FCI CRAWFORD PROBE INTUBATION SETS

K991238 · Fci Ophthalmics, Inc. · OKS · Jul 8, 1999 · OP

Device Facts

• Record ID: K991238
• Device Name: FCI CRAWFORD PROBE INTUBATION SETS
• Applicant: Fci Ophthalmics, Inc.
• Product Code: OKS · OP
• Decision Date: Jul 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

Epiphora in infants or adults, particularly in cases of canalicular pathologies (stenosis, obstruction or lacerations) dacryocysorhinostomy (conventional or laser) imperforation of the nasolacrimal duct in an infant .

Device Story

FCI Crawford Probe Intubation Set is a surgical instrument used for lacrimal system intubation. Device consists of a probe used to navigate the nasolacrimal duct to address epiphora caused by obstructions, stenosis, or lacerations. Used by ophthalmologists in clinical or surgical settings. Facilitates restoration of tear drainage by maintaining patency of the nasolacrimal duct. Benefits patient by relieving symptoms of excessive tearing.

Clinical Evidence

No clinical data provided; device is a surgical instrument.

Technological Characteristics

Surgical probe for lacrimal intubation. Form factor consists of a probe designed for nasolacrimal duct navigation. No electronic components, software, or energy sources.

Indications for Use

Indicated for infants or adults with epiphora due to canalicular pathologies (stenosis, obstruction, or lacerations), dacryocystorhinostomy (conventional or laser), or nasolacrimal duct imperforation.

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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DEC 112008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Anne Bohsack Vice President. General FCI Ophthalmics, Inc. P.O. Box 465 76 Prospect Street Marshfield Hills. MA 02051

Re: K991238

Trade/Device Name: FCI Crawford Probe Intubation Sets Regulatory Class: Unclassified Product Code: OKS Dated: April 6, 1999 Received: April 12, 1999

Dear Ms. Bohsack:

This letter corrects our substantially equivalent letter of July 8, 1999.

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 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.D 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):

Crawford Probe Device Name:

Indications For Use:

....

. .

.:

Epiphora in infants or adults, particularly in cases of

canalicular pathologies (stenosis, obstruction or lacerations)

dacryocysorhinostomy (conventional or laser)

imperforation of the nasolacrimal duct in an infant .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ashlin Barliave
(Division Sign-Off)
of Ophthalmic Devices

k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

・・。

(Optional Format 1-2-96)