(87 days)
The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
The AbClose™ - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures, facilitating standard suture closure techniques.
The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by folding the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site.
This document describes the AbClose - Port Site Closure Device, which is a sterile, single-use device used in laparoscopic procedures for tissue approximation and percutaneous suturing to close incision sites.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" for performance in a quantitative table. Instead, it states that various tests were performed and "all the results were passed," indicating that the device met the internal design specifications and requirements. The core acceptance is framed around demonstrating substantial equivalence to the predicate device (K160117).
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: | |
| - Cytotoxicity | Passed (in accordance with ISO 10993-5:2009) |
| - Irritation and Skin Sensitization | Passed (in accordance with ISO 10993-10:2009) |
| - Systemic Toxicity | Passed (in accordance with ISO 10993-11:2006) |
| - Pyrogenicity | Passed (in accordance with USP Chapter ) |
| Mechanical Integrity & Functionality: | |
| - Suture Guide Push Button Test | Passed |
| - Suture Guide Slider Test | Passed |
| - Suture Guide Durability Test | Passed |
| - Suture Guide Front Upper Cover Bonding | Passed |
| - Suture Guide Front Lower Cover Bonding | Passed |
| - Suture Passer Suture Button Test | Passed |
| - Suture Passer Suture Release Button Test | Passed |
| - Suture Passer Penetration Test | Passed |
| - Suture Passer Cover Bonding Test | Passed |
| - Suture Deployment Test | Passed |
| - Suture Guide Lock Mechanism Test | Passed |
| - Accelerated Aging Test (Sterile Barrier) | Passed |
| - Suture Guide Suture Catcher Torque Test | Passed (new test for modified device) |
| - Suture Passer Needle Retention Force Test | Passed (new test for modified device) |
| - Suture Passer Needle Torque Test | Passed (new test for modified device) |
| Functional Performance (Animal Model): | |
| - Intended Use Fulfillment | Passed (demonstrated in animal model) |
| - No Alteration in Function/Intended Use | Passed (design modifications did not alter function/use) |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the sample sizes used for each of the mechanical tests or the animal study. It only states that the tests were "successfully performed" with "all the results were passed."
- Data Provenance: The animal study was mentioned, implying prospective data collection for the functional testing. The biocompatibility and mechanical tests are typically lab-based studies. The country of origin for the data is implied to be related to the manufacturer, Medeon Biodesign, Inc., which is based in Taipei, Taiwan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- This information is not provided in the document. The studies described are primarily engineering/laboratory tests and an animal model, not studies requiring human expert adjudication for ground truth (e.g., image interpretation).
4. Adjudication Method for the Test Set:
- This information is not applicable/provided as the studies described do not involve human expert adjudication in the context of diagnostic accuracy or similar tasks.
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:
- An MRMC study was not performed. The device described is a surgical instrument (port site closure device), not an AI-assisted diagnostic or interpretive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- A standalone performance study in the context of an algorithm or AI was not performed, as the device is a physical surgical tool. The functional animal study could be considered a "standalone" performance test of the device itself.
7. The Type of Ground Truth Used:
- Biocompatibility: Ground truth is established by the well-defined scientific standards and recognized guidance (ISO 10993 series, USP Chapter ) which describe the expected biological responses to materials.
- Mechanical Testing: Ground truth is established by the engineering design specifications and predefined pass/fail criteria for each test (e.g., minimum force, number of cycles, dimensional tolerances).
- Functional Testing (Animal Model): Ground truth is established by the successful execution of the intended surgical function (approximating tissues, closing incision sites) in the animal model, as defined by appropriate veterinary/surgical endpoints. This typically involves observation of successful closure, absence of complications related to the device, and potentially histological examination of the tissue if relevant.
8. The Sample Size for the Training Set:
- This is not applicable as the device is a mechanical surgical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- This is not applicable for the reason stated in 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.