(148 days)
No
The device description and performance studies focus on the material properties and physical function of a punctum plug, with no mention of AI or ML capabilities.
Yes
The device is intended to temporarily enhance the efficacy of topical medications or ocular lubricants, and prevent complications due to dry eyes, which are therapeutic interventions.
Yes.
The device's intended use explicitly states it "may be used as a diagnostic aid to determine the potential effectiveness of long-term occlusion".
No
The device description clearly states it is a physical ophthalmic device (punctum plug) made of a synthetic polymer, designed to be placed into the horizontal canaliculus. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The VisiPlugST is a physical device inserted into the tear drainage system (horizontal canaliculus). Its function is to temporarily block tear drainage, not to analyze a biological sample for diagnostic purposes.
- Intended Use: The intended uses described are related to managing dry eye symptoms and evaluating the potential effectiveness of long-term occlusion, which are clinical interventions and assessments, not in vitro diagnostic tests.
- Device Description: The description focuses on the physical characteristics, material, and placement of the plug, not on any analytical or testing components.
- Performance Studies: The performance studies described relate to the material properties and biocompatibility of the plug, not to the accuracy or performance of a diagnostic test.
The VisiPlugST is a medical device used for a therapeutic and diagnostic aid purpose (evaluating the potential effectiveness of long-term occlusion), but it does not perform an in vitro diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
VisiPlugST provide temporary occlusion of the tear drainage system. VisiPlugST may be used as a diagnostic aid to determine the potential effectiveness of long-term occlusion, to temporarily enhance the efficacy of topical medication or ocular lubricants, after surgery to prevent complications due to dry eyes, to evaluate treatment of ocular dryness secondary to contact lens use, and to evaluate the dry eye component of ocular surface diseases (OSD).
Product codes
LZU
Device Description
The proposed device is an ophthalmic device commonly referred to as a punctum plug. It is designed to be placed by a practitioner into the horizontal canaliculus to restrict the natural lubricating tears from being pumped off the eye.
VisiPlugST provides temporary occlusion of the tear drainage system. The device may be used as a diagnostic aid to determine the potential effectiveness of long-term occlusion, to temporarily enhance the efficacy of topical medications or ocular lubricants, after surgery to prevent complications due to dry eyes, to evaluate treatment of ocular dryness secondary to contact lens use, and to evaluate the dry eye component of ocular surface diseases (OSD).
VisiPlugST plugs are cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. Each plug is cut from a monofilament strand of Glycoprene® MG23, a synthetic surgical grade polymer composed of poly(glycolide-co-trimethylene carbonate-co-caprolactone). The monofilament is dyed with an approved color additive, Green D & C 6 (CAS# 128-80-3; 0.1% by weight). Titanium dioxide is added to the polymer to make the plugs opaque, providing a satisfactory means with which to determine the plug's presence or absence following insertion by a practitioner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
horizontal 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)
Performance Data testing was conducted to compare the strength and mass loss degradation rates of Glycoprene® MG23 to that of gut suture (material used for the Primary Predicate Device). The material used for the proposed device, Glycoprene® MG23, has a similar strength retention and mass loss profile as that of the Primary Predicate Device. Glycoprene® MG23 has a 40% strength retention rate at 4-5 days compared to 40% strength retention at 3 days for gut suture. Mass loss profiles at 30 days are 46% and 45% respectively. Results of biocompatibility studies for VisiPlug®ST for the Lacrimal Efficiency Test indicate the proposed device is safe.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Section 5
JUN 0 3 2014 K140026
510(k) Summary - VisiPlug - for the Lacrimal Efficiency Test
| Submitted by:
Telephone:
Fax: | Lacrimedics, Inc.
PO Box 1209
434 Prune Alley
Eastsound, WA 98245-1209
360-376-7095
360-376-7085 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Rebecca Cyd Dutton
360-376-7095, ext. 201
rdutton@lacrimedics.com |
| Date Summary Prepared: | June 2, 2014 |
| Device Trade Name: | VisiPlugST for the Lacrimal Efficiency Test™ |
| Device Common Name: | Punctum plug |
| Classification Name: | Punctum Plug |
| Product Code: | LZU |
| Primary Predicate Devices: | Collagen Plugs for the Lacrimal Efficiency Test
510(k): K895342 |
| Device Description: | The proposed device is an ophthalmic device
commonly referred to as a punctum plug. It is
designed to be placed by a practitioner into the
horizontal canaliculus to restrict the natural
lubricating tears from being pumped off the eye.
VisiPlugST provides temporary occlusion of the
tear drainage system. The device may be used as
a diagnostic aid to determine the potential
effectiveness of long-term occlusion, to
temporarily enhance the efficacy of topical
medications or ocular lubricants, after surgery to
prevent complications due to dry eyes, to evaluate
treatment of ocular dryness secondary to contact
lens use, and to evaluate the dry eye component
of ocular surface diseases (OSD).
VisiPlugST plugs are cylindrical in shape,
approximately 1.75-2.00mm in length, and
available in three sizes: 0.3mm, 0.4mm and
0.5mm. Each plug is cut from a monofilament
strand of Glycoprene® MG23, a synthetic surgical
grade polymer composed of poly(glycolide-co-
trimethylene carbonate-co-caprolactone). |
| 510(k) Summary - | VisiPlugST for the Lacrimal Efficiency Test |
| | The monofilament is dyed with an approved color
additive, Green D & C 6 (CAS# 128-80-3; 0.1%
by weight). Titanium dioxide is added to the
polymer to make the plugs opaque, providing a
satisfactory means with which to determine the
plug's presence or absence following insertion by a
practitioner. |
| Indications for Use: | VisiPlugST provide temporary occlusion of the
tear drainage system. VisiPlugST may be used as
a diagnostic aid to determine the potential
effectiveness of long-term occlusion, to
temporarily enhance the efficacy of topical
medication or ocular lubricants, after surgery to
prevent complications due to dry eyes, to evaluate
treatment of ocular dryness secondary to contact
lens use, and to evaluate the dry eye component
of ocular surface diseases (OSD). |
| Differences: | The VisiPlugST Indications for Use do not name
the specific ocular surface diseases; the listed
conditions in the Predicate Device Indications for
Use are representative only, not all inclusive.
VisiPlugST plugs are for short-term (temporary)
occlusion. |
| Technological Characteristics: | The proposed device has the same design as the
Primary Predicate Device. |
| | Reference Devices:
Maxon, Sterile Synthetic Absorbable Sutures
510(k): K990951 |
| | CaproSyn Suture
510(k): K032586 |
| Differences: | The Primary Predicate Device is comprised of
animal tissue. The proposed device is comprised of
a copolymer similar to the Referenced Predicate
Devices which have been approved for soft tissue
approximation and ophthalmic surgeries. |
| Nonclinical Tests: | Performance Data testing was conducted to
compare the strength and mass loss degradation
rates of Glycoprene® MG23 to that of gut suture
(material used for the Primary Predicate Device). |
| | The material used for the proposed device,
Glycoprene® MG23, has a similar strength
retention and mass loss profile as that of the
Primary Predicate Device. Glycoprene® MG23 has
a 40% strength retention rate at 4-5 days |
| 510(k) Summary - | VisiPlug®ST for the Lacrimal Efficiency Test |
| Nonclinical Tests:
(continued) | compared to 40% strength retention at 3 days for
gut suture. Mass loss profiles at 30 days are 46%
and 45% respectively. |
| | Results of biocompatibility studies for VisiPlug®ST
for the Lacrimal Efficiency Test indicate the
proposed device is safe. |
| Conclusions: | The proposed device has the same design,
performance and safety profile as that of the
Primary Predicate Device and is therefore
substantially equivalent. |
1
2
Section 5 (continued)
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. .
.
.
and the control control control of the control of the controlled
.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002
June 3, 2014
Lacrimedies, Inc. Ms. Rebecca Dutton Director of Operations 434 Prune Allev Eastsound. WA 98245
Re: K140026
Trade/Device Name: VisiPlug" gr for the Lacrimal Efficiency Test (Models 1813, 1814, and 1815) Regulation Number: Preamendment
Regulation Name: Preamendment Regulatory Class: Unclassified Product Code: LZU Dated: April 21, 2014 · Received: April 24, 2014
Dear Ms. Dutton:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither 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.
4
Page 2 - Ms. Rebecca Dutton
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Deborah L. Falls -S
for 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
5
Indications for Use
510(k) Number (if known): K140026
Device Name: VisiPlugg
Indications for Use:
VisiPlugg, provide temporary occlusion of the tear drainage
system. VisiPlugs, may be used as:
- . a diagnostic aid to determine the potential effectiveness of long-term occlusion,
- to temporarily enhance the efficacy of topical medications or ● ocular lubricants,
- after surgery to prevent complications due to dry eyes, .
- to evaluate treatment of ocular dryness secondary to contact . lens use,
- and to evaluate the dry eye component of ocular surface ● diseases (OSD).
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Page 10
Claudine H. Krawczyk -S 2014.06.03 16:29:45 -04'00'