(211 days)
The Tissue Apposition System (TAS) is indicated for endoscopic placement of suture(s) and approximation of soft tissue.
The InScope™ Tissue Apposition System is a sterile, single patient use disposable suture system for approximating and securing soft tissue within the gastrointestinal tract. It is intended to perform suturing in conjunction with endoscopes having a working channel of 2.8 mm or larger. There are four essential devices, and two secondary components: 1. Tissue Anchor Applier 2. Tissue Anchor with suture a. Tissue Anchor Loader 3. Knotting Element Applier 4. Knotting Element a. Knotting Element Loader The InScope™ Tissue Anchor Applier is used to place and anchor sutures in the tissue of the GI tract. Suture position is maintained via a metal tissue anchor structure attached to the distal end of each suture strand. Following suture placement, the Knotting Element Applier is advanced over the trailing ends of the anchored sutures and advanced distally. After the sutures are properly tensioned to appose tissue, the Knotting Element is deployed to secure the suture and cut the trailing ends. The Tissue Apposition System can be used to treat a variety of defects endoscopically, including ulcers and perforations.
The submitted document describes a 510(k) premarket notification for the InScope™ Tissue Apposition System. The performance data section focuses on demonstrating substantial equivalence to predicate devices through bench and animal testing.
Here's a breakdown of the requested information based on the provided text, and where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench Testing | |
| Holding strength of InScope™ Knotting Element component substantially equivalent to Bard® EndoCinch™ suture anchor | Demonstrated substantially equivalent |
| Anchor attachment force meets USP requirement | Meets USP requirement |
| Animal Testing (Porcine Model) | |
| Successful closure of colonic and gastric perforations | Demonstrated successful closure |
| Normal healing process | Demonstrated normal results for the healing process |
| Biocompatibility | |
| Biocompatibility according to ISO 10993-1 and FDA G95-1 for limited and permanent patient-contacting/implant materials | Established through history of use in other marketed Ethicon Endo-Surgery medical devices and biocompatibility test results |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Bench Testing: Not specified.
- Sample Size for Animal Testing: Not specified, only mentions "porcine animal model" which implies a limited number of animals.
- Data Provenance: The document does not specify the country of origin for the data. The studies appear to be prospective, as they are described as "bench and animal testing was performed."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. The studies described are performance and biocompatibility tests on device components and animal models, not human diagnostic interpretation. Therefore, there's no "ground truth" in the context of expert consensus on medical images or diagnoses. The "ground truth" for the animal study would be the direct observation of surgical outcomes and histological analysis, likely performed by veterinary or pathology experts, but their number and qualifications are not provided.
4. Adjudication Method for the Test Set
- Not Applicable. As above, the nature of these tests does not involve human readers adjudicating results in the way it would for a diagnostic AI device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not done. The device is a surgical tool, not a diagnostic AI device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This is a physical medical device, not an algorithm or AI.
7. The Type of Ground Truth Used
- For bench testing: The ground truth for holding strength and anchor attachment force would be objective measurements against defined standards (e.g., USP requirements, comparative measurements against a predicate device).
- For animal testing: The ground truth for successful closure and normal healing process would be direct observation, potentially including histological examination, and evaluation by veterinary or pathology professionals.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, no training set is relevant for this device.
§ 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.