(84 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a light fiber for illumination, with no mention of AI or ML algorithms for data processing, analysis, or decision-making.
No.
The device is used for illumination and transillumination, which are diagnostic/visualization functions, not therapeutic ones.
No
The device is described as a light source to illuminate and transilluminate structures, which assists in visualization during procedures rather than diagnosing a condition. Its intended use focuses on location and illumination, not identifying diseases or conditions.
No
The device description clearly states it is a "flexible instrument" and mentions physical components like a "light fiber," "male tuohy borst adapter," and compatibility with "light post adapters and light cables." This indicates a physical hardware device, not software only.
No, 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.
- Device Function: The PathAssist Light Fiber is a surgical instrument used to illuminate and transilluminate structures within the body (nasal and sinus structures). It does not perform any tests on samples taken from the body.
- Intended Use: The intended use clearly states its purpose is to "locate, illuminate within, and transilluminate across nasal and sinus structures." This is a direct interaction with the body, not a test on a sample.
Therefore, based on the provided information, the PathAssist Light Fiber is a surgical illumination device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To locate, illuminate within, and transilluminate across nasal and sinus structures in adults aged 18 and over.
Product codes (comma separated list FDA assigned to the subject device)
LRC
Device Description
The PathAssist Light Fiber is a flexible instrument that can be connected to a light source to emit light from its distal end. The Light Fiber is provided sterile and is for single use only. It comes with a male tuohy borst adapter, which allows the device to be secured within compatible working lumen instruments. The Light Fiber is also compatible with standard light post adapters and light cables.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal and sinus structures
Indicated Patient Age Range
adults aged 18 and over.
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 testing of the PathAssist Light Fiber consisted of biocompatibility testing, design verification testing, packaging, sterilization, shelf life and simulated use in a cadaver model. Design verification testing included functional and mechanical testing, and compatibility testing. Animal and clinical data were not submitted. Performance testing showed that the device meets design specifications and performed 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.
Acclarent Relieva Luma Sinus Illumination System [K071845]
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
KIII763
CONFIDENTIAL
Image /page/0/Picture/2 description: The image shows the logo for "entellus MEDICAL". To the left of the text is a circular graphic made up of curved lines. Below the word "entellus" is the word "MEDICAL" in a smaller font size.
SEP 1 5 2011
510(k) Summary
Date Prepared: Submitter Information:
Establishment Registration:
Contact Information:
6705 Wedgwood Court, North Maple Grove, MN 55311
Entellus Medical, Inc.
3006345872
June 22, 2011
Karen E. Peterson Vice President Clinical, Regulatory and Quality (763) 463-7066 kpeterson@entellusmedical.com
Device Information: Trade Name: Common Name: Classification Regulation: Classification Name: Classification Panel: Device Classification: Product Code:
PathAssist Light Fiber Sinus Guidewire 21 CFR 874.4420 ENT Manual Surgical Instrument ENT Class I LRC
Predicate Device:
Acclarent Relieva Luma Sinus Illumination System [K071845]
Device Description:
The PathAssist Light Fiber is a flexible instrument that can be connected to a light source to emit light from its distal end. The Light Fiber is provided sterile and is for single use only. It comes with a male tuohy borst adapter, which allows the device to be secured within compatible working lumen instruments. The Light Fiber is also compatible with standard light post adapters and light cables.
Image /page/0/Figure/17 description: The image shows a diagram of a fiber optic cable. The cable consists of a light post, strain relief, flexible sheath, and the fiber itself. The flexible sheath is coiled in a loop.
PathAssist Light Fiber
1
Indication for Use
To locate, illuminate within, and transilluminate across nasal and sinus structures in adults aged 18 and over.
Contraindications:
None
Technological Characteristics:
The subject device has very similar technological characteristics (i.e., design, function, principle of operation, materials, biocompatibility and sterilization) as the predicate device: Acclarent Relieva Luma Sinus Illumination System [K071845].
Both the subject device and predicate device [K071845] are flexible devices that transmit light from the proximal to distal tip of the device via Light Fibers that can be seen via transillumination. Both devices can be connected to a standard light source via a light cable and an adapter.
Both the subject and predicate device [K071845] are sterilized using Ethylene Oxide (EtO), validated per ISO 11135-1, and have a Sterility Assurance Level (SAL) of 106. Both devices are provided sterile, are for single use only and are biocompatible per ISO 10993-1.
Substantial Equivalence:
The intended use and indications for use of the subject device are the same as the predicate device [Relieva Luma Sinus Illumination System, K071845]. The technological characteristics of the subject device are very similar to the predicate device [K071845], including: design, function, principle of operation, materials, biocompatibility and sterilization.
Performance Data:
Performance testing of the PathAssist Light Fiber consisted of biocompatibility testing, design verification testing, packaging, sterilization, shelf life and simulated use in a cadaver model. Design verification testing included functional and mechanical testing, and compatibility testing. Animal and clinical data were not submitted. Performance testing showed that the device meets design specifications and performed as intended.
Conclusion
In conclusion, the device is substantially equivalent based on a comparison of intended use, indications for use, and technological characteristics. The device 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 and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Entellus Medical, Inc. % Ms. Karen E. Peterson Vice President Clinical, Regulatory and Quality 6705 Wedgewood Court North Maple Grove. MN 55311
Re: K111763
1 5 2011 ුදුව
Trade/Device Name: PathAssist Light Fiber Regulation Number: 21 CFR 874.4420 Regulation Name: ENT manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: August 11, 2011 Received: August 12, 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.
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-
3
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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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6. Indications for Use Statement
K 111 763 510(k) Number (if known):
Device Name: PathAssist Light Fiber
Indications for Use
To locate, illuminate within, and transilluminate across nasal and sinus structures in adults aged 18 and over.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| OR/AND | |
| Over-the-Counter Use |
(Division Sign Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
| 510(k) Number | K111 763 |
|---|---|
| --------------- | ---------- |
510(k) PathAssist Light Fiber