(568 days)
LAP-iX is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.
The LAP-iX provides suction or irrigation and conducts high-frequency monopolar electrosurgical energy from compatible electrosurgical generators to a surgical site during laparoscopic and endoscopic procedures. It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids from the surgical site to aid visualization. They are used during endoscopic, and laparoscopic surgical procedures to ablate, remove, resect, and coagulate soft tissue where associated hemostasis is required. Depending on the shape of the handle, there are two types, PISTOL Type and TRUMPET Type. PISTOL Type has pistol grip handle design. TRUMPET Type has Trumpet grip handle design. The electrode offers three types: L-HOOK, SPOON and J-HOOK Type. All three electrode types are compatible with the PISTOL Type and the TRUMPET Type. The L-Hook & J-Hook electrode tip has a sharp contact surface that facilitates cutting especially for thin and long tissue. The SPOON electrode tip is mainly used for large area tissue and also for hemostasis procedure as well. The voltage should not exceed 175Vrms (300Ω standard), and set to minimum power (100W, 3002 standard). The connector of the subject device is compatible with all suction/irrigation pumps and electrosurgical generator in the market which have the connecting tubes or connectors of Ø10mm (Suction), Ø7mm(Irrigation) and Ø4mm(Electrode).
The provided text is a 510(k) summary for the LAP-iX electrosurgical accessory. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria for a new clinical application.
Therefore, the information requested in your prompt regarding acceptance criteria, specific study design details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details) is not present in the provided text.
The document states that "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified device. The device passed all of the tests based on pre-determined pass/fail criteria." However, it does not explicitly list the acceptance criteria or the detailed results demonstrating how the device met them beyond a general statement of passing.
The document lists the following performance tests conducted for the LAP-iX:
- Air tightness
- Continuity
- Dielectric Strength
- HF Leakage Current
- Tensile Strength
- Cut & Coagulation Button Function
- Electrode Cover
- Suction & Irrigation Test
- Thermal Effect Study
Additionally, it mentions validation tests for:
- Sterilization Validation Test in accordance with ISO11737-1
- Shelf Life Validation Test in accordance with ASTM F 1980
- Biocompatibility Tests in accordance with ISO 10993 (Cytotoxicity, Ethylene Oxide Sterilization Residuals, Skin Sensitization, Irritation).
In summary, the provided document indicates that performance and validation tests were conducted and the device passed, but it does not furnish the specific acceptance criteria or the detailed study results that would allow for a table comparing acceptance criteria to reported device performance. It also lacks the detailed information on study design, ground truth establishment, or expert involvement typically found in clinical performance studies for AI/software devices. This document is a regulatory submission for a medical device and not a peer-reviewed research paper.
§ 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.