(125 days)
Not Found
No
The device description and performance studies focus on the material safety and containment function of a contact lens case, with no mention of AI or ML technologies.
No
This device is for storage and chemical disinfection of contact lenses, not for treating a disease or condition.
No
This device is a contact lens case used for storage and chemical disinfection of contact lenses. Its intended use does not involve diagnosing any medical condition or disease.
No
The device description clearly states it is a physical contact lens case, which is a hardware device.
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 storage of contact lenses during chemical disinfection. This is a physical storage function, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is a contact lens case, designed to hold lenses and fluid. It does not contain reagents, test strips, or any components typically associated with in vitro diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies described are focused on the biological and toxicological safety of the materials used in the case, not on the accuracy or performance of a diagnostic test.
In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to diagnose, monitor, or screen for diseases or conditions. This contact lens case does not fit that description.
N/A
Intended Use / Indications for Use
For storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses.
For use during chemical disinfection only, Not to be used with heat.
Over the Counter Use (21 CFR 801 Subpart C)
Product codes (comma separated list FDA assigned to the subject device)
LRX
Device Description
The i-Promotions Contact Lens Case consists of a lens case base with adjoining dual wells for the containment of fluid, and separate integral hinged self-sealing caps.
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)
NAMSA preformed cytotoxicity testing on six completed i-Promotions Contact Lens Cases. The six cases tested were created using the correct proportion of Dow Chemical Company Low Density Polyethylene Product #9931 and one of five Carolina Color Corporation (listed on page 15). One case was created using no colorant. Five cases were created using one of each colorant. NAMSA took an equal sampling from each of the six cases and combined the sampling to perform one cytotoxicity test.
The six completed contact lens cases were tested using the biological and toxicology tests recommended by the USPXXII and the results of these studies show that the product is safe for its intended use.
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.
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.”
0
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Amended 510(k) K042578 Page #5 January 14, 2005
:
XII. Summary of Safety and Effectiveness
| Date of Preparation: | September 20, 2004 |
|---|---|
| Device Name: | i-Promotions Contact Lens Case |
| Classification Name: | Contact Lens Case |
| Manufacturer: | i-Promotions, Inc. |
| 9522 Gravois Rd. | |
| St. Louis, MO 63123 | |
| Contact: | Charlotte Slankard |
| President | |
| i-Promotion, Inc. | |
| Predicate Device: | Pelican Contact Lens Case K030987 |
| And OptiLens™ Contact Lens Case K920064 | |
| Device Description | |
| And Intended Use: | The i-Promotions Contact Lens Case consists of a lens case base with adjoining dual wells for the containment of fluid, and separate integral hinged self-sealing caps. |
The i-Promotions Contact Lens Case is intended for storage during disinfection of soft, rigid gas permeable or hard contact lenses. Not to be used with heat disinfection. Use only with chemical disinfection. |
| Summary of Safety
Testing: | NAMSA preformed cytotoxicity testing on six completed i-Promotions Contact Lens Cases. The six cases tested were created using the correct proportion of Dow Chemical Company Low Density Polyethylene Product #9931 and one of five Carolina Color Corporation (listed on page 15). One case was created using no colorant. Five cases were created using one of each colorant. NAMSA took an equal sampling from each of the six cases and combined the sampling to perform one cytotoxicity test.
The six completed contact lens cases were tested using the biological and toxicology tests recommended by the USPXXII and the results of these studies show that the product is safe for its intended use. |
1
| Table I |
|---|
| Summary of Equivalences and Differences |
| 510(k) Device and Predicate Devices |
| (Amended 1-14-05) |
| Device Name | 510(k) i-Promotions
Contact Lens Case | Pelican Contact
Lens Storage Case
(K030987)
Item #600 | Opti-LensTM
Contact Lens Case
(K920064) |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Indications | Storage and
Disinfection of Soft,
Rigid Gas
Permeable or Hard
Lenses | Storage and
Disinfection of Soft,
Rigid Gas
Permeable or Hard
Lenses | Storage and
Disinfection of Soft,
Rigid Gas
Permeable or Hard
Lenses |
| Disinfection Type | Chemical
(Not Heat) | Chemical
(Not Heat) | Chemical
(Not Heat) |
| Design | Two Adjoining
Wells With Integral
Hinged Caps Into
Which Respective
Lenses are
Immersed | Two Adjoining
Wells With Integral
Hinged Caps Into
Which Respective
Lenses are
Immersed | Two Adjoining
Wells With Screw
Top Caps Into
Which Respective
Lenses are
Immersed |
| Materials | -Dow Chemical
Company Low
Density
Polyethylene
Dow Product #9931
-One of the Carolina
Color Corporation
Colorants listed in
List of Materials
Page15 | -Dow Chemical
Company Low
Density
Polyethylene
Dow Product #9931
See 510(k)
(K030987)
Item #600 | -M.A. Industries,
Inc. #PO011AL
Polypropylene |
| Labeling | Refers to product as
i-Promotions
contact lens case;
instructs patient to
clean lens case with
a disinfecting
solution
recommended for
this purpose | See 510(k)
(K030987)
Item #600 | Refers to product as
Opti-Lens contact
lens case; instructs
patient to clean lens
case with Opti-Free
Daily Cleaner |
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, with three stylized wing or feather shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2005
i-Promotions, Inc. c/o Ms. Charlotte Slankard 9522 Gravois Rd. St. Louis, MO 63123
Re: K042578
Trade/Device Name: i-Promotion Contact Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Contact Lens Storage Case Regulatory Class: Class II Product Code: LRX Dated: December 27, 2004 Received: December 30, 2004
Dear Ms. Slankard:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for acce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered province that 20, 2017 - ) 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 If your device 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.
3
Page 2 - Ms. Charlotte Slankard
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 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,
Ahalpi forentthal
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
4
Amended 510(k) K042578 Page #7 January 14, 2005
Indications for Use
510 (k) Number: K042578
Device Name: i-Promotions Contact Lens Case
Indications for Use:
For storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses.
For use during chemical disinfection only, Not to be used with heat.
Over the Counter Use (21 CFR 801 Subpart C)
Over-the-Counter Use
Firdak Lee Cohen, MD
(Division Sign Division of Ophthalmic E Nose and Throat Devise
510(k) Number 042578