(59 days)
K 121943
Not Found
No
The summary describes a mechanical device for sinus dilation and does not mention any AI/ML components or capabilities.
Yes
The device is used to treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula by remodeling or recreating the sinus outflow tract via trans-nasal balloon dilation, which is a therapeutic intervention.
No
Explanation: The device description clearly states its purpose is to "access and treat" and "remodel or recreate the sinus outflow tract" through balloon dilation, which are therapeutic actions, not diagnostic ones.
No
The device description clearly describes a physical medical device (XprESS Multi-Sinus Dilation Tool) with hardware components like a curved suction tip, balloon, suction tube, and fittings, intended for physical manipulation of anatomical structures. There is no mention of software as the primary or sole component.
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 the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. This involves a physical procedure to remodel bony sinus outflow tracts.
- Device Description: The device is a tool used for physical dilation and manipulation of anatomical structures. It has features like a suction tip, a secker, and a balloon for tissue expansion.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to provide diagnostic information about a patient's health status. IVDs are specifically designed for in vitro examination of specimens derived from the human body.
The device described is a surgical tool used for a therapeutic procedure, not a diagnostic test performed on a sample outside the body.
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 secker 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
frontal recesses, sphenoid sinus ostia and 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
XprESS Multi-Sinus Dilation Tool [K 121943]
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
Entellus Medical
Image /page/0/Picture/1 description: The image contains a handwritten sequence of characters. The sequence appears to be "K13240". The characters are written in a simple, somewhat stylized manner, with varying stroke thicknesses. The image is in black and white.
OCT 0 4 2013
510(k) Summary
Date Prepared: Submitter Information:
Establishment Registration:
Contact Information:
August 5. 2013 Entellus Medical. Inc. 3600 Holly Lane North. Suite 40 Plymouth, MN 55447
3006345872
Karen E. Peterson Vice President Clinical. Regulatory and Quality (763) 463-7066 kpeterson@entellusmedical.com
Device Information: Trade Name: Common Name: Classification Name: Product Code: Regulation Number:
XprESS Multi-Sinus Dilation Tool Sinus Balloon Dilation System ENT Manual Surgical Instrument LRC Class 1, 21 CFR 874.4420
XprESS Multi-Sinus Dilation Tool [K 121943]
Device Description:
Predicate Device:
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 secker 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/0/Figure/20 description: The image shows a diagram of a system with several components. On the left side, there is a "Flow activation box". In the middle, there is a "Pressure Regulator". On the right side, there is a "Pressure Threshold Box" and a "Pressure Indicator Line".
XprESS Multi-Sinus Dilation Tool
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.
1
Image /page/1/Figure/0 description: The image shows proposed labeling for medical devices, specifically needle guide inserts. There are two labels displayed, one for "Needle Guide Marker Insert centered - Sterile for US" with REF 4876US and LOT 1010, and another for "Needle Guide Insert 19G. Sterile for US" with REF 5989Q19US and LOT 1010. The document is labeled with "Proposed Labeling 510(k) Number: K131433" and "PD/B18". Both labels include the SYS Medizintechnik GmbH logo and various symbols related to sterilization and usage.
| Doc No: PD 75 11543 | Revision 01 from: 03.06.2013 | 6/116 | ||
|---|---|---|---|---|
| Created by: | Approved by: | Invalid since: | Source: | Approval Date: |
| Oliver Spitz | Dr. Michael Vogele | FO 42 1996 | 06.06.2011 |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Go09 Silver Spring, MI) 20993-0002
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three lines representing its wings, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
October 4, 2013
Entellus Medical, Inc. % Karen E. Peterson Vice President Clinical, Regulatory and Quality 3600 Holly Lane North, Suite 40 Plymouth, MN 55447
Re: K132440
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 4, 2013 Received: September 5, 2013
Dear Ms. Peterson:
We have reviewed your Scction 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
3
Page 2 - Ms. Karen E. Peterson
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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
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
4
Indications for Use
| Applicant: | Entellus |
|---|---|
| 510(k) Number (if known): | K132440 |
| 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 (Part 21 CFR 801 Subpart D) | X OR/AND 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) |
Sageev George -S 2013.10.02 15:00:52 -04'00'
.