(23 days)
To locate, illuminate within, and transilluminate across nasal and sinus structures in patients aged 18 and over.
The PathAssist LED Light Fiber is a flexible instrument that emits light from the distal end. The LED Light Fiber is provided sterile and is for single use only. The device consists of a flexible illumination fiber, a protective sheath and an integrated battery powered LED light source. When the LED Light Fiber is activated the fiber will emit red light from the distal tip for over 60 minutes. It has a fiber nominal working length of 27.6cm with an outer diameter of 0.375mm (0.015").
The PathAssist LED Light Fiber is packaged alone or may be packaged with XprESS (LoProfile suction tip).
This document describes the PathAssist LED Light Fiber, a device intended to locate, illuminate within, and transilluminate across nasal and sinus structures. The document is a 510(k) summary submitted to the FDA, indicating a claim of substantial equivalence to a predicate device, rather than a clinical study establishing new performance criteria. Therefore, the information provided focuses on demonstrating equivalence to an existing device rather than presenting detailed acceptance criteria and a study proving the device meets them in a conventional sense.
Here's a breakdown based on the provided text, addressing the requested information to the extent possible:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for substantial equivalence, formal "acceptance criteria" for novel performance metrics are not explicitly stated in this document. Instead, the focus is on meeting "design specifications" and performing "as intended," which is implicitly tied to the performance of the predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Light Emission Duration | Over 60 minutes (based on predicate or new design spec) | Emits red light from the distal tip for over 60 minutes |
| Fiber Nominal Working Length | 27.6 cm (based on design specification) | 27.6 cm |
| Outer Diameter | 0.375 mm (0.015") (based on design specification) | 0.375 mm (0.015") |
| Sterility | Sterile and for single use | Provided sterile and is for single use only |
| Functional Performance | Performs as intended | Meets design specifications and performed as intended |
| Mechanical Performance | Performs as intended | Meets design specifications and performed as intended |
| Compatibility | Performs as intended | Meets design specifications and performed as intended |
| Thermal Safety | Safe | Meets design specifications and performed as intended |
| Biocompatibility | Biocompatible (implicit from predicate) | Not submitted, but claimed equivalent to predicate |
| Packaging | Adequate for sterility, shelf life (implicit from predicate) | Not submitted, but claimed equivalent to predicate |
| Shelf Life | Adequate for intended use (implicit from predicate) | Not submitted, but claimed equivalent to predicate |
| EMC and Electrical Safety | Complies with standards (implicit from predicate) | Not submitted, but claimed equivalent to predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Performance testing of the PathAssist LED Light Fiber consisted of design verification testing to support the device modifications." It does not specify a "test set" in the context of clinical or large-scale comparative studies. The testing described is primarily benchtop design verification.
- Sample Size: Not specified for individual tests.
- Data Provenance: Not applicable in the context of clinical data. It's internal company design verification data. This is retrospective in the sense that it evaluates the modified device's adherence to design specifications.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable as the document describes design verification testing, not a clinical study involving human readers or expert ground truth panels.
4. Adjudication Method for the Test Set
This information is not applicable as there is no "test set" in the context of expert review or clinical trial adjudication. Design verification results are typically evaluated against established engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. The document explicitly states: "animal and clinical data were not submitted."
6. Standalone Performance Study
A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not done in the clinical sense. The "performance data" refers to "design verification testing" (functional, mechanical, compatibility, thermal safety), which assesses the device's physical and operational characteristics, not its clinical efficacy in a standalone context.
7. Type of Ground Truth Used
The "ground truth" for the design verification testing would be the engineering design specifications and established quality control parameters for the device's physical and functional attributes.
8. Sample Size for the Training Set
This information is not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
Mr. Garrett P. Ahlborg Senior Regulatory Affairs Specialist c/o Entellus Medical, Inc. 3600 Holly Lane North Plymouth, MN 55447
Re: K141916
Trade/Device Name: Pathassist led light fiber Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, and Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: July 14, 2014 Received: July 15, 2014
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.
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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| Applicant: | Entellus Medical, Inc. |
|---|---|
| 510(k) Number (if known): | |
| Device Name: | PathAssist LED Light Fiber |
| Indications for Use |
To locate, illuminate within, and transilluminate across nasal and sinus structures in patients aged 18 and over.
| Prescription Use | X OR/AND | Over-the-Counter Use |
|---|---|---|
| (21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
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510(k) Summary
Date Prepared: Submitter Information: July 14, 2014 Entellus Medical, Inc. 3600 Holly Lane North, Suite 40 Plymouth, MN 55447
Establishment Registration:
Contact Information:
3006345872
Garrett P. Ahlborg Sr. Regulatory Affairs Specialist (763) 463-7074 gahlborg@entellusmedical.com
Device Information: Trade Name: Common Name: Classification Name: Product Code: Regulation Number:
PathAssist LED Light Fiber Sinus Guidewire ENT Manual Surgical Instrument LRC Class I, 21 CFR 874.4420
PathAssist LED Light Fiber [K130503]
Device Description:
Predicate Device:
The PathAssist LED Light Fiber is a flexible instrument that emits light from the distal end. The LED Light Fiber is provided sterile and is for single use only. The device consists of a flexible illumination fiber, a protective sheath and an integrated battery powered LED light source. When the LED Light Fiber is activated the fiber will emit red light from the distal tip for over 60 minutes. It has a fiber nominal working length of 27.6cm with an outer diameter of 0.375mm (0.015").
The PathAssist LED Light Fiber is packaged alone or may be packaged with XprESS (LoProfile suction tip).
Image /page/3/Figure/15 description: The image shows a diagram of a fiber optic light source. The diagram labels the different parts of the light source, including the fiber, housing, pull tab, integrated light source, and flexible sheath. The fiber is a thin strand of glass or plastic that carries light. The housing is the outer casing of the light source. The pull tab is used to activate the light source. The integrated light source is the part of the light source that produces light. The flexible sheath is a protective covering for the fiber.
PathAssist LED Light Fiber
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Indication for Use
To locate, illuminate within, and transilluminate across nasal and sinus structures in patients aged 18 and over.
Contraindications:
None
Technological Characteristics:
The subject device has the same indications for use and fundamental scientific technology as the predicate device [K130503]. The subject device has the same technological characteristics (i.e., principle of operation, basic design, function, basic materials, biocompatibility, packaging, shelf life and sterilization) as the predicate device.
Substantial Equivalence:
The subject device has the same indications for use and fundamental scientific technology as the predicate device. The LED Light Fiber is substantially equivalent to the predicate device.
Performance Data:
Performance testing of the PathAssist LED Light Fiber consisted of design verification testing to support the device modifications. Design verification testing included functional, mechanical, compatibility, and thermal safety testing. Packaging testing, sterilization, shelf life, EMC and electrical safety testing, biocompatibility, animal and clinical data were not submitted. Performance testing showed that the device meets design specifications and performed 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.
§ 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.