(132 days)
Phoenix Contact Lens Case is indicated for storage of soft (hydrophilic), rigid gas permeable and hard contact lenses during chemical disinfection.
There are three models of the Phoenix Contact Lens Case:
CL-01 "Dome Top Flat Pack" - made with LDPE and has 1.5ml wells on each side
CL-02 "Classic Flat Pack" - made with LDPE and has 1.5 ml wells on each side
CL-03 "Sunglass Shape Flat Pack" made with Polypropylene and has 2.0 ml wells on each side
All three models have hinged self sealing caps and are available in white, black, blue, orange, green, and natural.
The Phoenix contact lens cases are intended for storage during chemical disinfection of soft, rigid gas permeable or hard contact lenses. It is not to be used with heat disinfection.
The provided document is a 510(k) premarket notification for Phoenix Contact Lens Cases (CL-01, CL-02, CL-03). It outlines the device's substantial equivalence to legally marketed predicate devices.
Based on the provided text, the device in question is a contact lens case, not an AI/ML medical device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving the performance of AI/ML medical devices, is not applicable to this submission.
The document details non-clinical tests performed on the contact lens cases to demonstrate their substantial equivalence. These tests primarily focus on the biocompatibility and safety of the materials used in the contact lens cases, not on the performance of a diagnostic or therapeutic algorithm.
Here's a summary of the non-clinical tests and their conclusions, which serve as the "acceptance criteria" and "device performance" for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Objective) | Reported Device Performance (Conclusion) |
|---|---|
| Cytotoxicity (per ISO 10993-5): Assess if the device material extracts cause cell death or harm. | "Based on the results obtained under laboratory testing conditions, the extract of test item, Contact Lens Case was found to be 'non-cytotoxic' to the subconfluent monolayer of L-929 mouse fibroblast cells." |
| Intracutaneous skin irritation (per ISO 10993-23): Assess if extracts cause skin irritation when injected intradermally. | "Based on the results of the experiment, it is concluded that the polar extracts of test item, Contact Lens Case was 'Nonirritant' to the skin of New Zealand White Rabbits under the experimental conditions and the dose employed as per the ISO 1093 Part 23:2021 (E) Specification." |
| Guinea pig maximization (GPMT) skin sensitization (per ISO 10993-10): Assess the potential for the device material to cause allergic sensitization. | "Based on the above results of the experiment, it is concluded that the polar extracts of Contact Lens Case was found to be 'Non-sensitizer' to the skin of the Guinea pigs under the experimental conditions employed." |
| Acute systemic injection (per ISO 10993-11): Assess the potential for general toxic effects after systemic exposure to extracts. | "Based on the results of the experiment, it is concluded that the polar extracts of test item, Contact Lens Case when administered to Swiss Albino Mice through and intraperitoneal routes respectively at a dose volume of 50 mL/kg body weight did not reveal any systemic toxicity under the experimental conditions employed." |
| Material mediated pyrogenicity (per USP <151>): Assess the potential for the device material to induce fever. | "Based on the results of the experiment, it is concluded that the extract Lens Case evaluated for progen test in New Zealand White Rabbits is Non-pyrogenic as it meets the requirements of progen test as per U.S. Pharmacopoeia, and General Chapters: <151> Pyrogen Test." |
| Acute ocular irritation testing (per ISO 10993-23): Assess the potential for the device material to cause irritation to the eye. | "Under the experimental conditions employed and based on the observed results of the experiment, it is concluded that polar and non-polar extract of test item, Contact Lens Case did not produce any irritant effects to the eyes of New Zealand White Rabbits as per ISO 10993 'Biological Evaluation of Medical Devices' Part 23:2021(E) 'Test for Irritation'." |
The following numbered points are not applicable to this device, as it is a physical contact lens case and not an AI/ML software device.
- Sample sizes used for the test set and the data provenance: Not applicable. The tests involved in vitro cell cultures and in vivo animal models, with sample sizes determined by the respective ISO standards and USP guidelines for biocompatibility testing (e.g., specific numbers of cells, guinea pigs, rabbits, or mice as per the standard). The provenance is "laboratory testing conditions" and "experimental conditions." These are typically prospective in nature.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on objective biological responses measured in a laboratory setting per standardized protocols, not human expert consensus on images or clinical data.
- Adjudication method for the test set: Not applicable. The tests evaluate direct biological and material responses, not subjective interpretations requiring adjudication.
- 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 study type is for AI/ML diagnostic performance, not for a physical medical device like a contact lens case.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI/ML algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI context. The "ground truth" for these biocompatibility tests is the presence or absence of a specific biological or toxicological reaction as defined by the international standards (e.g., cell viability, skin erythema/edema, systemic toxicity, fever induction, ocular irritation).
- The sample size for the training set: Not applicable. This document describes pre-market testing for a physical device, not an AI/ML algorithm that requires training data.
- How the ground truth for the training set was established: Not applicable.
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August 30, 2023
Phoenix Innovative Healthcare Manufacturers Pvt. Ltd. Michael Stuart CFO EL-209, Shil Mahape Road Electronic Zone; MIDC TTC Industry Area, Mahape Navi Mumbai, Maharashtra 400710 India
Re: K231123
Trade/Device Name: Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LRX Dated: April 20, 2023 Received: July 24, 2023
Dear Michael Stuart:
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.
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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) for devices or postmarketing safety reporting (21 CFR 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 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-device-safety/medical-device-reportingmdr-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/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.
Digitally signed Bennett N. by Bennett N. Walker -S Walker -S Date: 2023.08.30 09:57:47 -04'00'
for Angelo Green 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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Phoenix Contact Lens Case - dome top flat pack (CL-01);
Phoenix Contact Lens Case - classic flat pack (CL-02);
Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)
Indications for Use (Describe)
Phoenix Contact Lens Case is indicated for storage of soft (hydrophilic), rigid gas permeable and hard contact lenses during chemical disinfection.
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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| 510(k) #: | K231123 | 510(k) Summary | Prepared on: | 2023-08-30 | Page | 1 | |
|---|---|---|---|---|---|---|---|
| ----------- | --------- | -- | ---------------- | -------------- | ------------ | ------ | --- |
Contact Details 21 CFR 807.92(a)(1)
| Applicant Name | Phoenix Innovative Healthcare Manufacturers Private Limited |
|---|---|
| Applicant Address | EL-209, Shil Mahape Road Electronic Zone; MIDC TTC Industry Area, Mahape Navi Mumbai Maharashtra 400710 India |
| Applicant Contact Telephone | 9548804274 |
| Applicant Contact | Mr. Michael Stuart |
| Applicant Contact Email | mikes@phoenix-hs.com |
Device Name 21 CFR 807.92(a)(2)
| Device Trade Name | Phoenix Contact Lens Case - dome top flat pack (CL-01);Phoenix Contact Lens Case - classic flat pack (CL-02);Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) |
|---|---|
| Common Name | Contact Lens Case |
| Classification Name | Opthalmic |
| Regulation Number | 886.5928 |
| Product Code | LRX |
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K112832 | Optego/Eye Care Cure | LRX |
| K013232 | Bausch & Lomb | LRX |
Device Description Summary 21 CFR 807.92(a)(4)
There are three models of the Phoenix Contact Lens Case:
CL-01 "Dome Top Flat Pack" - made with LDPE and has 1.5ml wells on each side
CL-02 "Classic Flat Pack" - made with LDPE and has 1.5 ml wells on each side
CL-03 "Sunglass Shape Flat Pack" made with Polypropylene and has 2.0 ml wells on each side
All three models have hinged self sealing caps and are available in white, black, blue, orange, green, and natural.
The Phoenix contact lens cases are intended for storage during chemical disinfection of soft, rigid gas permeable or hard contact lenses. It is not to be used with heat disinfection.
Intended Use/Indications for Use 21 CFR 807.92(a)(5)
Phoenix Contact Lens Case is indicated for storage of soft (hydrophilic), rigid gas permeable and hard contact lenses during chemical
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Indications for Use Comparison
The indications for use are the same.
Technological Comparison
The proposed device has the same classification and prodicate devices. The proposed device has the same intended use as the predicate devices. The proposed device has a similar design and is materials to the predicate devices.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The nonclinical tests submitted were:
Cytotoxicity per ISO 10993-5 Intracutaneous skin irritation per ISO 10993-23 Guinea pig maximization (GPMT) skin sensitization per ISO 10993-10 Acute systemic injection per ISO 10993-11 Material mediated pyrogenicity per USP <151> Acute ocular irritation testing per ISO 10993-23
The tests concluded the following:
Based on the results obtained under laboratory testing conditions, the extract of test item, Contact Lens Case was found to be "non-cytotoxic" to the subconfluent monolayer of L-929 mouse fibroblast cells.
Based on the above results of the experiment, it is concluded that the polar extracts of Contact Lens Case was found to be "Non-sensitizer" to the skin of the Guinea pigs under the experimental conditions employed.
Based on the results of the experiment, it is concluded that the polar extracts of test item, Contact Lens Case was "Nonirritant" to the skin of New Zealand White Rabbits under the experimental conditions and the dose employed as per the ISO 1093 Part 23:2021 (E) Specification.
Based on the results of the experiment. it is concluded that the polar extracts of test item. Contact Lens Case when administered to Swiss Albino Mice through and intraperitoneal routes respectively at a dose volume of 50 mL/kg body weight did not reveal any systemic toxicity under the experimental conditions employed.
Based on the results of the experiment, it is conduded that the extract Lens Case evaluated for progen test in New Zealand White Rabbits is Non-pyrogenic as it meets the requirements of progen test as per U.S. Pharmacopoeia, and General Chapters: <151> Pyrogen Test.
Under the experimental conditions employed and based on the observed results of the experiment. it is colar and non-polar extract of test tiem, Contact Lens Case did not produce any irritant effects to the eyes of New Zealand White Rabbits as per ISO 10993 "Biological Evaluation of Medical Devices" Part 23:2021(E) "Test for Irritation".
All testing demonstrates substantial equivalence.
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21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”