(96 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and physical design of the prosthesis, with no mention of AI or ML technologies.
Yes
The device is described as a prosthesis for non-surgical closure of nasal septum perforations, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is a prosthesis used for the non-surgical closure of nasal septum perforations, which is a treatment or corrective function, not a diagnostic one.
No
The device description clearly states it is a "bi-flanged elastomeric device" comprised of physical components (silicone stem, flanges, magnets) and describes bench testing related to mechanical properties and aging, indicating it is a physical medical device, not software-only.
Based on the provided information, the Blom-Singer® Septal Perforation Prosthesis is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Blom-Singer® Septal Perforation Prosthesis is a physical device designed to be inserted into the nasal septum to close a perforation. It does not perform any testing on bodily samples.
- Intended Use: The intended use is "for non-surgical closure of nasal septum perforations," which is a therapeutic or prosthetic function, not a diagnostic one.
Therefore, this device falls under the category of a medical device, but not specifically an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Blom-Singer® Septal Perforation Prosthesis is indicated for use for non-surgical closure of nasal septum perforations.
Product codes (comma separated list FDA assigned to the subject device)
LFB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal septum / nose
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The product will be placed in an outpatient or clinical setting by a qualified and trained medical professional. The patient may use the product in a hospital, clinical setting, or at home under the instructions of a qualified medical professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing Summary -
We performed a number of bench tests which demonstrated that the proposed device would meet the requirements for the intended and environment of use.
These tests included ·
- Mechanical strength of magnets ●
- . Real-time aging
- . Environmental and mechanical testing
- Cleaning degradation .
Discussion - All testing demonstrated that the proposed device meets its performance requirements and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Premarket Notification 510(k) Section 5 – 510(k) Summary
Blom-Singer® Septal Perforation Prosthesis
| 510(k) Summary Page 1 of 4 | |
|---|---|
| -- | ---------------------------- |
| Date Prepared: | 12-Jun-2013 |
|---|---|
| ---------------- | ------------- |
Helix Medical, LLC
1110 Mark Avenue
Carpinteria, CA 93013
Tel - 805-576-5444
Fax - 805-566-5385
SEP 17 2013
| Official Contact: | Thomas Vassallo
Executive Vice president |
|----------------------------|-------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | Blom-Singer® Septal Perforation Prosthesis |
| Common/Usual Name: | Nasal septal button |
| Classification Name: | LFB - unclassified
Nasal septal button |
| Predicate Devices: | K013686 - Silmed Nasal Septal Button
K810738 - Xomed-Treace - Goode-Magne nasal splint |
Device Description:
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.
Indications for Use:
The Blom-Singer® Septal Perforation Prosthesis is indicated for use for non-surgical closure of nasal septum perforations.
Patient Population:
The patient population is people who have a nasal septal perforation.
Environment of Use:
The product will be placed in an outpatient or clinical setting by a qualified and trained medical professional.
1
| 510(k) Summary |
|---|
| Page 2 of 4 |
| 12-Jun-2013 |
The patient may use the product in a hospital, clinical setting, or at home under the instructions of a qualified medical professional.
Contraindications:
- Septal deformities are relative contraindications for prosthesis placement, as the flange . on the convex side of the deformity may increase nasal obstruction.
- Women who are pregnant should consult their doctor before using a medical device . containing a magnet
- People who have pace makers, defibrillators, diabetic pumps or other electro-medical . equipment .
- Should not be in situ during MRI examination (Magnetic resonance imaging) .
- Should not be in situ during radiation therapv .
Substantial Equivalence Discussion
Table 1 compares the key features of the proposed Blom-Singer® Septal Perforation Prosthesis with the identified predicate and it demonstrates that the proposed device can be found to be substantially equivalent.
In summary one can conclude that substantial equivalence is met based upon the following:
Indications for Use -
The indications for use are identical for the proposed device when compared to the predicate -K013686 - Silmed Nasal Septal Button.
Discussion - Each device is indicated for use for non-surgical closure of nasal septum perforations.
Technology and construction -
The design, fabrication. shape, size, etc. are equivalent to the predicate - K013686 - Silmed Nasal Septal Button.
The technology of using magnets for "attaching" 2 components is equivalent to the predicate -K810738 - Xomed-Treace - Goode-Magne nasal splint.
Discussion - The design incorporates 2 thin, flat flanges of varying shapes which are connected in the center.
Environment of Use -
The environments of use are identical to predicate - K013686 - Silmed Nasal Septal Button. Discussion - The environments of use are identical to the predicate - K013686 - Silmed Nasal Septal Button.
Patient Population -
The patient population of individuals which have a perforated nasal septum is equivalent to the predicate - K013686 - Silmed Nasal Septal Button.
2
510(k) Summary
Page 3 of 4
Discussion - The patient populations are equivalent to the predicate - K013686 - Silmed Nasal Septal Button.
Non-Clinical Testing Summary -
We performed a number of bench tests which demonstrated that the proposed device would meet the requirements for the intended and environment of use.
These tests included ·
- Mechanical strength of magnets ●
- . Real-time aging
- . Environmental and mechanical testing
- Cleaning degradation .
Discussion - All testing demonstrated that the proposed device meets its performance requirements and is substantially equivalent to the predicate device.
Materials -
We have provided letters allowing FDA access to the Master Device File.
The materials in patient contact are considered per G95-1 as:
- Surface Communicating (direct) .
- Mucosal contact .
- . Prolonged duration of use (> 24 hours