(194 days)
The OTSC system set is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for haemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions.
The OTSC clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:
- Endoscopic marking .
- Hemostasis for:
- Mucosal/submucosal defects
The OTSC System Set is a single-use, pre-loaded mechanical clip and delivery system used for endoscopic clipping.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (OTSC System Set) |
|---|---|---|
| Functional Equivalence | Deployment: Ability to be deployed endoscopically to the target tissue in the correct location. | Deployment: "The test series resulted delivered identical results. Both devices can be accurately deployed to the target site." (Comparing OTSC with Resolution Hemostasis Clipping Device) |
| Dislodgement Force: Force required to dislodge the endoscopic clips from the tissue should be suitable for the intended use and comparable to the predicate device. | Dislodgement Force: "The dislodgement force of the Resolution Hemostasis Clip and the OTSC clip were comparable and suitable for the intended use." | |
| Biocompatibility | Conformance to ISO 10993-1 (Evaluation and testing within a risk management process), Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices (FDA Blue Book Memorandum #G95-1), ISO 10993-3 (Tests for genotoxicity, carcinogenicity and reproductive toxicity), ISO 10993-5 (Tests for in vitro cytotoxicity), ISO 10993-6 (Tests for local effects after implantation), ISO 10993-7 (Ethylene Oxide Sterilization Residuals), ISO 10993-10 (Tests for irritation and delayed-type hypersensitivity), ISO 10993-12 (Sample preparation and reference materials). | The document states: "The OTSC System Set meets the following Performance Standards" and lists all the aforementioned ISO standards and FDA guidance documents under the "BIOCOMPATIBILITY" category. This implies conformance and successful testing against these criteria. |
| Packaging | Conformance to ISO 11607-1 (Packaging requirements), ISO 11607-2 (Validation requirements for packaging processes), EN 868-5 (Sealable Pouches and Reels requirements), ASTM F1980-02 (Accelerated Aging of Sterile Medical Device Packages), ASTM F1929-98 (Test Method for Detecting Seal Leaks). | The document states: "The OTSC System Set meets the following Performance Standards" and lists all the aforementioned ISO, EN, and ASTM standards under the "GENERAL HOSPITAL" and "STERILIZATION" categories related to packaging. This implies conformance and successful testing against these criteria. |
| Risk Management | Conformance to ISO 14971 (Application of Risk Management to Medical Devices). | The document states: "The OTSC System Set meets the following Performance Standards" and lists ISO 14971. This implies a risk management process was followed. |
| Sterilization | Conformance to ISO 11135 (Ethylene oxide sterilization), Updated 510(k) Sterility Review Guidance K90-1, ASTM F1980-02 (Accelerated Aging), ASTM F1929-98 (Seal Leaks). | The document states: "The OTSC System Set meets the following Performance Standards" and lists all the aforementioned ISO, and ASTM standards and FDA guidance documents under the "STERILIZATION" category. This implies conformance and successful testing against these criteria. |
| MRI Safety | Conformance to ASTM F2503-08 (Marking for Safety in MR Environment), ASTM F2063-05 (Wrought Nickel-Titanium Shape Memory Alloys), FDA Guidance for Industry and FDA Staff Establishing Safety and Compatibility of Passive Implants in the MR Environment, ASTM F2052-02 (Magnetically Induced Displacement Force), ASTM F2182-02a (Radio Frequency Induced Heating), ASTM F2213-04 (Magnetically Induced Torque), ASTM F2119-01 (MR Image Artifacts). | The document states: "The OTSC System Set meets the following Performance Standards" and lists all the aforementioned ASTM standards and FDA guidance documents under the "OTHER" category related to MRI safety. This implies conformance and successful testing against these criteria, indicating the device's compatibility with MRI. |
| Substantial Equivalence | Demonstrates overall performance equivalent to the predicate device (Resolution Hemostasis Clipping Device) for its intended uses. | "It can be concluded that the Resolution Hemostasis Clipping Device and the OTSC system set are substantial equivalent in overall performance." and "The OTSC system set is substantially equivalent to the predicate devices." (Based on comparison of technological characteristics and performance testing). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a distinct "test set" sample size in terms of number of cases or patients for the performance testing. Instead, it refers to a "simulated deployment test" and a comparison of "dislodgement force."
- Data Provenance: The nature of the "simulated deployment test" and "dislodgement force" measurements implies laboratory or bench testing, not clinical data from specific countries. It's likely in vitro or ex vivo testing rather than in vivo human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The performance testing described (simulated deployment, dislodgement force) does not involve expert interpretation or ground truth establishment in the way clinical studies with image or physiological data would. These are engineering/mechanical performance tests.
4. Adjudication Method for the Test Set:
- Not applicable. The described tests are objective mechanical measurements (deployment confirmation, force measurement) and do not require 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:
- Not applicable. This device is a mechanical clipping system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This device is a mechanical instrument used by a human endoscopist. There is no standalone "algorithm-only" performance for such a device. The device's performance is intrinsically tied to human operation.
7. The Type of Ground Truth Used:
- The "ground truth" for the functional tests was the objective measurement of mechanical performance:
- Simulated Deployment: Successful deployment to the target site.
- Dislodgement Force: Quantitative measurement of force.
- For the other acceptance criteria (biocompatibility, packaging, sterilization, MRI safety, risk management), the "ground truth" was conformance to established international and national standards (ISO, ASTM, EN, FDA guidances).
8. The Sample Size for the Training Set:
- Not applicable. This is not a machine learning or AI-driven device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
§ 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.