(103 days)
Not Found
No
The summary describes a bioabsorbable stent for maintaining sinus patency after surgery. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on the physical properties and function of the stent.
Yes
The device is intended to maintain patency of the sinus by separating mucosal tissues, providing stabilization of the middle turbinate, and preventing obstruction by adhesions, which are all therapeutic actions.
No
The device is a bioabsorbable stent used to maintain patency of the sinus after surgery, separating tissues and preventing obstruction. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "bioabsorbable stent," which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Sinexus Sinus Stent Gen 2 Function: The description clearly states that the Sinexus Sinus Stent Gen 2 is a bioabsorbable stent designed to be placed in the ethmoid sinus after surgery. Its purpose is to maintain patency and prevent obstruction within the body.
The device is a surgical implant used in vivo (within the body), not a diagnostic tool used in vitro (outside the body).
N/A
Intended Use / Indications for Use
The Gen 2 Sinexus Sinus Stent is intended for use in adult patients following sinus surgery to maintain patency of the ethmoid sinus by separating mucosal tissues, providing stabilization of the middle turbinate and preventing obstruction by adhesions between healing and/or inflamed mucosal surfaces.
Product codes (comma separated list FDA assigned to the subject device)
LYA
Device Description
The Gen 2 Sinexus Sinus Stent is a bioabsorbable stent designed to be placed in the ethmoid sinus to maintain patency of the sinus after surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ethmoid sinus
Indicated Patient Age Range
adult patients
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Sinexus Sinus Stent (K062628), SyntheMed SinuShield (K082276), AdvaCoat Sinus Gel and Stent (K070496), Nasopore Nasal Dressing (K052099), LactoSorb Ethmoid Stent (K002131)
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
§ 874.4780 Intranasal splint.
(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(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 the limitations in § 874.9.
0
| 5.
| 510(k) Summary | K092401 |
|---|---|
| Submitter's name: | Sinexus, Inc. |
| Address: | 1049 Elwell Court |
| Palo Alto, CA, 94303 | |
| Phone Number: | 650-641-2115 |
| Fax Number: | 650-641-2065 |
| Contact Person: | Amy Conuel, Director, Regulatory Affairs |
| Date Prepared: | November 3, 2009 |
| Trade Name: | Sinus Stent |
| Regulation: | 21CFR 874.4780 |
| Product Code: | LYA |
| Product Classification: | I |
| Predicate Device: | Sinexus Sinus Stent (K062628) and |
| SyntheMed SinuShield (K082276) | |
| AdvaCoat Sinus Gel and Stent (K070496) | |
| Nasopore Nasal Dressing (K052099) | |
| LactoSorb Ethmoid Stent (K002131) | |
| Device Description: | The Gen 2 Sinexus Sinus Stent is a bioabsorbable stent |
| designed to be placed in the ethmoid sinus to maintain | |
| patency of the sinus after surgery. | |
| Intended Use: | The Gen 2 Sinexus Sinus Stent is intended for use in adult |
| patients following sinus surgery to maintain patency of the | |
| ethmoid sinus by separating mucosal tissues, providing | |
| stabilization of the middle turbinate and preventing | |
| obstruction by adhesions between healing and/or inflamed | |
| mucosal surfaces. | |
| Rationale for Substantial | |
| Equivalence / Comparison | |
| to Predicate: | The intended use, technological characteristics and materials |
| of the Sinexus Sinus Stent Gen 2 are substantially | |
| equivalent to the predicate devices. The performance | |
| testing demonstrates that the Sinexus Sinus Stent Gen 2 is | |
| safe and effective for its intended use. The information | |
| provided in the 510(k) support that the Sinexus Sinus Stent | |
| Gen 2 device is substantially equivalent to the predicate | |
| devices. |
.
.
1
Image /page/1/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. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Intersect ENT, Inc. % Ms. Amy Conuel Director of Regulatory Affairs 1049 Elwell Court Palo Alto, CA 94303.
NOV 1 7 2009
Re: K092401
Trade/Device Name: Sinexus Sinus Stent Gen 2 Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal splint Regulatory Class: Class I Product Code: LYA Dated: October 5, 2009 Received: October 7, 2009
Dear Ms. Conuel:
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.
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 (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.
2
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
R. A. h. m
Melvin R. Fudelman, M.D.
Malvina B. Eydelman, M.D Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K092401
Device Name: Sinexus Sinus Stent Gen 2
Indications For Use:
The Sinexus Sinus Stent Gen 2 is intended for use in adult patients following sinus surgery to maintain patency of the sinus by separating mucosal tissues, providing stabilization of the middle turbinate and preventing obstruction by adhesions between healing and/or inflamed mucosal surfaces.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | Page 1 of 1 |
| Division of Ophthalmic, Neurological and Ear, | |
| Nose and Throat Devices | |
| 510(k) Number | K092401 |