(57 days)
The disposable laparoscopic trocar has applications in abdominal and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.
The proposed devices are available in two types, bladeless type and bladed type, which consist of puncture needle, puncture sleeve, injection valve and sealing cover. In order to obtain access to the surgical site during laparoscopic surgery, the puncture needle is introduced into puncture sleeve to accomplish cannula penetration of the abdominal wall. The sleeve is connected to the injection valve at its proximal end and once the abdominal/thoracic wall is puncture needle is removed. The sleeve acts as a channel for the introduction of the endoscopes and instruments. The bladeless type disposable laparoscopic trocar is available in 5mm, 10mm, 12mm four diameters, and the bladed type disposable laparoscopic trocar is available in 5mm, 10mm and 12mm three diameters to accommodate different sizes surgical instrument.
This document describes the premarket notification (510(k)) for a Disposable Laparoscopic Trocar and its substantial equivalence to a predicate device, K190029. The information provided is primarily focused on demonstrating this equivalence through non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for the device's main function (e.g., specific force thresholds for insertion or leak rates). Instead, it lists various standard tests and their reported outcomes, or states that the proposed device performed similarly to the predicate. The "acceptance criteria" are implied by compliance with these standards and comparable performance to the predicate device.
| Test / Performance Metric | Acceptance Criteria (Implied by Standards/Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-7, 10993-5, 10993-10, 10993-11, and USP | No cytotoxicity, no intracutaneous reactivity, no sensitization, no acute systemic toxicity, no pyrogen |
| Ethylene Oxide (EO) Sterilization Residuals | Compliance with ISO 10993-7 | Met requirements for EO and ECH residue |
| Bacterial Endotoxin Limit | Compliance with USP (20 EU per device) | Met the limit of 20 EU per device |
| Seal Strength of Flexible Barrier Materials | Compliance with ASTM F88/F88M-15 | Performed testing |
| Detecting Seal Leaks in Porous Medical Packaging | Compliance with ASTM F1929-15 | Performed testing |
| Determining Integrity of Seals (Visual Inspection) | Compliance with ASTM F1886/F1886M-16 | Performed testing |
| Performance Testing of Shipping Containers and Systems | Compliance with ASTM D4169-16 | Performed testing |
| Instrument Insertion and Removal Forces | Comparable to predicate device (implied) | Bench tests conducted, performed comparably to predicate device |
| Leak Resistance | Comparable to predicate device (implied) | Bench tests conducted, performed comparably to predicate device |
| Snap Feature Retention Force | Comparable to predicate device (implied) | Bench tests conducted, performed comparably to predicate device |
| Penetration Force (in vivo) | Comparable to predicate device (implied) | Evaluated on a porcine model, performed comparably to predicate device |
| Fixation Force (in vivo) | Comparable to predicate device (implied) | Evaluated on a porcine model, performed comparably to predicate device |
| Device Integrity after Removal (in vivo) | No issues (implied) | Visual inspection performed, device integrity maintained |
| Sterility Assurance Level (SAL) | $10^{-6}$ | Achieved $10^{-6}$ |
| Shelf Life | Acceptable for a medical device (stated as 3 years, predicate was 2 years) | 3 years |
| Indications for Use (scope) | Abdominal and gynecologic minimally invasive surgical procedures (for proposed device) | Covers abdominal and gynecologic minimally invasive surgical procedures |
| Shaft Diameter (Bladeless) | Available in 5mm, 10mm, 12mm, 15mm (proposed) | Available in 5mm, 10mm, 12mm, 15mm |
| Shaft Diameter (Bladed) | Available in 5mm, 10mm, 12mm (proposed) | Available in 5mm, 10mm, 12mm |
| Shaft Length | Available in 100mm (proposed) | Available in 100mm |
| Other Device Characteristics (Product Code, Regulation No., Class, Single Use, Operation Mode, Safety features, Label/Labeling, Packaging method) | Same as predicate device | Same as predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each non-clinical test (e.g., bench tests for insertion force, or the number of porcine models used for the in vivo study). It states that "Bench tests were conducted on the proposed device and predicate device" and "An in vivo study was conducted on both proposed device and predicate device".
- Test Set Sample Size: Not explicitly stated for each test type. The term "test set" as typically used for AI/clinical studies isn't directly applicable here, as it's a medical device undergoing performance and safety testing.
- Data Provenance:
- Bench Tests: Likely conducted in a laboratory setting, presumably by the manufacturer or a contract testing organization. No country of origin is explicitly stated, but the manufacturer is Changzhou Ankang Medical Instruments Co., Ltd. in China.
- In vivo study: Conducted on a "porcine model". No country of origin is explicitly stated for the in vivo study.
- Biocompatibility, Sterilization, and Packaging tests: Conducted according to international and US standards (ISO, ASTM, USP). The specific testing facilities are not mentioned.
- Retrospective or Prospective: These are non-clinical studies and simulations, not clinical studies involving human patient data, so the terms "retrospective" or "prospective" do not apply in the typical sense. They are prospective tests designed to evaluate device performance and safety.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable (N/A). This document is for a traditional medical device (Disposable Laparoscopic Trocar), not an AI/Machine Learning diagnostic device. Therefore, there's no "ground truth" derived from expert consensus on medical images or patient data in the context of an "AI test set." The evaluations are based on objective physical measurements, material properties, and biological responses as per established standards for medical devices.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for the same reason as point 3. There is no ambiguous "ground truth" derived from multiple interpretations that would require an adjudication method like 2+1 or 3+1. The tests involve quantifiable measurements or pass/fail criteria against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
This information is not applicable (N/A). This device is a physical surgical instrument (trocar), not an AI diagnostic/interventional algorithm. Therefore, an MRMC study and analysis of human reader improvement with/without AI assistance are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
This information is not applicable (N/A) for the same reason as points 3 and 5. There is no algorithm to be evaluated in a standalone or human-in-the-loop context.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI studies (e.g., pathology, outcomes data) is not directly applicable here. For this medical device, the "ground truth" or reference standards are:
- Standardized Test Methods: Adherence to established international and national standards (ISO, ASTM, USP) for material properties, sterility, biocompatibility, and packaging integrity.
- Predicate Device Performance: The predicate device K190029 serves as a benchmark for comparable performance in mechanical tests (insertion/removal forces, leak resistance, fixation force) and in vivo studies.
- Objective Measurements: Directly measured physical properties and biological responses during the bench and in vivo tests.
8. The Sample Size for the Training Set
This information is not applicable (N/A). There is no AI algorithm being developed; therefore, there is no "training set" in the context of machine learning. The device development would have involved iterative design and testing, but not in the sense of an ML training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable (N/A) for the same reason as point 8.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.