(104 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 0.5mm (0.020").
The provided text describes the Entellus Medical PathAssist LED Light Fiber, a flexible instrument emitting light from its distal end for locating, illuminating, and transilluminating nasal and sinus structures.
Based on the information provided, the acceptance criteria and the study proving the device meets them are as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | Electromagnetic Compatibility (EMC) | Passed, device meets specifications |
| Electrical Safety | Passed, device meets specifications | |
| Biocompatibility (ISO 10993-1) | Validated (referenced) | |
| Sterilization Validation (ISO 11135-1) | Validated, SAL of 10⁻⁶ | |
| Shelf Life | Met (testing performed) | |
| Functional/Performance | Functional Testing | Met design specifications |
| Mechanical Testing | Met design specifications | |
| Compatibility Testing | Met design specifications | |
| Simulated Use in Cadaver Model | Performed as intended | |
| Light Emission Duration (> 60 min) | Met (device specification outlines this) | |
| Distal Tip Red Light Emission | Met (device description) | |
| Nominal Working Length (27.6cm) | Met (device description) | |
| Outer Diameter (0.5mm / 0.020") | Met (device description) | |
| Other | Packaging | Met design specifications |
2. Sample size used for the test set and the data provenance:
The provided document does not specify a numerical sample size for the test set used in the performance testing.
The testing appears to be primarily laboratory-based and simulated use (cadaver model). Data provenance would be from internal testing conducted by Entellus Medical, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the involvement of experts for establishing ground truth, as the testing described is primarily focused on engineering and performance validation rather than clinical ground truth (e.g., diagnosis of a condition). The simulated use in a cadaver model would likely be evaluated by internal engineers or potentially medical professionals involved in the simulated use, but specific numbers or qualifications are not provided.
4. Adjudication method for the test set:
The document does not describe any adjudication method like 2+1 or 3+1. Given the nature of the described performance tests (e.g., EMC, electrical safety, mechanical, functional, cadaver simulation), it's highly probable that pass/fail criteria based on predefined specifications were used, rather than an adjudication process involving multiple reviewers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. This device is a manual surgical instrument (light fiber), not an AI-assisted diagnostic tool. Therefore, there is no discussion of human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument, not an algorithm or AI.
7. The type of ground truth used:
The "ground truth" for this device's performance is based on engineering design specifications, industry standards (e.g., ISO for biocompatibility and sterilization, IEC for electrical safety), and the intended functional performance (e.g., light emission, physical dimensions, ability to transilluminate in a cadaver). There is no mention of pathology or clinical outcomes data being used for ground truth in this submission.
8. The sample size for the training set:
The document does not mention a training set. This device is a physical instrument and does not involve AI or machine learning algorithms that would typically require a training set.
9. How the ground truth for the training set was established:
As there is no training set, this question is not applicable.
{0}------------------------------------------------
Entellus Medical
K13.0503
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 several curved lines. The text "entellus" is in a sans-serif font, and below it is the word "MEDICAL" in a smaller font.
February 26, 2013
3006345872
Karen E. Peterson
(763) 463-7066
Sinus Guidewire
21 CFR 874.4420
Entellus Medical, Inc.
Plymouth, MN 55447
3600 Holly lane North, Suite 40
ENT Manual Surgical Instrument
PathAssist LED Light Fiber
Vice President Clinical, Regulatory and Quality
JUN 1 1 2013
510(k) Summary
Date Prepared: Submitter Information:
Establishment Registration:
Contact Information:
Device Information: Trade Name: Common Name: Classification Regulation: Classification Name: Classification Panel: Device Classification: Product Code:
Predicate Devices: PathAssist Light Fiber [K120962] "PLS" Portable Light Source [K091829]
Device Description:
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 0.5mm (0.020").
ENT
LRC
Class I
Image /page/0/Figure/12 description: This image shows a diagram of a medical device. The device has a housing with an integrated light source and a pull tab. A flexible sheath extends from the housing, and a fiber is connected to the sheath.
PathAssist LED Light Fiber
t
{1}------------------------------------------------
Indication for Use
To locate, illuminate within, and transilluminate across nasal and sinus structures in patients aged 18 and over.
The intended use of the subject device is the same as the predicate devices: PathAssist Light Fiber [K120962] and "PLS" Portable Light Source [K091829], and the indications for use of the subject device is the same as the predicate device [K120962].
Contraindications:
None
Technological Characteristics:
The subject device has the same technological characteristics (i.e., principle of operation, design, function, materials, biocompatibility, shelf life, packaging, sterilization and energy source) as the predicate devices: PathAssist Light Fiber [K120962] and/or "PLS" Portable Light Source [K091829].
Both the subject device and predicate device [K120962] are flexible devices that transmit light from the proximal to distal tip of the device via a light fiber that can be seen via transillumination. Both devices are sterilized using Ethylene Oxide (EtO) and validated per ISO 11135-1, and have a Sterility Assurance Level (SAL) of 10 . Both devices are provided sterile, are for single use only and are biocompatible per ISO 10993-1. The subject device has an internal light source whereas the predicate device [K120962] must be connected to a light source.
Both the subject device and the predicate device [K091829] incorporate an internal battery operated LED light source. Both devices have undergone EMC and electrical safety testing per IEC 60601-1. IEC 60601-2-18 and IEC 60601-1-2. The subject device is provided sterile and is for single use only whereas the predicate device is provided non-sterile and must be cleaned and high level disinfected between each use.
Substantial Equivalence:
The intended use of the subject device is the same as the predicate devices [K120962] and [K091829] and the indications for use is the same as the predicate device [K120962]. The technological characteristics of the subject device are the same as the predicate device [K120962] and/or predicate device [K091829], including: principle of operation, design, function, materials, biocompatibility, shelf life, packaging, sterilization and energy source.
Performance Data:
Performance testing of the PathAssist LED Light Fiber consisted of EMC and electrical safety, ~ design verification (functional, mechanical, and compatibility testing), packaging, shelf life, and simulated use in a cadaver model. ' Biocompatibility testing and sterilization validation was referenced. Animal and clinical data were not submitted. Performance testing showed that the device meets design specifications and performed 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.
{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 caduceus symbol, which features a staff with a serpent entwined around it, overlaid with three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
June 11, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Entellus Medical, Inc. Karen E. Peterson Vice President Clinical, Regulatory and Quality 3600 Holly lane North, Suite 40 Plymouth, MN 55447
Re: K130503
Trade Name: PathAssist LED Light Fiber Regulation Number: 21 CFR 874.4420 Regulation Name: ENT Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: February 26, 2013 Received: February 28, 2013
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. Issting 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 - Ms. Peterson
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Eric A. Mann -S
for Malvina B. Eydelman, MD
-Director -Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Entellus Medical
ר
Indications for Use Statement 6.
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
× Prescription Use OR/AND Over-the-Counter Use
EricAMann-S
Page 16
§ 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.