(142 days)
The OverStitch™ Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.
The OverStitch™ Endoscopic Suturing System and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing either a dual channel or 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 and Suture Cinch devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone and stainless steel materials.
The OverStitch ESS is designed for compatibility with dual channel endoscopes. The endcap of the Needle Driver Assembly attaches to the distal end of the endoscope, and the handle attaches to the proximal end. The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary suture assembly with the Anchor Exchange to perform stitching operations.
The OverStitch Sx ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using silicone straps distributed along the length of the catheter and 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 OverStitch Helix is an optional device that is designed to acquire tissue by rotating the device handle into targeted area until tissue is gathered into the exposed helix coil. The acquired tissue is then pull into proximity of the needle body to complete the stitching operation.
The OverStitch Suture-Anchor Assembly is comprised of a 510(k) cleared suture product, manufactured from either polydioxanone or polypropylene materials attached to an implantable anchor manufactured from cobalt chrome and stainless steel. The Anchor component is intended to function with the OverStitch ESS device to perform stitching operations and serves as an anchor to secure suture placement, once released from the ESS.
The Overstitch Suture Cinch device is comprised of thermoplastic and stainless steel materials and includes an implantable PEEK Cinch component designed to secure the placement of suture as a final step of an OverStitch procedure. The device functions by squeezing the handle and deploying the PEEK components that press-fit onto the tail end of the suture to maintain suture position in situ.
The Apollo Endosurgery OverStitch Endoscopic Suturing System is a Class II medical device intended for endoscopic placement of suture(s) and approximation of soft tissue. The 510(k) summary provides information on the device's technological characteristics and non-clinical performance data to demonstrate substantial equivalence to its predicate device (K081853).
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a structured format. However, it states that "Appropriate product testing was performed on all subject devices to evaluate conformance to product specifications and equivalence to the predicate designs. Verification and validation for the proposed system of devices was conducted in accordance with protocol. All devices were evaluated to their individual functional and reliability requirements, as well as system compatibility with various endoscopes."
The performance tests mentioned are:
| Test | Reported Performance |
|---|---|
| Needle Passing Reliability | Confirmed (part of "results of all studies confirmed equivalency") |
| Needle Pull-off Strength | Confirmed (part of "results of all studies confirmed equivalency") |
| Suture Cinch Deployment | Confirmed (part of "results of all studies confirmed equivalency") |
| Suture Cinch Pull-off Strength | Confirmed (part of "results of all studies confirmed equivalency") |
| Tissue Helix Acquisition Reliability | Confirmed (part of "results of all studies confirmed equivalency") |
| Tissue Helix Bond Strength | Confirmed (part of "results of all studies confirmed equivalency") |
| Sterility (SAL 10-6) | Confirmed in accordance with ISO 11135:2014 |
| Shelf-Life (1 and 3 years, depending on component) | Confirmed by repeating sterility and functional testing on aged product |
| Biocompatibility | Performed in accordance with ISO 10933-1 (cytotoxicity, sensitization, irritation, acute systemic toxicity, material mediated pyrogenicity, subacute/subchronic toxicity, implantation, and genotoxicity) |
| System Compatibility with various endoscopes | Confirmed |
The overall conclusion is that "The results of all studies confirmed equivalency between the subject and predicate devices, and that no new issues of safety or efficacy were raised." This implies that the device met its defined performance specifications, which serve as the acceptance criteria for each test.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each performance test (e.g., number of needles tested, number of suture cinches). It indicates that "Appropriate product testing was performed on all subject devices."
The data provenance is retrospective, as the tests were conducted as part of a 510(k) submission to demonstrate substantial equivalence to an already marketed predicate device. The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the document describes an evaluation of a physical medical device (suturing system) through engineering and bench testing, not an AI/software device that requires expert-established ground truth for image or data interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies or AI evaluations where there might be disagreement among reviewers or interpreters.
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 information is not applicable. The device is a suturing system, not an AI or imaging diagnostic device that would involve human readers or AI assistance for interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
For the performance testing, the "ground truth" refers to the established engineering specifications, physical measurements, and regulatory standards for device functionality, sterility, shelf-life, and biocompatibility.
- Bench Testing: Engineering specifications and physical measurements (e.g., strength measurements, deployment mechanisms).
- Sterility: Conformance to ISO 11135:2014.
- Shelf-Life: Functional and sterility testing results on aged products.
- Biocompatibility: Conformance to ISO 10933-1.
8. The Sample Size for the Training Set:
This information is not applicable as the document describes the evaluation of a physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons 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.