(117 days)
Not Found
No
The description focuses on mechanical dilation and does not mention any computational or algorithmic components indicative of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is used in surgical procedures to treat nasal and paranasal tissues by dilating sinus ostia. Treatment of a medical condition falls under the definition of a therapeutic device.
No
The device is described as a "Sinus Dilation System" intended for "surgical procedures to access, examine or treat" and "to access and treat" the nasal and paranasal tissues. Its function is to dilate sinus ostia. This indicates a therapeutic or interventional purpose, not a diagnostic one.
No
The device description clearly outlines physical components including a disposable balloon, reusable delivery instrument, balloon sleeve, connecting collar, and inflation line. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures to access, examine, or treat nasal and paranasal tissues, specifically for dilation of sinus ostia. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device is a physical system (balloon and delivery instrument) used for mechanical dilation. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Function: The description focuses on the physical action of dilation and access, not on identifying a disease, condition, or state based on in vitro analysis.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The ENTrigue® Sinus Dilation System does not fit this description.
N/A
Intended Use / Indications for Use
The ENTrigue® Sinus Dilation System is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia.
The ENTrigue® Sinus Dilation System is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach.
Product codes (comma separated list FDA assigned to the subject device)
LRC
Device Description
The ENTrigue® Sinus Dilation System consists of a disposable balloon which is mounted on a reusable delivery instrument to allow for dilation of sinus ostia in the paranasal cavity under endoscopic quidance. The Sinus Balloon components include a balloon sleeve to slide over the tip of the delivery instrument, a connecting collar to latch the balloon sleeve to the delivery instrument, and an inflation line to connect to the balloon inflation device. The features of this device enable a physician to quide the device to the sinus ostium using endoscopic visualization.
The ENTrigue® Sinus Balloon Dilation Balloon and inflation device are individually packaged and provided sterile for single use only. The delivery instrument is a reusable instrument which must be sterilized prior to use following the recommended and validated cleaning and sterilizing procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula, paranasal cavity, sinus ostium
Indicated Patient Age Range
adults
Intended User / Care Setting
physician
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)
Bench and cadaveric testing, fea turing multiple users, was conducted to validate that the instrument design met user requirements and confirmed that the ENTrigue® Sinus Dilation System is substantial equivalent to the legally marketed predicate device; the XprESS™ Multi-Sinus Dilation Tool. Biocompatibility, sterilization, packaging, distribution, and shelf life testing were also submitted. In all instances, the ENTrigue® Sinus Dilation System functioned as intended and the results observed were as expected.
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.
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
K 12135|
AUG 2 9 2012
510(k) Number
510(k) SUMMARY
ENTrigue Surgical's Sinus Dilation System
Date Prepared:
May 3, 2012
Trade Name:
Sponsor:
ENTrigue® Sinus Dilation System
ENTrigue Surgical, Inc. 12672 Silicon Drive, Suite 150 San Antonio, Texas 78249 USA Telephone: 1-877-300-5010 Fax: 1-210-298-6399 Contact Person: Gabriele G. Niederauer, Ph.D.
| Product Code and |
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| Device Classification Name: |
Classification:
Predicate Device:
Intended Use:
Indications for Use:
Technological: Characteristics LRC Sinus Dilation System (21 C.F.R. § 874.4420)
Class I (exempt from 510(k) requirements)
Entellus Medical, Inc. XprESS™ Multi-Sinus Dilation Tool [K102003]
The ENTrigue® Sinus Dilation System is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia.
The Sinus Dilation Balloon System is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach.
The ENTrigue® Sinus Dilation System consists of a disposable balloon which is mounted on a reusable delivery instrument to allow for dilation of sinus ostia in the paranasal cavity under endoscopic quidance. The Sinus Balloon components include a balloon sleeve to slide over the tip of the delivery instrument, a connecting collar to latch the balloon sleeve to the delivery instrument, and an inflation line to connect to the balloon inflation device. The features of this device enable a physician to quide the device to the sinus ostium using endoscopic visualization.
The ENTrigue® Sinus Balloon Dilation Balloon and inflation device are individually packaged and provided sterile for single use only. The delivery instrument is a reusable instrument which must be sterilized prior to use following the
1
recommended and validated cleaning and sterilizing procedures.
Performance Data:
Substantial Equivalence:
Bench and cadaveric testing,fea turing multiple users, was conducted to validate that the instrument design met user requirements and confirmed that the ENTrigue® Sinus Dilation System is substantial equivalent to the legally marketed predicate device; the XprESS™ Multi-Sinus Dilation Tool. Biocompatibility, sterilization, packaging, distribution, and shelf life testing were also submitted. In all instances, the ENTrigue® Sinus Dilation System functioned as intended and the results observed were as expected.
The ENTrique® Sinus Dilation System is as safe and effective as the Entellus Medical, Inc. XprESS™ Multi-Sinus Dilation Tool. The ENTrigue® Sinus Dilation System has the same intended uses and similar indications, technological characteristics (design, materials), principles of operation, packaging and sterilization (EtO) as the predicate device. The minor technological differences between the ENTrigue® Sinus Dilation System and its predicate device do not constitute differences in fundamental scientific technology. Performance data demonstrate that the ENTrigue® Sinus Dilation System is as safe and effective as the Entellus Medical, Inc. XprESS™ Multi-Sinus Dilation Tool. Thus, the ENTrigue® Sinus Dilation System is substantially equivalent to the XprESS™ Multi-Sinus Dilation Tool.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ENTrigue Surgical, Inc. c/o Gabriele G. Niederauer, Ph.D. Senior Vice President, Technology and Development 12672 Silicon Drive, Suite 150 San Antonio, TX 78249
Re: K121351
Trade/Device Name: ENTrigue® Sinus Dilation System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, and Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: July 31, 2012 Received: August 9, 2012
Dear Dr. Niederauer:
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. 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.
AUG 29 2012
3
Page 2 - Gabriele G. Niederauer, Ph.D.
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.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erica Newman, MD
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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K 12 135|
Indications for Use Statement
510(k) Number (if known): _
Device Name: ENTrigue® Sinus Dilation System
Intended Use:
The ENTrigue® Sinus Dilation System is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia.
Indications for Use:
The ENTrigue® Sinus Dilation System is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amalolal
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
The Course of Devices (Division Sign-Off) Division of Open of Open of Orices
Nose and Throat Devices
Number |