← Product Code OKS · K973633 # ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET (K973633) _Atrion Medical Products, Inc. · OKS · Jan 16, 1998 · OP · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K973633 ## Device Facts - **Applicant:** Atrion Medical Products, Inc. - **Product Code:** OKS - **Decision Date:** Jan 16, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** OP - **Attributes:** Therapeutic ## Intended Use The Atrion Medical Coated Lacrimal Intubation Set is valuable in the reconstruction of the lacrimal outflow system and also useful in canaliculus repair, lacrimal obstruction and complicated and uncomplicated dacryocystorhinostomy procedures. ## Device Story Atrion Medical Coated Lacrimal Intubation Set consists of two malleable stainless steel probes attached to a flexible coated silicone tube. Device is single-use and radiation-sterilized. Used by surgeons in clinical settings for lacrimal outflow system reconstruction, canaliculus repair, and dacryocystorhinostomy (DCR) procedures. Coating on silicone tube increases lubricity to facilitate insertion. Device functions as a mechanical stent to maintain patency of the lacrimal drainage system during healing. ## Clinical Evidence No clinical data. Substantial equivalence supported by bench testing, specifically biocompatibility testing including cytotoxicity, hemolysis (in vitro), acute systemic toxicity, intracutaneous toxicity, implantation test, and histology of the implant site. ## Technological Characteristics Malleable stainless steel probes; flexible silicone tube with lubricious coating. Single-use. Sterilized by radiation. ## Regulatory 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 - Ryder International Lacrimal Intubation Set ([K962151](/device/K962151.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ DUPLICATE | Atrion Medical Products, Inc. | |-------------------------------| | 1426 Curt Francis Road | | Post Office Box 564 | | Arab, AL 35016 | | Tel 205 586 1580 | | Fax 205 586 8529 | K973633 , and the corrected HTML is: | Atrion Medical Products, Inc. | | | | | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--| | 1426 Curt Francis Road | | | | | | Post Office Box 564 | | | | | | Arab. AL 35016 | 6 1998 | | | | | Tel 205 586 1580 | 73633 | | | | | Fax 205 586 8529 | | | | | | | | | | | | 11. | SUMMARY OF SAFETY AND EFFECTIVENE | | | | | Date of
Preparation: | October 9, 1997 | | | | | Device Name: | Atrion Medical Coated Lacrimal Intubation Set, K973633 | | | | | Common Name: | Coated Lacrimal Intubation Set | | | | | Classification
Name: | Lacrimal Probe / Manual Ophthalmic Surgical Instrument per 21 CFR
886.4350 | | | | | Manufacturer: | Atrion Medical Products, Inc.
1426 Curt Francis Road
Arab, AL 35016 | | | | | Contact: | Mr. Dan Clark
Atrion Medical Products, Inc.
1426 Curt Francis Road
Arab, AL 35016
Telephone: (250) 586-1580, Fax: (205) 586-5553 | | | | | Predicate: | Ryder International Lacrimal Intubation Set, K962151 | | | | | Device
Description: | The Atrion Medical Coated Lacrimal Intubation Set consists of two
malleable stainless steel probes (to facilitate insertion) securely
attached to a flexible coated silicone tube of varying thickness. The
intubation set is a single-use product, sterilized by radiation. | | | | | Intended Use: | The Atrion Medical Coated Lacrimal Intubation Set is valuable in the
reconstruction of the lacrimal outflow system and also useful in
canaliculus repair, lacrimal obstruction and complicated and
uncomplicated dacryocystorhinostomy procedures. | | | | | Technological
Characteristics: | The Atrion Medical Coated Lacrimal Intubation Set will be identical to
the predicate except that it will have a coating on the tube to
Increase lubricity and facilitate insertion. | | | | | Summary of
Safety Testing: | Based on biocompatibility testing, including cytotoxicity, hemolysis (in
vitro), acute systemic toxicity, intracutaneous toxicity, implantation
test and histology of the implant site, we conclude that the new
device is substantially equivalent to the predicate device under the
Federal Food, Drug and Cosmetic Act. | | | | | | 000028 | | | | | | | | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The logo is simple and clean, and it is easily recognizable. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 112008 Mr. Dan Clark Vice President Atrion Medical Products, Inc. 1426 Curt Francis Road P.O. Box 564 Arab, AL 35016 Re: K973633 Trade/Device Name: Atrion Medical Products Lacrimal Intubation Set Regulatory Class: Unclassified Product Code: OKS Dated: January 8, 1998 Received: January 12, 1998 Dear Mr. Clark: This letter corrects our substantially equivalent letter of January 16, 1998. 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. {2}------------------------------------------------ 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Malvina B. Epler, und Malvina B. Eydelman, M Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## 510(k) Number (if known): K973633 ## Device Name: Atrion Medical Coated Lacrimal Intubation Set Indications For Use: - Maintenance of lacrimal outflow post primary DCR surgical procedures. 1. - Maintenance of lacrimal outflow post failed open DCR surgical procedures with complete 2. obstruction. - Reconstruction of the canaliculi. 3. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF. . . . . . . . . . . . . . . NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use (Per 21 CFR 801.109) |
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| |---------------------------------------|---------------------------------------------------------| | Over-The- Counter Use | | | Division Sign-Off | | |--------------------------------|---------| | Division of Ophthalmic Devices | | | 510(k) Number | K973633 | | (Optional Format 1-2-96) | 000030 | |--------------------------|--------| |--------------------------|--------| --- **Source:** [https://fda.innolitics.com/device/K973633](https://fda.innolitics.com/device/K973633) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com