(424 days)
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.
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.
The provided text is a 510(k) summary for contact lens cases, not a study evaluating a medical device's performance against acceptance criteria. It primarily focuses on establishing substantial equivalence to a predicate device. Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment is not present in this document.
However, I can extract information related to the comparison with the predicate device, which serves as the basis for demonstrating "substantial equivalence."
Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with quantitative thresholds. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" is implied by similarity to the predicate.
| Feature/Criterion (Implied Acceptance by Equivalence) | Predicate Device (Alcon Opti-Free Contact Lens Case) | Bonasse Device Performance (Flat Bed Soaking Case, Non-Vented Barrel Case) |
|---|---|---|
| Intended Use | Storage and chemical disinfection | Storage and chemical disinfection |
| Materials | (Similar - implied safe for contact lens storage/disinfection) | Similar (Biocompatibility testing demonstrated materials are safe) |
| Design - Flat Bed Case | Flat bed case with screw on caps. R/L embossed on caps. R/L cap contrasting colors. Non-vented caps. | Flat bed case with screw on caps. R/L embossed on caps. R/L cap same color. Non-vented caps. |
| Design - Barrel Case | (Not explicitly detailed for Alcon, but implied similar to currently marketed products) | Clear Barrel, White (screw on) cap; lens holder, lens basket. R/L marked on lens baskets. Non-vented cap. |
| Labeling | Similar | Similar, extra precautions added |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. No clinical or performance test set (as would be used for an AI/diagnostic device) is described. The evaluation is based on a comparison of design, materials, and intended use to a predicate device.
- Data Provenance: Not applicable. The comparison is based on device characteristics rather than a study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment by experts is described as this is a device for contact lens storage, not a diagnostic or AI device requiring expert interpretation of results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is described as there is no test set or expert interpretation involved.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document describes contact lens cases, not an AI-assisted diagnostic or interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical contact lens case, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a contact lens storage case, the "ground truth" for safety and effectiveness is largely established through material biocompatibility and design similarity to existing safe and effective products.
8. The sample size for the training set
Not applicable. No training set is involved for this type of device.
9. How the ground truth for the training set was established
Not applicable. No training set is involved for this type of device.
Summary of the Study/Evaluation Performed:
The "study" presented here is a comparison to a predicate device to establish substantial equivalence.
- Non-Clinical Tests: Biocompatibility testing was performed by a third-party laboratory to demonstrate the materials are safe for use. This can be considered a "performance test" for the materials.
- Clinical Tests: None were performed.
- Conclusion: The Bonasse Contact Lens cases are deemed safe and effective for their intended use based on their similarity in design, materials, and intended use to the Alcon Opti-Free contact lens case, and positive biocompatibility testing of the materials.
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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.
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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-FreeContact LensCase | Bonasse Flat BedSoaking Case | Bonasse NonVented BarrelCase | |
|---|---|---|---|
| Intended Use | Storage andchemicaldisinfection | Storage andchemicaldisinfection | Storage andchemicaldisinfection |
| Materials | Similar | Similar | Similar to CibaVision disposablecup (see below) |
| Design | Similar | Similar | Similar |
| Flat bed case withscrew on caps. | Flat bed case withscrew on caps. | Clear Barrel,White (screw on)cap; lens holder,lens basket. | |
| R/L embossed oncaps. | R/L embossed oncaps. | R/L marked onlens baskets. | |
| R/L capcontrasting colors | R/L cap samecolor | Non-vented cap | |
| Non-vented caps | Non-vented caps. | ||
| Labeling | Similar | Similar | Similar, extraprecautions added |
Comparison to Predicate Device: 6.
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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.
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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 .
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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
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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)
§ 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.”