(75 days)
Not Found
No
The device description and performance studies focus on the mechanical and osmotic properties of the dilation system, with no mention of AI or ML.
Yes.
The device is intended for "therapeutic procedures" and functions to "dilate the maxillary sinus ostia and associated spaces," which is a therapeutic action.
Yes
The "Intended Use / Indications for Use" states that the device is intended for "diagnostic and therapeutic procedures," indicating its use in diagnosis.
No
The device description clearly states it is comprised of a "Dilation Device" and a "Placement Instrument," which are physical hardware components. The performance studies also detail testing on these physical components (e.g., device weight, bond strength, animal studies, cadaver testing).
Based on the provided information, the Vent-Os™ Sinus Dilation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "access the sinus space and to dilate the maxillary sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures." This describes a device used directly on or within the body for a physical procedure (dilation).
- Device Description: The description details a physical device that expands and remodels tissue. This is a mechanical action performed in vivo.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Vent-Os™ system does not perform this function. It is a surgical/interventional tool.
Therefore, the Vent-Os™ Sinus Dilation System is a medical device, but it falls under a different classification than an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LRC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary sinus ostia and associated spaces, sinus space
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
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)
Biocompatibility in compliance with EN ISO 10993 requirements was completed. This biocompatibility testing included:
- Cytotoxicity (MEM Elution) - ISO 10993-5:2009 - Non-cytotoxic
- Sensitization-Maximization - ISO 10993-10: 2010 - Non-sensitizing
- Intracutaneous Reactivity - ISO 10993-10: 2010 - Non-irritating
In Vitro bench evaluation including performance testing was completed. This performance testing included the following evaluations:
- 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:
- Transit Testing - Passed
- Sterile Barrier Integrity (Bubble Test) - Passed
- Packaging & System Visual Inspection - Passed
- Pouch Seal Testing - Passed
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.
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 (Acute) - Per Protocol:
N: 57
Patent: 54 (95%) (95% CI: 85.6% - 98.2%)
Non-Patent: 0
Indeterminate: 3 (5%) (95% CI: 1.8% - 14.4%)
SinuSys Study (3 Months) - Per Protocol:
N: 55
Patent: 51 (93%) (95% CI: 82.7% - 97.1%)
Non-Patent: 0
Indeterminate: 4 (7%) (95% CI: 2.9% - 17.3%)
Bolger Study (1 week) - Per Protocol:
N: 142
Patent: 106 (75%) (95% CI: 66.9% - 81.1%)
Non-Patent: 0
Indeterminate: 36 (25%) (95% CI: 18.9% - 33.1%)
Bolger Study (3 Months) - Per Protocol:
N: 116
Patent: 98 (84%) (95% CI: 76.8% - 90.0%)
Non-Patent: 3 (3%)
Indeterminate: 15 (13%) (95% CI: 8.0% - 20.2%)
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Patent Rate, Non-Patent Rate, Indeterminate Rate.
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.
Relieva Spin Sinus Dilation System (K111875), XprESS Multi-Sinus Dilation Tool (K121943), ENTrigue / Ventera (K121351)
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
§ 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.
0
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 |
| Palo 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:
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
1
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 |
2
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 & System | |
| Visual Inspection | Passed |
| Pouch Seal Testing | Passed |
3
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.
4
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
5
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
6
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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