MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)

K130354 · Entrigue Surgical, Inc. · LYA · May 29, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K130354
• Device Name: MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
• Applicant: Entrigue Surgical, Inc.
• Product Code: LYA · Ear, Nose, Throat
• Decision Date: May 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4780
• Device Class: Class 1
• Attributes: Therapeutic

Intended 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.

Device Story

Absorbable copolymer tack; provides temporary fixation of middle turbinate to nasal septum; prevents adherence to lateral nasal wall during post-surgical healing. Implanted by surgeons using standard instruments (e.g., graspers) in clinical settings. Device degrades over 2-3 months. Benefits include reduced synechia and lateralization risk; improved surgical outcomes. No electronic or software components.

Clinical Evidence

Prospective, randomized, multi-center trial (n=60) comparing MediENT® to MeroPack™ predicate. Endoscopic evaluation performed for 8 weeks post-op to assess edema, infection, turbinate position, and synechia by blinded reviewer. Results showed MediENT® as effective as predicate in preventing synechia and lateralization. No severe adverse events reported. Bench, cadaveric, biocompatibility, and shelf-life testing also performed.

Technological Characteristics

Absorbable copolymer tack; single-use; sterile. Designed for temporary tissue fixation. Mechanical operation; no energy source. No software or electronic components.

Indications for Use

Indicated for patients undergoing nasal/sinus surgery requiring separation of the middle turbinate from the lateral nasal wall to prevent synechia and lateralization during the healing phase.

Regulatory Classification

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.

Predicate Devices

• LactoSorb® Ethmoid Stent (K002131)
• MeroPack™ Nasal Packing and Sinus Stent (K041381)

Submission Summary (Full Text)

{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: [phone] Fax: [phone] 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.

{2}------------------------------------------------

#### 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 [phone] or [phone] 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 [phone] or [phone] 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

{4}------------------------------------------------

#### 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

Page 1 of 1