(18 days)
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Not Found
No
The summary describes a physical medical device (punctum plug) and contains no mention of software, image processing, AI, or ML.
Yes
The device is intended for punctal and canalicular occlusion in patients with chronic dry eye, which is a therapeutic intervention for a medical condition.
No
The device is described as a punctal and canalicular occluder for treating chronic dry eye, which is a therapeutic function rather than diagnostic.
No
The device description clearly identifies the device as a "FlexPlug Punctum Plug," which is a physical medical device intended for occlusion. There is no mention of software as the primary component or function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The EagleVision FlexPlug Punctum Plug is a physical device intended for occlusion (blocking) of the punctal and canalicular structures in the eye. This is a therapeutic or interventional device, not a diagnostic one. It is placed in the body to treat a condition (chronic dry eye), not to analyze a sample from the body to diagnose or monitor a condition.
The information provided clearly describes a device that is physically inserted into the eye to address a physical issue, which is the opposite of how an IVD functions.
N/A
Intended Use / Indications for Use
The EagleVision FlexPlug Punctum Plug intended use is punctal and canalicular occlusion in patients with chronic dry eye.
Product codes
86 LZU
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three horizontal lines above a wavy line.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 1999
Mr. C. Curtis Freeman President Eagle Vision, Inc. 6263 Poplar Ave, Suite 650 Memphis, TN 38119
Re: K991130 Trade Name: FlexPlug Punctum Plug Regulatory Class: II Product Code: 86 LZU Dated: April 1, 1999 Received: April 2, 1999
Dear Mr. Freeman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
1
Page 2 - C. Curtis Freeman, President
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Roerl lorentbal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for "EAGLEVISION Solutions for Better Vision". The logo features a stylized eye graphic to the left of the text "EAGLEVISION". Below "EAGLEVISION" is the text "Solutions for Better Vision". The text is in a simple, sans-serif font.
Indications for Use Statement
Page 1 of 1
510(k) Number (if known): _ L 99 1130
Device Name: FlexPlug Punctum Plug
Indications for Use:
The EagleVision FlexPlug Punctum Plug intended use is punctal and canalicular occlusion in patients with chronic dry eye.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cathleen A. Boulware
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K991130
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
6263 POPLAR AVENUE, SUITE 650 · MEMPHIS, TENNESSEE 38119 U S A 9 0 1 / 6 8 2 - 9 4 0 0 ・ F A X 9 0 1 / 7 6 1 - 5 7 3 6 ・ E - M A I L : e a g l e p l u g @ a o l . c o m