(37 days)
The HANAROSTENT® LowAxTM Colon/Rectum (NNN) is indicated for the palliative treatment of colorectal strictures caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
This self-expanding tubular prosthesis designed to maintain patency of colorectal obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery system. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire and the delivery system is made of polymeric materials. The stent is loaded into the distal part of the delivery system. The HANAROSTENT® LowAxTM Colon/Rectum (NNN) is intended for single use only.
The HANAROSTENT® LowAxTM Colon/Rectum (NNN) device is a self-expanding tubular prosthesis designed to maintain the patency of colorectal obstructions caused by malignant tumors. This device is an update to a previously cleared device (K183616) with the only difference being the inclusion of a 25mm diameter stent.
Here's an analysis of the acceptance criteria and study data provided:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a Special 510(k) submission for a device that is nearly identical to a previously cleared predicate (K183616), the acceptance criteria primarily focus on demonstrating that the expanded stent diameter range (to include 25mm) does not negatively impact the device's safety and effectiveness. The acceptance criteria and performance are derived from the existing predicate device and new bench testing for the expanded size.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Material & Biocompatibility | Biocompatible materials (same as predicate K183616) | Confirmed to use same biocompatible materials as K183616. | Leveraged from predicate; no new testing required for materials. |
| Stent Design | Stent design (except for diameter size range) identical to predicate K183616 | Confirmed identical stent design (except for the 25mm diameter addition). | Leveraged from predicate. |
| Delivery Device Design | Delivery device design identical to predicate K183616 | Confirmed identical delivery device design. | Leveraged from predicate. |
| Radiopaque Markers | Presence and functionality of radiopaque markers (same as predicate K183616) | Confirmed identical radiopaque markers to predicate. | Leveraged from predicate; allow visualization and placement accuracy. |
| Single Use & Method of Placement/Deployment | Single use and method of placement/deployment identical to predicate K183616 | Confirmed identical single-use and placement/deployment methods. | Leveraged from predicate. |
| Sterilization & Packaging | Sterilization method, processes, packaging configuration, and materials identical to predicate K183616 | Confirmed identical sterilization methods, processes, and packaging. | Leveraged from predicate, with new packaging validation for the subject device. |
| Shelf Life | Shelf life identical to predicate K183616 | Confirmed identical shelf life. | Leveraged from predicate. |
| Mechanical Performance (for 25mm stent) | Meet established standards for: |
- Axial force
- Compression force
- Deployment force
- Deployment accuracy
- Dimensions
- Expansion force
- Repositioning force
- Stent separation
- Tensile strength
- Trackability | M.I. Tech performed new bench testing to support the subject device in these areas.
The submission states these tests were performed and results support safety and effectiveness. (Specific values not provided in document) | New testing specifically conducted for the expanded 25mm diameter stent. |
| Corrosion Resistance | Meet established standards for corrosion (same as predicate K183616) | Testing provided with K183616 leveraged. | No new corrosion testing was required as the material is unchanged. |
| MR Compatibility | Meet established standards for MR compatibility (same as predicate K183616) | Testing provided with K183616 leveraged. | No new MR compatibility testing required. |
| Packaging Validation (for new 25mm stent) | Meet established standards for: - Dye penetration
- Seal strength
- Sterility | M.I. Tech performed new packaging validation testing to support the subject device in these areas. (Specific values not provided in document) | New packaging validation specific to the updated device configuration. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or patient outcomes for this particular submission. The evaluation is primarily based on bench testing for the new 25mm stent diameter. The document states:
- "M.I. Tech performed new bench testing to support the subject device."
- "M.I. Tech performed new packaging validation testing to support the subject device."
The specific sample sizes for these bench tests (e.g., number of stents tested for axial force, compression force, etc.) are not provided in this summary. The provenance of this bench testing data would be from the manufacturer, M.I. Tech Co., Ltd., based in the Republic of Korea. It is lab-based, not patient-derived, and is considered prospective with respect to the design modifications.
The submission is a Special 510(k) which relies heavily on the substantial equivalence to a predicate device (K183616). Therefore, much of the underlying data and validation for the core device characteristics would have been part of the K183616 submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The evaluation is focused on engineering and performance bench testing against established standards, not clinical ground truth established by medical experts for a diagnostic or predictive device. For device safety and performance evaluation, relevant engineers and quality control personnel within M.I. Tech would have performed and reviewed the bench testing.
4. Adjudication method for the test set
This information is not applicable and not provided in the document. Adjudication methods (e.g., 2+1, 3+1) refer to clinical judgment by multiple experts to establish ground truth, typically for diagnostic studies. The testing described here is bench testing against specified engineering parameters.
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
There was no MRMC comparative effectiveness study done. This device is a medical implant (stent) and not an AI-assisted diagnostic or imaging device, so MRMC studies involving human readers and AI assistance are not relevant.
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 (stent), not an algorithm or software. Therefore, standalone performance of an algorithm is not a relevant concept for this submission.
7. The type of ground truth used
The "ground truth" for this submission is established through engineering standards and specifications for physical device performance. The bench testing performed for the 25mm diameter stent confirms that it meets these predefined performance criteria (e.g., axial force, compression force, deployment accuracy, dimensions). For the characteristics leveraged from the predicate device, the ground truth was established through similar engineering tests and potentially clinical data submitted with K183616.
8. The sample size for the training set
This information is not applicable and not provided. This device is not an AI/ML device that requires a training set. The "training set" concept is relevant for machine learning models, not for physical medical device engineering validation.
9. How the ground truth for the training set was established
This information is not applicable. As stated above, this device does not utilize a training set in the context of AI/ML.
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”