(30 days)
The OverStitch NXT Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.
The OverStitch NXT Endoscopic Suturing System (ESS) and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing a single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix or NXT Tissue Helix Pro, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.
The OverStitch NXT ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using polyester medical tape for the endcap assembly. The external catheter sheath has two working channels through which the Anchor Exchange and OverStitch accessories can operate, independent of the endoscope channel.
The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor Assembly with the Anchor Exchange to perform stitching operations.
The document is a 510(k) summary for the OverStitch NXT Endoscopic Suturing System, indicating that clinical performance data was not required to demonstrate substantial equivalence. Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on clinical performance or AI algorithm output. The acceptance criteria and performance data mentioned in section {5} refer to non-clinical bench testing, functional testing on an ex vivo model, and packaging integrity, as well as biocompatibility.
Here's the information derived from the document regarding the non-clinical performance:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria Category | Specific Tests/Evaluations | Reported Device Performance (Met Acceptance Criteria?) |
|---|---|---|
| Non-Clinical Performance Data | Conformance to product specifications and equivalence to predicate designs (K210266) | Yes |
| Verification and validation for proposed system of devices | Yes | |
| Evaluation of individual functional and reliability requirements | Yes | |
| System compatibility | Yes | |
| Performance Testing (Bench Testing) | Suture drag testing | Yes |
| Tensile testing | Yes | |
| Torque testing | Yes | |
| Endoscope compatibility | Yes | |
| Sterility | Yes | |
| Reliability | Yes | |
| Bond strength | Yes | |
| Functional Testing | Ex vivo model evaluation (under same test methods as predicate) for device function and intended use | Yes |
| Packaging Integrity | ASTM F2096-11 | Yes |
| ASTM F1980-21 | Yes | |
| ASTM D4169-22 | Yes | |
| ASTM F88/F88M-21 | Yes | |
| Biocompatibility | Cytotoxicity (per ISO 10933-1) | Yes |
| Irritation (per ISO 10933-1) | Yes | |
| Skin sensitization (per ISO 10933-1) | Yes | |
| Systemic toxicity (per ISO 10933-1) | Yes | |
| Material mediated pyrogenicity (per ISO 10933-1) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical testing. It does not provide specific sample sizes for the bench tests, ex vivo model, or packaging integrity tests. The provenance of the data is from Apollo Endosurgery Inc./Boston Scientific's own testing procedures. The tests are prospective in the sense that they were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable to the non-clinical and ex vivo testing described. There were no human expert evaluations in the context of clinical "ground truth" establishment for this submission as clinical data was not required.
4. Adjudication Method for the Test Set
Not applicable as it was non-clinical and ex vivo testing, not human expert adjudication.
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
No MRMC study was conducted. This device is not an AI-assisted diagnostic or therapeutic device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device (endoscopic suturing system), not an AI algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" was established by engineering specifications, validated test methods (e.g., ASTM standards), and comparison to the predicate device's established performance parameters. For the ex vivo model, the ground truth was the expected device function and intended use observed in the model.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable 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.