(13 days)
Not Found
No
The summary describes a standard flexible endoscope and eyepiece without mentioning any AI/ML capabilities or image processing beyond basic visualization. The performance studies focus on physical and reprocessing characteristics, not algorithmic performance.
Yes
The intended use states that the device is for "diagnostic and therapeutic endoscope procedures."
Yes
The "Intended Use / Indications for Use" section states that the device is intended to "visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures." The mention of "diagnostic" procedures clearly indicates its use in diagnosing conditions.
No
The device description explicitly states it consists of a "flexible fiber optic scope and eyepiece," which are hardware components. The performance studies also include hardware-related testing like biocompatibility and dimensional verification.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for visualizing internal cavities during diagnostic and therapeutic procedures. This is a direct visualization tool used in vivo (within the body).
- Device Description: The description confirms it's a flexible fiber optic scope and eyepiece, designed for visualization.
- Lack of IVD Characteristics: There is no mention of the device being used to examine samples in vitro (outside the body), such as blood, urine, tissue, etc., which is the defining characteristic of an IVD.
IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to directly observe structures within the body.
N/A
Intended Use / Indications for Use
The Entellus Flexible Endoscope and Eyepiece is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures. The device can be used with compatible video systems.
Product codes
EOB
Device Description
The Entellus Medical Flexible Endoscope and Eyepiece consist of a flexible fiber optic scope and eyepiece that is compatible with most commercially available endoscopic video systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear, airways, nose and sinus cavities
Indicated Patient Age Range
Not Found
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)
The device performance test data is provided in the 510(k) submission included biocompatibility testing, dimensional verification, bench testing, and qualification of reprocessing procedures. The performance data demonstrates that the device meets its established specifications, is biocompatible, and is able to perform as intended following standard reprocessing procedures.
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.
Karl Storz Miniature Endoscope (K070752), Karl Storz Video Rhino-Laryngoscope System (K072387), Vision-Sciences Trans-Nasal Esophagoscope with Endosheath System (K031786)
Reference Device(s):
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
§ 874.4760 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
510(k) Summary K082569
SEP 1 8 2008
| Date Prepared:
| Submitted By: | September 17, 2008 |
|---|---|
| Company: | Entellus Medical, Inc. |
| Address: | 6705 Wedgwood Court North |
| Maple Grove, MN 55311 | |
| Establishment Reg: | Not Yet Assigned |
| Owner/Operator #: | 10025424 |
| Contact Person: | Deborah Neymark |
| V.P., Regulatory Affairs, Clinical Research and Quality | |
| 763-463-7056 (phone) | |
| 763-463-1599 (fax) | |
| Device Information: | |
| Trade Name: | Entellus Medical Flexible Endoscope and Eyepiece |
| Common Name: | Flexible Endoscope |
| Classification Name: | Nasopharyngoscope (flexible and rigid) |
| Classification: | 21 CFR 874.4760 |
| Product Code: | EOB |
Predicate Device:
The Entellus Medical Flexible Endoscope and Eyepiece is substantially equivalent to the following devices:
- Karl Storz Miniature Endoscope (K070752) ●
- Karl Storz Video Rhino-Laryngoscope System (K072387) .
- Vision-Sciences Trans-Nasal Esophagoscope with Endosheath System (K031786)
Device Description:
The Entellus Medical Flexible Endoscope and Eyepiece consist of a flexible fiber optic scope and eyepiece that is compatible with most commercially available endoscopic video systems.
Indications for Use:
The Entellus Flexible Endoscope and Eyepicce is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures. The device can be used with compatible video systems.
Performance Data:
The device performance test data is provided in the 510(k) submission included biocompatibility testing, dimensional verification, bench testing, and qualification of reprocessing procedures. The performance data demonstrates that the device meets its established specifications, is biocompatible, and is able to perform as intended following standard reprocessing procedures.
Conclusion:
The Entellus Medical Flexible Endoscope and Eyepiece is substantially equivalent to the identified predicate device based on a companson of the indications for use, the technological characteristics of the device and an assessment of the submitted performance data.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with outstretched wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 2008
Entellus Medical Inc. c/o Mark Job Regulatory Technology Services 1394 25th Street. NW Buffalo, MN 55313
Re: K082569
Trade/Device Name: Entellus Medical Flexible Endoscope and Eyepiece Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible and rigid) Regulatory Class: Class II Product Code: EOB Dated: September 4, 2008 Received: September 5, 2008
Dear Mr. Job:
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 such 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 mav 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); 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
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prestmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
M. B. Egerlins, mnd
Malvina B. Evdelman. M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
KOB-2569
Indications for Use Statement
510(k) Number:
Device Name:
Entellus Medical Flexible Endoscope and Eyepiece
Indications for Use:
The Entellus Flexible Endoscope and Eyepiece is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures. The device can be used with compatible video systems.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sein Mardin
(Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devises
510(k) Number
X cription Use r 21 CFR 801.109)