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510(k) Data Aggregation
(57 days)
Bio Optics Co., Ltd.
Hello,eyes® BIO Plug is intended to temporarily block tear drainage by the occlusion of the canaliculus in order to
- 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,
- Temporarily treat dry eye after ocular surgery, and.
- Determine the potential effectiveness of permanent occlusion.
Intracanalicular Plug named Hello,eyes@BIO Plug consists of lacrimal punctum plug and its holder. The plug is made of polydioxanone per 21 CFR 878.4840. The pigment for the violet dye is D&C Violet No.2 per 21 CFR 74.3602. It is 2.0mm long and available in three diameters: 0.3, 0.4, and 0.5mm which are based on USP synthetic absorbable suture diameters. Hello, eyes@ BIO Plug, the intracanalicular plug is a product sterile by ethylene oxide (EO) gas in accordance with ISO 11135:2014. It is designed to be inserted through the punctal opening and reside in the canaliculus until it is absorbed over time in tissue.
The provided text describes a 510(k) premarket notification for a medical device called "Hello,eyes® BIO Plug". This submission focuses on establishing substantial equivalence to a predicate device ("SOFT PLUG® Extended Duration 180 Canalicular Plug") rather than presenting a performance study with acceptance criteria in the typical sense of accuracy, sensitivity, or specificity for an AI/CADe device.
The "acceptance criteria" here are met by demonstrating that the new device is as safe and effective as the predicate device. The "study" described is a series of non-clinical tests to support this substantial equivalence.
Here's the breakdown of the information as requested, though some categories may not be directly applicable to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for a physical medical device (an intracanalicular plug), the "acceptance criteria" are the standards and design specifications it must meet to be considered safe and effective and comparable to the predicate. The "reported device performance" refers to the results of the non-clinical tests that demonstrate compliance with these standards and the equivalence to the predicate.
| Acceptance Criteria (Standards & Comparability) | Reported Device Performance |
|---|---|
| Product Code: LZU (Same as predicate) | Met: Product code is LZU |
| Indication for Use: Same as predicate | Met: Indication for use is identical |
| Intracanalicular Punctum Plug: Yes (Same as predicate) | Met: Is an intracanalicular punctum plug |
| Material: Polydioxanone (PDO) (Same as predicate) | Met: Made of Polydioxanone (PDO) |
| Color Additive: D&C Violet No. 2 (Same as predicate) | Met: Uses D&C Violet No. 2 |
| Shape: Cylindrical (Same as predicate) | Met: Cylindrical shape |
| Diameter Availability: Similar to predicate (0.3-0.5 mm vs. 0.2-0.5 mm) | Met: Available in 0.3-0.5 mm diameters |
| Length: 2.0 mm (Same as predicate) | Met: Length is 2.0 mm |
| Sterilization: EO Sterilization (Same as predicate) | Met: EO Sterilization |
| Single Use: Yes (Same as predicate) | Met: Single use device |
| Biocompatibility Standards: | |
| - Sterilization Validation (ISO 11135:2014) | Met: Validation Report provided |
| - Pre-sterilization Bioburden (ISO 11737-1:2018) | Met: Determination performed |
| - Shelf Life (ISO11607-1:2019, ISO11607-2:2019) | Met: Test report provided |
| - Cytotoxicity (ISO 10993-5:2009) | Met: Testing performed |
| - Sensitization (ISO 10993-10:2010) | Met: Testing performed |
| - Intracutaneous (ISO 10993-10:2010) | Met: Testing performed |
| - Acute Systemic Toxicity (ISO 10993-11:2017) | Met: Testing performed |
| - Pyrogenicity (Material-mediated, ISO 10993-11:2017) | Met: Testing performed |
| - Subchronic Toxicity (ISO 10993-11:2017) | Met: Testing performed |
| - Genotoxicity (ISO 10993-3:2014) | Met: Testing performed |
| - Implantation (ISO 10993-6:2016) | Met: Testing performed |
| - Carcinogenicity & Chronic Toxicity (ISO 10993-1:2018, ISO 10993-18:2020) | Met: Assured by chemical characterization and toxicological risk assessment |
| - Chemical Characterization & Toxicological Risk Assessment (ISO10993-18) | Met: Performed |
| - LAL, Bacterial Endotoxin (ANSI/AAMI ST72:2019) | Met: Testing performed |
| Intended Duration: (Approximately 90 Days – shorter than predicate) | Met: Supported by an animal implantation study, demonstrating no new safety/effectiveness questions despite the difference. |
2. Sample Size Used for the Test Set and the Data Provenance
This document describes non-clinical laboratory and animal studies, not a "test set" in the context of an AI/CADe clinical trial. The sample sizes and data provenance for each specific test (e.g., sterilization validation, biocompatibility) are not detailed in this summary but would be found in the full test reports referenced (e.g., "Sterilization Validation Report on Hello,eyes® Bio Plug").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is not an AI/CADe submission requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the non-clinical tests are the established scientific principles and measured outcomes as per the ISO/ANSI standards.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" requiring adjudication in the context of this substantial equivalence submission for a physical medical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/CADe device or a human-in-the-loop study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is based on:
- Established scientific principles and standards: Compliance with ISO and ANSI standards.
- Direct measurements and observations: Results of laboratory tests for material properties, sterilization, biocompatibility, etc.
- Animal study outcomes: For the implantation study that supported the intended duration.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/Machine Learning device.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set" or associated "ground truth" establishment in the context of an AI/ML model for this device.
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