(235 days)
Not Found
No
The summary describes a mechanical device for sinus dilation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used to "treat the maxillary sinus ostium and the ethmoid infundibulum" and involves "remodeling" of the bony sinus outflow tract, which indicates a therapeutic purpose.
No
The device description indicates that it is used for "access and treat" and "remodels" bony structures by balloon displacement, which are therapeutic actions, not diagnostic. There are no mentions of diagnosing conditions or providing diagnostic information.
No
The device description clearly outlines a system involving physical components like a balloon catheter and mentions procedures like trans-mucocutaneous access and displacement of tissue and bone, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure to access and treat the maxillary sinus ostium and ethmoid infundibulum by remodeling the bony sinus outflow tract using a balloon catheter. This is a surgical or interventional procedure performed directly on the patient's body.
- Device Description: The device description details a system for trans-mucocutaneous access, balloon catheter placement, and tissue/bone displacement. This aligns with a medical device used for treatment or intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. 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 maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
Product codes
ERL, LRC
Device Description
The Entellus Medical RS Series system allows for trans-mucocutaneous access of the sinus, placement of the balloon catheter with endoscopic guidance and the displacement of the tissue and bony structures by balloon catheter dilation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary sinus ostium, ethmoid infundibulum
Indicated Patient Age Range
adults
Intended User / Care Setting
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)
The device performance test data is provided in the 510(k) submission. The performance data demonstrates that the device meets specification, is biocompatible and meets sterility standards. Performance testing included dimensional verification, bench testing, and simulated use testing and showed that the device meets design specification 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
510(k) Summary
APR - 8 2008
Administrative Information
Name and address
Sponsor: Entellus Medical, Inc. 10200 73rd Ave. N., Suite 122, Maple Grove, MN 55369 Tel: 1-763-463-1595 Fax: 1-763-463-1599
FDA Est. Reg #: 9097639
Submitted on behalf of sponsor by: Sew-Wah Tay, Ph.D. (Regulatory Consultant) 18555 37th Ave North Plymouth, MN 55446 Cell: 612-801-6782 Fax: 763-208-4465 Email: swtay@libramed.com
Date Prepared: March 13. 2007
Device Name
Trade Name Entellus Medical RS Series System Common Name Trans-antral Sinus Access and Dilation Catheter System Classification Name Ear, nose, and throat electric or pneumatic surgical drill Classification 21 CFR 874.4250 Class II Product Code ERL
Indication for use
To access and treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
1
Device Description
The Entellus Medical RS Series system allows for trans-mucocutaneous access of the sinus, placement of the balloon catheter with endoscopic guidance and the displacement of the tissue and bony structures by balloon catheter dilation.
Substantial Equivalence
The Entellus Medical Series Device System is substantially equivalent to the previously cleared Kyphx Inflatable Bone Tamp (K981251), Diego RF Dissector and Drill System (K034004) and the Acclarent Relieva Sinus Balloon Catheter (K043527).
The Entellus Medical RS Series System (RS Series) has the same Intended Use as its predicate. The RS Series System, like the Kyphx Inflatable Bone Tamp, allows the use of a minimally invasive procedure to displace bony structure via balloon dilation. Like the Relieva Balloon catheter, it uses balloon to dilate inflamed tissue to produce the equivalent outcomes in the sinuses as the Diego RF Dissector and Drill System.
Performance Data
The device performance test data is provided in the 510(k) submission. The performance data demonstrates that the device meets specification, is biocompatible and meets sterility standards. Performance testing included dimensional verification, bench testing, and simulated use testing and showed that the device meets design specification and performed as intended.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 8 2008
Entellus Medical, Inc c/o Sew-Wah Tay, PhD. Regulatory Consultant 18555 37th Ave. n Plymouth, MN 55446
Re: K072302
Trade/Device Name: Entellus Medical RS Series Balloon System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose, and throat manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: March 10, 2008 Received: March 13, 2008
Dear Dr. Wah:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Malvina B. Egleston, und
Malvina B. Eydelman, M. 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Entellus Medical RS Series System
Indications for Use
To access and treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
OR/AND Prescription Use X
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Karent Boker
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K072302