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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Vent-Os™ Sinus Dilation System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary focuses on demonstrating "substantial equivalence" rather than providing explicit numeric acceptance criteria for each test. Instead, it reports "Passed" or specific outcomes that are compared to a literature control for clinical efficacy.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility
Non-cytotoxic	Non-cytotoxic
Non-sensitizing	Non-sensitizing
Non-irritating	Non-irritating
In Vitro Bench Evaluation
Device weight acceptable	Passed
Placement System Working Length Profile acceptable	Passed
Placement System Working Length acceptable	Passed
Crossing Profile acceptable	Passed
Deployment Force acceptable	Passed
Dilation Device Diameter @ 1 hour acceptable	Passed
Dilation Device Working Length @ 1 hour acceptable	Passed
Dilation Device Integrity acceptable	Passed
Bond Strength acceptable	Passed
Proximal Anchoring Force acceptable	Passed
Sterilization & Packaging
Sterilization compliant	Compliant with ANSI/AAMI/ISO 11137-2
Transportation integrity	Passed (Transit Testing)
Sterile barrier integrity	Passed (Bubble Test)
Packaging & System visual inspection acceptable	Passed
Pouch seal integrity	Passed
Clinical Efficacy (Maxillary Ostia Patency)	SinuSys Study (Per Protocol)
Acute Patency comparable to literature	54/57 (95%) with 95% CI: 85.6% - 98.2%
3 Months Patency comparable to literature	51/55 (93%) with 95% CI: 82.7% - 97.1%

Study That Proves the Device Meets Acceptance Criteria:

The 510(k) submission details several studies to demonstrate safety and effectiveness for substantial equivalence:

Biocompatibility Studies: In compliance with EN ISO 10993 requirements (ISO 10993-5:2009 and ISO 10993-10:2010).
In Vitro Bench Evaluation: Performance testing was completed on various physical and mechanical attributes of the device.
Transportation, Sterilization, and Shelf-life Testing: Sterilization compliant with ANSI/AAMI/ISO 11137-2. Transportation and packaging validation included transit testing, sterile barrier integrity, packaging/system visual inspection, and pouch seal testing.
Animal Studies: Four (4) Dilation Devices were deployed into four (4) separate sheep maxillary sinuses to confirm safe placement and dilation.
Cadaver Testing: Performed by multiple users (investigators) using two (2) adult cadaveric head specimens. The device was placed four (4) times into each target site.
Clinical Trial: A prospective, non-randomized, single-arm, open-label study was conducted.

2. Sample Size Used for the Test Set and Data Provenance

Clinical Trial Test Set Sample Size:
- Patients: 34 patients
- Maxillary Ostia Treated: 57 maxillary ostia
- Data Provenance: The study was conducted at five (5) clinical sites. The summary does not specify the country of origin, but given the applicant is a US company (Palo Alto, CA) and the FDA submission is for the US market, it's highly probable the study was conducted in the United States.
- Retrospective or Prospective: Prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The summary states that five (5) investigators conducted the clinical trial at five (5) clinical sites.
Their specific qualifications are not explicitly stated beyond being "investigators," but for a study involving sinus dilation, they would typically be Ear, Nose, and Throat (ENT) specialists or Otolaryngologists. Their years of experience are not mentioned.
The "ground truth" for the clinical trial was likely established by these investigators through post-procedure assessments of ostia patency, potentially using endoscopy or other clinical evaluation methods.

4. Adjudication Method for the Test Set

The information provided does not specify an explicit adjudication method (e.g., 2+1, 3+1). For a single-arm, open-label study, it's common for the treating physician/investigator to evaluate the outcome. There is no mention of independent reviewers or a consensus process for the clinical trial results presented in the table.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a surgical instrument, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a manual surgical instrument, not an algorithm, so a standalone algorithmic performance study was not performed.

7. Type of Ground Truth Used

Biocompatibility: Standardized laboratory test results based on established ISO guidelines.
In Vitro Bench: Quantitative measurements and qualitative assessments ("Passed") against pre-defined performance specifications.
Animal Studies: Direct observation and assessment of safe placement and dilation in sheep maxillary sinuses by qualified personnel.
Cadaver Testing: Endoscopic delivery and placement of the device confirmed by investigators.
Clinical Trial: Clinical assessment of maxillary ostia patency at acute and 3-month follow-ups, likely by the treating investigators based on clinical examination (e.g., endoscopy). This falls under expert clinical assessment/outcomes data.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/Machine Learning algorithm, so there is no "training set" in the computational sense. The "training" for the device would involve manufacturing process controls, design iterations, and perhaps early prototype testing, none of which are detailed as a formal "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an algorithm. The "ground truth" during device development and manufacturing would be established through engineering specifications, material standards, and quality control metrics.

Summary

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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 WayPalo Alto, CA 94303
Phone:	650-213-9988
Fax:	650-213-9688

Contact Person:

Michael A Daniel, Consultant

Phone Number:	(415) 407-0223
Office:	(925) 254-5228
Facsimile Number:	(925) 254-5187

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:

DEC 9 2013

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Premarket Notification 510(k) Summary - Continued 8

Indications for Use:

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(Bubble Test)	Passed
Packaging & SystemVisual 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

× 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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Regulation Number and Section

§ 874.4420 Ear, nose, and throat manual surgical instrument.

(a)
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.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.