(64 days)
Not Found
No
The summary describes a mechanical device for sinus dilation and does not mention any computational or algorithmic components indicative of AI/ML.
Yes
The device is described as a 'Multi-Sinus Dilation Tool' intended to 'remodel or recreate the sinus outflow tract via trans-nasal balloon dilation', directly indicating its use in treating a medical condition.
No
Explanation: The device is intended to "access and treat" and "remodel or recreate" the sinus outflow tract, indicating a therapeutic rather than a diagnostic purpose. While it uses "endoscopic visualization" for tracking, this is to guide the treatment, not to diagnose a condition.
No
The device description clearly outlines a physical medical device with hardware components (curved suction tip, balloon, suction tube, barbed fitting, extension line, syringe connection). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to access and treat anatomical structures (sinuses) in adults using a trans-nasal approach. This involves a physical intervention (balloon dilation) to remodel bony structures.
- Device Description: The device is a surgical tool designed for physical manipulation within the body. It has features like a suction tip, balloon, and is used with endoscopic visualization.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide information for the diagnosis of a disease or condition. Its purpose is therapeutic (treatment) and procedural (accessing and remodeling).
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device operates in vivo (within the body) and is used for treatment.
N/A
Intended Use / Indications for Use
To access and treat the frontal recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
Product codes
LRC
Device Description
The XprESS Multi-Sinus Dilation Tool is intended to remodel or recreate the sinus outflow tract via trans-nasal balloon dilation. The XprESS device combines features of a curved suction tip and a frontal ostium seeker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device to the sinus ostium using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient.
The XprESS curved suction tip has an atraumatic ball tip. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Extension Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation.
The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only.
XprESS is available in the following suction tip sizes and balloon sizes. All suction tips and balloon lengths are appropriate for treating all sinuses: selection is based on physician preference.
| Standard Suction Tip (2mm ball tip, 1mm ID, 1.5mm OD) | LoProfile Suction Tip (1.75mm ball tip, 0.7mm ID, 1.2mm OD) | Ultra Suction Tip (1.5mm ball tip, 0.5mm ID, 1.0mm OD) |
|---|---|---|
| Balloon Diameter x Length (mm) | Balloon Diameter x Length (mm) | Balloon Diameter x Length (mm) |
| NA | 5 x 8 | 5 x 8 |
| 5 x 18 | 5 x 18 | 5 x 20 |
| 6 x 8 | 6 x 8 | 6 x 8 |
| 6 x 18 | 6 x 18 | 6 x 20 |
| 7 x 18 | 7 x 18 | NA |
The XprESS Multi-Sinus Dilation Tool has been tested to withstand multiple inflations and device tip manipulations in a surgical case wherein all 6 sinus ostia are being dilated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
frontal recesses, sphenoid sinus ostia, maxillary ostia/ethmoid infundibula
Indicated Patient Age Range
adults
Intended User / Care Setting
physician
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 XprESS device consisted of biocompatibility, design verification testing, simulated use in a cadaver model, and sterilization to support the additional Ultra suction tip and balloon size. Animal and clinical data was not required for this change. Performance testing showed that the device meets design specifications and performed as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure, with three stylized profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and dimension.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2014
Entellus Medical, Inc. % Ms. Karen Peterson Vice President, Clinical, Regulatory and Quality 3600 Holly Lane North. Suite 40 Plymouth, MN 55447
Re: K142252
Trade/Device Name: Xpress Multi-Sinus Dilation Tool Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, and Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: September 16, 2014 Received: September 17, 2014
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, 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.
1
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.
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" (21 CFR 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
2
Indications for Use Statement
| Applicant: | Entellus Medical, Inc. |
|---|---|
| 510(k) Number (if known): | K142252 |
| Device Name: | XprESS Multi-Sinus Dilation Tool |
| Indications for Use |
To access and treat the frontal recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
Prescription Use X - OR/AND (Part 21 CFR 801 Subpart D)
Over-the-Counter Use (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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Image /page/3/Picture/0 description: The image shows the logo for "entellus MEDICAL". To the left of the text is a circular graphic made of blue and black curved lines. The text "entellus" is in a sans-serif font, and the word "MEDICAL" is in smaller, all-caps letters below the first word.
510(k) Summary
| Date Prepared: | August 13, 2014 |
|---|---|
| Submitter Information: | Entellus Medical, Inc. |
| 3600 Holly Lane North, Suite 40 | |
| Plymouth, MN 55447 | |
| Establishment Registration: | 3006345872 |
| Contact Information: | Karen E. Peterson |
| Vice President Clinical, Regulatory and Quality | |
| (763) 463-7066 | |
| kpeterson@entellusmedical.com | |
| Device Information: | |
| Trade Name: | XprESS Multi-Sinus Dilation Tool |
| Common Name: | Sinus Balloon Dilation System |
| Classification Name: | ENT Manual Surgical Instrument |
| Product Code: | LRC |
| Regulation Number: | Class I, 21 CFR 874.4420 |
| Predicate Device: | XprESS Multi-Sinus Dilation Tool [K132440] |
Device Description:
The XprESS Multi-Sinus Dilation Tool is intended to remodel or recreate the sinus outflow tract via trans-nasal balloon dilation. The XprESS device combines features of a curved suction tip and a frontal ostium seeker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device to the sinus ostium using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient.
Image /page/3/Figure/5 description: The image shows a diagram of the XprESS Multi-Sinus Dilation Tool. The diagram labels the different parts of the tool, including the curved suction tip, balloon slide mechanism, proximal barbed fitting, and balloon inflation luer. The tool is used for sinus dilation.
The XprESS curved suction tip has an atraumatic ball tip. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Extension Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation.
The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only.
4
XprESS is available in the following suction tip sizes and balloon sizes. All suction tips and balloon lengths are appropriate for treating all sinuses: selection is based on physician preference.
| Standard Suction Tip
(2mm ball tip, 1mm ID,
1.5mm OD) | LoProfile Suction Tip
(1.75mm ball tip, 0.7mm ID,
1.2mm OD) | Ultra Suction Tip
(1.5mm ball tip, 0.5mm ID,
1.0mm OD) |
|-------------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------|
| Balloon Diameter x Length (mm) | Balloon Diameter x Length (mm) | Balloon Diameter x Length (mm) |
| NA | 5 x 8 | 5 x 8 |
| 5 x 18 | 5 x 18 | 5 x 20 |
| 6 x 8 | 6 x 8 | 6 x 8 |
| 6 x 18 | 6 x 18 | 6 x 20 |
| 7 x 18 | 7 x 18 | NA |
The XprESS Multi-Sinus Dilation Tool has been tested to withstand multiple inflations and device tip manipulations in a surgical case wherein all 6 sinus ostia are being dilated.
Indication for Use:
To access and treat the frontal recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
Contraindications:
- Do not use this XprESS device in patients who are allergic to nickel or barium sulfate.
- Do not attach the XprESS device directly to the CT Image Guidance systems. This may result in inaccurate device positioning.
Technological Characteristics:
The XprESS device has the same indications for use and fundamental scientific technology as the predicate device [K132440]. 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 XprESS device has the same indications for use and fundamental scientific technology as the predicate device. The XprESS device is substantially equivalent to the predicate device.
Performance Data:
Performance testing of the XprESS device consisted of biocompatibility, design verification testing, simulated use in a cadaver model, and sterilization to support the additional Ultra suction tip and balloon size. Animal and clinical data was not required for this change. 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.