(57 days)
No
The device description and performance studies focus on the material properties, sterilization, and biological compatibility of a physical plug, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to temporarily treat dry eye syndrome and enhance the efficacy of topical medications, which are therapeutic functions.
No
The Hello,eyes® BIO Plug is intended to temporarily block tear drainage to treat dry eye syndrome and related conditions, enhance medication efficacy, or determine the potential effectiveness of permanent occlusion. It acts as a physical barrier for treatment and is not designed to diagnose a condition or provide diagnostic information.
No
The device description clearly states that the device is a physical intracanalicular plug made of polydioxanone, a material used for physical implants, and describes its dimensions and sterilization method. This indicates it is a hardware 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 clearly describes a device that is physically inserted into the body (the canaliculus) to block tear drainage. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a physical plug made of polydioxanone, designed for insertion into the canaliculus. This aligns with a medical device used for treatment, not a diagnostic reagent or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's condition. The device's function is purely mechanical occlusion.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
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.
Product codes
LZU
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Non clinical tests were conducted to verify that the subject device(Hello,eyes® BIO Plug) met all design specifications as was Substantially Equivalent (SE) to the predicate device(K162361). The test results demonstrated that the proposed device complies with the following standards.
- Sterilization Validation Report on Hello,eyes® Bio Plug according to ISO 11135:2014
- Pre-sterilization Bioburden Determination, ISO 11737-1:2018
- Shelf Life Test report on Plug and Holder according to ISO11607-1:2019, ISO11607-2:2019
- Cytotoxicity testing according to ISO 10993-5:2009
- Sensitization testing according to ISO 10993-10:2010
- Intracutaneous testing according to ISO 10993-10:2010
- Acute Systemic Toxicity testing according to ISO 10993-11:2017
- Pyrogenicity (Material-mediated pyrogenicity) testing according to ISO 10993-11:2017
- Subchronic toxicity testing according to ISO 10993-11:2017
- Genotoxicity testing according to ISO 10993-3:2014
- Implantation testing according to ISO 10993-6:2016
- Carcinogenicity and chronic toxicity which were assured by used chemical characterization and toxicological risk assessment according to ISO 10993-1:2018 and ISO 10993-18:2020.
- LAL, Bacterial Endotoxin Testing on Hello,eyes® Bio Plug according to ANSI/AAMI ST72:2019.
- Chemical characterization and Toxicological Risk Assessment on Hello,eyes® Bio Plug according to ISO10993-18
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
The intended duration (approximately 90 days) was supported by an animal implantation study.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 28, 2024
Bio Optics Co., Ltd. Gayun Kim Manager of KMC Inc. KMC, Inc. Room no. 1709, 123, Digital-ro 26-gil, Guro-gu Seoul, 08390 Korea. South
Re: K241229
Trade/Device Name: Hello,eyes® BIO Plug Regulatory Class: Unclassified Product Code: LZU Dated: May 2, 2024 Received: May 2, 2024
Dear Gayun Kim:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-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 -S
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
2
Indications for Use
Submission Number (if known)
Device Name
Hello, eyes® BIO Pluq
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for Bio Optics. The logo features a stylized graphic to the left of the text "Bio Optics". The graphic is a blue swirl with colorful leaf-like shapes emanating from it. The text "Bio Optics" is in a bold, blue font.
Date Prepared: June 11th, 2024
1. 510(k) Submitter
Bio Optics Co., Ltd. Address: A-1215, SKV1 Tower, 14, Galmachi-ro 288beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13201, Republic of Korea Tel: +82-31-747-4850/ Fax: +82-31-747-4820 Email: zevany1003@biooptics.co
2. Official Correspondent
Gayun Kim / KMC, Inc. Address: Room no. 1709, 123, Digital-ro 26-gil, Guro-gu, Seoul, 08390, Republic of Korea Tel: +82-70-8965-5554/ Fax: +82-2-2672-0579 Email: gy.kim@kmcerti.com
3. Device Information
- Trade Name/Device Name: Hello, eyes® BIO Plug
- Common name: Intracanalicular Plug
- Classification Regulation: Unclassified
- Device Class: Unclassified
- Panel: Ophthalmic
- Product Code: LZU
4. Predicate Device
The subject device is substantially equivalent to the following predicate devices : K162361, SOFT PLUG® Extended Duration 180 Canalicular Plug by OASIS Medical, Inc.
5. Device Description
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.
6. Indication for use
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.
4
7. Substantial Equivalence Discussion
7.1 Comparison Table
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Manufacturer | Bio Optics Co., Ltd. | OASIS Medical, Inc. | - |
| Device Name | Hello, eyes® BIO Plug | SOFT PLUG® Extended Duration | |
| 180 Canalicular Plug | - | ||
| 510(k) No. | K241229 | K162361 | - |
| Product Code | LZU | LZU | Same |
| Indication for | |||
| Use | 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. | The SOFT PLUG® Extended
Duration 180 Canalicular Plugs are
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 | Same |
| Intracanalicular
Punctum Plug | Yes | Yes | Same |
| Intended
Duration | Approximately 90 Days | Approximately 180 Days | Different |
| Material | Polydioxanone (PDO) | Polydioxanone (PDO) | Same |
| Color Additive | D&C Violet No. 2 | D&C Violet No. 2 | Same |
| Shape | Cylindrical | Cylindrical | Same |
| Diameter
Availability | 0.3-0.5(mm) which are based
on USP synthetic absorbable suture
diameters | 0.2-0.5 (mm) which are based
on USP synthetic absorbable suture
diameters | Similar |
| Length | 2.0 (mm) | 2.0 (mm) | Same |
| Sterilization | EO Sterilization | EO Sterilization | Same |
| Single Use | Yes | Yes | Same |
7.2 Technical Characteristics
- Same/Similar Points between subject device and predicate device
| Item | Description |
|---|---|
| Product Code | The product code(LZU) is same between subject device and predicate device. |
| Indication for Use | The indication for use is same between subject device and predicate device. |
| Intracanalicular | |
| Punctum Plug | The subject device is Intracanalicular Punctum Plug. It is same with the predicate device. |
| Material | The material of subject device is Polydioxanone (PDO). It is same with the predicate device. |
| Color Additive | The color additive of subject device is D&C Violet No. 2. It is same with the predicate device. |
| Shape | The shape of subject device is Cylindrical. It is same with the predicate device. |
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Image /page/5/Picture/1 description: The image shows the logo for Bio Optics. The logo features a stylized sun-like graphic with colorful rays in yellow, blue, and pink. To the right of the graphic, the words "Bio Optics" are written in a bold, blue font. The logo appears to be for a company in the field of biology and optics.
| Item | Description |
|---|---|
| Diameter Availability | The diameter availability of the subject device is “0.3-0.5(mm) which are based on USP synthetic absorbable suture diameters”. |
| The diameter availability of the predicate device is “0.2-0.5 (mm) which are based on USP synthetic absorbable suture diameters”. | |
| It is similar with the predicate device. | |
| Length | The length of subject device is 0.2mm. It is same with the predicate device. |
| Sterilization | The sterilization of subject device is E.O sterilization. It is same with the predicate device. |
| Single Use | The subject device is single use. It is same with the predicate device. |
- Different Points between subject device and predicate device
| Item | Description |
|---|---|
| Intended Duration | The Intended duration of the subject device is “Approximately 90 Days”. |
| The Intended duration of the predicate device is “Approximately 180 Days”. | |
| These differences in intended duration do not raise different questions of safety and | |
| effectiveness because intended duration of the subject device has a shorter contact time | |
| within the human body than the predicate device. | |
| The intended duration (approximately 90 days) was supported by an animal | |
| implantation study. |
7.3 Comparison conclusion to predicate device
Subject device and Predicate device have the same Indication for use, material, color additive, shape, diameter, length, sterilization, and single use, and the only difference is Intended Duration. However, The intended duration (approximately 90 days) was supported by an animal implantation study. Any differences do not raise different questions of safety and effectiveness than the predicate. Therefore, there is no difference between the subject and predicate with respect to the indications or technology. Therefore, the subject device is substantially equivalent to the predicate device.
8. Summary of Non-Clinical Testing:
Below tests were performed on the subject device:
Non clinical tests were conducted to verify that the subject device(Hello,eyes® BIO Plug) met all design specifications as was Substantially Equivalent (SE) to the predicate device(K162361). The test results demonstrated that the proposed device complies with the following standards.
- · Sterilization Validation Report on Hello,eyes® Bio Plug according to ISO 11135:2014
- · Pre-sterilization Bioburden Determination, ISO 11737-1:2018
- Shelf Life Test report on Plug and Holder according to ISO11607-1:2019, ISO11607-2:2019
- Cytotoxicity testing according to ISO 10993-5:2009
- Sensitization testing according to ISO 10993-10:2010
- Intracutaneous testing according to ISO 10993-10:2010
- Acute Systemic Toxicity testing according to ISO 10993-11:2017
- · Pyrogenicity (Material-mediated pyrogenicity) testing according to ISO 10993-11:2017
- Subchronic toxicity testing according to ISO 10993-11:2017
- · Genotoxicity testing according to ISO 10993-3:2014
- Implantation testing according to ISO 10993-6:2016
- Carcinogenicity and chronic toxicity which were assured by used chemical characterization and
- toxicological risk assessment according to ISO 10993-1:2018 and ISO 10993-18:2020.
- LAL, Bacterial Endotoxin Testing on Hello,eyes® Bio Plug according to ANSI/AAMI ST72:2019.
6
Image /page/6/Picture/1 description: The image shows the logo for Bio Optics. The logo consists of a stylized image of a sun or flower with blue, yellow, and pink petals or rays. To the right of the image is the text "Bio Optics" in a bold, blue font. The text is slightly larger than the image, making it the focal point of the logo.
■ Chemical characterization and Toxicological Risk Assessment on Hello,eyes® Bio Plug according to ISO10993-18
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
Conclusion
The Hello,eyes Bio Plug, subject device of this submission, constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, Hello,eyess Bio Plug and its predicates are substantially equivalent.