VENT-OS SINUS DILATION SYSTEM

K133016 · Sinusys Corporation · LRC · Dec 9, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K133016
• Device Name: VENT-OS SINUS DILATION SYSTEM
• Applicant: Sinusys Corporation
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Dec 9, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4420
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Vent-Os™ Sinus Dilation System is an instrument intended to provide a means to access the sinus space and to dilate the maxillary sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures.

Device Story

Vent-Os Sinus Dilation System is an osmotically driven manual surgical instrument for maxillary sinus ostia dilation. System consists of a dilation device preloaded on a placement instrument. Physician accesses target site via nasal passageway; placement instrument delivers dilation device. Device expands via osmotic pressure, remodeling target tissues; device is subsequently removed. Used in clinical settings by physicians. Output is physical dilation of sinus ostia, facilitating diagnostic or therapeutic access. Benefits include minimally invasive sinus ostia remodeling.

Clinical Evidence

Prospective, non-randomized, single-arm, open-label study (N=34 patients, 57 maxillary ostia). Primary endpoint: ostial patency. Results at 3 months: 93% patency (95% CI: 82.7% - 97.1%), comparable to literature control (Bolger et al., 84% patency). Additional evidence: biocompatibility (ISO 10993), bench testing (weight, profile, force, integrity), and cadaver usability testing.

Technological Characteristics

Osmotically driven dilation device; manual placement instrument. Materials compliant with ISO 10993 (cytotoxicity, sensitization, reactivity). Sterilization via radiation (ANSI/AAMI/ISO 11137-2). No electronic components or software.

Indications for Use

Indicated for adults requiring access to sinus space and dilation of maxillary sinus ostia and associated spaces for diagnostic and therapeutic procedures.

Regulatory Classification

Identification

An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.

Predicate Devices

• Relieva Spin Sinus Dilation System (K111875)
• XprESS Multi-Sinus Dilation Tool (K121943)
• ENTrigue / Ventera (K121351)

Reference Devices

• Bolger W et al. Safety and outcomes of balloon catheter sinusctomy: a multicenter 24-week analysis in 115 patients. Otolaryngol Head and Neck Surg 2001, 137: 10-20

Submission Summary (Full Text)

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#### Premarket Notification 510(k) Summary 8

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## 510(k) Number: K133016

## Applicant Information:

Date Prepared: December 6, 2013 ·

| Name: | SinuSys Corporation |
|----------|----------------------------------------|
| Address: | 4030 Fabian Way<br>Palo Alto, CA 94303 |
| Phone: | 650-213-9988 |
| Fax: | 650-213-9688 |

## Contact Person:

Michael A Daniel, Consultant

| Phone Number: | [phone] |
|-------------------|----------------|
| Office: | [phone] |
| Facsimile Number: | [phone] |

Device Information:

| Device Trade Name: | Vent-Os™ Sinus Dilation System |
|---------------------------|---------------------------------------------------|
| Common Name: | Instrument, ENT Manual Surgical |
| Classification Name(s): | Ear, nose, and throat manual surgical instrument. |
| Product Code/ Regulation: | LRC / 874.4420 |
| Classification: | Class I, Exempt |

# Predicate Devices:

Relieva Spin Sinus Dilation System (K111875) XprESS Multi-Sinus Dilation Tool (K121943) ENTrigue / Ventera (K121351)

## Device Description:

The Vent-OsTM Sinus Dilation System is an osmotically driven device that dilates maxillary sinus ostia and associated spaces. The Vent-Os™ Sinus Dilation System is comprised of a Dilation Device preloaded on a Placement Instrument. The Placement Instrument accesses the target site through the nasal passageway and delivers the Dilation Device. The Vent-Os™ Sinus Dilation Device then expands and remodels the target tissues and then is removed.

### DEC 9 2013

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### Premarket Notification 510(k) Summary - Continued 8

# Indications for Use:

The Vent-Os™ Sinus Dilation System is an instrument intended to provide a means to access the sinus space and to dilate the maxillary sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures.

# Comparison to Predicate Devices:

The Vent-OsTM Sinus Dilation System has the same intended use and similar indication, mechanism of action and procedural outcomes as the Relieva Spin Sinus Dilation System, the ENTrigue Ventera dilation device and the XprESS Multi-Sinus Dilation Tool (the predicate devices). The SinuSys Dilation System dilates maxillary sinus ostia and associated spaces via pressure applied circumferentially in a substantially equivalent manner to the predicate devices. The technological differences between the Vent-Os™ Sinus Dilation System and its predicates do not raise new questions of safety or efficacy. Performance data demonstrates substantially equivalence in terms of safety and effectiveness to the predicate devices.

# Performance Testing:

Biocompatibility in compliance with EN ISO 10993 requirements was completed. This biocompatibility testing included:

| Item # | Test | Standard Reference | Results |
|--------|----------------------------|--------------------|-----------------|
| 1 | Cytotoxicity (MEM Elution) | ISO 10993-5:2009 | Non-cytotoxic |
| 2 | Sensitization-Maximization | ISO 10993-10: 2010 | Non-sensitizing |
| 3 | Intracutaneous Reactivity | ISO 10993-10: 2010 | Non-irritating |

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### Premarket Notification 510(k) Summary - Continued 8

In Vitro bench evaluation including performance testing was completed. This performance testing included the following evaluations:

| Attribute Tested | Pass/Fail |
|-----------------------------------------|-----------|
| Device weight | Passed |
| Placement System Working Length Profile | Passed |
| Placement System Working Length | Passed |
| Crossing Profile | Passed |
| Deployment Force | Passed |
| Dilation Device Diameter @ 1 hour | Passed |
| Dilation Device Working Length @ 1 hour | Passed |
| Dilation Device Integrity | Passed |
| Bond Strength | Passed |
| Proximal Anchoring Force | Passed |

Transportation, sterilization, and shelf-life testing was completed. Sterilization was performed in compliance with all requirements of ANSI/AAMI/ISO 11137-2: Sterilization of Health Care Products - Radiation. Transportation and packaging validation included the following:

| Attribute Tested | Pass/Fail |
|--------------------------------------------|-----------|
| Transit Testing | Passed |
| Sterile Barrier Integrity<br>(Bubble Test) | Passed |
| Packaging & System<br>Visual Inspection | Passed |
| Pouch Seal Testing | Passed |

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### Premarket Notification 510(k) Summary - Continued 00

Animal studies confirming safe placement and dilation were conducted. Four (4) Dilation Devices were deployed into four (4) separate sheep maxillary sinuses (MSO).

Cadaver testing was completed by multiple users to validate usability. This cadaver evaluation included use of two (2) adult cadaveric head specimens with the device placed four (4) times into each target site. Investigators confirmed successful endoscopic delivery and placement of the device.

Finally, clinical trials to demonstrate safety and effectiveness were performed by SinuSys Corporation to demonstrate substantial equivalence of the Vent-Os™ Sinus Dilation System to the predicate devices cited. A prospective, non-randomized, single arm, open label, study was conducted at five (5) clinical sites with five (5) investigators. A total of 34 patients and 57 maxillary ostia were treated. Results were comparable to the literature control as summarized in the following table:

| | SinuSys Study | | Bolger Study | |
|---------------|---------------|---------------|--------------|---------------|
| Analysis | Per Protocol | 95% CI* | Per Protocol | 95% CI* |
| | Acute | | 1 week | |
| N | 57 | | 142 | |
| Patent | 54 (95%) | 85.6% - 98.2% | 106 (75%) | 66.9% - 81.1% |
| Non-Patent | 0 | | 0 | |
| Indeterminate | 3 (5%) | 1.8% - 14.4% | 36 (25%) | 18.9% - 33.1% |
| | 3 Months | | 3 Months | |
| N | 55 | | 116 | |
| Patent | 51 (93%) | 82.7% - 97.1% | 98 (84%) | 76.8% - 90.0% |
| Non-Patent | 0 | | 3 (3%) | |
| Indeterminate | 4 (7%) | 2.9% - 17.3% | 15 (13%) | 8.0% - 20.2% |

*Wilson score confidence intervals

Bolger W et al. Safety and outcomes of balloon catheter sinusctomy: a multicenter 24-week analysis in 115 patients. Otolaryngol Head and Neck Surg 2001, 137: 10-20.

### Summary:

Based upon the device description and test data provided in this submission the Vent-Os™ Sinus Dilation System is substantially equivalent to the predicate devices cited.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

December 9, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

SinuSys Corporation c/o Mr. Michael A. Daniel Regulatory Consultant 8 Snowberry Court Orinda, CA 94563

Re: K133016

Trade/Device Name: Vent-OsTM Sinus Dilation System Regulation Number: 21 CFR 874.4420 Regulation Name: ENT Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: November 24, 2013 Received: November 26, 2013

Dear Mr. Daniel:

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. Iisting 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 your 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.

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 of medical

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Page 2 - Mr. Michael A. Daniel

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

htto://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Denise L. Hampton -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

510(k) Number (if known): K133016

Device Name: Vent-Os™ Sinus Dilation System

Indications For Use:

The Vent-Os™ Sinus Dilation System is an instrument intended to provide a means to access the sinus space and to dilate the maxillary sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/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 Center for Devices and Radiological Health (CDRH)

Sunny Park 2013.12.08 20:32:07 -05'00'

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