← Product Code OKS · K962151 # RYDER LACRIMAL INTUBATIONSET (K962151) _Ryder Intl. Corp. · OKS · Sep 18, 1996 · OP · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K962151 ## Device Facts - **Applicant:** Ryder Intl. Corp. - **Product Code:** OKS - **Decision Date:** Sep 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** OP - **Attributes:** Therapeutic ## Intended Use The Ryder 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 Ryder Lacrimal Intubation Set consists of two malleable stainless steel probes attached to a flexible silicone tube; used by ophthalmologists for lacrimal outflow system reconstruction, canaliculus repair, and dacryocystorhinostomy. Probes facilitate insertion of silicone tube into lacrimal system. Device is single-use and sterilized via gamma radiation. Provides mechanical support/stenting for lacrimal passages during healing. ## Clinical Evidence No clinical data provided; substantial equivalence based on design and material comparison. ## Technological Characteristics Materials: malleable stainless steel probes, flexible silicone tubing. Sterilization: gamma radiation. Form factor: two probes attached to a silicone tube. Design variation: variable outside diameter of silicone tubing compared to fixed diameter of predicate. ## 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 - Concept 9035 Guibor Canaliculus Intubation Set ## 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} K962151 RJRPER SEP 18 1996 # 11. SUMMARY OF SAFETY AND EFFECTIVENESS Date of Preparation: May 31, 1996 Device Name: Ryder Lacrimal Intubation Set Common Name: Lacrimal Intubation Set Classification Name: Lacrimal Probe / Manual Ophthalmic Surgical Instrument per 21 CFR 886.4350 Manufacturer: Ryder International Corporation, 1426 Curt Francis Road, Arab, AL 35016 Contact: Mr. Dan Clark Ryder International Corporation, 1426 Curt Francis Road Arab, AL 35016 Telephone: (250) 586-1580 Fax: (205) 586-5553 Predicate: Concept 9035 Guibor Canaliculus Intubation Set Device Description: The Lacrimal Intubation Set consists of two malleable stainless steel probes (to facilitate insertion) securely attached to a flexible silicone tube of varying thickness. The intubation set is a single-use product, sterilized by gamma radiation. Intended Use: The Ryder 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 design of the predicate device is such that the outside diameter of the silicone tubing is fixed while the Ryder device has variations in the outside diameter of the silicone tubing. Summary of Safety Testing: 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 device under the Federal Food, Drug and Cosmetic Act. Ryder International Corporation 1426 Curt Francis Road Arab, Alabama 35016 205-586-1580 000031 {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service DEC 11 2008 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ryder International Corp. c/o Mr. Dan Clark Vice President Regulatory and Quality 1426 Curt Francis Road Arab, AL 35016 Re: K962151 Trade/Device Name: Ryder Lacrimal Intubation Set Regulatory Class: Unclassified Product Code: OKS Dated: May 31, 1996 Received: June 4, 1996 Dear Mr. Clark: This letter corrects our substantially equivalent letter of September 18, 1996. 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} Page 2 – Mr. Dan Clark 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. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure --- **Source:** [https://fda.innolitics.com/device/K962151](https://fda.innolitics.com/device/K962151) **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