(103 days)
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.
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.
The provided text is a 510(k) summary for the Sinexus Sinus Stent Gen 2. This document is a regulatory submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device. It primarily focuses on comparing the new device's intended use, technological characteristics, and materials to existing devices, and often summarizes performance testing to support claims of safety and effectiveness.
However, the provided text does not contain the detailed study information required to fill out the table and answer all the questions about acceptance criteria and device performance as it would for a software device or a diagnostic device. The 510(k) summary for a medical device like a stent typically focuses on material safety, mechanical properties, biocompatibility, and perhaps animal or limited human trials to show it performs its intended function similarly to predicate devices. It does not typically involve metrics like sensitivity, specificity, or reader performance improvement, which are common for AI/ML-based diagnostic devices.
Therefore, I cannot populate most of the requested fields directly from the provided text. I will indicate where the information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. The 510(k) summary states "The performance testing demonstrates that the Sinexus Sinus Stent Gen 2 is safe and effective for its intended use" but does not detail specific acceptance criteria or quantitative performance metrics. | Not specified in the provided text. The document indicates that performance testing was conducted, leading to a determination of substantial equivalence, but it does not provide the specific results or metrics from this testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. (e.g., country of origin, retrospective or prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable or not specified in the provided text. For a physical device like a sinus stent, "ground truth" establishment in the context of expert consensus or pathology is typically not a central part of a 510(k) summary, which often relies on in-vitro, ex-vivo, or limited clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable or not specified in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device (stent), not an AI/ML diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (stent), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly specified in the provided text. For a device like this, ground truth would likely refer to clinical outcomes (e.g., maintained patency, absence of adhesions) observed in human or animal studies, or validation against engineering and biocompatibility standards. The 510(k) relies on comparison to predicate devices, implying that their established safety and effectiveness serve as a benchmark.
8. The sample size for the training set
Not applicable or not specified in the provided text. The concept of a "training set" in the context of AI/ML is not relevant here for a physical medical device. Performance testing for a stent would involve mechanical tests and potentially biological studies, not training data.
9. How the ground truth for the training set was established
Not applicable or not specified in the provided text due to the nature of the device and the submission document.
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| 5.510(k) Summary | K092401 |
|---|---|
| Submitter's name: | Sinexus, Inc. |
| Address: | 1049 Elwell CourtPalo 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) andSyntheMed 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 stentdesigned to be placed in the ethmoid sinus to maintainpatency of the sinus after surgery. |
| Intended Use: | The Gen 2 Sinexus Sinus Stent is intended for use in adultpatients following sinus surgery to maintain patency of theethmoid sinus by separating mucosal tissues, providingstabilization of the middle turbinate and preventingobstruction by adhesions between healing and/or inflamedmucosal surfaces. |
| Rationale for SubstantialEquivalence / Comparisonto Predicate: | The intended use, technological characteristics and materialsof the Sinexus Sinus Stent Gen 2 are substantiallyequivalent to the predicate devices. The performancetesting demonstrates that the Sinexus Sinus Stent Gen 2 issafe and effective for its intended use. The informationprovided in the 510(k) support that the Sinexus Sinus StentGen 2 device is substantially equivalent to the predicatedevices. |
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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.
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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
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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 |
§ 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.