IOLAB LACRIMAL DUCT CATHETER
Device Facts
| Record ID | K935233 |
|---|---|
| Device Name | IOLAB LACRIMAL DUCT CATHETER |
| Applicant | Chiron Vision Corp. |
| Product Code | OKS · OP |
| Decision Date | Sep 15, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
| Attributes | Therapeutic |
Indications for Use
The new device and the predicate devices are intended for single-use during dilatation of an obstructed nasolacrimal duct system to correct epiphora.
Device Story
IOLAB Lacrimal Duct Catheter; single-use device for nasolacrimal duct dilatation. Features inflatable balloon allowing adjustable diameter to match patient anatomy; contrasts with fixed-diameter predicate probes/dilators. Used by clinicians to treat epiphora (excessive tearing) caused by duct obstruction. Device provides mechanical dilatation of the duct system.
Clinical Evidence
No clinical data provided; substantial equivalence based on design and intended use comparison.
Technological Characteristics
Single-use catheter featuring an inflatable balloon for adjustable diameter. Predicate devices utilize fixed-diameter rigid probes/dilators. No specific material standards or software/electronic components described.
Indications for Use
Indicated for use in the nasolacrimal duct system for the dilatation of an obstructed nasolacrimal duct to correct 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.
Predicate Devices
- Lacrimal Probe
- Lacrimal Dilator
Submission Summary (Full Text)
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K435233
SEP 15 1994
# IV. SUMMARY OF SAFETY AND EFFECTIVENESS
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's "510(k) 'SE' Decision-Making Process Documentation" and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
Device Name: IOLAB Lacrimal Duct Catheter
Predicate Device(s) Name: Lacrimal Probe and Lacrimal Dilator
Indications Statement: Yes. The new device and the predicate devices have the same indications statement. Both are indicated for use in the nasolacrimal duct system.
Intended Use: Yes. The new device and the predicate devices are intended for single-use during dilatation of an obstructed nasolacrimal duct system to correct epiphora.
Technological Characteristics: No. The design of the predicate device is such that the outside diameter is fixed. Both the probe and the dilator are not adjustable in diameter size. The IOLAB lacrimal duct catheter has an adjustable diameter specific to the patient anatomy due to the use of an inflatable balloon.
The new characteristics do not raise new types of safety or effectiveness questions based on the fact that the IOLAB lacrimal duct catheter does not create a new indication for use.
Based on the 510(k) "Substantial Equivalence" decision-making process and the information provided herein, we conclude that the new device is substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.
Contact Person:
Susan H. Caballa
Date: October 29, 1993
IOLAB Corporation
500 Iolab Drive
Claremont, CA. 91711
0012
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[LOGO]
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Room -WO66-G609
Silver Spring, MD 20993-0002
Quest Medical, Inc.
c/o Ms. Susan H. Caballa
Director, Regulatory Affairs
IOLAB
500 IOLAB Drive
Claremont, CA 91711
MAR 23 2012
Re: K935233
Trade/Device Name: IOLAB Lacrimal Duct Catheter
Regulation Number: None
Regulation Name: Lacrimal Stents and Intubation Sets
Regulatory Class: Unclassified
Product Code: OKS
Dated (Date on orig SE ltr): June 15, 1994
Received (Date on orig SE ltr): June 17, 1994
Dear Ms. Caballa:
This letter corrects our substantially equivalent letter of September 15, 1994. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Malvina B. Eydelman, M.D.
Director
Division of Ophthalmic, Neurological,
and Ear, Nose and Throat Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
for
