(106 days)
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.
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.
The provided text is a summary of safety and effectiveness for a medical device (Ryder Lacrimal Intubation Set) and a subsequent correction letter from the FDA. It does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it detail any performance data, sample sizes, expert involvement, or ground truth methodologies typically associated with clinical studies or AI/algorithm performance evaluations.
The document explicitly states: "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." This indicates that the device was approved based on its similarity to a previously approved predicate device, not through a study demonstrating it meets specific performance acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving the device meets them from the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for Ryder International. The logo is black and white and features a stylized "R" in a square shape. The word "RYDER" is written in bold, sans-serif letters next to the square, and the word "INTERNATIONAL" is written in smaller letters below the word "RYDER".
SEP 118 1998
SUMMARY OF SAFETY AND EFFECTIVENESS 11.
| Date of Preparation: | May 31, 1996 |
|---|---|
| Device Name: | Ryder Lacrimal Intubation Set |
| Common Name: | Lacrimal Intubation Set |
| ClassificationName: | Lacrimal Probe / Manual Ophthalmic Surgical Instrument per 21CFR 886.4350 |
| Manufacturer: | Ryder International Corporation, 1426 Curt Francis Road,Arab, AL 35016 |
| Contact: | Mr. Dan ClarkRyder International Corporation, 1426 Curt Francis RoadArab, AL 35016Telephone: (250) 586-1580Fax: (205) 586-5553 |
| Predicate: | Concept 9035 Guibor Canaliculus Intubation Set |
| DeviceDescription: | The Lacrimal Intubation Set consists of two malleable stainlesssteel probes (to facilitate insertion) securely attached to a flexiblesilicone 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 reconstructionof the lacrimal outflow system and also useful in canaliculus repair,lacrimal obstruction and complicated and uncomplicateddacryocystorhinostomy procedures. |
| TechnologicalCharacteristics: | The design of the predicate device is such that the outsidediameter of the silicone tubing is fixed while the Ryder device hasvariations in the outside diameter of the silicone tubing. |
| Summary ofSafety Testing: | Based on the 510(k) "Substantial Equivalence" decision-makingprocess and the information provided herein, we conclude that thenew device is substantially equivalent to the predicate deviceunder the Federal Food, Drug and Cosmetic Act. |
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings outstretched, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a simple, clean design. The eagle is a common symbol of the United States, and its presence in the logo reinforces the department's connection to the federal government.
DEC 112008
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 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 (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 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,
Madina Bepeta, us
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
N/A