BLOM-SINGER SEPTAL PERFORATION PROSTHESIS

K131745 · Helix Medical, LLC · LFB · Sep 17, 2013 · EN

Device Facts

• Record ID: K131745
• Device Name: BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
• Applicant: Helix Medical, LLC
• Product Code: LFB · EN
• Decision Date: Sep 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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)

Device Story

Bi-flanged elastomeric prosthesis; two silicone pieces connected by two enclosed magnets at center. Center post (oval or circular) fills nasal septal perforation; flanges extend beyond perforation for retention. Placed by medical professional in outpatient/clinical setting; patient may use at home under instruction. Device intended for up to 29 days. Magnets facilitate attachment of flanges. Clinician may trim flanges to fit individual septal anatomy. Provides non-surgical closure of perforations; benefits patient by potentially reducing nasal obstruction or symptoms associated with septal defects.

Clinical Evidence

Bench testing only. Testing included mechanical strength of magnets, real-time aging, environmental and mechanical testing, and cleaning degradation. No clinical data provided.

Technological Characteristics

Bi-flanged elastomeric device made of silicone and Parylene C. Uses rare earth magnets (sealed, no patient contact) for attachment. Oval or circular stem geometry. Dimensions vary to accommodate septal shape; flanges trimmable. Single-patient use, up to 29 days. Non-sterile (implied by cleaning degradation testing).

Indications for Use

Indicated for non-surgical closure of nasal septal perforations in patients with nasal septal perforations. Contraindicated in patients with septal deformities, pregnant women (due to magnets), patients with pacemakers, defibrillators, or insulin pumps, and should not be used during MRI or radiation therapy.

Predicate Devices

• Silmed Nasal Septal Button (K013686)
• Xomed-Treace - Goode-Magne nasal splint (K810738)

Submission Summary (Full Text)

{0}------------------------------------------------

K131745

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<br>Executive Vice president |
|----------------------------|-------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | Blom-Singer® Septal Perforation Prosthesis |
| Common/Usual Name: | Nasal septal button |
| Classification Name: | LFB - unclassified<br>Nasal septal button |
| Predicate Devices: | K013686 - Silmed Nasal Septal Button<br>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 < 30 days)

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

- . Cytotoxicity
- . Sensitization
- . Intracutaneous / Irritation

{3}------------------------------------------------

emarket Notification 510
ction 5 – 510(k) Summa

.

om-Singer® Septal Perforation Prostl

| Attribute | Proposed<br>Blom-Singer® Septal Perforation Prosthesis | Predicate<br>Silmed - Nasal Septum Button<br>K013696 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Blom-Singer® Septal Perforation Prosthesis is indicated for<br>use 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.<br>The product will be placed in an outpatient or clinical setting by a<br>qualified and trained medical professional. The patient may use<br>the product in a hospital or clinical setting, or at home under the<br>instructions of a qualified medical professional. | Environment of use - hospital, sub-acute, physician office settings.<br>The product will be placed in an outpatient or clinical setting by a<br>qualified and trained medical professional. The patient may use the<br>product in a hospital or clinical setting, or at home under the<br>instructions of a qualified medical professional. |
| rescriptive | Yes | Yes |
| Patient population | The patient population is people who have a nasal septal<br>perforation. | The patient population is people who have a nasal septal<br>perforation. |
| Single patient use | Yes, up to 29 days | Yes |
| Basic components | Thin flat flanges of various sizes and shapes held together via 2<br>magnets | Thin, flat circular flanges of various sizes centrally connected by a<br>post |
| Technology of<br>Attaching Flanges | Magnets | Center mechanical post |
| Sizes | Various sizes and shapes | Predicate which uses magnets to hold together 2 nasal splint<br>K810738 - Xomed-Treace Goode-Magne Splint Plus<br>Various sizes and shapes |
| Materials | Silicone<br>Parylene C<br>Rare earth magnets (sealed and not in patient contact) | Silicone<br>Rare earth magnets (sealed and not in patient contact) |
| Performance testing | Pull test for strength of magnets | |
| Testing | Mechanical<br>Real-time aging<br>Cleaning 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

{4}------------------------------------------------

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.

{5}------------------------------------------------

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 [phone] or [phone] 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

{6}------------------------------------------------

# 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.