(59 days)
No
The device description and performance studies focus on the physical properties, reprocessing, and functional testing of a fiber optic light seeker, with no mention of AI or ML algorithms for image processing, data analysis, or decision support.
No.
The device is used to locate, illuminate, and transilluminate nasal and sinus structures, which are diagnostic or procedural uses, not therapeutic.
No
The device is intended to locate, illuminate, and transilluminate structures, which are functions for visualization or procedural guidance, not for diagnosing any medical condition.
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 physical medical device, not software-only.
Based on the provided information, the PathAssist Light Seeker is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to locate, illuminate, and transilluminate nasal and sinus structures within the patient's body. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The device is a manually operated, reusable sinus seeker that emits light. It is used to visualize structures directly, not to analyze samples of bodily fluids or tissues.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing chemical reactions, or providing diagnostic information based on laboratory tests.
IVD devices are typically used to examine specimens (like blood, urine, or tissue) outside the body to diagnose diseases or conditions. The PathAssist Light Seeker is a surgical/examination tool used directly on the patient.
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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the Light Seeker consisted of design verification testing after repetitive reprocessing cycling consisting of manual cleaning and manual high level disinfection. Design verification testing included functional testing to support the useful life of the device. High level disinfection validation results obtained from device [K102366] were submitted. Cleaning validation results obtained from device [K102366] and sterilization validation data were submitted and cleared for the subject device in [K110158]. Biocompatibility, packaging testing, animal and clinical data was not submitted. Performance testing showed that the subject device meets design specifications and performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
JAN 2 7 2012
entellus
MEDICAL™
510(k) Summary
Date Prepared: Submitter Information:
January 23, 2012 Entellus Medical, Inc. 6705 Wedgwood Court, North Maple Grove, MN 55311
Establishment Registration:
Contact Information:
3006345872
Garrett P. Ahlborg 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 I, 21 CFR 874.4420
Predicate Device: PathAssist™ Light Seeker™ [K110158]
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 light guides (cables).
Image /page/0/Figure/16 description: The image shows a diagram of a medical instrument. The instrument has a curved, tapered probe with a 1.5 mm lighted ball tip. The instrument also has a handle and a light post.
PathAssist™ Light Seeker™
1
Entellus Medical
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 [K110158]. The subject device has the same technological characteristics (i.e., principle of operation, design, function, materials, and biocompatibility per ISO 10993-1) as the predicate device. The reprocessing methods for the subject device have been modified to include the option of high level disinfection, in addition to the previously cleared validated methods for cleaning and sterilization.
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 testing after repetitive reprocessing cycling consisting of manual cleaning and manual high level disinfection. Design verification testing included functional testing to support the useful life of the device. High level disinfection validation results obtained from device [K102366] were submitted. Cleaning validation results obtained from device [K102366] and sterilization validation data were submitted and cleared for the subject device in [K110158]. Biocompatibility, packaging testing, animal and clinical data was not submitted. Performance testing showed 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 7 2012
Entellus Medical, Inc. c/o Garrett P. Ahlborg Regulatory Affairs Specialist 6705 Wedgwood Court North Maple Grove, MN 55311
Re: K113522
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: December 28, 2011 Received: December 29, 2011
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
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,
Edithrim
Malvina B. Evdelman, 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
Page 3 - Garrett P. Ahlborg
Indications for Use
510(k) Number (if known): K113522
PathAssist™ Light Seeker™ Device Name:
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 X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rudy, CRWP
Page 1 of
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, · Nose and Throat Devices
510(k) Number K113522