presumably conducted internally or by a contracted lab.
- Retrospective or Prospective: These are laboratory/benchtop tests and simulated use conditions, not clinical studies on patients. Therefore, the terms "retrospective" or "prospective" as typically applied to patient data are not directly applicable. These were newly conducted tests to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: N/A. Ground truth in this context (performance of a physical device) typically relies on engineering specifications, physical measurements, and standardized testing protocols rather than expert consensus on subjective interpretations.
- Qualifications of Experts: N/A. The qualification of personnel performing the tests would be governed by internal quality systems and standards for medical device manufacturing and testing, but not explicitly stated as "experts" for ground truth establishment in the way it's done for AI models interpreting medical images.
4. Adjudication Method for the Test Set
- Adjudication Method: N/A. Adjudication methods (like 2+1 or 3+1) are typically used for establishing ground truth from multiple human readers in image interpretation tasks. For physical device testing, results are typically objective measurements against predefined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No. This device is not an AI/ML system or diagnostic imaging tool that would benefit from an MRMC study. Its function is direct surgical smoke clearance and trocar access, not interpretation by human readers.
- Effect Size of Human Readers Improvement: N/A, as no MRMC study was conducted or relevant for this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: N/A. This is a physical medical device, not an algorithm. Its "performance" is its physical and functional operation.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's performance is established by:
- Predicate Device Performance: Demonstrating "equivalence" to the legally marketed predicate device (Ultravision™ Visual Field Clearing System, DEN150022) under simulated use conditions.
- Industry Standards and Specifications: Adherence to standards like ISO 10993 for biocompatibility, industry standards for luer fittings, and general engineering principles for strength, sealing, etc.
- Established Methods for Sterilization and Shelf-Life Validation: Following recognized protocols for these critical aspects.
- Objective Measurements: Dimensional verification, pressure tests, electrical safety measurements provide objective data points.
8. The Sample Size for the Training Set
- Sample Size for Training Set: N/A. This device is not an AI/ML system that requires a "training set" in the computational sense. Device design and development are based on engineering principles and iterative testing, not statistical training on a data set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: N/A. As there is no training set as understood in AI/ML, there is no method for establishing ground truth for it. The development and refinement of the device would involve engineering design, prototyping, and testing against functional requirements and safety standards.
§ 878.5050 Surgical smoke precipitator.
(a)
Identification. A surgical smoke precipitator is a prescription device intended for clearance of the visual field by precipitation of surgical smoke and other aerosolized particulate matter created during laparoscopic surgery.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Adverse tissue reaction must be mitigated through the following:
(i) Chemical characterization and toxicological risk assessment of the treated surgical smoke.
(ii) Demonstration that the elements of the device that may contact the patient are biocompatible.
(2) Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended.
(3) Software verification, validation, and hazard analysis must be performed.
(4) Performance data must demonstrate the sterility of the patient contacting components of the device.
(5) Performance data must support the shelf life of the sterile components of the device by demonstrating continued functionality, sterility, and package integrity over the identified shelf life.
(6) Animal simulated-use testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Device must be demonstrated to be effectively inserted, positioned, and removed from the site of use.
(ii) Device must be demonstrated to precipitate surgical smoke particulates to clear the visual field for laparoscopic surgeries.
(iii) Device must be demonstrated to be non-damaging to the site of use and animal subject.
(7) Labeling must identify the following:
(i) Detailed instructions for use.
(ii) Electrical safety and electromagnetic compatibility information.
(iii) A shelf life.