MICROMEDICS SPHENOID SINUS STENT

K050340 · Micromedics, Inc. · KAM · Apr 27, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050340
• Device Name: MICROMEDICS SPHENOID SINUS STENT
• Applicant: Micromedics, Inc.
• Product Code: KAM · General, Plastic Surgery
• Decision Date: Apr 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Intended for use as a postoperative stent to maintain an opening to the sphenoid sinus, for ventilation and drainage during the first 14 days and helps prevent obstruction by adhesions.

Device Story

Sphenoid Sinus Stent is a postoperative device designed to maintain patency of the sphenoid sinus opening following surgery. The stent facilitates ventilation and drainage while preventing the formation of adhesions that could obstruct the sinus ostium. It is intended for short-term use, specifically during the first 14 days post-procedure. The device is placed by a physician in a clinical setting. By maintaining an open pathway, the stent supports proper healing and reduces the risk of postoperative complications related to sinus obstruction.

Clinical Evidence

No clinical data provided; bench testing only.

Indications for Use

Indicated for use as a postoperative stent in patients undergoing sphenoid sinus surgery to maintain sinus patency, facilitate ventilation and drainage, and prevent adhesion formation during the initial 14-day postoperative period.

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.

Submission Summary (Full Text)

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APR 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Micromedics, Inc. c/o Thomas Lopac Manager of Quality Assurance 1270 Eagan Industrial Road Suite 120

Re: K050340

Trade/Device Name: Micromedics Sphenoid Sinus Stent Regulatory Class: Unclassified Product Code: KAM Dated: April 6, 2005 Received: April 12, 2005

Dear Mr. Lopac:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section 910(x) premainted instantially equivalent (for the indications felerenced above and nave determined we are and marketed predicate devices marketed in interstate for use stated in the encrosuly to regally manatise to of the Medical Device Amendments, or to commence province to May 20, 1978, the exactions of the Federal Food. Drug, devices that have been reclassified in acceraanse who was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval and Cosment Act (Act) that to not requence subject to the general controls provisions of the Act. The You may, merclore, market the device, basjer to the ...
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the floor labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in II your device is classified (500 above) and existing major regulations affecting your device can may be subject to such additional controls. Enisting may one of on 898. In addition, FDA may be found in the Out of I satis concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination oes not mean Prease be advised that I DA 3 issuates of a sevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a decormination an administered by other Federal agencies. You must of any Federal statutes and regulations anninetees or your not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CPK Part 807), adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Thomas Lopac

This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin manketing your averal equivalence of your device to a legally premarket nothleation: "The PDA maing of castimation 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 If you desire specific advice for your ac [phone]. Also, please note the regulation entitled, Contact the Office of Complanoo at (301) 327 - 31 - 31 807.97). You may obtain Milsolalling by relevelec to premanteensbillities under the Act from the Division of Small other general Information on your response Assistance at its toll-free number (800) 638-204 or Manufacturers, International and Ochsal http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting 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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## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): __________________________________________________________

Device Name: Sphenoid Sinus Stent

Indications for Use:

Intended for use as a postoperative stent to maintain an opening to the sphenoid sinus, of Intenaed for use as a postoperative sient to manufacturer worders for ventilation and drainage of uuring the Just 14 aays Journag and helps prevent obstruction by adhesions.

X Prescription Use: (Per 21 CFT 801.109)

OR

Over-The-Counter _____________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kamat Bolu

Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number J

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