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510(k) Data Aggregation
(15 days)
AMBIT TUNNELER
The ambIT® Tunneler is a non-sterile, reusable device indicated for use in the percutaneous introduction of catheters into and around the surgical wound site or close to the nerve.
The ambIT Tunnelers are intended for the perculaneous introduction of catheters.
The ambIT® Tunneler is a non-sterile, reusable device indicated for use in the percutaneous introduction of catheters into and around the surgical wound site or close to the nerve. The ambIT® Tunneler is packaged and shipped non-sterile and must be cleaned and autoclaved by the purchaser/facility prior to use.
Summit Medical Products, Inc. is adding a tunneling device to the ambIT® Tunneler product line for use in the placement of catheters. This specification is specifically for a 16 gauge (GA), 12 inch shaft length, re-useable tunneler and single use sterilized peelable sheath.
The ambIT® Tunneler will consist of 2 components:
· The component is a stainless steel shaft (blunt end) with a handle. The diameter of the shaft is 16 GA (S French) and the length of the shaft will accommodate a 12 inch useable length sheath, The end of the shaft will have a rounded blunt tip.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Standard Met | Reported Device Performance |
|---|---|---|
| Design & Performance (General) | Requirements of FDA recognized consensus standards for device design and performance | "The ambIT® Tunneler design meets product specifications and intended uses." |
| - | ISO 10555-5:1996 (Sterile, Single-Use Intravascular Catheters - Over Needle Peripheral Catheters) | Met the requirements of this standard. |
| - | ISO 9626:2001 (Stainless Steel Needle Tubing) | Met the requirements of this standard. |
| - | ISO 17665-1:2006 (Sterilization of health care products - Moist heat - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices) | Met the requirements of this standard. |
| - | ISO 10993-1:2009 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing) | Met the requirements of this standard. |
| - | ISO 9626:1991/amd 1:2001 (Stainless steel needle tubing) | Met the requirements of this standard. |
| - | ISO 17664-2004 (Sterilization of Medical devices) | Met the requirements of this standard. |
| Material Equivalence | Medical grade malleable stainless steel per ASTM 304 | "The overall device component material is substantially equivalent" to the predicate, both made from ASTM 304. |
| Tip Design | Blunt tip, free from feathered edges, burrs, and hooks. | "The proposed and predicate tunnelers are designed to have a blunt tip, as well as free from feathered edges, burts and hooks." |
| Size (Specific to this device) | 16 GA shaft diameter, 12 inch shaft length | The device is explicitly designed to these specifications and is compared to a predicate device with a range of sizes. |
| Safety & Effectiveness | No adverse effect on safety and effectiveness due to minor technological differences from predicate. | "performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device." |
| Substantial Equivalence | Same indications for use and technological characteristics as the predicate device. | "The ambIT® Tunneler has the same indications for use and technological characteristics as the predicate device." "the proposed ambIT® Tunneler has been shown to be substantially equivalent to the cleared On-Q® Tunneler." |
2. Sample size used for the test set and the data provenance:
The provided text does not specify a sample size or data provenance (e.g., country of origin, retrospective/prospective) for any specific test set. The submission refers to "Non-Clinical Testing" which met various ISO standards and states "Results of testing demonstrate that the ambIT® Tunneler design meets product specifications and intended uses." This implies that the testing was likely laboratory-based and simulated, rather than involving human subjects or real-world data collection in a clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the involvement of experts to establish ground truth. The evaluation criteria appear to be based on adherence to established international and national standards (ISO, ASTM) for medical device performance, materials, and sterilization. These standards themselves are developed by expert consensus within their respective fields, but the document doesn't detail specific experts involved in this particular device's ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe an adjudication method. Since the testing
primarily references adherence to engineering and material standards, it's unlikely that a human-based adjudication process (like 2+1, 3+1 for clinical endpoints) would be applicable or required. The "results demonstrate" implies meeting predefined thresholds within the standards.
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 is not applicable. The device, an "ambIT® Tunneler" (a catheter tunneler), is a physical medical device, not an AI or imaging software. Therefore, there would be no MRMC study, human readers, or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. As mentioned above, the device is a physical medical tool, not an algorithm or software. Its performance is evaluated through non-clinical laboratory testing against physical and material standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for this device's performance is primarily based on adherence to recognized engineering, material, and sterilization standards (e.g., ISO, ASTM). This represents a form of pre-defined technical and safety criteria established by expert consensus within the standards bodies themselves. It's not clinical "ground truth" like pathology or outcomes data, but rather a demonstration of inherent device properties and manufacturing processes meeting established benchmarks.
8. The sample size for the training set:
This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are validated against standards.
9. How the ground truth for the training set was established:
This is not applicable for the same reasons as above.
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