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.

AI/ML Overview

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.

Summary

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K131745

Premarket Notification 510(k) Section 5 – 510(k) Summary

Blom-Singer® Septal Perforation Prosthesis

	510(k) Summary Page 1 of 4
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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 VassalloExecutive Vice president
Proprietary or Trade Name:	Blom-Singer® Septal Perforation Prosthesis
Common/Usual Name:	Nasal septal button
Classification Name:	LFB - unclassifiedNasal septal button
Predicate Devices:	K013686 - Silmed Nasal Septal ButtonK810738 - Xomed-Treace - Goode-Magne nasal splint

Device Description:

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.

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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.

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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 < 30 days)

Based upon G95-1 the following tests are required if a material certification cannot be provided.

. Cytotoxicity
. Sensitization
. Intracutaneous / Irritation

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emarket Notification 510
ction 5 – 510(k) Summa

om-Singer® Septal Perforation Prostl

Attribute	ProposedBlom-Singer® Septal Perforation Prosthesis	PredicateSilmed - Nasal Septum ButtonK013696
Indications for Use	The Blom-Singer® Septal Perforation Prosthesis is indicated foruse for non-surgical closure of nasal septum perforations.	Indicated for non-surgical closure of nasal septum perforations.
Environments of use	Environment of use - hospital, sub-acute, physician office settings.The product will be placed in an outpatient or clinical setting by aqualified and trained medical professional. The patient may usethe product in a hospital or clinical setting, or at home under theinstructions of a qualified medical professional.	Environment of use - hospital, sub-acute, physician office settings.The product will be placed in an outpatient or clinical setting by aqualified and trained medical professional. The patient may use theproduct in a hospital or clinical setting, or at home under theinstructions of a qualified medical professional.
rescriptive	Yes	Yes
Patient population	The patient population is people who have a nasal septalperforation.	The patient population is people who have a nasal septalperforation.
Single patient use	Yes, up to 29 days	Yes
Basic components	Thin flat flanges of various sizes and shapes held together via 2magnets	Thin, flat circular flanges of various sizes centrally connected by apost
Technology ofAttaching Flanges	Magnets	Center mechanical post
Sizes	Various sizes and shapes	Predicate which uses magnets to hold together 2 nasal splintK810738 - Xomed-Treace Goode-Magne Splint PlusVarious sizes and shapes
Materials	SiliconeParylene CRare earth magnets (sealed and not in patient contact)	SiliconeRare earth magnets (sealed and not in patient contact)
Performance testing	Pull test for strength of magnets
Testing	MechanicalReal-time agingCleaning degradation

T .

ostantial Equivalence Conclusion

'he sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predical
ave been found to substantially

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

September 17, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Helix Medical, LLC c/o Mr. Paul E. Dryden Regulatory Consultant 1110 Mark Ave. Carpinteria, CA 93013

Re: K131745/S001

Trade/Device Name: Bloom-singer Septal Perforation Prosthesis Regulation Number: Unclassified Regulatory Class: Unclassified Product Code: LFB Dated: August 11, 2013 Received: August 13, 2013

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Paul E. Dryden

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Deborah L. Falls -S

for: Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health'

Enclosure

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Indications for Use Statement

510(k) Number:

K131745 (To be assigned)

Indications for Use:

The Blom-Singer® Septal Perforation Prosthesis is indicated for the non-surgical closure of nasal septal perforations.

Environment of use - hospital, sub-acute, physician office settings.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/6/Picture/11 description: The image shows a digital signature from Vasant G. Malshet. The signature includes the name Vasant G. Malshet, along with the date 2013.09.17 and a time stamp of 14:04:00 -04'00'. The signature also includes a DN (Distinguished Name) with fields such as c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, and a unique identifier 0.9.2342:19200300.100.1.1=1300.

Regulation Number and Section

N/A