(132 days)
Not Found
No
The device description and performance studies focus on the mechanical design and material safety of a contact lens case, with no mention of AI or ML technologies.
No
The device is indicated for the storage and chemical disinfection of contact lenses, which is not a therapeutic function. It is an accessory for lens care.
No
Explanation: The device is a contact lens case used for storage and disinfection, not for diagnosing any medical condition.
No
The device description clearly states it is a physical contact lens storage case made of plastic with chambers and drainage mechanisms, indicating it is a hardware device.
Based on the provided information, the NoveLens® 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 device used in conjunction with contact lenses and disinfection solutions, not for performing diagnostic tests on biological samples.
- Device Description: The description details a physical case for holding and rinsing contact lenses. It does not describe any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Function: The device's function is purely for the physical storage and rinsing of contact lenses during disinfection. It does not measure, detect, or analyze any biological markers or substances to provide a diagnosis.
- Performance Studies: The performance studies focus on the toxicology of the materials and equivalence to predicate contact lens cases, not on the accuracy or performance of a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health or condition. The NoveLens® Contact Lens Case does not fit this description.
N/A
Intended Use / Indications for Use
The NoveLens® Contact Lens Case is indicated for storage of hard, rigid gas permeable (silicone acrylate and fluro silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection.
Product codes (comma separated list FDA assigned to the subject device)
LRX
Device Description
The NoveLens® Contact Lens Case is a contact Iens storage case comprised of a plastic case that houses two chambers. The upper chamber which holds the lenses separately in individually attached concave reservoirs and a lower chamber that provides space for rinsed solution as it passes through holes from the upper chamber and through a drainage toube into the lower portion of the device. The NoveLens® Contact Lens Case is constructed to take solution introduced into the upper chamber in a rinse fashion and force, by gravity, solution through the drainage holes through a drainage tube and into a lower collecting chamber. Additional solution is added until both chambers are completely filled to the top. Screw caps when closed hermetically seal the system to hold disinfection solution while the lenses are stored and disinfected in accordance with directions consistent with labeled multipurpose contact lens solutions. The design provides for one-way ingress of solution and expulsion of spent solution through external drainage holes from the lower chamber upon tipping the unit on its side.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A battery of toxicology tests were conducted on the plastic components to verify the safety of the materials used in the device. The tests included Cytotoxicity, Ocular Irritation, and Systemic Toxicity in conformance with FDA Guidance for contact lens case products; Guidance for Industry-Premarket Notification 510(k) Guidance Document for Contact Lens Care Products- dated May 1, 1997, and ISO-10993-1. Results of the testing demonstrate that the safety and effectiveness of the NoveLens® Contact Lens Case is equivalent to the predicate devices listed above. No further testing for case effectiveness was warranted for demonstration of substantial equivalence. Clinical studies were deemed unnecessary as the solutions used in the NoveLens® Contact Lens Case are already cleared for marketing as cleaning, rinsing, disinfection, and storage solution for soft, RGP, and hard contact lenses.
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.
K013232, K852384, K971618, K974281, K021248
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
§ 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.”
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K032309 510(k) Summary Statement
SUBMITTER:
Submitted on behalf of:
| Company Name: | NoveLens®, Inc. |
|---|---|
| Address: | 17-25 Hunter Place |
| Fair Lawn, New Jersey 07410 | |
| Phone: | (201) 794-7999 |
| Fax: | (201) 794-7958 |
| CONTACT PERSON: | Richard E. Lippman, O.D., F.A.A.O. |
| Official Representative and Correspondent | |
| R.P. Chiacchierini & Associates, LLC | |
| 15825 Shady Grove Road | |
| Suite 30 | |
| Rockville, Maryland 20850 | |
| Phone: | (240) 683-3738 |
| FAX: | (240) 683-9236 |
| DATE SUMMARY PREPARED: | November 10, 2003 |
| TRADE NAME: | NoveLens® Contact Lens Case |
COMMON NAME: CLASSIFICATION:
contact lens case Class II: LRX
ESTABLISHMENT REGISTRATION: PENDING
SUBSTANTIALLY EQUIVALENT TO:
The NoveLens® Contact Lens Case is substantially equivalent to the following devices:
| K013232 | Bausch & Lomb CyberCase Contact Lens Case |
|---|---|
| K852384 | Bausch & Lomb CyberCase Contact Lens Case |
| K971618 | Alcon Contact Lens Case |
| K974281 | Alcon Contact Lens Case |
| K021248 | iCase: IKeeps, Inc, |
DESCRIPTION of the DEVICE:
The NoveLens® Contact Lens Case is a contact Iens storage case comprised of a plastic case that houses two chambers. The upper chamber which holds the lenses separately in individually attached concave reservoirs and a lower chamber that provides space for rinsed solution as it passes through holes from the upper chamber and through a drainage toube into
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the lower portion of the device. The NoveLens® Contact Lens Case is constructed to take solution introduced into the upper chamber in a rinse fashion and force, by gravity, solution through the drainage holes through a drainage tube and into a lower collecting chamber. Additional solution is added until both chambers are completely filled to the top. Screw caps when closed hermetically seal the system to hold disinfection solution while the lenses are stored and disinfected in accordance with directions consistent with labeled multipurpose contact lens solutions. The design provides for one-way ingress of solution and expulsion of spent solution through external drainage holes from the lower chamber upon tipping the unit on its side.
INDICATIONS FOR USE:
The NoveLens® Contact Lens Case is indicated for storage of hard, rigid gas permeable (silicone acrylate and fluro silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection.
ACTIONS:
The NoveLens® Contact Lens Case provides for lens storage during chemical disinfection as well as storage up to the labeled time listed on the user's multipurpose disinfection solution. Directions for use accompany the NoveLens® Contact Lens Case for continued safe use of the device.
TOXICITY TESTING
A battery of toxicology tests were conducted on the plastic components to verify the safety of the materials used in the device. The tests included Cytotoxicity, Ocular Irritation, and Systemic Toxicity in conformance with FDA Guidance for contact lens case products; Guidance for Industry-Premarket Notification 510(k) Guidance Document for Contact Lens Care Products- dated May 1, 1997, and ISO-10993-1.
Results of the testing demonstrate that the safety and effectiveness of the NoveLens® Contact Lens Case is equivalent to the predicate devices listed above.
EFFECTIVENESS TESTING for the NoveLens® Contact Lens Case .
No further testing for case effectiveness was warranted for demonstration of substantial equivalence.
CLINICAL INFORMATION
Clinical studies were deemed unnecessary as the solutions used in the NoveLens® Contact Lens Case are already cleared for marketing as cleaning, rinsing, disinfection, and storage solution for soft, RGP, and hard contact lenses.
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LABELING
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The NoveLens® Contact Lens Case is provided to the user with an outer carton as well as User Instructions.
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NoveLens® Inc. 17-25 Hunter Place Fair Lawn, New Jersey 07410 (201) 794-7999 FAX: (201) 794-7958
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
$$\mathtt{2EC} \text{ - 4 } \mathtt{2003}$$
NoveLens®, Inc. C/O Richard Lippman, O.D., F.A.A.O. Vice President, Ophthalmic Regulatory Medical Products R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Rd., Suite 30 Rockville, MD 20850
Re: K032309
Trade/Device Name: NoveLens® Contact Lens Case Regulation Number: 21 CFR 886.5928, 21 CFR 886.5918 Regulation Name: Soft (hydrophilic) contact lens care products, Rigid gas permeable contact lens care products Regulatory Class: Class II
Product Code: LRX Dated: November 10, 2003 Received: November 10, 2003
Dear Dr. Lippman:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Richard Lippman, O.D., F.A.A.O.
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication Statement
510(k) Number (if known): K032309
Device Name: NoveLens® Contact Lens Case
Indications for Use:
The NoveLens® Contact Lens Case is indicated for storage of hard, rigid gas permeable (silicone acrylate and fluro silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Presription Use _
Over -The-Counter Use
(Optional Format 1.26)
(Oprtional Format 1-2-96)
Karen Wabont
ion Sion-Off Division of Ophthalmic Ear Nose and Throat Devi
510(k) Number K032309
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