(155 days)
Not Found
No
The device description and performance studies focus on the physical properties, materials, and mechanical function of a punctum plug, with no mention of AI or ML.
Yes
The device is intended to treat Dry Eye Syndrome and other related conditions, which falls under the definition of a therapeutic device designed to alleviate or cure a medical condition.
No
The device is a punctum plug designed to treat dry eye conditions by restricting tear drainage, not to diagnose a condition.
No
The device description clearly describes a physical punctum plug made of silicone liquid rubber, which is a hardware component. There is no mention of any software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The LacriPro plug is a physical device inserted into the punctal opening of the eye. Its function is to physically block the drainage of tears, thereby treating dry eye conditions. It does not analyze any biological specimens.
- Intended Use: The intended uses listed are all related to treating conditions of the eye by physically altering tear drainage, not by analyzing biological samples.
The description clearly indicates a physical medical device used for treatment, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
LacriPro plugs may be used to:
- Treat Dry Eye Syndrome
- Treat ocular dryness secondary to contact lens use
- Enhance the efficacy of topical ocular medications
- Prevent complications due to dry eyes after surgery
- Treat the Dry Eye component of ocular surface diseases
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 punctal opening (upper/lower) to restrict the natural lubricating tears from being pumped off the surface of the eye.
This treatment is prescribed for long-term treatment of certain eye conditions collectively referred to as Dry Eye Disease, as well as the dry eye component of ocular surface diseases and other conditions of tear insufficiency.
LacriPro Punctum Plugs have a distal tip, a proximal cap and a body (tubular shaft) connecting the tip to the cap. The cap is designed to rest on the opening of the puncta after the tip and body are inserted into the canalicular canal. The cap has one or more recesses (depending on diameter) for retaining tear fluid.
The plug has a passage extending in the distal direction from an opening in the proximal cap to facilitate mounting on an insertion tool.
The LacriPro Punctum Plugs are available in the following models, diameters and lengths:
| Model # 1833 | 0.6mm (1.42mm length) x-small |
|---|---|
| Model # 1835 | 0.7mm (1.52mm length) Small |
| Model # 1837 | 0.8mm (1.60mm length) Medium |
| Model # 1839 | 0.9mm (1.78mm length) Large |
The device is made from silicone liquid rubber MED 4870 by Nusil, Inc. The plugs are clear, or translucent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
punctum plug; punctal opening (upper/lower); canalicular canal; eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use only.
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)
Non-clinical performance data includes sterilization, package integrity testing, and biocompatibility studies.
Sterilization: AquaFlo and LacriPro use the same sterilization method: VDmax25 Gamma Sterilization.
Packaging: Molded plugs are mounted onto an insertion tool and sealed in a tray with a Tyvek® lid barrier prior to sterilization. A Package Integrity Study was performed using a five-year accelerated aging study and a five-year real time aging study. The tray seals were challenged using the Burst Test method and a sterility test was performed on both the accelerated and real time aging samples. A Shipping and Handling Study was performed to support the seal of the pouch up to five years under normal shipping and handling conditions.
Biocompatibility Testing: Results of Biocompatibility Studies indicate LacriPro Punctum Plug is a safe device.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. The profiles are stylized and appear to be formed by a continuous line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2016
Lacrimedics, Inc. Ms. Rebecca Cyd Dutton Regulatory and Compliance Officer 2620 Williamson Place NW. Suite 113 DuPont, WA 98327
Re: K161673
Trade/Device Name: LacriPro Punctum Plug Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LZU Dated: September 28, 2016 Received: October 11, 2016
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 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.
1
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 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" (21 CFR 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.
Kesia Alexander
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
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Indications for Use
510(k) Number (if known) K161673
Device Name
LacriPro Punctum Plug
Indications for Use (Describe)
LacriPro plugs may be used to:
- Treat Dry Eye Syndrome
- Treat ocular dryness secondary to contact lens use
- Enhance the efficacy of topical ocular medications
- Prevent complications due to dry eyes after surgery
- Treat the Dry Eye component of ocular surface diseases
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| Submitter's Name: | Lacrimedics, Inc. |
|---|---|
| Submitter's Address: | 2620 Williamson Place NW |
| Suite 113 | |
| DuPont, WA 98327 | |
| Submitter's Telephone/Fax: | 253-964-0360 / 253-964-2699 |
| Submitter's Contact: | Rebecca Cyd Dutton |
| 360-376-7900 | |
| rdutton@lacrimedics.com | |
| Date 510 (k) Summary Prepared: | January 13, 2016 |
| Device Trade Name: | LacriPro® Punctum Plugs |
| Device Common Name: | Punctum Plug |
| Classification Name: | Punctum Plug |
| Product Code: | LZU |
| Predicate Device: | AquaFlo Punctum Plugs |
| Predicate Device 510(k) No.: | K021936 |
Description of Device
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 punctal opening (upper/lower) to restrict the natural lubricating tears from being pumped off the surface of the eye.
This treatment is prescribed for long-term treatment of certain eye conditions collectively referred to as Dry Eye Disease, as well as the dry eye component of ocular surface diseases and other conditions of tear insufficiency.
LacriPro Punctum Plugs have a distal tip, a proximal cap and a body (tubular shaft) connecting the tip to the cap. The cap is designed to rest on the opening of the puncta after the tip and body are inserted into the canalicular canal. The cap has one or more recesses (depending on diameter) for retaining tear fluid.
The plug has a passage extending in the distal direction from an opening in the proximal cap to facilitate mounting on an insertion tool.
Image /page/3/Picture/7 description: The image shows a white, plastic-looking object that appears to be a type of fastener or connector. It has a cylindrical shape with a wider, circular flange at both ends. The object is oriented diagonally in the frame, and the background is plain white, which helps to isolate and highlight the object's form and features.
4
Device Description (continued)
The LacriPro Punctum Plugs are available in the following models, diameters and lengths:
| Model # 1833 | 0.6mm (1.42mm length) x-small |
|---|---|
| Model # 1835 | 0.7mm (1.52mm length) Small |
| Model # 1837 | 0.8mm (1.60mm length) Medium |
| Model # 1839 | 0.9mm (1.78mm length) Large |
The device is made from silicone liquid rubber MED 4870 by Nusil, Inc. The plugs are clear, or translucent.
Indications for Use
LacriPro plugs may be used to:
- . Treat Dry Eye Syndrome
- Treat ocular dryness secondary to contact lens use
- . Enhance the efficacy of topical ocular medications
- Prevent complications due to dry eyes after surgery .
- Treat the Dry Eye component of ocular surface diseases ●
The Indications for Use for the LacriPro Punctum Pluq are similar to the Indications for Use for the Predicate Device. Enhancing efficacy of topical ocular medications and prevention of complications due to dry eyes after surqery have been included in the indications for LacriPro, but are not included in the predicate device indications. There is sufficient clinical evidence to support the use of punctum plugs after surgery, as well as enhancing the efficacy of topical ocular medications. The predicate device includes treating allergies as an indication; this treatment was not included in the indications for use for the LacriPro due to a lack of sufficient clinical evidence.
Technological Characteristics
The proposed device has the same design as the Predicate Device. Both devices are made with medical grade silicone, Nusil, Inc. MED 4870.
Neither the Predicate device or the proposed device use software or an energy source, contain biologics or drugs, and do not use coatings or additives.
Both devices are molded using injection molding.
Differences: There are no technological differences.
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Performance Data
Non-clinical performance data includes sterilization, package integrity testing, and biocompatibility studies.
Sterilization: AquaFlo and LacriPro use the same sterilization method: VDmax25 Gamma Sterilization.
Environment of Use: LacriPro Punctum Plugs and the predicate device are for professional use only.
Performance Data (continued)
Packaging: Molded plugs are mounted onto an insertion tool and sealed in a tray with a Tyvek® lid barrier prior to sterilization. A Package Integrity Study was performed using a five-year accelerated aging study and a five-year real time aging study. The tray seals were challenged using the Burst Test method and a sterility test was performed on both the accelerated and real time aging samples. A Shipping and Handling Study was performed to support the seal of the pouch up to five years under normal shipping and handling conditions.
Biocompatibility Testing: Results of Biocompatibility Studies indicate LacriPro Punctum Plug is a safe device.
Conclusions
The proposed device has the same design, performance and safety profile as that of the Predicate Device and is therefore substantially equivalent.