(30 days)
No
The device description and performance studies focus on the physical properties and functionality of a fiber optic light seeker, with no mention of AI or ML.
No
The device is described as a diagnostic tool used to locate, illuminate, and transilluminate structures, not to treat or cure a disease or condition. The performance studies focus on design verification and safety, not therapeutic efficacy.
No
The device is described as a fiber optic based illumination tool used to locate and illuminate nasal and sinus structures. Its intended use is to assist in visualization rather than to provide a diagnosis or diagnostic information.
No
The device description explicitly states it is a "fiber optic based, manually operated, reusable sinus seeker" and mentions physical components like a fiber optic cable, light post adapters, and the need for cleaning and sterilization, indicating it is a hardware device.
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 device used in vivo (within the body) for visualization and examination of anatomical structures.
- Device Description: The description details a fiber optic based, manually operated, reusable sinus seeker that emits light. This aligns with a surgical or examination tool used directly on or within the patient.
- 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 status. The provided information does not mention any analysis of biological samples.
Therefore, the PathAssist Light Seeker is a medical device used for direct examination and visualization of anatomical structures, not an in vitro diagnostic device.
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 patients 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 or cleaned and high level disinfected prior to each use. The Light Seeker comes with two standard light post adapters, which allow the device to be compatible with commonly used 2.5mm - 3.5mm 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
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
Performance testing of the Light Seeker consisted of design verification, biocompatibility and packaging testing. Design verification testing included dimensional, and thermal safety testing to support the device modifications. Biocompatibility testing was performed per ISO 10993-1. Packaging testing was performed per ASTM D4169-09. Sterilization, cleaning, high level disinfection, animal and clinical data were not submitted. Performance testing demonstrated that the subject device meets design specifications and performs as intended.
Key Metrics
Not Found
Predicate Device(s)
PathAssist™ Light Seeker™ [K120735]
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
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 of curved lines. The text is in all lowercase letters, with the word "MEDICAL" in smaller letters below the first word.
510(k) Summary
Date Prepared: Submitter Information: November 19, 2013 Entellus Medical, Inc. 3600 Holly Lane North, Suite 40 Plymouth, MN 55447
Establishment Registration:
Contact Information:
Garrett P. Ahlborg
3006345872
Sr. Regulatory Affairs Specialist (763) 463-7074 gahlborg@entellusmedical.com
Device Information: Trade Name: Common Name: Classification Name: Product Code: Regulation Number:
PathAssist™ Light SeekerTM Illuminating Sinus Seeker ENT Manual Surgical Instrument LRC Class 1, 21 CFR 874.4420
Predicate Device: PathAssist™ Light Seeker™ [K120735]
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 or cleaned and high level disinfected prior to each use. The Light Seeker comes with two standard light post adapters, which allow the device to be compatible with commonly used 2.5mm - 3.5mm light guides (cables),
Image /page/0/Figure/15 description: The image shows a diagram of a medical instrument with several labeled parts. The instrument has a long, thin handle with a light post at the end. The other end has a curved, tapered probe with a 1.5mm lighted ball tip.
PathAssist™ Light Seeker™
1
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 patients aged 18 and over.
Contraindications:
None
Technological Characteristics:
The Light Seeker has the same indications for use and fundamental scientific technology as the predicate device [K 120735]. The subject device has the same technological characteristics (i.e., principle of operation, basic design, function, materials, biocompatibility and reprocessing methods) as the predicate device.
Substantial Equivalence:
The Light Seeker has the same indications for use and fundamental scientific technology as the predicate device. The Light Seeker is substantially equivalent to the predicate device.
Performance Data:
Performance testing of the Light Seeker consisted of design verification, biocompatibility and packaging testing. Design verification testing included dimensional, and thermal safety testing to support the device modifications. Biocompatibility testing was performed per ISO 10993-1. Packaging testing was performed per ASTM D4169-09. Sterilization, cleaning, high level disinfection, animal and clinical data were not submitted. Performance testing demonstrated that the subject device meets design specifications and performs as intended.
Conclusion:
In conclusion, the indications for use and technological characteristics are the same as or equivalent to the predicate device. Performance testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
Entellus Medical Mr. Garrett P. Ahlborg Sr. Regulatory Affairs Specialist 3600 Holly Lane North, Suite 40 Plymouth, MN 55447
Re: K133563
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: November 19, 2013 Received: November 20, 2013
Dear Mr. Ahlborg:
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
Page 2 - Mr. Garrett P. Ahlborg
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
Deborah L. Falls -S
for 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
4
Indications for Use
510(k) Number (if known): K133563
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 patients aged 18 and over.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Sunny Park : 上 2013.12.19 17:13:38 -05'00'
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