(139 days)
No
The summary describes a simple fiber optic device for illumination and transillumination, with no mention of AI, ML, image processing, or data-driven decision making.
No.
The device's intended use is to locate, illuminate, and transilluminate nasal and sinus structures for diagnostic or guidance purposes, not to treat a disease or condition.
No
The device is used to illuminate nasal and sinus structures during procedures, not to diagnose conditions. Its intended use is to "locate, illuminate within, and transilluminate across nasal and sinus structures."
No
The device description explicitly states it is a "fiber optic based, manually operated, reusable sinus seeker" and mentions physical components like a "distal end" and "light post adapters." It also details performance testing related to physical attributes like biocompatibility, dimensional testing, and sterilization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "locate, illuminate within, and transilluminate across nasal and sinus structures." This describes a surgical or procedural tool used directly on the patient's body for visualization and guidance.
- Device Description: The description details a "fiber optic based, manually operated, reusable sinus seeker" that emits light. This is consistent with a medical device used for direct examination or assistance during a procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not process or analyze biological specimens.
The device is clearly a surgical instrument used in vivo (within the body) for visualization purposes.
N/A
Intended Use / Indications for Use
The PathAssist Light Seeker is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in adults aged 18 and over.
Product codes
LRC
Device Description
The PathAssist Light Seeker is a fiber optic based, manually operated, reusable sinus seeker that can be connected to a light source to emit light from its distal end. It is labeled non-sterile and must be cleaned and sterilized prior to each use. The PathAssist Light Seeker comes with two standard light post adapters, which allow the device to be compatible with commonly used 2.5mm light guides (cables).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses
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 device consisted of biocompatibility testing, design verification testing, simulated use design validation testing in a cadaver model, steam sterilization, compatibility testing, and storage and transportation testing. Design verification testing included dimensional and functional testing to support the useful life of the device. Cleaning validation testing performed on device [K102366] was submitted. Animal and clinical data were not submitted. Performance testing showed that the device meets design specifications and performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Relieva Luma™ Sinus Illumination System [K071845]
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
§ 874.4420 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.
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Entellus Medical
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. The text "entellus" is in a sans-serif font, and below it is the word "MEDICAL" in a smaller font size.
JUN - 7 2011
510(k) Summary
Date Prepared: Submitter Information:
Establishment Registration:
Contact Information:
May 10, 2011 Entellus Medical, Inc. 6705 Wedgwood Court, North Maple Grove, MN 55311
3006345872
Karen E. Peterson Vice President Clinical, Regulatory and Quality (763) 463-7066 kpeterson@entellusmedical.com
Device Information: Trade Name: Common Name: Classification Name: Product Code: Regulation Number:
PathAssist Light Seeker Sinus Seeker ENT Manual Surgical Instrument LRC Class I, 21 CFR 874.4420
Predicate Devices:
Sinus Seekers - Surgical Instrument - [510(k) exempt] Relieva Luma™ Sinus Illumination System [K071845]
Device Description:
The PathAssist Light Seeker is a fiber optic based, manually operated, reusable sinus seeker that can be connected to a light source to emit light from its distal end. It is labeled non-sterile and must be cleaned and sterilized prior to each use. The PathAssist Light Seeker comes with two standard light post adapters, which allow the device to be compatible with commonly used 2.5mm light guides (cables).
Image /page/0/Figure/17 description: The image shows a diagram of a PathAssist Light Seeker. The diagram labels the different parts of the device, including the 1.5 mm Lighted Ball Tip, Curved Tapered Probe, Handle, and Light Post. The PathAssist Light Seeker appears to be a medical device with a curved, tapered probe and a lighted ball tip.
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Indication for Use:
The PathAssist Light Seeker is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in adults aged 18 and over.
Contraindications:
None
Technological Characteristics:
The subject device has the same technological characteristics (i.e., principle of operation, design, function, materials, biocompatibility, reusability and reprocessing methods) as the predicate devices: [Sinus Seekers, 510(k) exempt] and/or [Relieva Luma Sinus Illumination System, K0930071.
Both the subject device and predicate device [Sinus Seekers, 510(k) exempt] are shaped like a sinus seeker and are advanced under endoscopic visualization into the sinus, are made of stainless steel, are provided non-sterile, are reusable, and must be cleaned and sterilized between each use. Both devices are biocompatible per ISO 10993-1.
Both the subject device and predicate device [Relieva Luma Sinus Illumination System, K071845] 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 devices are biocompatible per ISO 10993-1.
Substantial Equivalence:
The intended use and indications for use of the subject device is the same as the intended use and indications for use of the predicate device [Relieva Luma Sinus Illumination System, K093007]. The technological characteristics of the subject device are the same as the predicate devices. [Sinus Seekers, 510(k) exempt] and/or [Relieva Luma Sinus Illumination System. K093007], including: principle of operation, design, function, materials, biocompatibility, reusability and reprocessing methods.
Performance Data:
Performance testing of the device consisted of biocompatibility testing, design verification testing, simulated use design validation testing in a cadaver model, steam sterilization, compatibility testing, and storage and transportation testing. Design verification testing included dimensional and functional testing to support the useful life of the device. Cleaning validation testing performed on device [K102366] was submitted. Animal and clinical data were not submitted. Performance testing showed that the device meets design specifications and performs 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.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Entellus Medical, Inc. c/o Karen E. Peterson Vice President, Clinical, Regulatory and Quality 705 Wedgwood Court North Maple Grove, MN 55311 USA
JUN - 7 2011
Re: K110158
Trade/Device Name: PathAssist Light Seeker Regulation Number: 21 CFR 874.4420 Regulation Name: ENT Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: May 12, 2011 Received: May 13, 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
3
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/ycm115809.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/ReportalProblem/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.
Signature
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
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Indications for Use Statement
KI10158 510(k) Number (if known):
Device Name: PathAssist Light Seeker
Indications for Use
The PathAssist Light Seeker is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, 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
Susan Rudy CRNP
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110158