(59 days)
The GTK Veress Needles are intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
The structure of the GTK Veress Needles contain inner needle, outer needle, warning block, spring, handle and valve. It contains a spring-loaded blunt stylet mechanism, which is also the major principle mechanism of GTK Veress Needles to achieve the intended use. It is used to establish pneumoperitoneum prior to trocar and cannula insertion in laparoscopic procedures. The veress needle is connected to the insufflators with a luer connector. There are two models of veress needles: VN-120 and VN-150, with different lengths of needle bodies (120mm and 150mm). The GTK Veress Needles are for single use and are supplied sterile. The contact time is no more than 24 hours. The product is sterilized by Ethylene oxide. The manufacture date and expiry date are shown on the labeling. The GTK Veress Needles are only intended for use in a hospital setting/environment.
The provided text describes the 510(k) premarket notification for the GTK Veress Needles, a medical device used in laparoscopic procedures. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing an AI/ML-based device approval. As such, information regarding AI/ML-specific acceptance criteria, ground truth establishment, training/test set sample sizes, and human reader studies (MRMC) is not present.
However, I can extract the relevant acceptance criteria and the study that proves the device meets the acceptance criteria for the GTK Veress Needles as a hardware medical device, based on the provided document.
Acceptance Criteria and Device Performance for GTK Veress Needles
The study demonstrating the device meets acceptance criteria is a series of non-clinical performance tests. The acceptance criteria themselves are implied by the successful completion and meeting of standards for these tests. All listed tests "meet the acceptance criteria," indicating satisfactory performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance | Comments on Meeting Criteria |
|---|---|---|---|
| Biocompatibility | ISO 10993-5: 2009 (In Vitro Cytotoxicity) | Conducted | Met acceptance criteria (implied by "The following tests were conducted" and absence of failure) |
| ISO 10993-10: 2010 (Skin Sensitization, Intracutaneous Reactivity) | Conducted | Met acceptance criteria (implied by "The following tests were conducted" and absence of failure) | |
| ISO 10993-11: 2006 (Acute Systemic Toxicity, Pyrogen test) | Conducted | Met acceptance criteria (implied by "The following tests were conducted" and absence of failure) | |
| USP 39 (Bacterial Endotoxin test) | Conducted | Met acceptance criteria (implied by "The following tests were conducted" and absence of failure) | |
| Sterilization Validation | ISO 11135:2014 (EO Sterilization) | Conducted | Met acceptance criteria (implied by "The sterilization validation was conducted according to ISO 11135:2014." and absence of failure) |
| ISO 10993-7:2008 (EO and ECH Residual) | Evaluated | Met acceptance criteria (implied by "The EO and ECH residual...was evaluated by ISO 10993-7:2008." and absence of failure) | |
| Shelf Life Validation | ASTM F 1980-07 (2011) (Accelerated Aging for 3 years) | Conducted | All results "meet the acceptance criteria." |
| ISO 11737-2:2009 (Sterility test after aging) | Conducted | All results "meet the acceptance criteria." | |
| ASTM D 3078-02:2013 (Vacuum leak test after aging) | Conducted | All results "meet the acceptance criteria." | |
| ASTM F 88 (Seal strength test after aging) | Conducted | All results "meet the acceptance criteria." | |
| ASTM F 1929-12 (Leakage (dye penetration) test after aging) | Conducted | All results "meet the acceptance criteria." | |
| Din 58953-6:2010 (Microbial barrier properties after aging) | Conducted | All results "meet the acceptance criteria." | |
| Physical performance after natural aging | Conducted | All results "meet the acceptance criteria." | |
| Performance Test - Bench | Appearance | Conducted | All results "meet the acceptance criteria." |
| Size | Conducted | All results "meet the acceptance criteria." | |
| Tip Pull Test | Conducted | All results "meet the acceptance criteria." | |
| Switch Operation Test | Conducted | All results "meet the acceptance criteria." | |
| Spring Obturator Operation | Conducted | All results "meet the acceptance criteria." | |
| Needle Puncture Force Test | Conducted | All results "meet the acceptance criteria." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of devices) used for each non-clinical test. It only states that the tests were "conducted" or "evaluated."
- Data Provenance: The tests are non-clinical, meaning they were likely performed in a laboratory setting by the manufacturer, Guangzhou T.K Medical Instrument Co., Ltd., in China. The data would be internally generated prospective test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to this type of device submission. Ground truth in this context refers to established engineering and medical device standards (e.g., ISO, ASTM, USP) for performance, sterility, and biocompatibility. There are no human "experts" establishing a "ground truth" in the way one would for an AI/ML-based diagnostic device (e.g., radiologists annotating images).
4. Adjudication Method for the Test Set
Not applicable. The tests are laboratory-based and measured against predefined quantitative or qualitative standards. There is no human subjective assessment requiring adjudication in the context of this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices, especially those incorporating AI, to assess the impact of the technology on human reader performance. The GTK Veress Needles are a surgical instrument, not a diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. The device performance is assessed through its physical, material, and functional characteristics.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests for this medical device is based on established international and national standards (e.g., ISO, ASTM, USP) and predefined engineering specifications for acceptable performance (e.g., appearance, size, force, leak resistance). The successful completion of these tests against these benchmarks constitutes the "proof" that the device meets its acceptance criteria for substantial equivalence to a predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires training data.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device.
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). 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.