(183 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a silicone tube and probes, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for the reconstruction of the lacrimal outflow system, canaliculus repair, and maintenance of lacrimal outflow, which are therapeutic interventions.
No
The device description and intended use indicate that the device is an implantable medical device used for reconstruction and maintenance of the lacrimal outflow system, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical components: "two malleable stainless steel probes" and a "flexible coated silicone tube." This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the Atrion Medical Coated Lacrimal Intubation Set clearly indicate it is a surgical device used within the body to reconstruct and maintain the lacrimal outflow system. It is not used to test samples taken from the body.
The device is a surgical implant/instrument, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
OKS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lacrimal outflow system, canaliculus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ryder International Lacrimal Intubation Set, K962151
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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) | |
|---|---|
| Over-The- Counter Use |
| Division Sign-Off | |
|---|---|
| Division of Ophthalmic Devices | |
| 510(k) Number | K973633 |
| (Optional Format 1-2-96) | 000030 |
|---|---|
| -------------------------- | -------- |