(92 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a contact lens case, with no mention of AI or ML capabilities.
No
The device is a contact lens case used for storage during chemical disinfection of contact lenses, not for treating any medical condition.
No
This device is a contact lens case used for storage during chemical disinfection. Its purpose is for handling and sanitizing contact lenses, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (case bottom, case caps) made of specific materials (Polypropylene, color additives) and describes their physical characteristics (volume, height, labeling). This indicates a hardware device, not a software-only 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 process related to the care and maintenance of a medical device (contact lenses), not a diagnostic test performed on a biological sample.
- Device Description: The description details a physical container for contact lenses and disinfection solution. It does not describe any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition
- Using reagents or assays
The performance studies mentioned (ISO 10993 series) are related to the biocompatibility and safety of the materials used in the device when in contact with the body, which is typical for medical devices that come into contact with patients, but not specifically indicative of an IVD.
In summary, this device is a medical device used for the care of contact lenses, not a diagnostic tool.
N/A
Intended Use / Indications for 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.
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.
Product codes
LRX
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.
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.
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
Contact lens wearer or practitioner
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
1
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, Inc
Contact Lens Case | i-Promotions Contact Lens
Case (K042578) |
|--------------|---------------------------------------------------|---------------------------------------------------|
| Intended Use | Contact Lens Storage and
Chemical Disinfection | Contact Lens Storage and
Chemical Disinfection |
| Materials | Similar | Similar |
| Design | Similar | Similar |
| | Case bottom with screw on
caps | Case bottom with hinged on
caps |
| | The letter "R" embossed on
right cap | The letter "R" embossed on
right cap |
| | Right and Left cap
contrasting colors | Right and Left cap same
colors |
| 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
2
device is safe and effective for the intended use. Thus, Sacks Holding's contact lens storage case is substantially equivalent.
・
| | Sacks Holdings, Inc.'s
Contact Lens Storage Case | i-Promotions
Contact Lens Case
(K042578) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. |
| Disinfection Type | Chemical; Not heat | Chemical; Not heat |
| Design | Two adjoining wells with
screw top caps into which
respective lens are immersed | Two adjoining wells with
integral hinged caps into
which respective lens are
immersed |
| Materials | M800E Polypropylene
(Sinopec Shanghai
Petrochemical Company
Limited Plastics Division)
BASF Corporation Colorants:
Heliogen Blue K6911D,
BASF Heliogen Green K8730 | Dow Chemical Company
Low Density Polyethylene
(Product #9931)
Various Carolina Color
Corporation Colorants |
| Biocompatibility | · ISO 10993-5: In Vitro
cytotoxicity
· ISO 10993-10: Irritation
and delayed-type
hypersensitivity
· ISO 10993-11: Systemic
toxicity | · In Vitro cytotoxicity
· Delayed-type
hypersensitivity
· Eye irritation
· Systemic toxicity |
| Sterilization | Not sold sterile | Not sold sterile |
Substantial Equivalence Chart
3
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
4
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
5
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_