XOMED T-STENT, FRONTAL SINUS STENT

K973273 · Xomed, Inc. · KAM · Sep 29, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973273
• Device Name: XOMED T-STENT, FRONTAL SINUS STENT
• Applicant: Xomed, Inc.
• Product Code: KAM · General, Plastic Surgery
• Decision Date: Sep 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

This device is intended for use as a postoperative stent to maintain an opening to the frontal sinus during the first 7 to 14 days following sinus surgical procedures. The selfretaining stent provides for the ventilation and drainage of fluids from the frontal sinus and helps prevent obstruction by adhesions when used alone or with other nasal stents or packs.

Device Story

The T-Stent is a one-piece, radiopaque, C-Flex thermoplastic elastomer drainage tube. It features T-shaped flanges at the proximal end for self-retention within the frontal sinus cavity. The device is used postoperatively by surgeons following sinus surgical procedures. It functions as a mechanical stent to maintain an opening to the frontal sinus, facilitating ventilation and drainage of fluids while preventing obstruction by adhesions. The device is intended for short-term use (7 to 14 days).

Technological Characteristics

One-piece, radiopaque, C-Flex thermoplastic elastomer drainage tube. Features T-shaped flanges for positioning and retention. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients undergoing sinus surgery requiring the placement of a drainage stent for the frontal sinus to maintain patency and facilitate ventilation and drainage postoperatively.

Regulatory Classification

Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

Predicate Devices

• Rains stent

Submission Summary (Full Text)

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K973273

# XOI

SEP 2 9 1997

27

K

# 510(k) Summary Xomed T-Stent Date Prepared August 29, 1997 Submitter (Contact) Debra B. Cortner Xomed Surgical Products Jacksonville, FL [phone] Device Name Proprietary Name: T-Stent Sinus stent, frontal sinus drain tube Common Name(s): Sinus Catheter Classification Name:

### 4.0 Device Classification

1.0

2.0

3.0

Sinus Catheter KAM Procode 77 Class I ; 21 CFR 874. Tier II

## Device Description

The T-Stent is a one-piece radiopaque C-Flex thermoplastic elastomer drainage tube with T-shaped flanges at the proximal end for positioning and retention in the prepared sinus cavity.

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Image /page/1/Picture/0 description: The image shows the word "XOMED" in a bold, sans-serif font. To the right of the word is a registered trademark symbol and a circular logo. The logo contains a white circle with a black cross inside, and each section of the cross has a black arrow pointing towards the center. The overall design is simple and professional.

#### 6.0 Intended Use

This device is intended for use as a postoperative stent to maintain an opening to the frontal sinus during the first 7 to 14 days following sinus surgical procedures. The selfretaining stent provides for the ventilation and drainage of fluids from the frontal sinus and helps prevent obstruction by adhesions when used alone or with other nasal stents or packs.

## 7.0 Substantial Equivalence

The T-Stent described in this notification has the same intended use as the predicate Rains stent, and the same technological characteristics as other sinus stents currently on the market, and does not raise any new issues of safety or effectiveness.

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Image /page/2/Picture/0 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with three curved lines representing its wings and body, giving it a modern and abstract appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Debra B. Cortner Senior Regulatory Affairs and Quality System Specialist Xomed Surgical Products, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216

Re:

K973273 Xomed Frontal Sinus T-Stent Dated: August 29, 1997 Received: September 2, 1997 Regulatory class: Unclassified Procode: 77 KAM

SEP 2 9 1997

Dear Ms. Cortner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the inclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation vou might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

hillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): K973273

Device Name: _________________________________________________________________________________________________________________________________________________________________

## Indications for Use:

This device is intended for use as a postoperative stent to maintain an opening to the frontal sinus during the first 7 to 14 days following sinus surgical procedures. The self-retaining stent provides for the ventilation and drainage of fluids from the frontal sinus and helps prevent obstruction by adhesions when used alone or with other nasal stents or packs

.Indications: Any sinus surgery requiring the placement of a drainage stent for the frontal sinus.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

Or

Over-the-Counter Use _________

(Optional Format 1-2-96)

David A. Bergman
(Division Sign-Off)

Reproductive, Abdominal, ENT 510(k) Number