(15 days)
No
The device description and intended use are for a simple plastic contact lens case, with no mention of any computational or analytical capabilities that would suggest AI/ML.
No
The device is a contact lens case used for disinfection and storage of lenses, which is a utility device, not a therapeutic device meant to treat or cure a medical condition.
No
The device is indicated for disinfection and storage of contact lenses, which are functions related to maintenance rather than diagnosis of a condition.
No
The device description clearly states it is a plastic contact lens case, which is a physical 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 is for the "disinfection and storage of rigid gas permeable contact lenses." This is a physical process applied to a medical device (contact lenses), not a diagnostic test performed on a biological sample to provide information about a patient's health.
- Device Description: The description details a plastic case with features for holding and preventing adherence of contact lenses. This is a container/storage device, not a diagnostic instrument or reagent.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The performance studies mentioned (Systemic Injection Test, Eye Irritation Test, Cytotoxicity Test) are related to the biocompatibility and safety of the material the case is made from, which is relevant for a device that comes into contact with contact lenses that are placed in the eye, but not indicative of an IVD function.
N/A
Intended Use / Indications for Use
The BOSTON Contact Lens Case is indicated for disinfection and storage of rigid gas permeable contact lenses.
Product codes
Not Found
Device Description
The BOSTON® Contact Lens Case is plastic and double-welled with ridged screw caps on the wells. The interiors of the wells and caps contain elevated ridges to prevent the adherence of rigid gas permeable contact lenses to the surfaces.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
BOSTON® Contact Lens Case (K951552)
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 text 'Polymer Technology' at the top. Below that, the text 'K962512' is written inside of a hand-drawn circle. The text and circle are in black ink on a white background. The image appears to be a scan or photocopy of a document.
JUL 1 2 1396
BOSTON® Contact Lens Case
Summary of Safety and Effectiveness
| Sponsor/Applicant: | Polymer Technology,
a Division of Wilmington Partners L.P.
100 Research Drive
Wilmington, MA 01887 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/Proprietary Name: | BOSTON® Contact Lens Case |
| Classification Name: | Contact lens case |
| Common/Usual Name: | Contact lens case |
| Contact: | Quality/Regulatory Affairs
(508) 658-6111 |
| Statement of Equivalence: | Based on similar designs and on indications for use
with rigid gas permeable contact lenses, The BOSTON
Contact Lens Case is substantially equivalent to the
following marketed product:
BOSTON® Contact Lens Case (K951552) |
| Device Description: | The BOSTON® Contact Lens Case is plastic and
double-welled with ridged screw caps on the wells.
The interiors of the wells and caps contain elevated
ridges to prevent the adherence of rigid gas permeable
contact lenses to the surfaces. |
| Toxicology Testing: | In support of this premarket notification information
from the following was submitted for review:
Systemic Injection Test
Eye Irritation Test
Cytotoxicity Test |
| Indications for Use: | The BOSTON Contact Lens Case is indicated for
disinfection and storage of rigid gas permeable contact
lenses. |
V Final Lens Case 510(k)