(262 days)
Not Found
No
The device description and performance studies focus on the physical properties, biocompatibility, sterilization, and packaging of a dissolvable punctum plug. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is used to enhance the efficacy of topical medications or ocular lubricants, prevent complications after ocular surgery, and evaluate treatment of ocular dryness, indicating its role in treating and managing medical conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that Punctum Plugs are indicated "As a diagnostic aid to determine the potential effectiveness of long term occlusion."
No
The device is a physical punctum plug made of polydioxanone (PDO) and an insertion tool. The description details the material, shape, size, packaging, and sterilization of a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide temporary occlusion of the tear drainage system for therapeutic and diagnostic purposes related to dry eye conditions. It is a physical device inserted into the body.
- Device Description: The description details a physical plug made of polydioxanone, designed for insertion into the canaliculus.
- Lack of In Vitro Testing: The performance studies focus on biocompatibility, sterilization, insertion tool performance, and packaging. There are no mentions of testing biological samples (like tears) in vitro to diagnose a condition.
- Anatomical Site: The device is applied directly to the tear drainage system and eye, which is an in vivo application, not an in vitro test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Tear Pool Dissolvable Punctum Plugs are designed to provide for temporary occlusion of the tear drainage system.
Punctum Plugs are indicated for:
- 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 ocular surgery to prevent complications due to dry eyes
- To evaluate treatment of ocular dryness
- To evaluate the dry eye component of ocular surface diseases
Product codes (comma separated list FDA assigned to the subject device)
LZU
Device Description
The Tear Pool Dissolvable Punctum Plug is an ophthalmic device commonly referred to as a punctum plug. It is designed to be inserted by a practitioner into the canaliculus to temporarily restrict the natural lubricating tears from draining off the surface of the eye.
This treatment is prescribed for temporary occlusion in the 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.
Tear Pool Dissolvable Punctum Plugs are cylindrical in shape. Approximately 2.0mm in length and are available in two sizes: 0.4mm and 0.5mm. Each plug is composed of polydioxanone(PDO). The plug is dyed with an approved color additive, D & C Violet No. 2.
A Tear Pool Dissolvable Punctum Plug is mounted on a specially designed insertion tool and placed into a plastic tray then sealed with a Tyvek® cover. The primary package is sent to the sterilizer for Ethylene Oxide sterilization. Two sterile trays, one IFU, two chart labels and one silica gel packet are sealed in a pouch and placed in a shelf box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
canaliculus, 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 biocompatiblity testing, sterilization validation, insertion tool testing, package validation and environment of use.
Biocompatibility Testing:
- L929 Neutral Red Uptake Test per ISO 10993-5 Biological Evaluatio of Medical Devices -Part 5. The requirements of the standard were met.
- Kligman Maximization Test per ISO 10993-10, 2010 Biological Evaluation of Medical Devices -Part 10. The requirements of the standard were met.
- Intracutaneous Injection Test per ISO 10993-10, 2010 Biological Evaluation of Medical Devices -Part 10. The requirements of the standard were met.
- Physicochemical Test for Plastic Material of Construction - Polycarbonate per United States Pharmacopoeia 42, National Formulary 37, 2019, . The requirements of the standard were met.
Results of Biocompatibility Studies indicate that the Pre-Loaded Tear Pool Dissolvable Punctum Plug is a safe device.
Sterilization:
- Ethylene Oxide Sterilization Validation per ISO 11135: 2014. The requirements of the standard were met.
- EO Residual per ISO 10993-7: 2008. The requirements of the standard were met.
- Bacterial Endotoxin Test per USP 41, Chapter & ANSI/AAMI ST72:2011. The requirements of the standard were met.
Insertion Tool:
- The performance of the insertion tool was assessed using a Simulated Use Deployment Test in gel to verify that the plug is not damaged and that it is retained and delivered easily by the user. To test the reliability of the pre-loaded insertion tool, multiple deployments were performed.
The insertion tool performs as intended.
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.
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with a stylized image of a human figure, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font size than the rest of the text.
October 24, 2019
AlphaMed, Inc. Mr. James Gubachy VP - Ouality Assurance 3912 Mountain Ave El Paso, TX 79930
Re: K190210
Trade/Device Name: Tear Pool Dissolvable Punctum Plugs Regulatory Class: Unclassified Product Code: LZU Dated: September 25, 2019 Received: September 26, 2019
Dear Mr. Gubachy:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 (reporting of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidanceregulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-devices/medical-devicesafety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-andconsumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190210
Device Name Tear Pool Dissolvable Punctum Plugs
Indications for Use (Describe)
Tear Pool Dissolvable Punctum Plugs are designed to provide for temporary occlusion of the tear drainage system.
Punctum Plugs are indicated for:
-
- 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 ocular surgery to prevent complications due to dry eyes
-
- To evaluate treatment of ocular dryness
-
- To evaluate 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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3
| Submitter's Name: | AlphaMed Inc. |
|---|---|
| Submitter's Address: | 3912 Mountain Ave |
| El Paso, TX 79930 | |
| Submitter's Telephone: | 915-595-2020 |
| Submitter's Contact: | James Gubachy |
| 915-595-2020 | |
| jgubachy@alphamedco.com | |
| Date 510 (k) Summary Prepared: | October 24, 2019 |
| Device Trade Name: | Tear Pool Dissolvable Punctum Plugs |
| Device Common Name: | Punctum Plug |
| Classification Name: | Unclassified |
| Product Code: | LZU |
| Predicate Device: | Dissolvable Opaque Herrick Lacrimal Plug |
| Predicate Device 510(k) No .: | K030300 |
Description of Device
The Tear Pool Dissolvable Punctum Plug is an ophthalmic device commonly referred to as a punctum plug. It is designed to be inserted by a practitioner into the canaliculus to temporarily restrict the natural lubricating tears from draining off the surface of the eye.
This treatment is prescribed for temporary occlusion in the 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.
Tear Pool Dissolvable Punctum Plugs are cylindrical in shape. Approximately 2.0mm in length and are available in two sizes: 0.4mm and 0.5mm. Each plug is composed of polydioxanone(PDO). The plug is dyed with an approved color additive, D & C Violet No. 2.
A Tear Pool Dissolvable Punctum Plug is mounted on a specially designed insertion tool and placed into a plastic tray then sealed with a Tyvek® cover. The primary package is sent to the sterilizer for Ethylene Oxide sterilization. Two sterile trays, one IFU, two chart labels and one silica gel packet are sealed in a pouch and placed in a shelf box.
4
Device Description (continued)
The Pre-Loaded Tear Pool Dissolvable Punctum Plugs are available in the following models and diameters and are 2.0mm in length
| Model# 20-5304 | 0.4mm |
|---|---|
| Model# 20-5305 | 0.5mm |
The device is make from Polydioxanone(PDO). The plugs are violet in color.
Differences: The Tear Pool Dissolvable Punctum Plug and the Predicate Device are identical except the Tear Pool Dissolvable Punctum Plug uses an insertion tool. The results of performance testing on the insertion tool and biocompatibility studies with the addition of an insertion tool demonstrate that it does not impact the safety and effectiveness of the Device.
Indications for Use: Tear Pool Dissolvable Punctum Plugs are designed to provide for temporary occlusion of the tear drainage system.
Punctum Plugs are indicated for:
- 米 As a diagnostic aid to determine the potential effectiveness of long term occlusion
- 米 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
-
- To evaluate the dry eye component of ocular surface diseases
Differences: There is no content difference between the Indication for Use for the Predicated Device and the Tear Pool Dissolvable Punctum Plug.
Technological Characteristics
The Tear Pool Dissolvable Punctum Plug has the same design as the Predicate Device. Both devices are made with Polydioxanone(PDO).
Neither the Tear Pool Dissolvable Punctum Plug nor the Predicate Device us software or an energy source, contain biologics or drugs, and do not use coatings or additives.
Differences: There are no technological differences.
Performance Data
Non-clinical performance data includes biocompatiblity testing, sterilization validation, insertion tool testing, package validation and environment of use.
Biocompatibility Testing:
L929 Neutral Red Uptake Test per ISO 10993-5 Biological Evaluatio of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity.
The requirements of the standard were met.
5
Performance Data (continued)
Kligman Maximization Test per ISO 10993-10, 2010 Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization.
The requirements of the standard were met.
Intracutaneous Injection Test per ISO 10993-10, 2010 Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization.
The requirements of the standard were met.
Physicochemical Test for Plastic Material of Construction - Polycarbonate per United States Pharmacopoeia 42, National Formulary 37, 2019, Plastic Materials of Construction -Polycarbonate.
The requirements of the standard were met.
Results of Biocompatibility Studies indicate that the Pre-Loaded Tear Pool Dissolvable Punctum Plug is a safe device.
Sterilization:
Ethylene Oxide Sterilization Validation per ISO 11135: 2014 Sterilization of Health Care Products -Ethylene Oxide-Part 1: Requirement for Development. Validation and Routine Control of a Sterilization Process for Medical Devices.
The requirements of the standard were met
EO Residual per ISO 10993-7: 2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals.
The requirements of the standard were met.
Bacterial Endotoxin Test per USP 41, Chapter & ANSI/AAMI ST72:2011 Bacterial Endotoxins - Test Methods, Routine Monitoring, and Alternatives to Batch Testing. The requirements of the standard were met.
Pre-Loaded Tear Pool Dissolvable Punctum Plugs and the Predicate Device use the same sterilization method: Ethylene Oxide
Insertion Tool:
The performance of the insertion tool was assessed using a Simulated Use Deployment Test in gel to verify that the plug is not damaged and that it is retained and delivered easily by the user. To test the reliability of the pre-loaded insertion tool, multiple deployments were performed.
The insertion tool performs as intended.
6
Performance Data (continued)
Packaging:
A Tear Pool Dissolvable Punctum Plug is mounted onto an insertion tool and sealed in a tray with a Tyvek® sterile barrier lid. Final packaging includes two sterile trays (two plugs), one instructions for use, one silica gel packet, vacuum sealed in a pouch then placed in a shelf box.
Environment of Use: Tear Pool Dissolvable Punctum Plugs and the Predicate Device are for professional use only.
Conclusions:
The proposed Device has the same design, performance and safety profile as that of the Predicate Device and is therefore Substantially Equivalent.