(28 days)
Not Found
No
The summary describes a mechanical device for accessing and treating the sinuses and does not mention any AI/ML components or capabilities.
Yes
The device is described as accessing and treating an anatomical site to remodel bony sinus outflow tracts, indicating a therapeutic purpose.
No.
The device's intended use is to access and treat anatomical structures, and its description focuses on mechanical components for delivery and access, not on collecting or analyzing data for diagnosis.
No
The device description explicitly details physical hardware components such as an access sheath, trocar, cannula, endoscope, and balloon catheter, indicating it is a physical medical device system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- FinESS Description: The description of the FinESS system clearly indicates it is a surgical device used to access and treat anatomical structures (maxillary sinus ostium and ethmoid infundibulum) within the body. It involves physical manipulation (balloon displacement of bone) and is used in vivo (within a living organism), not in vitro (in a lab setting).
The intended use and device description are consistent with a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
To access and treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
Product codes
LRC
Device Description
The access sheath component of the FinESS™ Sinus Treatment System is comprised of a polycarbonate flange that is over-molded on a stainless steel fluted tube which, when mated with the trocar provided in the kit, gains access to the maxillary sinus. Once the trocar is removed, the access sheath allows delivery of the FinESS cannula, endoscope and balloon catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary sinus ostium and the ethmoid infundibulum
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
Non-clinical testing of the modified access sheath included assessments of the outer profile, fit of the trocar to the sheath, as well as tensile and torque strength of the overmolded component. Biocompatibility of the new material (grey polycarbonate) was also completed. No clinical evaluations were conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL - 8 2009
510(k) Summary
Date Prepared:
Submitter Information:
June 1, 2009
3006345872
Entellus Medical, Inc. 6705 Wedgwood Court, North Maple Grove, MN 55311
Establishment Registration:
Contact Information:
Deborah L. Neymark V.P. Regulatory Affairs (763) 463-7056 (phone) (763) 463-1599 (fax) dneymark@entellusmedical.com
Device Information: Trade Name: Common Name: Classification Name: Product Code: Regulation Number:
FinESS™ Sinus Treatment Access Sheath Ear, nose and throat manual surgical instrument LRC Class I, 21 CFR 874.4420
Predicate Device:
FinESS Sinus Treatment (K073202)
Device Description:
The access sheath component of the FinESS Sinus Treatment System is comprised of a polycarbonate flange that is over-molded on a stainless steel fluted tube which, when mated with the trocar provided in the kit, gains access to the maxillary sinus. Once the trocar is removed, the access sheath allows delivery of the FinESS cannula, endoscope and balloon catheter.
Indication for Use:
To access and treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
Entellus Medical, Inc. FinESS™Sinus Treatment June 4, 2009
Page 7-2
1
Summary of Non-Clinical Testing:
Non-clinical testing of the modified access sheath included assessments of the outer profile, fit of the trocar to the sheath, as well as tensile and torque strength of the overmolded component. Biocompatibility of the new material (grey polycarbonate) was also completed.
Summary of Clinical Data:
No clinical evaluations were conducted.
Statement of Equivalence:
The modified access sheath is shown to be substantially equivalent to the existing access sheath included in the FinESS Sinus Treatment System based on a comparison of indications for use and device technology.
Entellus Medical, Inc. FinESS™Sinus Treatment June 4, 2009
Page 7-3
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing service, knowledge, and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 8 2009
Entellus Medical, Inc. c/o Deborah L. Neymark V.P. Regulatory Affairs Clinical Research and Quality 6705 Wedgwood Court North Maple Grove, MN 55311
Re: K091681
Trade/Device Name: FinESS™ Sinus Treatment Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose and Throat Manual Surgical Instrument Regulatory Class: I Product Code: LRC Dated: June 4, 2009 Received: June 10, 2009
Dear Ms. Neymark:
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 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.
3
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Malvina B. Eydelman, M.I Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K09168/
Indications for Use Statement
510(k) Number: K091681
FinESS™ Sinus Treatment Device Name:
Indications for Use:
FinESS is indicated to access and treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
| Prescription Use | X |
|---|---|
| (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel C. Cepp
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Numb