(71 days)
TIPSTOP is intended to be used as a sterile compression dressing for puncture of the vascular access site.
The Hospal TIPSTOP is a compressive dressing made of polyamide compressive element covered with alginate, which is placed on an adhesive film. TIPSTOP has been specially designed to stop bleeding after venipuncture in a manner similar to other compression dressings. The action mechanism consists of prolonging the manual compression with a mechanical compression carried out by the compressive element. TIPSTOP is sterilized by gamma irradiation.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility characteristics of lyophilized alginate are acceptable. | In vitro testing confirmed acceptable biocompatibility of lyophilized alginate. |
| The device is safe, effective, and performs as well as the predicate device. | Testing indicates the device is safe, effective, and performs as well as predicate. |
| Substantial equivalence to the predicate device in indications for use, labeling, and materials. | The device is identical to the predicate except for the compression body material (alginate vs. bovine collagen). |
2. Sample Size Used for the Test Set and Data Provenance
No dedicated test set of patient data or clinical samples was used. The evaluation of the device relied on in vitro testing for biocompatibility and a comparison to the predicate device (Hospal TIPSTOP, K896068).
- Test Set Sample Size: Not applicable, as no clinical testing or patient data set was used.
- Data Provenance: Not applicable for a clinical test set. The "data" primarily comes from in vitro laboratory tests performed on the new alginate material, and a comparison of the device's design to its predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No ground truth based on expert consensus was established for a clinical test set, as clinical testing was not performed.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication was used.
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 medical dressing, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical dressing, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission was primarily based on:
- Biocompatibility Standards: The in vitro tests for the alginate material would have been assessed against established biocompatibility standards for medical devices.
- Predicate Device Performance: The underlying assumption is that the predicate device (Hospal TIPSTOP with bovine collagen) had an established safety and effectiveness profile, and the new device was deemed "substantially equivalent" if it performed similarly for its intended use, with the only significant change being the compression material.
8. The Sample Size for the Training Set
Not applicable. This submission does not describe a machine learning or AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set for a machine learning model.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.