(196 days)
Fetzer Medical vessel dilators are devices used to enlarge or calibrate a vessel during cardiovascular surgery.
Fetzer Medical Vessel Dilators are reusable manual surgical instruments. They are rod-like devices with a long, slender, solid shaft and a distal tip of various shapes and sizes. They are sold unsterile and can be reused (cleaned and sterilized) according the instructions for use.
There are several types of dilators made from stainless steel or aluminum:
- Cooley Coronary Dilators
- Cooley Vessel Dilators
- Garrett Vascular Dilators
- Hiebert Vascular Dilators
- DeBakey Vascular Dilators
- Sarns-Style Dilators
- Myocardial Dilators
These dilators are available in a range of different length and diameters.
The handle of the DeBakey Vascular Dilator, the Cooley Vessel Dilator, the Cooley Coronary Dilator, the Hiebert Vascular Dilator and the Garrett Vascular Dilator is textured with one site flat. The handles of the Sarns and Myocardial Dilators are smooth. The Myocardial Dilator has a flat distal end for holding it and the Sarns Dilator has a hollow handle at the distal end.
Apart from the Hiebert Vascular Dilator and the Myocardial Dilator, the handle is connected to a thin shaft. The diameter of the shaft of the different dilator types varies. The shaft of the Cooley Coronary Dilator, the Cooley Vessel Dilator, The Garrett Vascular Dilator and the DeBakey Vascular Dilator can be thin so that the shaft is flexible. The handle of the Myocardial Dilator has no shaft while the Hiebert Vascular Dilator is double-ended; it possesses two flexible shafts, with the handle located in between the two thin shafts.
The tips of all dilators have the aim to enlarge a vessel. The design of the Sarns and Myocardial Dilator is similar to an elephant's tusk. The diameter increases steadily, moving towards the handle's direction. The tips of the other Dilators are olive-shaped. The Cooley Coronary Dilator possesses no formed tip. For all dilators, the penetrating diameter corresponds to the diameter of the shaft. The Hiebert Vascular Dilators working elements are each malleable wires with an olive tip in different diameters.
The provided document is a 510(k) premarket notification for a medical device: Fetzer Medical Vessel Dilators. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness from scratch through extensive clinical trials for new medical technologies like AI/ML devices. As such, the information you're asking for, particularly regarding acceptance criteria, study design for proving performance, and expert-driven ground truth establishment (which is typical for AI/ML diagnostic devices), is not present in this document.
The document focuses on non-clinical performance testing (reprocessing, sterilization, biocompatibility, mechanical tests) to demonstrate that the Fetzer Medical Vessel Dilators are as safe and effective as existing, legally marketed predicate devices.
Here's a breakdown of why your specific questions cannot be answered by this document and what is provided:
Why the document does not contain the requested information (related to AI/ML device performance studies):
- Device Type: The Fetzer Medical Vessel Dilators are manual surgical instruments, specifically vessel dilators. They are not an AI/ML diagnostic or therapeutic device.
- Regulatory Pathway: A 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device. This involves comparing indications for use, technological characteristics (design, materials, performance), and demonstrating that any differences do not raise new questions of safety or effectiveness. It does not typically involve defining acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC) or conducting large-scale clinical studies with human readers, ground truth consensus, or advanced statistical analyses like MRMC studies, which are common for AI/ML-driven diagnostic devices.
- Performance Data Scope: The "performance data" mentioned in this document refers to physical testing of the device (e.g., cleanability, sterilizability, mechanical strength), not diagnostic accuracy or clinical outcomes in patients.
What the document does provide regarding "Testing":
The document details performance testing conducted to show the device's characteristics are similar to the predicate devices and that it meets relevant standards for a surgical instrument.
1. A table of acceptance criteria and the reported device performance:
-
Acceptance Criteria (Implicit): For this type of device, the "acceptance criteria" are broad and relate to meeting industry standards and demonstrating comparable performance to the predicate device in specific functional aspects.
- Automatic Reprocessing Validation according to ANSI/AAMI ST81: The implicit acceptance criterion is that "contamination...could be removed...by the given cleaning and disinfection instructions."
- Sterilization testing: The implicit acceptance criterion is that "the device will be adequately sterilized under the validated sterilization parameters" to achieve a SAL (Sterility Assurance Level) of 10^-6.
- Biocompatibility testing (ISO 10993-5): The implicit acceptance criterion is that materials are "non cytotoxic for the indicated contact duration."
- Mechanical tests: The implicit acceptance criterion is that devices "were able to withstand the required pulling force without deformation or failure."
-
Reported Device Performance:
| Test | Reported Device Performance |
|---|---|
| Automatic Reprocessing Validation | "This validation provides evidence that contamination of the 'Vessel Dilators' could be removed in health care facilities by the given cleaning and disinfection instructions." |
| Sterilization testing | "A reduction of test bacteria was observed and provided assurance that the device will be adequately sterilized under the validated sterilization parameters." |
| Biocompatibility testing (Cytotoxicity) | "All patient contacting materials were from the same material as the equivalent predicate devices. They were considered non cytotoxic for the indicated contact duration." |
| Mechanical tests | "All devices were able to withstand the required pulling force without deformation or failure." |
2. Sample size used for the test set and the data provenance:
- Test Sets: The document refers to "worst case devices" for reprocessing validation and "test specimens" for sterilization testing. The exact number of units or biological samples tested is not specified.
- Data Provenance: This is not applicable in the context of clinical patient data. The tests are laboratory-based. No country of origin for clinical data is mentioned as no clinical studies were performed. The tests are retrospective in the sense they were done before submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications:
- Not applicable. The "ground truth" for these tests relates to measurable physical/biological parameters (e.g., residual protein levels, bacterial reduction, material cytotoxicity, mechanical force applied), not expert interpretation of medical images or patient outcomes.
4. Adjudication method for the test set:
- Not applicable. This refers to consensus building among experts for subjective interpretations, which is not relevant for the objective laboratory tests performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No. This type of study is for evaluating observer performance, typically in diagnostic imaging. It was not conducted for this surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This relates to AI/ML algorithm performance. The device is a manual surgical tool.
7. The type of ground truth used:
- Laboratory-based measurements against established standards:
- Reprocessing: Measured contamination levels (red blood cells, residual protein, organisms, total organic carbon) against AAMI TIR 30 guidelines.
- Sterilization: Reduction of bioindicators/challenge suspension to achieve SAL 10^-6.
- Biocompatibility: Cytotoxicity results per ISO 10993-5.
- Mechanical: Resistance to pulling forces.
8. The sample size for the training set:
- Not applicable. This is typically for machine learning models. No training set for an algorithm was used.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 870.4475 Surgical vessel dilator.
(a)
Identification. A surgical vessel dilator is a device used to enlarge or calibrate a vessel.(b)
Classification. Class II (performance standards).