(73 days)
Not Found
Not Found
No
The device description and performance studies focus on the material safety and design 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, not for treating a medical condition or disease.
No
Explanation: The device is a contact lens case used for storage and disinfection, not for diagnosing medical conditions. The performance studies focus on safety (toxicity, irritation), not diagnostic accuracy.
No
The device description explicitly states it is a "moulded plastic" case, indicating it 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 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 device is a plastic case for holding contact lenses. This is a medical device, but not one used for in vitro diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body 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
The SAUFLON Flat and Barrel Lens Case 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.
Product codes (comma separated list FDA assigned to the subject device)
LRX
Device Description
The SAUJFLON contact lens cases are moulded plastic, flat or barrel style cases with screw top leads, similar in design to currently marketed products. The barrel style include a lens basket used for holding the lens during storage.
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 SAUFLON Flat and Barrel Lens Case. Results of the testing show no evidence of cellular or systemic toxicity, or ocular irritation.
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.
The Bausch and Lomb Lens Case
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
Image /page/0/Picture/1 description: The image shows a logo for Salifron Pharmaceutical Limited. The logo consists of a stylized image of a water droplet on the left, and the company name on the right. The company name is written in a simple, sans-serif font.
FEB - 2 2004
510(k) Summary
SUBMITTER INFORMATION:
| Company Name: | Sauflon Pharmaceuticals Ltd. |
|---|---|
| Address: | 49 – 53 York Street |
| Twickenham | |
| Middlesex | |
| TW1 3LP | |
| Phone: | 020 8322 4200 |
| Fax: | 020 8891 3001 |
| Official Correspondent | Dr Ligia Delacruz |
| DATE PREPARED: | 14th November 2003 |
| DEVICE NAME: | |
| Trade Name: | SAUFLON Flat Lens Case |
| SAUFLON 2003 Barrel Lens Case | |
| Common Name: | Contact Lens Case |
| Classification: | CLASS II (21 CFR 886.5925) |
DEVICE DESCRIPTION
The SAUJFLON contact lens cases are moulded plastic, flat or barrel style cases with screw top leads, similar in design to currently marketed products. The barrel style include a lens basket used for holding the lens during storage.
INTENDED USE
The SAUFLON Flat and Barrel Lens Case 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.
PREDICATE DEVICE
The Bausch and Lomb Lens Case was selected as the predicate device for the SAUFLON contact lens cases.
SUMMARY OF SAFETY AND EFFECTIVENESS
Cytotoxicity, systemic toxicity and ocular irritation studies were performed to assess the safety and effectiveness of the SAUFLON Flat and Barrel Lens Case. Results of the testing show no evidence of cellular or systemic toxicity, or ocular irritation.
SUBSTANTIAL EQUIVALENCE:
The SAUFLON contact lens cases are substantially equivalent in terms of indication for use, safety and effectiveness to the Bausch and Lomb Lens Case.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 2 2004
KEA Plastics Ltd. c/o Dr. Ligia Delacruz Sauflon Pharmaceuticals Ltd. 49-53 York Street Twickenham, Middlesex TW1 3LP United Kindom
Re: K033656
Trade/Device Name: SAUFLON Flat Lens Case SAUFLON 2003 Barrel Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LRX Dated: November 14, 2003 Received: November 21, 2003
Dear Dr. Delacruz:
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 adultcration.
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 requrements, 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
Pagc 2 - Dr. Ligia Delacruz
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.
Ahalye 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
Image /page/3/Picture/0 description: The image shows a logo with a stylized eye-like symbol on the left and the text "SAURON PHARMACEU LIMITED" on the right. The text is stacked vertically, with "SAURON" on the top line, "PHARMACEU" on the second line, and "LIMITED" on the bottom line. The font appears to be sans-serif and the text is in black.
4-1
SAUFLON CONTACT LENS CASES 510(k)
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K033686
Device Name:
SAUFLON Flat Lens Case SAUFLON 2003 Barrel Lens Case
Indications For Use:
Prescription Use
Storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection only. Not to be used for heat disinfection.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Harvel W. Brown, Ph.D.
Concur(Since Sion Sign Off)Office of Device Evaluation (ODE) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K033656
Prescription Use __ OR Over-The-Counter X
(Per 21 CFR 801.109)