(99 days)
Not Found
No
The description focuses on mechanical aspects of the device (balloon dilation, suction, re-shapeable tip) and does not mention any computational or data-driven features indicative of AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The device is described as a "Multi-Sinus Dilation Tool" used to "remodel or recreate the sinus outflow tract via trans-nasal balloon dilation," which directly addresses a physiological condition (sinus obstruction) and provides a therapeutic effect (restoring sinus outflow).
No
The device is described as an XprESS Multi-Sinus Dilation Tool intended to "remodel or recreate the sinus outflow tract via trans-nasal balloon dilation," which is a surgical treatment method rather than a diagnostic one.
No
The device description clearly outlines a physical medical device (XprESS Multi-Sinus Dilation Tool) with hardware components like a suction tip, balloon, and connections for inflation and infusion lines. 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 (frontal recesses, sphenoid sinus ostia, maxillary ostia/ethmoid infundibula) in the body using a trans-nasal approach. This involves a physical intervention (balloon dilation) to remodel bony structures.
- Device Description: The device is a tool used for a surgical procedure. It's described as a "dilation tool" that combines features of a suction tip and a seeker with balloon dilation.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (like blood, urine, tissue) or to provide information for the diagnosis of a disease or condition. Its purpose is therapeutic (treatment).
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, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for a therapeutic procedure.
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 (comma separated list FDA assigned to the subject device)
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 Multi-Sinus Dilation Tool has been tested to withstand multiple inflations and device tip manipulations (up to 25) in a surgical case wherein all 6 sinus ostia are being dilated.
The XprESS device curved suction tip has a 2 mm atraumatic ball tip with a 1 mm inside diameter. A suction tube may be connected to the proximal barbed fitting to provide active suction.
The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only.
The items packaged with the Xpress Multi-Sinus Dilation Tool include the Inflation Device and the Infusion Line.
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 / Not Found
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 design verification testing and a cadaver study. Design verification testing included testing for additional balloon inflations and device tip manipulations. A cadaver study was conducted to support the utility of this device in the maxillary sinus. Biocompatibility, sterilization, packaging, distribution, shelf life testing, animal and clinical data were not submitted. 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K093007 (Entellus Medical Balloon Device), K081542
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
| Date Prepared: | September 20, 2010 |
|---|---|
| Submitter Information: | Entellus Medical, Inc. |
| 6705 Wedgwood Court, North | |
| Maple Grove, MN 55311 | |
| 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 Devices: |
XprESS Multi-Sinus Dilation Tool [K093007 (Entellus Medical Balloon Device)] FinESS Sinus Treatment System [K081542]
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 Multi-Sinus Dilation Tool has been tested to withstand multiple inflations and device tip manipulations (up to 25) in a surgical case wherein all 6 sinus ostia are being dilated.
The XprESS device curved suction tip has a 2 mm atraumatic ball tip with a 1 mm inside diameter. A suction tube may be connected to the proximal barbed fitting to provide active suction.
Image /page/0/Figure/8 description: The image shows a medical device with several labeled parts. The device has a curved suction tip on one end and a proximal barbed fitting on the other end. There is also a balloon slide mechanism and a balloon inflation luer, which are located on the main body of the device. The image provides a clear view of the device's components and their arrangement.
XprESS Multi-Sinus Dilation Tool
1
The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only.
The items packaged with the Xpress Multi-Sinus Dilation Tool include the Inflation Device and the Infusion Line.
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 device has identical technological characteristics (i.e., design, materials, chemical composition, function, mode of operation, packaging and sterilization) as the predicate device [K093007]. Both devices are sterilized using Ethylene Oxide (EtO), are validated per ISO 11135-1, and have a Sterility Assurance Level (SAL) of 10°. Both devices are for single use only. Items packaged with both devices include an inflation device and an infusion line. Both devices are biocompatible per ISO 10993-1.
Substantial Equivalence:
No design modifications were necessary to support the expanded indications for use: therefore this device is identical to the currently marketed XprESS device [K093007] in terms of technological characteristics including: the materials, design, function, packaging and sterilization. The intended use of the device is the same as the intended use of the predicate . devices. The expanded indication for use in the maxillary sinus is similar to the FinESS Sinus Treatment System [K081542].
Performance Data:
Performance testing of the XprESS device consisted of design verification testing and a cadaver study. Design verification testing included testing for additional balloon inflations and device tip manipulations. A cadaver study was conducted to support the utility of this device in the maxillary sinus. Biocompatibility, sterilization, packaging, distribution, shelf life testing, 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Entellus Medical,Inc. c/o Ms. Karen Peterson Vice President Clinical, Regulatory and Quality 6705 Wedgwood Court North Maple Grove, MN 55311
Re: K102003
Trade/Device Name: XprESS Multi-Sinus Dilation Tool (JD-100) Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose & Throat Manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: August 27, 2010 Received: August 30, 2010
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.
OCT 2 2 2010
..
3
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Alexander
for
MR
DR
DR
Malvina B. Eydelman. M.D. Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K10.2003
Indications for Use Statement
K102003 510(k) Number:
XprESS Multi-Sinus Dilation Tool Device Name:
Indications for Use:
OCT 2 2 2010
To access and treat frontal recesses, sphenoid sinus ostia and maxillary ostialethmoid 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 × (21 CFR 801 Subpart D)
AND/OR
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)
Susan Rudy CRNP
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K102003