(96 days)
The Blom-Singer® Septal Perforation Prosthesis is indicated for use for non-surgical closure of nasal septum perforations.
The Blom-Singer® Septal Perforation Prosthesis is a bi-flanged elastomeric device, each prosthesis are comprised of two (2) pieces which are attached to one another using a set of 2 enclosed magnets at the center of the flanges. The center post is either an oval or circular silicone stem that will fill most of the nasal septal perforation. The overlapping thin section or flange will extend beyond perforation to help with the closure of the perforation and the retention of the device.
The flanges will be offered is various sizes and shapes to accommodate the individual's septal shape. In addition, the clinician may trim the flanges to fit.
The device is intended to be used up to 29 days.
Here is the information about the acceptance criteria and study for the Blom-Singer® Septal Perforation Prosthesis, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance Study
The Blom-Singer® Septal Perforation Prosthesis received 510(k) clearance based on demonstrating substantial equivalence to predicate devices, K013686 (Silmed Nasal Septal Button) and K810738 (Xomed-Treace - Goode-Magne nasal splint). The primary method of demonstrating this equivalence was through non-clinical bench testing and a comparison of key features.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly quantified performance metrics in the way a diagnostic algorithm's sensitivity/specificity would be. Instead, the "acceptance criteria" are implied by demonstrating that the proposed device performs functionally as intended and is safe, similar to the predicate devices, across various non-clinical tests. The reported device performance is that these tests were successfully passed, meeting the "requirements for the intended and environment of use."
| Attribute/Test Type (Implied Acceptance Criteria) | Reported Device Performance |
|---|---|
| Indications for Use Equivalence (Same intended use as predicate) | Outcome: Identical to predicate device K013686: Non-surgical closure of nasal septum perforations. |
| Technology and Construction Equivalence (Similar design, fabrication, shape, size; similar magnetic attachment technology) | Outcome: Design, fabrication, shape, size equivalent to K013686. Magnetic attachment technology equivalent to K810738. Design incorporates 2 thin, flat flanges. |
| Environment of Use Equivalence (Same intended environments) | Outcome: Identical to predicate K013686: Hospital, clinical setting, or at home under medical professional instruction. |
| Patient Population Equivalence (Same target patient group) | Outcome: Equivalent to predicate K013686: Individuals with a perforated nasal septum. |
| Mechanical Strength of Magnets (Magnets hold the device together securely) | Outcome: Test demonstrated the proposed device meets performance requirements. (Specific strength not provided, but implies satisfactory performance). |
| Real-time Aging (Device withstands intended use duration) | Outcome: Test demonstrated the proposed device meets performance requirements. (Specific aging data not provided, but implies satisfactory performance for up to 29 days). |
| Environmental and Mechanical Testing (Device functions in intended environment and withstands physical stresses) | Outcome: Test demonstrated the proposed device meets performance requirements. (Specific tests/results not provided beyond categories, but implies satisfactory performance). |
| Cleaning Degradation (Device integrity maintained after cleaning) | Outcome: Test demonstrated the proposed device meets performance requirements. (Specific data not provided, but implies satisfactory performance). |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous/Irritation) (Materials are safe for patient contact) | Outcome: Tests required based on material classification (Surface Communicating (direct), Mucosal contact, Prolonged duration of use) and were presumably passed to establish safety. Specific results are not detailed but the device was cleared. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable as this was a premarket notification (510(k)) that relied on non-clinical bench testing and comparison to predicates for substantial equivalence. There was no "test set" of patient data in the context of clinical trials. The bench tests would have used an unspecified number of device prototypes or components.
- Data Provenance: Not applicable. The data is from internal bench testing performed by the manufacturer, Helix Medical, LLC.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There was no clinical ground truth established by experts for a test set of patient data. The "ground truth" for the non-clinical tests was likely established by engineering specifications and industry standards for mechanical and material performance.
4. Adjudication Method for the Test Set
Not applicable. There was no test set involving human interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (prosthesis), not an AI algorithm or a diagnostic tool that would typically undergo such a study. The substantial equivalence was based on physical and material characteristics and bench testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission was primarily:
- Engineering specifications and performance requirements for the device's mechanical integrity (e.g., magnet strength, aging, environmental resilience).
- Biocompatibility standards and certifications for materials in prolonged mucosal contact.
- The established safety and effectiveness profile of the predicate devices.
8. The Sample Size for the Training Set
Not applicable. There was no "training set" in the context of AI or machine learning for this physical medical device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there was no training set.
N/A