(91 days)
Not Found
No
The device description and intended use focus on a physical, absorbable punctum plug made of suture material. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to temporarily treat dry eye syndrome and enhance the efficacy of topical medications or ocular lubricants, which are therapeutic uses.
Yes
The intended use explicitly states, "Determine the potential effectiveness of permanent occlusion," which is a diagnostic purpose to evaluate if a more permanent solution would be beneficial.
No
The device description clearly states it is a physical plug made of absorbable suture material intended to be inserted into the canaliculus. It is a hardware device, not software.
Based on the provided information, 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 information is used for diagnosis, monitoring, or screening.
- Device Function: The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are physical devices inserted into the canaliculus to block tear drainage. They are used to treat symptoms and enhance the effectiveness of other treatments, not to analyze a biological sample for diagnostic purposes.
- Intended Use: The intended uses listed are all related to physically blocking tear drainage for therapeutic or temporary assessment purposes. None involve analyzing a sample from the body.
- Device Description: The description details the physical composition and design of the plug, not a system for analyzing biological samples.
Therefore, the Comfortear® Lacrisolve™ Absorbable Punctum Plugs fall under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are 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,
- . Temporarily enhance the efficacy of topical medications or ocular lubricants.
- . Temporarily treat contact lens intolerance secondary to dry eye, and
- Temporarily treat dry eye after ocular surgery.
Product codes
LZU
Device Description
Comfortear® Lacrisolve™ Absorbable Punctum Plugs are intended to temporarily block tear drainage by occlusion of the canaliculus. The plug is supplied in various sizes ranging from 0.2mm to 0.5mm in diameter and has a length of approximately 1.75mm, see table below. The plug is dyed (D&C Violet No. 2). Comfortear® Lacrisolve™ Absorbable Punctum Plugs are composed of the following absorbable suture materials: polydioxanone (PDO).
Comfortear® Lacrisolve™ Absorbable Punctum Plugs are provided sterile. The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are available in various sizes to accommodate different patient physiologies and achieve occlusion of the canaliculus (or punctum). Two plugs are included in each package and there is one package in each box. This device is sub-punctal, to limit contact and possible irritation to the eye.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
canaliculus (or 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
Comfortear® Lacrisolve™ Absorbable Punctum Plugs will be sterilized by ethylene oxide sterilization. The program used to validate the sterilization process complies with the EN ISO 11135-1:2007 Medical Devices - Validation and routine control of ethylene oxide sterilization. A half cycle was utilized to validate the ethylene oxide sterilization process.
This process is validated to ensure that a sterility assurance level of 10 o or better is achieved. Each sterilization run is monitored by an independent accredited laboratory.
The levels of ethylene oxide sterilization residuals that remain on Comfortear® Lacrisolve™ Absorbable Punctum Plugs will comply with the requirements of ANSI/AAMI/ISO 10993-7:2008(R)2012 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals.
During testing for EO and ECH residuals, the results fell far below the standard stated above.
In order to ensure consistency of product, an upper control limit was set that is more indicative of routine testing. The calculation of +3 standard deviations from the data could not be calculated based on the results being the same number for all lots tested; therefore a value of three (3) times the measured value is the upper limit. This number remains well below the ISO standards acceptable for the device. The lower limit is zero (0) for all values. All routine testing shall be trended as well to ensure consistency of sterilization.
Limulus Amebocyte Lysate (LAL) testing was performed to assess the level of endotoxins on the product. (The Bacterial Endotoxins Test, or Limulus Amebocyte Lysate (LAL) test, is an in vitro assay to detect and quantify bacterial endotoxin, a component of the cell wall of Gram negative bacteria. Standard controls and a positive product control (PPC) demonstrate a compliant assay. A PPC recovery within the 50%-200% range indicates that the test solution is free of interfering factors given the specific conditions of the test. If applicable, dilutions are calculated into the reported endotoxin level.) The testing was conducted in accordance with the following regulatory documents: ANSI/AAMI ST72:2011, USP , USP , EP 2.6.14, and JP 4.01. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.
Preparation: The extraction was performed by immersing the test article in endotoxin free water and placing it on an orbital shaker in an incubator for 40-60 minutes at 37-40°C.
Test Procedure: The assay was performed at a sensitivity of 0.005EU/mL using Charles River reagents. For valid results, the combination of lysate and test solution was verified to be within 6-8 pH units.
Based on the testing above, the device has passed all LAL testing.
Key Metrics
Total Extractable Residual Upper Limits:
Extraction (hrs): Prolonged or Lifetime
EO: 0.003 Total mg/device
ECH: 0.021 Total mg/device
LAL Testing:
| Test Article | Quantity | Extraction Volume | Detected Endotoxin | PPC Recovery |
|---|---|---|---|---|
| 1 | 2 (pooled) | 7.5 mL/device |
N/A
0
Image /page/0/Picture/0 description: The image shows the logo for Paragon BioTeck, Inc. The logo features a stylized abstract figure on the left, followed by the word "Paragon" in a larger font. Below "Paragon" is the text "BioTeck, Inc." in a smaller font. The logo appears to be in black and white.
Page 1 of 7 K140711 JUN 2 0 2014
510(k) Summary or 510(k) Statement
Contact Details
Applicant Name: Paragon BioTeck, Inc.
4640 SW Macadam Avenue, Suite 80
Portland, OR 97239
1-888-424-1192
Lauren M-C Bluett
Date Prepared: 13JUN2014
Device Name
Trade Name: (1) Comfortear® Lacrisolve™ Absorbable Punctum Plug
(2) Lacrisolve™ Absorbable Punctum Plug
(3) Comfortear® Lacrisolve™ Punctum Plug
(4) Lacrisolve™ Punctum Plug
Common Name: Intracanalicular Plug/Punctum Plug
Classification Name: Plug, Punctal
1
Image /page/1/Picture/1 description: The image shows the logo for Paragon BioTeck, Inc. The logo features a stylized human figure on the left, with the company name to the right. The words "BioTeck, Inc." are written in a smaller font size below the word "Paragon."
Legally Marketed Predicate Device(s)
The Comfortear® Lacrisolve™ Absorbable Punctum Plugs have similar technological characteristics as the predicate devices. Like the currently marketed Opaque Herrick Lacrimal Plug (K030300), and the Temporary Intracanalicular Collagen Implant (K890919) the modified device is a sterile, monofilament synthetic absorbable suture material at the same or similar diameters and at the same or similar lengths.
| 510(k) Number | Product Code | Trade Name | Applicant |
|---|---|---|---|
| K030300 | LZU | DISSOLVABLE OPAQUE | |
| HERRICK LACRIMAL | |||
| PLUG | LACRIMEDICS, INC. | ||
| K890919 | LZU | TEMPORARY | |
| INTRACANALICULAR | |||
| COLLAGEN IMPLANT | EAGLE VISION, INC. |
Device Description
Comfortear® Lacrisolve™ Absorbable Punctum Plugs are intended to temporarily block tear drainage by occlusion of the canaliculus. The plug is supplied in various sizes ranging from 0.2mm to 0.5mm in diameter and has a length of approximately 1.75mm, see table below. The plug is dyed (D&C Violet No. 2). Comfortear® Lacrisolve™ Absorbable Punctum Plugs are composed of the following absorbable suture materials: polydioxanone (PDO).
| Size (mm) | 0.2 | 0.3 | 0.4 | 0.5 |
|---|---|---|---|---|
| Length (mm) | 1.75 | 1.75 | 1.75 | 1.75 |
The design features of the Comfortear@ Lacrisolve™ Absorbable Punctum Plugs raise no new issues of safety or effectiveness. Comfortear® Lacrisolve™ Absorbable Punctum Plugs consist of a length of monofilament synthetic absorbable suture material. The
2
Image /page/2/Picture/1 description: The image shows the logo for Paragon BioTeck, Inc. The logo features a stylized human figure on the left, followed by the word "Paragon" in a bold, outlined font. Below "Paragon" is the text "BioTeck, Inc." in a smaller font. The overall design is simple and professional.
Comfortear® Lacrisolve™ Absorbable Punctum Plugs are provided sterile. The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are available in various sizes to accommodate different patient physiologies and achieve occlusion of the canaliculus (or punctum). Two plugs are included in each package and there is one package in each box. This device is sub-punctal, to limit contact and possible irritation to the eye.
Comfortear® Lacrisolve™ Absorbable Punctum Plugs are contraindicated for use in patients with known sensitivity to any one of the materials that comprise the device, infectious conjunctivitis, dacrocycstitis, inflammation of the eyelid, infected eyes, or epiphora.
Intended Use/Indications for use
The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are 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,
- . Temporarily enhance the efficacy of topical medications or ocular lubricants.
- . Temporarily treat contact lens intolerance secondary to dry eye, and
- Temporarily treat dry eye after ocular surgery.
3
Image /page/3/Picture/0 description: The image shows the logo for Paragon BioTeck, Inc. The logo features a stylized abstract symbol on the left, followed by the word "Paragon" in a bold, outlined font. Below "Paragon" is the text "BioTeck, Inc." in a smaller font. The overall design is simple and professional.
Substantial Equivalence Comparison
1
| Elements | DISSOLVABLE OPAQUE
HERRICK LACRIMAL
PLUG (K030300) | Comfortear® Lacrisolve™
Absorbable Punctum Plug | TEMPORARY
INTRACANALICULAR
COLLAGEN IMPLANT
(K890919) |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Indications | Dissolvable Opaque Herrick
Lacrimal Plug® may be
used:
• As a diagnostic aid to
determine the potential
effectiveness of Occlusion
Therapy with non-
dissolvable plugs.
• To temporarily enhance
the efficacy of topical
medications or ocular
lubricants.
• After ocular surgery to
prevent complications due
to dry eyes.
• To evaluate treatment of
ocular dryness secondary
to contact lens use.
• In the treatment of Dry
Eye Syndrome and the dry
eye components of
varying Ocular Surface
Diseases. | The Comfortear® Lacrisolve™
Absorbable Punctum Plugs are
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,
• Temporarily enhance the
efficacy of topical medications
or ocular lubricants,
• Temporarily treat contact lens
intolerance secondary to dry
eye, and
• Temporarily treat dry eye after
ocular surgery. | Ideal for:
• Treatment of post lasik
induced dry eye
• Treatment of seasonal
dry eye
• Retention of ocular
medication |
ﺩ
・
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Image /page/4/Picture/1 description: The image shows the logo for Paragon BioTeck, Inc. The logo consists of a stylized human figure on the left, followed by the word "Paragon" in a bold, sans-serif font. Below "Paragon" is the text "BioTeck, Inc." in a smaller font. The logo is simple and professional, and it is likely used to represent the company's brand.
| Design Elements | |||
|---|---|---|---|
| Intracanalicular | |||
| Punctum Plug | Yes | Yes | Yes |
| Intended | |||
| Duration | Approximately 180 days | Approximately 180 days | 60-180 days |
| Material | A copolymer of L-lactide | ||
| and ε-caprolactone (PCL) or | |||
| Polydioxanone (PDO) or | |||
| glycolic acid & | |||
| trimethylene carbonate | |||
| copolymer | Polydioxanone (PDO) | Polycaprolactone (PCL) | |
| Color Additive | D&C Violet No. 2 | D&C Violet No. 2 | N/A |
| Packaging | Tyvek/Poly pouch | Tyvek/Poly pouch | Tyvek/Poly pouch |
| Method of | |||
| Insertion | Forceps | Forceps | Forceps |
| Method of | |||
| Removal | Dissolution, Saline | ||
| irrigation, or Lacrimal | |||
| probe | Dissolution, Saline irrigation, or | ||
| Lacrimal probe | Dissolution, Saline | ||
| irrigation, or Lacrimal | |||
| probe | |||
| Method of | |||
| Sterilization | EtO Sterilization (EO) | EtO Sterilization (EO) | Gamma Irradiation |
| Available Sizes | 0.4mm, 0.5mm | 0.2mm, 0.3mm, 0.4mm, 0.5mm | 0.2mm, 0.3mm, 0.4mm |
Similarities: The indications for use of the Comfortear® Lacrisolve™ Absorbable Punctum Plug and the predicate devices are very similar. The wording is different, but all the same situations are covered by the indications for use. In addition, most of the design elements are identical: type of plug, intended duration, suture material, color additive, packaging, method of insertion, method of removal, method of sterilization, and available sizes.
Differences: The only differences are that one (K030300) predicate submission covers punctum plugs made of three different suture materials and the current submission covers only one of those suture materials.
Based on the comparison tables above, the Comfortear® Lacrisolve™ Absorbable Punctum Plug is substantially equivalent to the predicate products.
Testing
Comfortear® Lacrisolve™ Absorbable Punctum Plugs will be sterilized by ethylene oxide sterilization. The program used to validate the sterilization process complies with the EN ISO 11135-1:2007 Medical Devices - Validation and routine control of ethylene oxide sterilization. A . half cycle was utilized to validate the ethylene oxide sterilization process.
5
Image /page/5/Picture/1 description: The image shows the logo for Paragon BioTeck, Inc. The logo consists of a stylized human figure on the left, followed by the word "Paragon" in a bold, outlined font. Below "Paragon" is the text "BioTeck, Inc." in a smaller font. The overall design is simple and professional.
This process is validated to ensure that a sterility assurance level of 10 o or better is achieved. Each sterilization run is monitored by an independent accredited laboratory.
The levels of ethylene oxide sterilization residuals that remain on Comfortear® Lacrisolve™ Absorbable Punctum Plugs will comply with the requirements of ANSI/AAMI/ISO 10993-7:2008(R)2012 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals.
During testing for EO and ECH residuals, the results fell far below the standard stated above.
In order to ensure consistency of product, an upper control limit was set that is more indicative of routine testing. The calculation of +3 standard deviations from the data could not be calculated based on the results being the same number for all lots tested; therefore a value of three (3) times the measured value is the upper limit. This number remains well below the ISO standards acceptable for the device. The lower limit is zero (0) for all values. All routine testing shall be trended as well to ensure consistency of sterilization.
Total Extractable Residual Upper Limits
| Extraction (hrs) | EO | ECH |
|---|---|---|
| Total mg/device | Total mg/device | |
| Prolonged or | ||
| Lifetime | 0.003 | 0.021 |
Limulus Amebocyte Lysate (LAL) testing was performed to assess the level of endotoxins on the product. (The Bacterial Endotoxins Test, or Limulus Amebocyte Lysate (LAL) test, is an in vitro assay to detect and quantify bacterial endotoxin, a component of the cell wall of Gram negative bacteria. Standard controls and a positive product control (PPC) demonstrate a compliant assay. A PPC recovery within the 50%-200% range indicates that the test solution is free of interfering factors given the specific conditions of the test. If applicable, dilutions are calculated into the reported endotoxin level.) The testing was conducted in accordance with the following regulatory documents: ANSI/AAMI ST72:2011, USP , USP , EP 2.6.14, and JP 4.01. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.
6
Image /page/6/Picture/0 description: The image shows the logo for Paragon BioTeck, Inc. The logo features a stylized human figure on the left, with the company name "Paragon" in a bold, outlined font to the right. Below "Paragon" is the text "BioTeck, Inc." in a smaller font. The overall design is simple and professional.
| Test
Article | Quantity | Extraction
Volume | Detected Endotoxin | PPC Recovery |
|-----------------|---------------|----------------------|----------------------------------------|--------------|
| 1 | 2
(pooled) | 7.5 mL/device | Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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