(81 days)
No
The summary describes physical medical devices (stents and delivery systems) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a lacrimal stent intended for use in lacrimal system reconstruction and treatment of various conditions like epiphora, stenosis, obstruction, and laceration, which are therapeutic interventions.
No
The device description and intended use clearly state that these are lacrimal stents and delivery systems used for reconstruction and treatment of specified lacrimal system pathologies, not for diagnosing conditions.
No
The device description explicitly details physical components such as silicone tubing, punctum plugs, stainless steel stylets, and probes, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The provided text clearly describes the devices as lacrimal stents and their delivery systems. They are intended for use within the lacrimal system to treat conditions like stenosis, obstruction, or laceration. This is a therapeutic intervention performed in vivo (within the body).
The device is a medical device used for treatment, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are lacrimal stents and their delivery systems. They are intended for use in lacrimal system reconstruction. This includes, but is not limited to, treatment of: epiphora in infants or 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.
Product codes
HNL
Device Description
The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are lacrimal stents and delivery systems.
The MonoStent™ Monocanalicular Stents consist of a length of silicone tubing, with a silicone punctum pluq molded perpendicularly onto one end of the tubing. A stainless steel stylet is provided with the stent to assist in the insertion of the silicone tubing.
The EagleVision® Lacrimal Intubation Set is comprised of stents for use in monocanalicular and bicanalicular intubation procedures. The stents are made of medical grade silicone tubing that is attached to malleable stainless steel probes. The intubation set allows for probing and stenting as a one step procedure.
The EagleVision® K Type Lacrimal Intubation Set is comprised of stents for use in monocanalicular and bicanalicular intubation procedures. The stents are made of silicone probes attached with a silicone rod.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lacrimal system, nasolacrimal duct
Indicated Patient Age Range
infants or adults
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)
Descriptive characteristics were sufficient for assurance of equivalence. A comprehensive literature and MDR review was conducted to demonstrate that the MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are substantially equivalent to the EV™ Monocanalicular Stent (cleared under K883233), the Lacrimal Intubation Set & DCR Set (cleared under K990672), and the Ritleng Bicanaliculus Intubation Set (cleared under K955671), respectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
APR 2 5 2003
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Eagle Vision, Inc. | |
|---|---|---|
| 8500 Wolf Lake Drive, Suite 110 | ||
| Memphis Tennessee, 38133 USA | ||
| OFFICIAL | ||
| CORRESPONDENT | Billy Hannaford | |
| RA/QA Manager | ||
| Eagle Vision, Inc. | ||
| 8500 Wolf Lake Drive, Suite 110 | ||
| Memphis Tennessee, 38133 USA | ||
| Tel: (901) 380-7000 | ||
| FAX: (901) 380-7001 | ||
| e-mail: billyh@eaglevis.com | ||
| TRADE NAME: | Eagle Vision Lacrimal Stents and Intubation Sets | |
| COMMON NAME: | Monocanalicular stents | |
| Lacrimal Intubation Sets | ||
| CLASSIFICATION | ||
| NAME: | Probe, lacrimal | |
| DEVICE | ||
| CLASSIFICATION: | Class II per 21 CFR § 886.4350 | |
| PRODUCT CODE | 86 (HNL) | |
| PREDICATE DEVICE: | EVT™ Monocanalicular Stent (cleared under K883233), the | |
| Lacrimal Intubation Set & DCR Set (cleared under K990672), and | ||
| the Ritleng Bicanaliculus Intubation Set (cleared under K955671) |
SUBSTANTIALLY EQUIVALENT TO:
The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are substantially equivalent to the EV™ Monocanalicular Stent (cleared under K883233), the Lacrimal Intubation Set & DCR Set (cleared under K990672), and the Ritleng Bicanaliculus Intubation Set (cleared under K955671), respectively.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are lacrimal stents and delivery systems.
1
INDICATION FOR USE:
The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are lacrimal stents and their delivery systems. They are intended for use in lacrimal system reconstruction. This includes, but is not limited to, treatment of: epiphora in infants or 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.
TECHNICAL CHARACTERISTICS:
The MonoStent™ Monocanalicular Stents consist of a length of silicone tubing, with a silicone punctum pluq molded perpendicularly onto one end of the tubing. A stainless steel stylet is provided with the stent to assist in the insertion of the silicone tubing.
The EagleVision® Lacrimal Intubation Set is comprised of stents for use in monocanalicular and bicanalicular intubation procedures. The stents are made of medical grade silicone tubing that is attached to malleable stainless steel probes. The intubation set allows for probing and stenting as a one step procedure.
The EagleVision® K Type Lacrimal Intubation Set is comprised of stents for use in monocanalicular and bicanalicular intubation procedures. The stents are made of silicone probes attached with a silicone rod.
PERFORMANCE DATA:
Descriptive characteristics were sufficient for assurance of equivalence. A comprehensive literature and MDR review was conducted to demonstrate that the MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are substantially equivalent to the EV™ Monocanalicular Stent (cleared under K883233), the Lacrimal Intubation Set & DCR Set (cleared under K990672), and the Ritleng Bicanaliculus Intubation Set (cleared under K955671), respectively.
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are substantially equivalent to the EV™ Monocanalicular Stent (cleared under K883233), the Lacrimal Intubation Set & DCR Set (cleared under K990672), and the Ritleng Bicanaliculus Intubation Set (cleared under K955671), respectively. All of the devices have the same indication for use, "... for use in lacrimal system reconstruction ..." The devices have similar designs and technological characteristics.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in promoting the health and well-being of Americans.
Public Health Service
APR 2 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eagle Vision, Inc. c/o Mr. Billy Hannaford RA/OA Manager 8500 Wolf Lake Drive, Suite 110 Memphis Tennessee, 38133 USA
Re: K030353
Trade/Device Name: Eagle Vision Lacrimal Stents and Intubation Sets Regulation Number: 886.4350 Regulation Name: Monocanalicular stents; Lacrimal Intubation Sets Regulatory Class: II Product Code: HNL Dated: January 31, 2003 Received: February 3, 2003
Dear Mr. Hannaford:
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 application (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 such 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.
3
Page 2 - Mr. Billy Hannaford
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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A halyi Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1_of_1
510(k) Number (if known): ريب 30 3 3 3 3
Device Name: The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set
Indications for Use:
The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are lacrimal stents and their delivery systems. They are intended for use in lacrimal system reconstruction. This includes, but is not limited to, treatment of: epiphora in infants or 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K030353 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter Use ______ | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |