(106 days)
Not Found
No
The device description and performance studies focus on a physical implant and its clinical efficacy, with no mention of AI/ML components or data processing for diagnostic or therapeutic purposes.
Yes
The device is intended to separate the middle turbinate from the lateral nasal wall during the healing phase after nasal/sinus surgery to minimize the risk of adherence, which is a therapeutic intervention aimed at preventing complications and promoting proper healing.
No
The device is described as an implant intended to mechanically separate nasal tissues to prevent adherence after surgery. Its function is therapeutic/surgical, not diagnostic.
No
The device is a physical implant made of an absorbable copolymer, clearly described as a "tack" and a "sterile, single-use implant." It is delivered using standard surgical instruments. This description indicates a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- MediENT® Middle Turbinate Implant Function: The description clearly states that the MediENT® Middle Turbinate Implant is a physical device (a tack) that is implanted into the body to provide structural support and separation during the healing process after nasal/sinus surgery. It does not analyze or test any bodily fluids or tissues.
The device is a surgical implant used in vivo (within the body) for a mechanical purpose.
N/A
Intended Use / Indications for Use
The MediENT® Middle Turbinate Implant is intended to separate the middle turbinate from the lateral nasal wall during the clinically relevant healing phase associated with nasal/sinus surgery. The implant provides short-term fixation of the middle turbinate to the nasal septum and thus minimizes the risk of adherence to the lateral nasal wall.
Product codes (comma separated list FDA assigned to the subject device)
LYA
Device Description
The MediENT® Middle Turbinate Implant is a tack made of an absorbable copolymer that is designed to hold the middle turbinate away from the lateral nasal wall. The sterile, single-use implant is delivered using standard surqical instruments, such as Alligator grasper, Pediatric Blakesly, MediENT® Grasper or similar. The implant provides temporary fixation and can be expected to start degrading approximately 2 to 3 months post-implantation. The MediENT® Middle Turbinate Implant is packaged and provided sterile for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
middle turbinate, lateral nasal wall, nasal septum
Indicated Patient Age Range
Not Found
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)
Bench, cadaveric and clinical testing, using multiple users and study sites, was conducted to validate that the MediENT® Middle Turbinate Implant design met user requirements. Biocompatibility, sterilization, packaging, distribution, and shelf life testing were conducted in compliance with relevant standards. For clinical testing, a prospective, randomized, multi-center randomized trial was conducted at five U.S. centers and included 60 patients. Each subject was randomly treated with either MediENT® or the predicate MeroPack™. For up to 8 weeks, subjects were endoscopically examined to rate edema, infection and turbinate position and synechia was evaluated by a blinded reviewer. Clinical study results showed that MediENT was as good as MeroPack in preventing synechia and preventing lateralization of the middle turbinate. MediENT placement and implantation were safe and not associated with severe or significant adverse events. Results confirmed that the MediENT® Middle Turbinate Implant is substantial equivalent to the legally marketed predicate devices. In all instances, the MediENT® Middle Turbinate Implant functioned 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.
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
§ 874.4780 Intranasal splint.
(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(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 the limitations in § 874.9.
0
510(k) Number: K130354
510(k) SUMMARY
MAY 2 9 2013
Date Prepared:
Common Name:
Trade Name:
Sponsor:
May 28, 2013
MediENT® Middle Turbinate Implant
Intranasal splint
Class |
ENTrigue Surgical, Inc. 12672 Silicon Drive, Suite 150 San Antonio, Texas 78249 USA Telephone: 1-210-298-6336 Fax: 1-210-298-6399 Contact Person: Gabriele G. Niederauer, Ph.D.
Product Code and LYA Device Classification Name: Intranasal Splint (21 C.F.R. § 874.4780)
Classification:
Predicate Devices:
Intended Use/ Indications for Use:
Technological Characteristics: Walter Lorenz Surgical Inc., LactoSorb® Ethmoid Stent [K002131] Medtronic Xomed Inc., MeroPack™ Nasal Packing and Sinus Stent [K041381]
The MediENT® Middle Turbinate Implant is intended to separate the middle turbinate from the lateral nasal wall during the clinically relevant healing phase associated with nasal/sinus surgery. The implant provides short-term fixation of the middle turbinate to the nasal septum and thus minimizes the risk of adherence to the lateral nasal wall.
The MediENT® Middle Turbinate Implant is a tack made of an absorbable copolymer that is designed to hold the middle turbinate away from the lateral nasal wall. The sterile, single-use implant is delivered using standard surqical instruments, such as Alligator grasper, Pediatric Blakesly, MediENT® Grasper or similar. The implant provides temporary fixation and can be expected to start degrading approximately 2 to 3 months post-implantation. The MediENT® Middle Turbinate Implant is packaged and provided sterile for single use only.
1
Performance Data:
Substantial Equivalence:
Bench, cadaveric and clinical testing, using multiple users and study sites, was conducted to validate that the MediENT® Middle Turbinate Implant design met user requirements. Biocompatibility, sterilization, packaging, distribution, and shelf life testing were conducted in compliance with relevant standards. For clinical testing, a prospective, randomized, multi-center randomized trial was conducted at five U.S. centers and included 60 patients. Each subject was randomly treated with either MediENT® or the predicate MeroPack™. For up to 8 weeks, subjects were endoscopically examined to rate edema, infection and turbinate position and synechia was evaluated by a blinded reviewer. Clinical study results showed that MediENT was as good as MeroPack in preventing synechia and preventing lateralization of the middle turbinate. MediENT placement and implantation were safe and not associated with severe or significant adverse events. Results confirmed that the MediENT® Middle Turbinate Implant is substantial equivalent to the legally marketed predicate devices. In all instances, the MediENT® Middle Turbinate Implant functioned as intended.
The MediENT® Middle Turbinate Implant is substantially equivalent to Medtronic Xomed's MeroPack™ Nasal Packing / Sinus Stent (K041381) and the Walter Lorenz Surgical's LactoSorb® Ethmoid Stent (K002131). The MediENT® Middle Turbinate Implant has the same intended uses and similar indications, technological characteristics (design, materials), and principles of operation as the predicate devices. The minor differences in technological characteristics or principles of operation between the MediENT® Middle Turbinate Implant and the predicate devices do not raise any new types of safety or effectiveness questions because the issues related to effective approximation of tissue for a sufficient period to allow for healing are common to each of these products. Performance data, including randomized clinical comparison testing in 60 patients, demonstrate that the MediENT® Middle Turbinate Implant is as safe and effective as the Medtronic Xomed's MeroPack™ Nasal Packing / Sinus Stent. Thus, the MediENT® Middle Turbinate Implant is substantially equivalent to the Medtronic Xomed's MeroPack™ Nasal Packing / Sinus Stent and the Walter Lorenz Surgical's LactoSorb® Ethmoid Stent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
May 29, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ENTrigue Surgical, Inc. Gabriele G. Niederauer, Ph.D. Senior Vice President, Technology & Development 12672 Silicon Drive, Suite 150 San Antonio, TX 78249
Re: K130354
Trade/Device Name: MediENT® Middle Turbinate Implant Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal Splint Regulatory Class: Class I Product Code: LYA Dated: April 25, 2013 Received: April 26, 2013
Dear Dr. Niederauer:
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 warrantics. 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.
3
Page 2 - Gabriele G. Niederauer, Ph.D.
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 (OS) 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Deborah L. Falls -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K130354
Device Name: MediENT® Middle Turbinate Implant
Indications for Use:
The MediENT® Middle Turbinate Implant is intended to separate the middle turbinate from the lateral nasal wall during the clinically relevant healing phase associated with nasal/sinus surgery. The implant provides short-term fixation of the middle turbinate to the nasal septum and thus minimizes the risk of adherence to the lateral nasal wall.
Prescription Use × (Part 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)
Eric A. Mann -S
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K130354
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