(152 days)
K850649 ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT, K890919 TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT, K895342 COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST, K897190 LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT, K946357 COLLAGEN INTRACANALICULAR PLUG, K013613 SOFT PLUG ABSORBABLE PLUG-SA, K020882 SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG, K022043 SMARTPLUG MODEL 500, K030300 OPAQUE HERRICK LACRIMAL PLUG
Not Found
No
The device description focuses on the physical properties and mechanism of action of a resorbable implant, with no mention of AI or ML technologies.
Yes
Explanation: The device is intended to treat dry eye syndrome, increase retention of ocular medications, and treat contact lens intolerance and post-surgical dry eye, all of which are therapeutic uses.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to "Determine the potential effectiveness of permanent occlusion." This indicates a diagnostic purpose to assess a patient's suitability for a permanent solution.
No
The device description clearly states that the device is a physical implant made of a hydrophilic, resorbable material, designed to be inserted into the canaliculus. This is a hardware device, not software.
Based on the provided information, the EagleVision Gellansert is not an In Vitro Diagnostic (IVD) device.
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 for diagnosis, monitoring, or screening.
- EagleVision Gellansert's Function: The EagleVision Gellansert is a physical implant designed to be inserted into the canaliculus to block tear drainage. It directly interacts with the body's anatomy to achieve a therapeutic effect (treating dry eye, increasing medication retention, etc.). It does not analyze or test any bodily fluids or tissues in vitro (outside the body).
The intended use and device description clearly indicate a therapeutic device for physical intervention, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
The EagleVision Gellansert® is intended to temporarily block tear drainage by the occlusion of the canaliculus in order to:
- Determine the potential effectiveness of permanent occlusion, .
- Temporarily treat dry eye syndrome, and the dry eye components of various . ocular surface diseases,
- Increase retention of ocular medications .
- Temporarily treat contact lens intolerance secondary to dry eye, and .
- Treat dry eye after surgery. .
Product codes (comma separated list FDA assigned to the subject device)
LZU
Device Description
EagleVision Gellanserts are intended to temporarily block tear drainage by occlusion of the canaliculus. EagleVision Gellanserts are made of a hydrophilic, resorbable material, and are designed to expand only laterally after insertion into the canaliculus, so that only one size is needed to occlude most patients' lacrimal systems. The EagleVision Gellanserts are designed to expand and fit virtually all patient anatomies from 0.3mm up to 1.1 mm, so multiple inserts in one canaliculus are generally not necessary. There are five inserts per sterile pouch, so that one EagleVision Gellansert can be placed in each punctum with one additional EagleVision Gellansert in case one is dropped or mishandled.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
canaliculus, punctum
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)
Not Found
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.
K850649 ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT, K890919 TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT, K895342 COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST, K897190 LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT, K946357 COLLAGEN INTRACANALICULAR PLUG, K013613 SOFT PLUG ABSORBABLE PLUG-SA, K020882 SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG, K022043 SMARTPLUG MODEL 500, K030300 OPAQUE HERRICK LACRIMAL PLUG
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
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 | | MAY 2 2006 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|------------|
| OFFICIAL
CORRESPONDENT | Jeff Cobb
Vice President, RA/CA/QA
Eagle Vision, Inc.
8500 Wolf Lake Drive, Suite 110
Memphis Tennessee, 38133 USA
Tel: (901) 380-7000
FAX: (901) 380-7001
e-mail: jeff@eaglevis.com | | |
| TRADE NAME: | EagleVision Gellanserts | | |
| COMMON NAME: | Temporary Punctum Plugs
Temporary Inserts | | |
| CLASSIFICATION
NAME: | Plug, Punctal | | |
| DEVICE
CLASSIFICATION: | Class II per 21 CFR § 886 | | |
| PRODUCT CODE | 86 (LZU) | | |
| PREDICATE
DEVICES: | EagleVision Gellanserts are substantially equivalent to:
K850649 ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT K890919 TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT K895342 COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST K897190 LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT K946357 COLLAGEN INTRACANALICULAR PLUG K013613 SOFT PLUG ABSORBABLE PLUG-SA K020882 SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG K022043 SMARTPLUG MODEL 500 K030300 OPAQUE HERRICK LACRIMAL PLUG | | |
1
Description of the Device Subject to Premarket Notification:
EagleVision Gellanserts are intended to temporarily block tear drainage by occlusion of the canaliculus. EagleVision Gellanserts are made of a hydrophilic, resorbable material, and are designed to expand only laterally after insertion into the canaliculus, so that only one size is needed to occlude most patients' lacrimal systems. The EagleVision Gellanserts are designed to expand and fit virtually all patient anatomies from 0.3mm up to 1.1 mm, so multiple inserts in one canaliculus are generally not necessary. There are five inserts per sterile pouch, so that one EagleVision Gellansert can be placed in each punctum with one additional EagleVision Gellansert in case one is dropped or mishandled.
INDICATION FOR USE:
The EagleVision Gellansert® has the same primary intended use as the predicated devices. The EagleVision Gellansert is intended to temporarily block tear drainage by the occlusion of the canaliculus in order to:
- Determine the potential effectiveness of permanent occlusion, .
- Temporarily treat dry eye syndrome, and the dry eye components of various . ocular surface diseases,
- Increase retention of ocular medications .
- Temporarily treat contact lens intolerance secondary to dry eye, and .
- Treat dry eye after surgery. .
Contraindications:
EagleVision Gellanserts have the same primary contraindications as the predicate devices. EagleVision Gellanserts are contraindicated for use in patients with known gellan sensitivity, infectious conjunctivitis, dacrocycstitis, inflammation of the eyelid, infected eves, or epiphora.
MATERIALS:
Gellan is an anionic polysaccharide that gels in the presence of cations such as Sodium (Na ) and Calcium (Ca *). It is soluble in water, and hydrates rapidly in solution. As the gel hydrates, it also expands (up to 500% or more depending on the concentration of gellan and the strength of the ionic bonds). After hydration, the gellan becomes pliable and malleable to conform to the inside of the volume that constrains it (assuming the volume is less than or equal to the physical size of the gel in its hydrated state). 21 CFR 172.665 states that gellan gum may be safely used in food, in accordance with the following conditions:
-
- The additive is of a high molecular weight, produced from Pseudomonas elodea (P. elodea) by a pure culture fermentation process, and purified by recovery with isopropyl alcohol (IPA).
-
- The strain of P. elodea is non-pathogenic and nontoxic in man and animals
2
-
- The additive is produced by a process that renders it free of viable cells of P. elodea
-
- The additive meets the following specifications:
- a. A tough worm-like gel forms when a 1% solution is extruded through a wide bore pipet into a 10% Calcium Chloride bath
- b. A firm gel forms when 0.50 grams of Sodium Chloride is added (under 80 °C heat for 1 minute) to the 1% solution above.
- Residual IPA does not exceed 0.075% ﻦ
-
- The additive is intended for use in accordance with good manufacturing practices
Gellan is also listed in:
- . USP-National Formulary (NF 22) 71010-52-1
- The Toxic Substances Control Act (TSCA) Chemical Substances Inventory 트
- I The Canadian Non-Domestic Substances List (NDSL)
- The European Inventory of existing Commercial Chemical Substances (EINECS) 트
In addition to the above, Toxicological Studies performed by the gellan manufacturer demonstrate the following Safety Data for gellan:
- Oral dosage - rat LD50: >5,000 mg/kg
- Inhalation -rat LC50 (4-hr): >6mg/L (nominal) .
- 트 Eye irritation - rabbit: nonirritating
- 트 Skin irritation - rabbit: nonirritating
- No SARA Hazard notifications are applicable for this material 이
DESIGN FEATURES:
The design features of the EagleVision Gellanserts raise no new issues of safety or effectiveness. EagleVision Gellanserts consist of a length of rigid, hydrophilic, resorbable material. Common forceps (jewelers, collagen or otherwise) are used in the insertion of EagleVision Gellanserts. The EagleVision Gellanserts are provided sterile. EagleVision Gellanserts expand to accommodate different patient physiologies and achieve occlusion of the punctum and/or canaliculus. This device is sub-punctal, to limit contact and possible irritation to the eye due to abrasion.
Comparison of the design features of the EagleVision Gellanserts to the predicate devices are given in the table below.
SIMILARITIES AND DIFFERENCES OF EAGLEVISION GELLANSERTS TO PREDICATE DEVICES
A comparison of the similarities and differences between EagleVision Gellanserts to the predicate devices is given in the following table.
3
Summary of Safety & Efficac
| Elements | EagleVision
Gellanserts | Absorbable
Intracanalic-
ular Collagen
Implant
(K850649) | Temporary
Intracanalic-
ular Collagen
Implant
(K890919) | Collagen
Implant for
the Lacrimal
Efficiency
Test
(K895342) | Look
Temporary
Intracanalic-
ular Collagen
Implant
(K897190) | Collagen
Intracanalic-
ular Plug
(K946357) | Soft Plug
Absorbable
Plug-SA
(K013613) | SharPoint
UltraPlug
Extended
Wear Plug
(K020882) | SmartPlug
Model 500
(K022043) | Dissolvable
Opaque
Herrick
Lacrimal
Plug
(K030300) | rrigation or
Dissolution,
acrima
saline
probe | Gamma (y)
Irradiation |
|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------|-------------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | Temporary punctal or canalicular occlusion may be used to temporarily block tear drainage by the occlusion of the canaliculus in order to:
Determine the potential effectiveness of permanent occlusion, Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases, Increase retention of ocular medications Temporarily treat contact lens intolerance secondary to dry eye, and Treat dry eye after surgery. | | | | | | | | | | rrigation or
_acrimal
Saline
orobe | --------------------------------------------------------------------------------
Gamma (y
Irradiation
Continued and concesso |
| Design Characteristics | | | | | | | | | | | Dissolution
rrigation o
Lacrimal
Saline
probe | Затта (ү)
| rradiation |
|---|
| Intracanalic- |
| ular Punctum |
| Plug |
| Dissolution |
| rrigation or |
| _acrima |
| Saline |
| orobe |
| Gamma (y) |
| Irradiation |
| Intended |
| Duration |
| months |
| Dissolution, |
| _acrima |
| Saline |
| orobe |
| marily(ANNo) (ANN) (ATTITUTE T |
| rradiation |
| DOCADORESCORDS |
| Material |
| dissolvable |
| polymer |
| Collagen |
| Collagen |
| Collagen |
| Collagen |
| Collagen |
| nate suture |
| Monofila- |
| ment |
| Synthetic |
| Absorbable |
| Suture |
| sitive |
| Hydrophobic |
| Acrylic |
| Polymer |
| or glycolic |
| acid & |
| trimethylene |
| carbonate |
| copolymer |
| Dissolution, |
| irrigation of |
| Lacrimal |
| Saline |
| probe |
| rradiation |
| Concession Concessional |
| Packaging |
| pouch |
| pouch |
| pouch |
| pouch |
| pouch |
| pouch |
| pouch |
| pouch |
| pouch |
| pouch |
issolution,
Lacrima
Saline
probe | Gamma (y)
rradiation
--------------------------------------------------------------------------------------------- |
| Elements | EagleVision
Gellanserts | Absorbable
Intracanalic-
ular Collagen
Implant
(K850649) | Temporary
Intracanalic-
ular Collagen
Implant
(K890919) | Collagen
Implant for
the Lacrimal
Efficiency
Test
(K895342) | Look
Temporary
Intracanalic-
ular Collagen
Implant
(K897190) | Collagen
Intracanalic-
ular Plug
(K946357) | Soft Plug
Absorbable
Plug-SA
(K013613) | SharPoint
UltraPlug
Extended
Wear Plug
(K020882) | SmartPlug
Model 500
(K022043) | Opaque
Herrick
Lacrimal
Plug
(K030300) | CART FOR CONSULTION CONCELLER THE CONTRACT
Dissolution,
rrigation or
_acrimal
Saline
orobe | Comments of Contractions And States Concession And
Gamma (y)
rradiation |
| Method of
Insertion | Forceps | Forceps | Forceps | Forceps | Forceps | Forceps | Forceps | Forceps | Forceps | Forceps | Jissolution
rigation or
_acrima
Saline
orobe | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Gamma (y
rradiation |
| Dissolution, Dissolution,
followed by
rrigation, or
rrigation.
acrima
Saline
orobe
saline | Address State of Activities of Active School State
Sterilization
EO
EtC | | | | | | | | | | | |
| would and submit and and the contribution of the country of the course of the course of
Method of
Removal | Method of
Sterilizatio
AND STATE CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION | | | | | | | | | | | |
510(k) Premarket Notification
EagleVision Gellanserts
ব
4
Kos3333
Summary of Safety & Efficac
CONCLUSION:
Based on the above, the EagleVision Gellanserts are substantially equivalent to the predicate device
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2006
Eagle Vision, Inc. c/o Mr. Jeff Cobb 8500 World Lake Drive, Suite 110 Memphis, Tennessee 38133
Re: K053333
Trade/Device Name: EagleVision Gellanserts Regulation Number: Unclassified Regulation Name: Plug, Punctal Regulatory Class: Class II Product Code: LZU Dated: April 18, 2006 Received: April 19, 2006
Dear Mr. Cobb:
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.
6
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) 827-8910. 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/industry/support/index.html.
Sincerely yours,
M.B. Egelston - M.D.
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
7
Page _1_of 1
510(k) Number (if known): KO533333
Device Name: EagleVision Gellanserts
Indications for Use:
.
The EagleVision Gellansert™ is intended to temporarily block tear drainage by the occlusion of the canaliculus in order to:
- . Determine the potential effectiveness of permanent occlusion,
- . Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases,
- . Increase retention of ocular medications
- Temporarily treat contact lens intolerance secondary to dry eye, and ●
- . Treat dry eye after surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRHI, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devices
| 510(k) Number | K053333 |
|---|---|
| --------------- | --------- |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
CONFIDENTIAL Eagle Vision, Inc. November 29, 2005
510(k) Premarket Notification EagleVision Gellanserts