(29 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 technologies.
No
The device is described as a storage case for contact lenses during chemical disinfection, not as a device intended to treat or prevent a disease or condition in a patient.
No
Explanation: The device description and intended use clearly state that it is a case for storing contact lenses during chemical disinfection. There is no indication that it is used to diagnose any medical condition or to provide any diagnostic information.
No
The device description explicitly states it is a "moulded plastic, flat style 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 device used in the care and maintenance of a medical device (contact lenses), not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description is of a plastic case for storing contact lenses.
- 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.)
- Providing diagnostic information
- Using reagents or assays
The device is a contact lens accessory, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The SAUFLON Coloured Flat 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 SAUFLON Flat Coloured Lens Case are moulded plastic, flat style cases with screw top lids, similar in design to currently marketed products.
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 Coloured 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.”
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SAUFLON FLAT COLOURED CONTACT LENS CASES 510(k)
Image /page/0/Picture/2 description: The image shows a logo for a company called "SAUFLON PHARMACEUTIC LIMITED". The logo consists of a stylized eye symbol on the left, followed by the company name in a simple, sans-serif font. The eye symbol is made up of concentric shapes, creating a modern and abstract design. The text is stacked in three lines, with "SAUFLON" on the top, "PHARMACEUTIC" in the middle, and "LIMITED" on the bottom.
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 2833 |
| Official Correspondent | Miss Azitta Jadalizadeh |
| DATE PREPARED: | 30th September 2005 |
| Trade Name: | SAUFLON Flat Coloured Lens Case |
| Common Name: | Contact Lens Case |
| Classification: | CLASS II (21 CFR 886.5925) |
DEVICE DESCRIPTION
The SAUFLON Flat Coloured Lens Case are moulded plastic, flat style cases with screw top lids, similar in design to currently marketed products.
INTENDED USE
The SAUFLON Coloured Flat 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 Flat Coloured 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 Coloured Lens Case. Results of the testing show no evidence of cellular or systemic toxicity, or ocular irritation.
SUBSTANTIAL EQUIVALENCE:
The SAUFLON Flat Coloured contact lens cases are substantially equivalent in terms of indications for use, safety and effectiveness to the Bausch and Lomb Lens Case.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.
NOV - 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sauflon Pharmaceuticals, Ltd. c/o Azitta Jadalizadeh 49-53 York Street Twickenham, Middlesex TW1 3LP UK
Re: K052809
Trade/Device Name: Sauflon Flat Colored Contact Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LRX Dated: September 30, 2005 Received: October 4, 2005
Dear Ms. Jadalizadeh:
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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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) 827-8910. 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/industry/support/index.html.
Sincerely yours.
David M. Whipple
David M. Whipple Acting 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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Image /page/3/Picture/0 description: The image shows a logo with a stylized eye-shaped symbol on the left and the text "SAUFLON PHARMACEUTICALS LIMITED" on the right. The eye-shaped symbol is made up of curved lines and a solid black circle in the center. The text is stacked in three lines, with "SAUFLON" on the top line, "PHARMACEUTICALS" on the second line, and "LIMITED" on the bottom line. The text is in a simple, sans-serif font.
SAUFLON FLAT COLOURED CONTACT LENS CASE 510(k)
:
:
ాంభేష . . . .
・
INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K052809 |
|---|---|
| Device Name: | SAUFLON Flat Coloured Lens Case |
| Indications For 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)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The Counter | X |
|---|---|---|---|
| (Division Sign-Off) /Division of Ophthalmic Ear, Nose and Throat Devises | gs | ||
| 510(k) Number | K052809 |
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