(179 days)
No
The description focuses on the mechanical and optical components of the endoscope and its use in a surgical procedure, with no mention of AI or ML capabilities.
Yes
The device is intended to treat a condition by allowing visualization and delivery of a balloon dilation catheter to treat the maxillary sinus ostium and ethmoid infundibulum.
No.
The device is used to visualize the maxillary sinus cavity and deliver a balloon dilation catheter for treatment, not to diagnose a condition.
No
The device description clearly states it is a fiber optic based, manually operated, reusable rigid antroscope, which is a physical hardware device.
Based on the provided information, the FinESS Endoscope is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to visualize the maxillary sinus cavity and deliver a balloon dilation catheter for treatment. This is a therapeutic and diagnostic imaging use, not a diagnostic test performed on samples taken from the body (in vitro).
- Device Description: The device is a rigid endoscope used for direct visualization and delivery of a therapeutic device. This aligns with surgical/interventional devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
The device is clearly intended for direct visualization and intervention within the body, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The FinESS Endoscope is intended to provide a means to visualize the maxillary sinus cavity and deliver the FinESS balloon dilation catheter to treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The endoscope is part of the FinESS Sinus Treatment and is inserted via a sterile access sheath through the canine fossa.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
The FinESS Endoscope is a fiber optic based, manually operated, reusable rigid antroscope designed for performing the FinESS Sinus Treatment procedure. It is short, all metal and fully immersible. It is labeled non-sterile and must be cleaned and disinfected or sterilized prior to use. The endoscope is compatible with standard "B" mount camera couplers, and comes with two light post adapters, which allows the endoscope to be compatible with most commonly used light guides. The endoscope also has a working channel that allows for delivery of the FinESS balloon dilation catheter to treat the maxillary ostium and ethmoid infundibulum.
The FinESS Endoscope is part of and used with the FinESS Sinus Treatment [K081542] and insertion of the endoscope is performed using a sterile access sheath [K091681].
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary sinus cavity, maxillary sinus ostium, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests included biocompatibility testing, dimensional verification, cadaver studies, manual cleaning validation utilizing total organic carbon as study endpoint, manual high level disinfection validation, sterilization validation of STERRAD NX system (per ISO 14937), compatibility testing, and storage and transportation testing. Animal and clinical data were not submitted. The testing showed that the device meets design specifications and performs as intended.
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.
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
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for "entellus MEDICAL". To the left of the company name is a circular graphic made up of several curved lines. The company name is in all lowercase letters, and below it is the word "MEDICAL" in all caps with a trademark symbol.
FEB 1 5 2011
K102366 510(k) Summary
Submitter's Name, Address, and Date of Submission
Karen E. Peterson Vice President Clinical, Regulatory and Quality 6705 Wedgwood Court North Maple Grove, MN 55311 Tel: 1-763-463-7056 Fax: 1-763-463-1599
Submitted:
February 15, 2011
Device Name
Trade Name: Common Name: Classification Name: Product Code:
FinESS Endoscope Endoscope or Antroscope or Sinuscope Nasopharyngoscope (flexible or rigid), 21CFR 874.4760 EOB
Predicate Device
Entellus Medical Flexible Endoscope [K082569] used with Entellus Sinus Cannula [K072302]
Device Description
The FinESS Endoscope is a fiber optic based, manually operated, reusable rigid antroscope designed for performing the FinESS Sinus Treatment procedure. It is short, all metal and fully immersible. It is labeled non-sterile and must be cleaned and disinfected or sterilized prior to use. The endoscope is compatible with standard "B" mount camera couplers, and comes with two light post adapters, which allows the endoscope to be compatible with most commonly used light guides. The endoscope also has a working channel that allows for delivery of the FinESS balloon dilation catheter to treat the maxillary ostium and ethmoid infundibulum.
Image /page/0/Picture/14 description: The image shows a diagram of a medical device. The device has a syringe-like component attached to a rectangular piece with the word "AnESS" printed on it. Two tubes are connected to the rectangular piece on either side.
The FinESS Endoscope is part of and used with the FinESS Sinus Treatment [K081542] and insertion of the endoscope is performed using a sterile access sheath [K091681].
1
Indications for Use
The FinESS Endoscope is intended to provide a means to visualize the maxillary sinus cavity and deliver the FinESS balloon dilation catheter to treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The endoscope is part of the FinESS Sinus Treatment and is inserted via a sterile access sheath through the canine fossa.
Substantial Equivalence
The FinESS Endoscope has the same intended use, principal of operation, biocompatibility, device and accessory compatibility, reusability, and reprocessing methods as the predicate device.
The FinESS Endoscope has some different technological features compared to the predicate device, however. these differences present the same type of questions about safety or effectiveness, accepted scientific methods exist for evaluating the features, and data are provided to demonstrate that the features have not diminished safety or effectiveness.
Performance Data
The device performance test data is provided in the 510(k) submission. Performance tests included biocompatibility testing, dimensional verification, cadaver studies, manual cleaning validation utilizing total organic carbon as study endpoint, manual high level disinfection validation, sterilization validation of STERRAD NX system (per ISO 14937), compatibility testing, and storage and transportation testing. Animal and clinical data were not submitted. The testing showed that the device meets design specifications and performs as intended.
Conclusion
FinESS Endoscope is substantially equivalent to the predicate device. FinESS Endoscope is safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized design featuring a symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
Entellus Medical, Inc. c/o Ms. Karen Peterson Vice President, Clinical, Regulatory and Quality 6705 Wedgewood Court North Maple Grove, MN 55311
FEB 15 201
Re: K102366
Trade/Device Name: Entellus FinESS Endoscope (Model ES300) Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: February 11, 2011 Received: February 14, 2011
Dear Ms. Peterson:
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.
:
. ・
3
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,
R.C. Turner
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
4
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: FinESS Endoscope
Indications for Use
The FinESS Endoscope is intended to provide a means to visualize the maxillary sinus cavity and deliver the FinESS balloon dilation catheter to treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The endoscope is part of the FinESS Sinus Treatment and is inserted via a sterile access sheath through the canine fossa.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use X X OR/AND
Over-the-Counter Use
Susan Rudy CRWP
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) FinESS Endoscope
K102366 510(k) Number_
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