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.

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.

AI/ML Overview

Acceptance Criteria and Device Performance for MediENT® Middle Turbinate Implant (K130354)

The MediENT® Middle Turbinate Implant is intended to provide temporary fixation of the middle turbinate to the nasal septum to separate it from the lateral nasal wall during the post-surgical healing phase, thereby minimizing the risk of adherence (synechia) and lateralization. The device's performance was evaluated through a clinical study against a predicate device, MeroPack™.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria (e.g., "Synechia rate must be less than X%"). Instead, the acceptance criterion for substantial equivalence was qualitative: to demonstrate that the MediENT® device is "as good as" the predicate device, MeroPack™, in preventing synechia and lateralization of the middle turbinate, and that its placement and implantation are safe.

Acceptance Criteria (Implicit)	Reported Device Performance
Effectiveness: As good as MeroPack™ in preventing synechia.	"Clinical study results showed that MediENT was as good as MeroPack in preventing synechia."
Effectiveness: As good as MeroPack™ in preventing lateralization of the middle turbinate.	"Clinical study results showed that MediENT was as good as MeroPack in preventing lateralization of the middle turbinate."
Safety: Placement and implantation are safe and not associated with severe or significant adverse events.	"MediENT placement and implantation were safe and not associated with severe or significant adverse events."
Functionality: In all instances, the device functioned as intended.	"In all instances, the MediENT® Middle Turbinate Implant functioned as intended."
Biocompatibility, Sterilization, Packaging, Distribution, and Shelf Life: Compliance with relevant standards.	"Biocompatibility, sterilization, packaging, distribution, and shelf life testing were conducted in compliance with relevant standards." (Specific results for these tests are not provided in the summary but were part of the submission.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 60 patients.
Data Provenance: Prospective, randomized, multi-center randomized trial conducted at five U.S. centers.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The summary mentions that "synechia was evaluated by a blinded reviewer." It does not specify the exact number of experts (it implies one primary blinded reviewer) or their qualifications (e.g., radiologist, ENT surgeon, experience level).

4. Adjudication Method for the Test Set

The summary states that "synechia was evaluated by a blinded reviewer." This suggests a single blinded reviewer for this particular outcome. There is no mention of an adjudication method like 2+1 or 3+1, which implies that a consensus process involving multiple reviewers was not explicitly used for the final determination of synechia in the clinical trial description. Other elements like edema and infection were "endoscopically examined to rate" by unspecified personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done in the context of comparing human readers' performance with and without AI assistance. This device is an implantable medical device, not an AI-powered diagnostic or assistive tool for human interpretation.

6. If a Standalone Performance Study Was Done

Yes, a standalone clinical performance study was done for the MediENT® device, but it was a comparative effectiveness study against a predicate device, not a "standalone" in the sense of an algorithm-only review for AI systems. The device itself (the implant) was evaluated directly in human subjects, functioning as intended without constant human intervention after placement.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on clinical observation and assessment by a "blinded reviewer," specifically for synechia, and also included endoscopic examination for edema and infection, as well as turbinate position. This is a form of expert clinical assessment serving as the reference standard.

8. The Sample Size for the Training Set

This question is not applicable in the context of this traditional medical device submission. The MediENT® Middle Turbinate Implant is a physical implant, not a software algorithm or AI model that requires a "training set" in the machine learning sense. The "training" for such a device would involve bench testing, cadaveric studies, and usability testing, all focused on its physical and mechanical properties and surgical delivery.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, this question is not applicable. For a physical device, the "ground truth" during development (analogous to training) would be established through engineering specifications, biomechanical testing standards, and preclinical feedback from surgeons on usability and performance in cadaveric models. These activities are designed to optimize the device design to meet performance requirements rather than to train an algorithm.

Summary

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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]

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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.

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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:

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

Page 1 of 1

Regulation Number and Section

§ 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.