(60 days)
The LAP-iX Suction Irrigation provides suction to a surgical site during laparoscopic and endoscopic procedures.
The LAP-iX Suction Irrigation provides suction or irrigation 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. It consists of 4.50 diameter shaft, suction/irrigation buttons and suction/irrigation tubes with hand piece. It has two types of hand piece, pistol and trumpet grip. The subject device is compatible with all suction and irrigation pumps in the market which have the connecting tubes or connectors of Ø10mm (Suction) or Ø7mm(Irrigation).
This document describes the LAP-iX Suction Irrigation device, which provides suction and irrigation to a surgical site during laparoscopic and endoscopic procedures. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics and acceptance criteria for a novel AI-based diagnostic device.
Therefore, the following information will be structured to extract what is available from the provided text, while also explicitly stating what is not present given the nature of the submission (a 510(k) for a physical medical device, not an AI/ML algorithm).
Acceptance Criteria and Study for LAP-iX Suction Irrigation Device
The submission for the LAP-iX Suction Irrigation device (K173111) is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria for a novel technology or diagnostic accuracy. The "acceptance criteria" here are implicitly meeting the standards demonstrated by the predicate device and satisfying various regulatory performance tests.
1. A table of acceptance criteria and the reported device performance
Since this is a physical device attempting to show substantial equivalence, the "acceptance criteria" are generally that the device performs safely and effectively, and is as safe and effective as the predicate device. The document does not provide specific quantitative acceptance criteria or detailed performance reports with numerical values, but rather lists the types of tests performed and states that the "test results support that the subject device is substantially equivalent to the predicate devices."
| Acceptance Criteria Category (Implied) | Reported Device Performance Summary (from text) |
|---|---|
| Safety | |
| Sterilization Validation | Test in accordance with ISO11737-1 performed; results support substantial equivalence. |
| Biocompatibility | Tests in accordance with ISO 10993 (Cytotoxicity, EO Sterilization Residuals, Skin Sensitization, Systemic Toxicity, Irritation) performed; results support substantial equivalence. |
| Leakage | Performance test performed; results support substantial equivalence. |
| Ethylene Oxide Sterilization | |
| Residuals | Performance test performed; results support substantial equivalence. |
| Sterility Test | Performance test performed; results support substantial equivalence. |
| Effectiveness/Functionality | |
| Shelf Life Validation | Test performed; results support substantial equivalence. |
| Appearance | Performance test performed; results support substantial equivalence. |
| Measurement | Performance test performed; results support substantial equivalence. |
| Tensile Strength | Performance test performed; results support substantial equivalence. (Specifically notes that differences in dimensions are "very small" and would not raise a question in safety and effectiveness according to tensile strength tests.) |
| Suction/Irrigation Functionality | Device provides suction/irrigation; compatible with market pumps (Ø10mm Suction / Ø7mm Irrigation connectors). |
| Equivalence to Predicate | |
| Indications for Use | Same as predicate (Surgiwand II, K903207), except for cautery procedure; difference in indications does not raise a new intended use question for the subject device. |
| Raw Materials | Same as predicate (stainless steel for tube). |
| Handle Type | Subject device offers an additional pistol handle type (predicate has trumpet grip, implied); not considered to affect safety or performance. |
| Dimensions (Diameter, Length) | Slightly smaller tube diameter and slightly longer length than predicate; difference is "very small" and does not impact safety/effectiveness per performance tests. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes (e.g., number of devices or units) used for each individual test (e.g., Sterilization Validation, Biocompatibility tests, Performance tests like Tensile Strength). It only states that "The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices."
The data provenance (country of origin, retrospective/prospective) is not mentioned for these tests. The device manufacturer is Sejong Medical Co., Ltd. in Paju-si, Gyeonggi-do, Republic of Korea, suggesting the testing likely occurred in or was arranged by the manufacturer, but this is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable to this 510(k) submission. The LAP-iX Suction Irrigation is a physical medical device (an accessory for laparoscopic/endoscopic procedures) and does not involve AI or algorithms that require expert interpretation or ground truth establishment in the context of diagnostic accuracy. The tests performed are engineering and biological evaluations, not diagnostic assessments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. As explained above, this device does not involve human interpretation of outputs that would require an adjudication method.
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
This section is not applicable. An MRMC study is relevant for AI-powered diagnostic aids. This 510(k) pertains to a physical surgical instrument, not an AI diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This section is not applicable in the context of diagnostic "ground truth." The "ground truth" for this device's performance would be the objective results obtained from the engineering and biological tests (e.g., sterility achieved, material strength, biocompatibility within limits). There is no "pathology" or "outcomes data" to establish a ground truth for diagnostic accuracy.
8. The sample size for the training set
This section is not applicable. There is no "training set" as this is a physical device and not an AI/ML algorithm.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set, there is no ground truth establishment for it.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.