(132 days)
Not Found
No
The device description and performance studies focus on the material properties and biological safety of a contact lens case, with no mention of AI or ML technology.
No
The device is a contact lens case used for storage during chemical disinfection. It does not perform any therapeutic function on the body or treat any condition.
No
The device described is a contact lens case, indicated for storage during chemical disinfection. Its function is containment, not diagnosis. The performance studies focus on material safety, not diagnostic accuracy.
No
The device description clearly indicates it is a physical contact lens case made of LDPE and Polypropylene, not software.
Based on the provided information, the Phoenix Contact Lens Case is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the storage of contact lenses during chemical disinfection. This is a physical storage function, not a diagnostic test performed in vitro (outside the body) on a specimen to provide information about a disease or condition.
- Device Description: The description details the materials and design of a container for contact lenses. It does not describe any components or functions related to diagnostic testing.
- Performance Studies: The performance studies focus on the biocompatibility and safety of the materials in contact with the lenses and potentially the eye (through residual solution). These are typical tests for medical devices that come into contact with the body, but not for IVDs which focus on analytical and clinical performance of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing a specimen (like blood, urine, or tissue), detecting a specific analyte, or providing diagnostic information.
In summary, the Phoenix Contact Lens Case is a medical device intended for the storage and disinfection of contact lenses, not for performing diagnostic tests.
N/A
Intended Use / Indications for Use
Phoenix Contact Lens Case is indicated for storage of soft (hydrophilic), rigid gas permeable and hard contact lenses during chemical disinfection.
Product codes
LRX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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 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: 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
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.
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 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| 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
4
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 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: 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.