(92 days)
For storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only. Not to be used with heat.
The applicant contact lens case is a lens care product used by the contact lens wearer or practitioner for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only. Not to be used with heat. This device is manufactured in two variations: clear cap/blue cap and clear base and clear cap/green cap and clear base. The variants follow the same design and have the same intended use. The only difference is the color appearance between the two models. These variations do not affect the safety or effectiveness of the products' intended use. The right cap is labeled with the Letter 'R' to distinguish right and left lenses. The primary materials which compose the applicants device are M800E Polypropylene produced by Sinopec Shanghai Petrochemical Company Limited Plastics Division which is a translucent raw material and Heliogen Blue K6911D and Heliogen Green K8730 by BASF Corporation used as color additives. The applicant device of Contact Lens Case consists of 2 parts: case bottom (body) and case caps (covers). The volume of each of the two chambers in the applicant device is 3.8ml and the inner height of both wells is 10mm. The capacity of each well is sufficient for contact lens to be fully immersed under use conditions and can accommodate all lenses currently on the market.
This document describes the Sacks Holdings, Inc. Contact Lens Storage Case (K121030) and its substantial equivalence to a predicate device. It is a 510(k) summary, which focuses on demonstrating safety and effectiveness by comparing the new device to a legally marketed predicate device, rather than providing extensive clinical study data as might be found in a Premarket Approval (PMA) application for a novel, high-risk device.
Therefore, many of the typical acceptance criteria and study details relevant to AI/ML or efficacy studies are not applicable or detailed in this type of submission.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are essentially demonstrating substantial equivalence to the predicate device, primarily through non-clinical biocompatibility testing and showing similar technological characteristics and intended use. The "performance" is reported in terms of meeting these biocompatibility standards and aligning with the predicate.
| Acceptance Criteria (Demonstrated Equivalency) | Reported Device Performance |
|---|---|
| Intended Use/Indications for Use: For storage during chemical disinfection of soft (hydrophilic), rigid gas permeable, and hard contact lenses. For use during chemical disinfection only. Not to be used with heat. | Met: Matches the Intended Use/Indications for Use of the predicate device. |
| Disinfection Type: Chemical; Not heat. | Met: Matches the disinfection type of the predicate device. |
| Design: Two adjoining wells sufficient for lens immersion. Features like an 'R' label. | Similar, with minor differences: The subject device has two adjoining wells with screw-top caps and an embossed 'R' on the right cap, with contrasting cap colors. The predicate has two adjoining wells with integral hinged caps and an embossed 'R' on the right cap, with same cap colors. These differences are deemed not to affect safety or effectiveness. The well volume (3.8ml) and inner height (10mm) are sufficient for full immersion for all lenses currently on the market. |
| Materials: Biocompatible and suitable for intended use. | Different, but found safe: The subject device uses M800E Polypropylene and BASF Corporation colorants (Heliogen Blue K6911D, Heliogen Green K8730). The predicate uses Dow Chemical Company Low Density Polyethylene (Product #9931) and various Carolina Color Corporation Colorants. Despite different materials, biocompatibility testing (ISO 10993 series) demonstrated similar safety. |
| Biocompatibility: Meet ISO 10993 standards. | Met:- ISO 10993-5: 1999 (Cytotoxicity): Test article considered non-cytotoxic.- ISO 10993-10: 2002 (Irritation and Delayed-Type Hypersensitivity): Classified as non-irritating.- ISO 10993-11: 2006 (Systemic Toxicity): Requirements of Acute Systemic Injection Test met. The predicate device also underwent similar biocompatibility tests (In Vitro cytotoxicity, Delayed-type hypersensitivity, Eye irritation, Systemic toxicity). |
| Sterilization: Not sold sterile. | Met: Matches the status of the predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in this context. The "testing" referred to is biocompatibility testing of the material, not a clinical study involving human subjects or a dataset of patient cases. The tests are performed on material samples.
- Data Provenance: The biocompatibility tests (ISO 10993 standards) are laboratory-based, non-clinical tests performed on the device materials. There is no country of origin for "data" in the sense of clinical cases, nor is it retrospective or prospective in that manner.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/ML models (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for biocompatibility is whether the material meets the established safety standards (e.g., non-cytotoxic, non-irritating) as determined by laboratory assays and observations by qualified toxicology/biology experts, but their number and specific qualifications are not detailed in the 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for clinical outcome assessment or image interpretation, not for standard material biocompatibility testing. The results of the ISO 10993 tests are typically objective measurements or observations by a single, qualified lab technician/scientist and then interpreted against the standard criteria.
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 device is a physical contact lens case, not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical contact lens case, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for showing safety is adherence to established international standards for biocompatibility (ISO 10993 series). This is determined by laboratory test results (e.g., cell viability assays, skin irritation scores, systemic toxicity observations) compared against pre-defined thresholds within the standard, not by expert consensus on clinical cases, pathology, or outcomes data in the usual sense.
8. The sample size for the training set
Not applicable. This is a physical non-AI/ML medical device. There is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or corresponding ground truth for this type of device.
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510(k) SUMMARY
Sacks Holdings, Inc.
Contact Lens Storage Case
6 2012 JUL
1.0 Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Sacks Holdings, Inc. P.O. Box 676211 Rancho Santa Fe, CA 92067 Phone: 617-510-8796 Fax: 858-367-8798
Contact Person: Devin Chodorow
Date Prepared: July 5, 2012
- 2.0 Applicant Device Information Trade Name: Contact Lens Case Common Name: Contact Lens Case Classification Name: Case, Contact Lens Device Class II Product Code: LRX Regulation Number: 886.5928
- 3.0 Predicate Devices Trade Name: i-Promotions Contact Lens Case Applicant: i-Promotions, Inc. Classification Name: Case, Contact Lens Device Class II Product Code: LRX Regulation Number: 886.5928 510(k) Number: K042578
4.0 Device Description:
The applicant contact lens case is a lens care product used by the contact lens wearer or practitioner for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only. Not to be used with heat.
This device is manufactured in two variations: clear cap/blue cap and clear base and clear cap/green cap and clear base. The variants follow the same design and have the same intended use. The only difference is the color appearance between the two models. These variations do not affect the safety or effectiveness of the products' intended use. The right cap is labeled with the Letter 'R' to distinguish right and left lenses.
The primary materials which compose the applicants device are M800E Polypropylene produced by Sinopec Shanghai Petrochemical Company Limited Plastics Division which is a translucent raw material and Heliogen Blue K6911D and Heliogen Green K8730 by BASF Corporation used as color additives.
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The applicant device of Contact Lens Case consists of 2 parts: case bottom (body) and case caps (covers). The volume of each of the two chambers in the applicant device is 3.8ml and the inner height of both wells is 10mm. The capacity of each well is sufficient for contact lens to be fully immersed under use conditions and can accommodate all lenses currently on the market.
5.0 Intended Use:
The applicant contact lens case is for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only. Not to be used with heat.
| Sacks Holdings, IncContact Lens Case | i-Promotions Contact LensCase (K042578) | |
|---|---|---|
| Intended Use | Contact Lens Storage andChemical Disinfection | Contact Lens Storage andChemical Disinfection |
| Materials | Similar | Similar |
| Design | Similar | Similar |
| Case bottom with screw oncaps | Case bottom with hinged oncaps | |
| The letter "R" embossed onright cap | The letter "R" embossed onright cap | |
| Right and Left capcontrasting colors | Right and Left cap samecolors | |
| Labeling | Similar | Similar |
6.0 Technological Characteristics
Non-Clinical Performance Data
Sacks Holdings, Inc. Contact Lens Cases have been evaluated in accordance with Part 10993 of the International Standard Organization (ISO). Standard tests administered include:
- . ISO 10993-5: 1999 Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity. The test article is considered non-cytotoxic under the conditions of the test.
- ISO 10993-10 2002 Biological Evaluation of Medical Devices Tests of . Irritation and Delayed-Type Hypersensitivity. Under the conditions of this study, the Contact Lens Cases were classified as non-irritating.
- ISO 10993-11: 2006 Biological Evaluation of Medical Devices -- Tests for . Systemic Toxicity. The requirements of the ISO Acute Systemic Injection Test have been met by the test article.
Substantial Equivalence
Sacks Holding's contact lens storage case is as safe and effective as the identified predicate device. Sacks Holding's contact lens storage case has the same intended uses / indications for use and similar technological characteristics and principles of operation as the predicate device. Similar to the predicate device, biocompatibility testing demonstrates that the subject
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device is safe and effective for the intended use. Thus, Sacks Holding's contact lens storage case is substantially equivalent.
・
| Sacks Holdings, Inc.'sContact Lens Storage Case | i-PromotionsContact Lens Case(K042578) | |
|---|---|---|
| Intended Use/Indications for use | For storage during chemicaldisinfection of soft(hydrophilic), rigid gaspermeable and hard contactlenses. For use duringchemical disinfection only.Not to be used with heat. | For storage duringchemical disinfection ofsoft (hydrophilic), rigid gaspermeable and hardcontact lenses. For useduring chemicaldisinfection only. Not tobe used with heat. |
| Disinfection Type | Chemical; Not heat | Chemical; Not heat |
| Design | Two adjoining wells withscrew top caps into whichrespective lens are immersed | Two adjoining wells withintegral hinged caps intowhich respective lens areimmersed |
| Materials | M800E Polypropylene(Sinopec ShanghaiPetrochemical CompanyLimited Plastics Division)BASF Corporation Colorants:Heliogen Blue K6911D,BASF Heliogen Green K8730 | Dow Chemical CompanyLow Density Polyethylene(Product #9931)Various Carolina ColorCorporation Colorants |
| Biocompatibility | · ISO 10993-5: In Vitrocytotoxicity· ISO 10993-10: Irritationand delayed-typehypersensitivity· ISO 10993-11: Systemictoxicity | · In Vitro cytotoxicity· Delayed-typehypersensitivity· Eye irritation· Systemic toxicity |
| Sterilization | Not sold sterile | Not sold sterile |
Substantial Equivalence Chart
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sacks Holdings, Inc. c/o Mr. Devin Chodorow C.E.O. P.O. Box 676211 Rancho Santa Fe, CA 92067
JUL 6 2012
Re: K121030
Contact Lens Storage Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LRX Dated: June 6, 2012 Received: June 7, 2012
Dear Mr. Chodorow:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Devin Chodorow
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name: Contact Lens Storage Case
Indications for Use:
For storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only. Not to be used with heat.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Audie Klein, M.D.
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of 1
1121630 510(k) Number_
§ 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.”