(43 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical compatibility of a contact lens cleaner, with no mention of AI or ML technologies.
No
The device is a cleaner for contact lenses, designed to remove deposits and debris from the lenses. It is not applied to the body or used to treat or diagnose a medical condition.
No
Explanation: The device is described as a cleaner for contact lenses, designed to remove film, deposits, and debris. Its purpose is maintaining the cleanliness and compatibility of contact lenses, not diagnosing medical conditions or diseases.
No
The device description clearly states it is a sterile, viscous, aqueous solution packaged in a plastic bottle, indicating it is a physical product (liquid cleaner and packaging) and 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 to clean contact lenses, which are medical devices worn on the eye. This is a cleaning and maintenance function for a medical device, not a diagnostic test performed on a biological sample in vitro (outside the body).
- Device Description: The description details a cleaning solution for contact lenses. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on the compatibility and cytotoxicity of the cleaner with contact lenses, not on the accuracy or performance of a diagnostic test.
- Predicate Device: The predicate device is also a contact lens cleaner, further supporting that this device falls under the category of contact lens care products, not IVDs.
IVDs are devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is a cleaner for removal of film, deposits and other accumulated debris, which accumulate on Silicone Hydrogel soft contact lenses during wear.
Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is to be used with a Multipurpose Solution indicated for Silicone Hydrogel soft contact lenses. Follow the recommendation of your eye care practitioner when disinfecting your lenses.
Product codes (comma separated list FDA assigned to the subject device)
LPN
Device Description
Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is a sterile, viscous, aqueous solution with an alkaline pH. The cleaner contains no added preservatives. The cleaner contains an amphoteric surfactant to aid in the removal of film, deposits and other debris that accumulates on contact lenses during wear. The cleaner is not meant for use in the eve and must be thoroughly rinsed from the lenses.
Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is packaged in a 1 FL OZ plastic bottle (polyethylene) with red dropper tip (polyethylene) and white over-cap (polypropylene). It has an outside cardboard carton. It has an expiration date of two years from the date of bottling.
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)
Pre-Clinical Performance Data:
A 30 day Silicone Hydrogel compatibility study was conducted to test the compatibility of Sereine Extra Strength Daily Cleaner on Silicone Hydrogel soft lens parameters. Four Silicone Hydrogel contact lens types were tested: senofilcon A, lotrafilcon A, comfilcon A, and balafilcon A. A baseline of parameters was measured using ISO standard 81369-2, and none of the lenses showed a change in baseline parameters as well as none of the lenses showed discoloration or any change in lens clarity. It was concluded that the Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is physically compatible with senofilcon A, lotrafilcon A, comfilcon A. and balafilcon A lenses.
Cytotoxicity studies - ISO Direct Contact Test:
Studies were conducted on the four Silicone Hydrogel lenses after a 30 day regime cleaning period with the Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses. It was concluded that the lenses met ISO requirements for Cytotoxicity.
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
JUN 1 3 2007
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
1071203
Applicant information:
Date Prepared:
April 25, 2007
Ms. Sally Cook
(303) 936-1137
President
Name: Address Optikem International, Inc. 2172 South Jason Street Denver, CO 80223
Contact Person:
Phone number:
USA Consultant:
Phone number: Fax number: Email address:
MedVice Consulting, Inc. Mr. Martin Dalsing (970) 243-5490 (970) 243-5501 marty@FDApproval.com
Device Information:
Device Classification:
Classification Name:
Class II
Classification Number:
LPN 886.5928
Accessories, soft lens products Soft (hydrophilic) contact lens care products
Trade Name:
Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses
1
Purpose of 510(k) Submission:
New Device
Optikem International, Inc. proposes to market and sell in United States interstate commerce. The Sereine Extra Strength Daily Cleaner for use with Silicone Hydrogel contact lens material. Data supporting the safety and effectiveness of cleaning Silicon. Hydrogel contact lens materials are included in this submission. The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is the same solution as cleared in 510(k) K011561.
Equivalent Devices:
The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is the same solution as cleared in 510(k) K011561, which is substantially equivalent to the MIRAFLOW cleaner by CIBA Vision. The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is substantially equivalent in terms of its actions, and formulation.
PREDICATE DEVICE ~
-
The Sereine Extra Strength Daily Cleaner Manufactured by Optikem International, Inc.
Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses meets the guidelines set forth in FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.
Device Description:
Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is a sterile, viscous, aqueous solution with an alkaline pH. The cleaner contains no added preservatives. The cleaner contains an amphoteric surfactant to aid in the removal of film, deposits and other debris that accumulates on contact lenses during wear. The cleaner is not meant for use in the eve and must be thoroughly rinsed from the lenses.
Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is packaged in a 1 FL OZ plastic bottle (polyethylene) with red dropper tip (polyethylene) and white over-cap (polypropylene). It has an outside cardboard carton. It has an expiration date of two years from the date of bottling.
2
Intended Use:
The intended use of the device is as a daily cleaner or the removal of proteins, lipids and other debris that accumulates on contact lenses during wear. The device is to be used for the removal of this debris immediately after the lenses are removed from the eye. The device is intended for use as a cleaner with Silicone Hydrogel contact lenses. The device is not intended for use in the eye and must be physically rinsed from the lens using either saline solution or multipurpose solution cleared for use on Silicone Hydrogel prior to insertion.
Pre-Clinical Performance Data:
Data to demonstrate the safety and effectiveness of the Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses when used to clean Silicone Hydrogel contact lenses are included in this submission and supported by the following studies:
30 day Silicone Hydrogel compatibility study 용
A study was conducted to test the compatibility of Sereine Extra Strength Daily Cleaner on Silicone Hydrogel soft lens parameters. Four Silicone Hydrogel contact lens types were tested: senofilcon A, lotrafilcon A, comfilcon A, and balafilcon A. A baseline of parameters was measured using ISO standard 81369-2, and none of the lenses showed a change in baseline parameters as well as none of the lenses showed discoloration or any change in lens clarity. It was concluded that the Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is physically compatible with senofilcon A, lotrafilcon A, comfilcon A. and balafilcon A lenses.
| Product
Name | Lens Type
(USAN) | Parameter
Change 15 days | Parameter Change
30 days | Color
Change |
|-----------------|---------------------|-----------------------------|-----------------------------|-----------------|
| OASYS | senofilcon A | No Change | No Change | No Change |
| Night & Day | lotrafilcon A | No Change | No Change | No Change |
| Biofinity | comfilcon A | No Change | No Change | No Change |
| Purevision | balafilcon A | No Change | No Change | No Change |
3
Cytotoxicity studies - ISO Direct Contact Test l
Studies were conducted on the four Silicone Hydrogel lenses after a 30 day regime cleaning period with the Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses. It was concluded that the lenses met ISO requirements for Cytotoxicity.
All other safety and efficacy data can be referenced in previously cleared 510(k) K011561. Permission to reference 510(k) K011561 is included in this 510(k).
Substantial Equivalence:
The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is substantially equivalent to the following predicate devices:
- The Sereine Extra Strength Daily Cleaner Manufactured by Optikem l International, Inc.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with three curved lines representing its wings and tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Optikem International, Inc. c/o Mr. Martin Dalsing MedVice Consulting, Inc. 2214 Sanford Drive, Unit B7 Grand Junction, CO 81505
JUN 1 8 2007
Re: K071203
Trade/Device Name: Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SiHy) Soft Contact Lenses Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: April 25, 2007 Received: May 1, 2007
Dear Mr. Dalsing:
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.
5
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eichelman Simd
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE STATEMENT
Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Device Name: Lenses
INDICATIONS FOR USE:
The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is a cleaner for removal of film, deposits and other accumulated debris, which accumulate on Silicone Hydrogel soft contact lenses during wear.
Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is to be used with a Multipurpose Solution indicated for Silicone Hydrogel soft contact lenses. Follow the recommendation of your eye care practitioner when disinfecting your lenses.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K071203
Prescription Use __
or
Over-The-Counter Use X
(Per 21 CFR 801.109)
(Optional Format 1-2-96)