(76 days)
Not Found
There are no Reference Devices listed in the provided text.
No
The device description and performance studies focus on the material safety and disinfection capabilities of a contact lens storage case, with no mention of AI or ML.
No
The device is a storage case for contact lenses during chemical disinfection, not a treatment for a medical condition.
No
Explanation: The document clearly states the device is intended for "Storage of soft (hydrophilic)/rigid gas permeable and hard contact lenses during chemical disinfection." It does not mention any function related to diagnosing medical conditions or diseases.
No
The device description clearly states it is a "contact lens storage case," which is a physical hardware product. The performance studies also focus on material safety (cytotoxicity, systemic toxicity, ocular irritation), which are relevant to a physical 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 taken from the human body.
- Device Description: The description reinforces the storage function.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on safety (cytotoxicity, systemic toxicity, ocular irritation) related to the materials and their interaction with the contact lenses and the eye, not on diagnostic accuracy.
- Predicate Device: The predicate device is another contact lens case, further indicating its non-diagnostic nature.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This contact lens case does not perform any such function.
N/A
Intended Use / Indications for Use
Storage of soft (hydrorophilic)/rigid gas permeable and hard contact lenses during chemical disinfection. Use during chemical disinfection only. DO NOT USE WITH HEAT
Product codes
LRX
Device Description
The Pelican Products, Inc contact lens storage cases are intended for use for storage of soft, hard and rigid gas permeable contact lenses during chemical disinfection. Not to be used for 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Cytotoxicity, systemic toxicity and ocular irritation studies were performed to assess the safety and effectiveness of the Pelican Products, Inc in accordance with the guidelines set forth in the FDA'S Guidance document titled " Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.
The test results showed no evidence of cellular or systemic toxicity, or ocular irritation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
8.0 510 (k) Summary
| 1.0 | Name and
address of
Submitter | Pelican Products, Inc.
2248 Highway 43 North
Pelahatchie, MS 39145c | JUN 1 2 2003 |
|-----|-------------------------------------|---------------------------------------------------------------------------|--------------|
| | Contact Person | James Hemphill Jr.
Tel.: 601-854-6777
Fax 601-854-6998 | |
| | Date Prepared | 3/26/03 | |
2.0 Name of Device
-
� Trade Name:
#500/600 (deep well lens case with integral lids) #700 (ultra clear single lens case with cap) #750/750U (billboard lens case with caps) #800 (curved lens case with caps) #900G (lens vial w/gasket and cap) -
Classification Name: Contact Lens Storage Case �
3.0 Indications
Storage of soft (hydrophilic)/rigid gas permeable and hard contact lenses during chemical disinfection. Use during chemical disinfection only. DO NOT USE WITH HEAT
4.0 Device Description
The Pelican Products, Inc contact lens storage cases are intended for use for storage of soft, hard and rigid gas permeable contact lenses during chemical disinfection. Not to be used for heat disinfection.
5.0 Substantially Equivalent:
Pelican Products, Inc. contact lens storage cases are substantially equivalent in terms of indication for use and safety and effectiveness to the Alcon contact Lens Case.
6.0 Summary of Safety and Effectiveness
Cytotoxicity, systemic toxicity and ocular irritation studies were performed to assess the safety and effectiveness of the Pelican Products, Inc in accordance with the guidelines set forth in the FDA'S Guidance document titled " Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.
The test results showed no evidence of cellular or systemic toxicity, or ocular irritation.
7.0 Conclusion
The Pelican Products, Inc contact lens storage case are safe and effective for their intended use.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2003
Pelican Products, Inc. c/o Ms. Carol Noble Horizon Consulting 611 Eisenhauer Street Grand Junction, CO 81505
Re: K030987
Trade/Device Name: Contact Lens Storage Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LRX Dated: March 26, 2003 Received: March 28, 2003
Dear Ms. Carol Noble:
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.
2
Page 2 - Ms. Carol Noble
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.
A. Palgyi 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
3
INDICATIONS FOR USE STATEMENT 5.0
Device Name:
- #500/600 (deep well lens case with integral lids) �
- #700 (ultra clear single lens case with cap) �
- #750/750U (billboard lens case with caps) �
- #800 (curved lens case with caps) �
- #900G (lens vial w/gasket and cap) �
Indication of Use:
Storage of soft (hydrophilic)/rigid gas permeable and hard contact lenses during chemical disinfection. Use during chemical disinfection only. DO NOT USE WITH HEAT
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR |
|---|---|
| (Per 21 CFR 801.109) | |
| (Optional Format 1-2+96) . |
Over-The-Counter Use
t 1-2-96).
Daniel W. C. Brown, P.H.D.
(Division Sign Off)
K030987 510/k) Numbe