(424 days)
Alcon Opti-Free Contact Lens case
Not Found
No
The device description and intended use are for a simple plastic contact lens case, with no mention of any computational or analytical capabilities.
No
The device is described as a storage container for contact lenses during chemical disinfection, not a device that provides therapy or treatment for a disease or condition.
No
The device is a contact lens case used for storage during chemical disinfection, and no diagnostic function is mentioned in its intended use, indications for use, or device description.
No
The device description explicitly states it is a molded plastic contact lens case, which is a physical 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 taken from the human body.
- Device Description: The device is a plastic case for holding contact lenses. This is a physical container, not a reagent, instrument, or system used for in vitro examination of specimens.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze a sample (like blood, urine, tissue, etc.) to provide information about a person's health or condition.
- No Mention of Diagnostic Performance: The performance studies mentioned focus on biocompatibility, not diagnostic accuracy (like sensitivity, specificity, etc.).
IVDs are devices used to perform tests on samples taken from the human body 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
The Bonasse Flat Bed and non-vented barrel style of Contact Lens Cases are For storage of soft (hydrophilic), rigid gas permeable (RGP), and hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Not to be used with hydrogen peroxide disinfection systems.
Product codes (comma separated list FDA assigned to the subject device)
86 LRX
Device Description
The Bonasse contact lens cases are molded plastic, flat or barrel style cases with screw top lids, similar in design to currently marketed products. The barrel styles 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)
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence is as follows: Biocompatibility testing by a third party laboratory demonstrated the materials are safe for use in contact lens storage and disinfection.
Discussion of Clinical Tests Performed: 8. No clinical test were performed
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.
Alcon Opti-Free Contact 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
JUN - 6 2000
510(K) SUMMARY
This summary of 5l0(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is: K991206
Submitter's Identification: 1.
Sponsor:
Bonasse Enterprises Company, Ltd. No. 7 Lane 16 Yuon-An South Rd., Sec. 2 Luchou City, Taipei, Taiwan
Submitted by:
Carolann Kotula mdi Consultants Phone: 770-985-8293 770-736-8218 Fax: mdi@mdiconsultants.com
Date Summary Prepared: May 30, 2000
2. Name of the Device:
The subject devices for this submission are the following:
Bonasse Flat Bed Soaking case, Model SC 106 White case and caps
Bonasse Non-Vented Barrel Style Contact Lens Case. Models BC 760-1-2-3; BC-793. White cap, lens holder, lens basket Clear Barrel
3. Predicate Device Information:
The Bonasse Contact Lens cases are substantially equivalent in design, materials, and intended use to the Alcon Opti-Free contact lens case.
1
Device Description: 4.
The Bonasse contact lens cases are molded plastic, flat or barrel style cases with screw top lids, similar in design to currently marketed products. The barrel styles include a lens basket used for holding the lens during storage.
ક. intended Use:
The Bonasse Flat Bed and non-vented barrel style of Contact Lens Cases are For storage of soft (hydrophilic), rigid gas permeable (RGP), and hard contact lenses during chemical disinfection.
2007年07月26日 10時間 2007 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
| | Alcon Opti-Free
Contact Lens
Case | Bonasse Flat Bed
Soaking Case | Bonasse Non
Vented Barrel
Case |
|--------------|-----------------------------------------|-----------------------------------------|------------------------------------------------------------------------|
| Intended Use | Storage and
chemical
disinfection | Storage and
chemical
disinfection | Storage and
chemical
disinfection |
| Materials | Similar | Similar | Similar to Ciba
Vision disposable
cup (see below) |
| Design | Similar | Similar | Similar |
| | Flat bed case with
screw on caps. | Flat bed case with
screw on caps. | Clear Barrel,
White (screw on)
cap; lens holder,
lens basket. |
| | R/L embossed on
caps. | R/L embossed on
caps. | R/L marked on
lens baskets. |
| | R/L cap
contrasting colors | R/L cap same
color | Non-vented cap |
| | Non-vented caps | Non-vented caps. | |
| Labeling | Similar | Similar | Similar, extra
precautions added |
Comparison to Predicate Device: 6.
2
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence is as follows:
Biocompatibility testing by a third party laboratory demonstrated the materials are safe for use in contact lens storage and disinfection.
Discussion of Clinical Tests Performed: 8.
No clinical test were performed
න් Conclusions:
The Bonasse Contact Lens cases are safe and effective for their intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
JUN - 6 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bonasse Enterprise Co., Ltd. c/o Ms. Carolann Kotula MDI Consultants, Inc. 55 Northern Blvd. Great Neck, NY 11021
Re: K991206 Trade Name: Bonasse Flat Bed Soaking Case Model SC 106 (white: case and caps) Bonasse Non-Vented Barrel Style Contact Lens Case onasse Non- Vol. Vol. 1-2-3; BC-793 (white: cap, lens holder, and lens basket; clear: barrel) Regulatory Class: Unclassified Product Code: 86 LRX Dated: April 21, 2000 Received: April 25, 2000
Dear Mr. Beneke:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your boomen be device is substantially equivalent (for the indications for above and we have determined thices marketed in interstate commerce prior to May 28, 1976, use stated in the enereday) volical Device Amendments, or to devices that have been the chactified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act 1 coulsment in accordino ", market the device, subject to the general controls provisions of the (Icc. The general controls provisions of the Act include requirements for annual registration, I sting 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 (Premarket Approval), it may be subject to such additional controls. Existing major (1 remained iffecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System earrent Good Manazonical Devices: General regulation (21 CFR Part 820) and that, through rogations (QS) inspections, the Food and Drug Administration (FDA) will verify such perfoule (Q) inspections with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under ally Selectronic Product Radiation Control provisions, or other Federal laws or regulations .
4
Page 2 - Mr. Ralph H. Larsen
This letter will allow you to begin marketing your device as described in your 510(k) premarket I has letter will are your finding of substantial equivalence of your device to a legally marketed notication: "The PDF intentig of cation 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 and 11 you desire openite an were diagnostic devices), please contact the Office of Compliance at (301) 594-6413. Additionally, for questions on the promotion and advertising of your device, please 571 0115. Traditional), and Compliance at (301) 594-4639. Also, please note the regulation entitled, eonation by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers on your respendents and are and or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Attachment 3
Page 1 of 1
510(k) Number (if known): K991206
- Device Name: Bonasse Flat Bed Soaking case, Model SC 106 White caps and case
Bonasse Non-Vented Barrel Style Contact Lens Case. Models BC 760-1-2-3, BC-793. White cap, lens holder, lens basket Clear barrel
Indications for Use:
For storage of soft (hydrophilic), rigid gas permeable (RGP), and hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Not to be used with hydrogen peroxide disinfection systems.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) | |
Division of Ophthalmic Devices |
510(k) Number | K 991206 |
---|---|
--------------- | ---------- |
Prescription Use | Over-The-Counter Use |
---|---|
(Per 21 CFR 801.109) | OR |
(Optional Format 1-2-96)