MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE

K061404 · Fci Ophthalmics, Inc. · OKS · Aug 7, 2006 · OP

Device Facts

• Record ID: K061404
• Device Name: MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE
• Applicant: Fci Ophthalmics, Inc.
• Product Code: OKS · OP
• Decision Date: Aug 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Indicated in initial surgery in the treatment of monocanalicular lacerations and stenoses requiring intubation. Further indications are: Congenital lacrimal duct obstructions Canalicular lacerations After treatment of canaliculitis with concretions when curettage of a canaliculus has been performed. After clacryocystorhinostomy Epiphora

Device Story

The Mono-Crawford Naso-lacrimal Intubation Device is a surgical implant used for the treatment of lacrimal duct obstructions and lacerations. It is intended for use by ophthalmologists during surgical procedures. The device facilitates the intubation of the nasolacrimal system to maintain patency and support healing. It is a mechanical device; no software or electronic components are involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical naso-lacrimal intubation device. Materials and specific technical dimensions are not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring monocanalicular intubation for conditions including monocanalicular lacerations, stenoses, congenital lacrimal duct obstructions, canalicular lacerations, post-canaliculitis curettage, post-dacryocystorhinostomy, and epiphora.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES · USA

DEC 16 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

FCI Ophthalmics, Inc. c/o Hillard W. Welch 344 Annabelle Point Rd. Centerville, MA 02632-2402

Re: K061404

Trade/Device Name: Mono-Crawford Naso-lacrimal Intubation Device Regulatory Class: Unclassified Product Code: OKS Dated: May 15, 2006 Received: May 19, 2006

Dear Mr. Welch:

This letter corrects our substantially equivalent letter of August 7, 2006.

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 (QS) 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 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, wid

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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## Indications for Use

510(k) Number (if known): __ K061404__________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Indicated in initial surgery in the treatment of monocanalicular lacerations and stenoses requiring intubation.

Further indications are:

Congenital lacrimal duct obstructions

Canalicular lacerations

After treatment of canaliculitis with concretions when curettage of a

canaliculus has been performed.

After clacryocystorhinostomy

Epiphora

Prescription Use
X
(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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Moidulite Viswani

vision of Onhthalmir and Threat Dev

310(k) Number_Ko61404

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(Posted November 13, 2003)