(24 days)
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.
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).
PathAssist™ Light Seeker™ Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a Class I medical device (ENT Manual Surgical Instrument), and as such, the focus of the performance data is on demonstrating its functional equivalence to a predicate device and meeting design specifications, rather than clinical performance metrics typically seen for diagnostic or therapeutic AI devices.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Design Specifications & Functional Equivalence | Compatibility with LED light sources (2.5mm - 3.5mm light guides) | Performance testing demonstrated compatibility with LED light sources. |
| Device performs as intended (locating, illuminating, and transilluminating nasal and sinus structures) | Performance testing demonstrated the subject device meets design specifications and performs as intended. | |
| Same indications for use as predicate device | Indications for use are the same as the predicate device. | |
| Same fundamental scientific technology as predicate device | Fundamental scientific technology is the same as the predicate device. | |
| Same technological characteristics (principle of operation, design, function, materials, biocompatibility, reprocessing) as predicate device | Technological characteristics are the same as the predicate device. | |
| Safety | No adverse events or safety concerns identified through performance testing relevant to this Class I device. | Performance testing demonstrated the device is safe. |
| Effectiveness | Achieves its stated purpose (locating, illuminating, and transilluminating nasal and sinus structures). | Performance testing demonstrated the device is effective. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a "test set" in the context of clinical data for algorithmic performance. Instead, it refers to "design verification testing" and "functional testing." This type of testing typically involves a set number of devices or components to confirm manufacturing and functional parameters.
- Sample Size for Test Set: Not explicitly stated, as this is not a clinical study involving patient data. The testing would have involved a sufficient number of manufactured devices or components to demonstrate consistent functionality.
- Data Provenance: Not applicable in the context of clinical data. The testing was conducted by Entellus Medical, Inc. as part of its design verification process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a manual surgical instrument, and its performance evaluation does not involve establishing ground truth through expert consensus on medical images or diagnoses. The "ground truth" here is adherence to design specifications and functional requirements.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically used in studies involving subjective expert review (e.g., radiology reads) to resolve discrepancies and establish a consensus ground truth. The performance testing for this device focused on objective functional parameters.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC comparative effectiveness study was not conducted for the PathAssist™ Light Seeker™. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a manual surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This device is a manual surgical instrument and does not incorporate any AI algorithms. Its performance is entirely human-in-the-loop.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation was its design specifications and functional requirements. This includes ensuring compatibility with standard light guides, proper light emission, and adherence to physical design characteristics.
8. The Sample Size for the Training Set
Not applicable. As this device does not utilize AI or machine learning, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As this device does not utilize AI or machine learning, there is no "training set" and thus no ground truth to be established for it.
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APR - 2 2012
510(k) Summary
Date Prepared: Submitter Information:
Establishment Registration:
Contact Information:
March 8, 2012 Entellus Medical, Inc. 6705 Wedgwood Court, North Maple Grove, MN 55311
3006345872
Garrett P. Ahlborg Regulatory Affairs Specialist (763) 463-7074 gahlborg@entellusmedical.com
PathAssist™ Light Seeker™
ENT Manual Surgical Instrument
Illuminating Sinus Seeker
Class I, 21 CFR 874.4420
Device Information: Trade Name: Common Name: Classification Name: Product Code: Regulation Number:
Predicate Device: PathAssist™ Light Seeker™ [K113522]
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).
LRC
Image /page/0/Figure/15 description: The image shows a diagram of a medical instrument. The instrument has a handle, a curved tapered probe, and a 1.5 mm lighted ball tip. There is also a light post on the instrument.
PathAssist™ Light Seeker™
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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 [K113522]. The subject device has the same technological characteristics (i.e., principle of operation, 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 testing. Design verification testing included functional testing to support compatibility of the Light Seeker with LED light sources. Sterilization, cleaning, high level disinfection, biocompatibility, packaging. testing, 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
APR - 2 2012
Entellus Medical, Inc. % Garrett P. Ahlborg 6705 Wedgwood Court North Maple Grove, MN 55311
Re: K120735
Trade/Device Name: PathAssist TM Light Seeker™ Regulation Number: 21 CFR 874.4420 Regulation Name: ENT Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: March 8, 2012 Received: March 9, 2012
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.
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 devicerelated 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.
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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,
Charles. Thormin fo
Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose, Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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6. Indications for Use Statement
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 patients 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 | K120735 |
|---|---|
| --------------- | --------- |
§ 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.