(167 days)
The X-Tack™ Endoscopic HeliX Tacking System is intended for approximation of soft tissue in minimally invasive gastroenterology procedures (e.g. closure and healing of ESD/EMR sites, and closing of fistula, perforation or leaks). X-Tack is not intended for hemostasis of acute bleeding ulcers.
The X-Tack™ Endoscopic HeliX Tacking System is a sterile, single-use device that enables the user to approximate soft tissue in the gastrointestinal (GI) tract using helix tacks and a 3-0 suture through a 2.8 mm or larger working channel of an endoscope (e.g. gastroscope or colonoscope).
OverStitch Suture Cinch
The Overstitch Suture Cinch device is comprised of thermoplastic and stainless steel materials and includes an implantable PEEK Cinch component designed to secure and cut the suture once tissue approximation is complete. It is the final step of the X-Tack procedure. The device functions by squeezing the handle and deploying the PEEK components, which form a press-fit onto the tail end of the suture to maintain suture position in situ.
The X-Tack™ Endoscopic HeliX Tacking System is intended for approximation of soft tissue in minimally invasive gastroenterology procedures. The device's performance was evaluated through non-clinical and animal testing to demonstrate substantial equivalence to a predicate device (K151802 - Resolution™ 360 Clip).
Here's an overview of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (X-Tack) | Predicate Device Performance (Resolution™ 360 Clip) |
|---|---|---|
| Endoscope compatibility | Scopes with a 2.8mm working channel. | Scopes with a 2.8mm working channel. |
| Working length | Gastric: 155 cm, Colon: 235 cm | Gastric: 160 cm, Colonic: 235 cm |
| Repositionable prior to deployment | Yes | Yes |
| Physician control over placement and final locking | Yes | Yes |
| Expected implant duration | Approximately 1 month or less, then implant is passed in stool. | Approximately 1 month or less, then implant is passed in stool. |
| Clip opening width | Not applicable. Device uses independent tacks, suture and cinch and is not limited by a clip opening dimension. | 11 mm |
| Closure efficacy in animal study (at 4 weeks) | 100% closure. Histologic evaluations of closure were consistent with wound healing. | 100% closure. Histologic evaluations of closure were consistent with wound healing. |
| Sterilization Method | EO | EO |
| Usage | Single-use | Single-use |
| Implanted Materials | Helix Tack: 316L Stainless Steel; Cinch: VESTAKEEP i4 (PEEK); Suture: Polypropylene USP 3-0 Polypropylene; Copper Phthalocyanine Blue (Below 0.5WT%) | Capsule: 304 Stainless Steel; Arms: 17-7 PH SS; Tension breaker: Luran 968R (polystyrene); Yoke: F75 Cobalt Chrome |
| Biocompatibility | Tested per ISO 10993. | Tested per ISO 10993. |
| MR Compatibility | MR Conditional with 1.5 and 3 T MR scanners with spatial field gradient of 2500 Gauss/cm (extrapolated or less) and SAR of 2.0 W/kg for 15 minutes of continuous scanning | MR Conditional with 1.5 and 3T MR scanners with spatial field gradient of 2500 Gauss/cm (extrapolated or less) and SAR of 2.0 W/kg for 15 minutes of continuous scanning |
| Anchor retention, Suture tensile strength, Endoscope compatibility | Performed (details not specifically provided beyond "performed") | Not explicitly stated; assumed to be met due to predicate status |
| Usability and human factors, Packaging, Shelf-life, Distribution forces | Validated (details not specifically provided beyond "validated") | Not explicitly stated; assumed to be met due to predicate status |
2. Sample size used for the test set and the data provenance:
- Animal Study: 4 pigs and 40 defects (created in the stomach and colon) were used in a randomized, controlled animal study.
- Data Provenance: The animal study was conducted to compare closure rates and healing between X-Tack and the predicate device. The location of the study (country of origin) is not specified. The study appears to be prospective, specifically designed for this comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions "direct visualization and histological analysis" for evaluation in the animal study. However, it does not specify the number of experts, their qualifications, or their role in establishing ground truth.
4. Adjudication method for the test set:
- The document does not specify any adjudication method (e.g., 2+1, 3+1). The evaluation was based on direct visualization and histological analysis in the animal study.
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 comparative effectiveness study was done as the device is a medical instrument (tacking system), not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable, as this is a physical medical device and not an algorithm.
7. The type of ground truth used:
- For the animal study: Direct visualization and histological analysis of the defects were used to determine closure rates and healing.
8. The sample size for the training set:
- Not applicable, as this device's performance was evaluated through non-clinical (bench) and animal testing, not through machine learning training data.
9. How the ground truth for the training set was established:
- Not applicable, as there was no training set for a machine learning algorithm.
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.