BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)

K023758 · Fci Ophthalmics, Inc. · OKS · Sep 17, 2003 · OP

Device Facts

• Record ID: K023758
• Device Name: BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)
• Applicant: Fci Ophthalmics, Inc.
• Product Code: OKS · OP
• Decision Date: Sep 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Transnasal Lacrimal Stent is indicated in treatments of epiphora treated by dacryocystorhinostomy. Dacryocystorhinostomy (DCR) is the common surgical procedure used to correct nasolacrimal duct obstruction.

Device Story

Becker Transnasal Lacrimal Stent is a surgical implant used during dacryocystorhinostomy (DCR) procedures to treat nasolacrimal duct obstruction and associated epiphora. The device is placed by an ophthalmologist or ENT surgeon to maintain patency of the newly created lacrimal drainage pathway. It functions as a mechanical stent to prevent closure or scarring of the surgical opening. The device is used in a clinical/surgical setting.

Clinical Evidence

bench testing only

Technological Characteristics

Mechanical lacrimal stent; dimensions and materials not specified in provided text. Non-powered, implantable device.

Indications for Use

Indicated for patients with epiphora requiring dacryocystorhinostomy (DCR) to correct nasolacrimal duct obstruction.

Regulatory Classification

Identification

Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system. Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 16 2008

FCI Ophthalmics, Inc. c/o Hillard W. Welch 344 Annabelle Point Rd. Centerville, MA 02632

Re: K023758

Trade/Device Name: Becker Transnasal Lacrimal Stent Regulatory Class: Unclassified Product Code: OKS Dated: November 5, 2002 Received: November 8, 2002

Dear Mr. Welch:

This letter corrects our substantially equivalent letter of September 17, 2003.

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 (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.

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. 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Egleston, ind

Malvina B. Eydelman, M.I 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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510(k) Number (if known): K023758

Becker Transnasal Lacrimal Stent

, i

Device Name:

Indications for Use:

The Transnasal Lacrimal Stent is indicated in treatments of epiphora treated by dacryocystorhinostomy.

Dacryocystorhinostomy (DCR) is the common surgical procedure used to correct nasolacrimal duct obstruction.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign Off) | |
|-----------------------------------------------------|---------|
| Division of Ophthalmic Ear, Nose and Throat Devises | |
| 510(k) Number | K023758 |

| Prescription Use (Per 21 CFR 801.109) | Yes | OR | Over-The-Counter Use |
|---------------------------------------|-----|----|----------------------|
|---------------------------------------|-----|----|----------------------|

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