(43 days)
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No
The device description and intended use are for a contact lens cleaning solution, which is a chemical product and does not involve software or data processing. There are no mentions of AI, ML, or image processing.
No.
The document describes a contact lens solution for cleaning and disinfection, not a device used to treat a medical condition.
No
Explanation: The device is a multi-purpose solution for cleaning, rinsing, disinfecting, and storing contact lenses. Its function is to maintain the lenses, not to diagnose any medical condition or disease.
No
The device description clearly states it is a sterile, isotonic solution containing various chemical components and packaged in plastic bottles, indicating it is a physical product, 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 for the cleaning, rinsing, disinfection, protein removal, and storage of contact lenses. This is a product used on a medical device (contact lenses) and by the patient or eye care practitioner, not a test performed on a biological sample to diagnose a condition or provide information about a physiological state.
- Device Description: The description details the chemical composition of a solution for contact lens care. It doesn't describe a test kit, reagent, instrument, or system intended for in vitro examination of specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVDs, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes
- Using reagents for testing
Therefore, the JSZ Multipurpose Solution falls under the category of a medical device used for the care of another medical device (contact lenses), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The JSZ Multipurpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage of soft (hydrophilic) contact lenses as recommended by the eye care practitioner.
Product codes (comma separated list FDA assigned to the subject device)
LPN
Device Description
The JSZ-Multipurpose Solution is a sterile, isotonic solution that contains poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorhexidine or thimerosal. This product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Chemistry:
- Solution compatibility: Demonstrated by cycling lenses through 30 cycles of simulated use (cleaning, rinsing, disinfecting, storing). Parameters of lenses were measured before and after 30 cycles, and no differences were found.
- Cleaning effectiveness: Shown by determining the critical micelle concentration.
- Toxicology:
- Agar Overlay Cytotoxicity: Test lens types exposed to JSZ-Multipurpose Solution for 24 hours, then tested in a direct contact cytotoxicity assay. All test lens types were noncytotoxic.
- Systemic Toxicity: Evaluated by intraperitoneal (ip) injection in healthy mice (50ml/kg body weight), observed over 72 hours. No difference from control animals injected with saline.
- Acute Oral Toxicity: Evaluated by intubation in healthy rats (5ml/kg body weight), observed immediately, after 2 and 4 hours, then daily for fourteen days. Animals weighed prior to intubation, at 7 days, and at 14 days. No clinical signs of toxicity.
- Acute Ocular Irritation: Instilled directly into one eye of three rabbits, other eye received sterile water as control. Examinations over 72 hours showed no differences between test and control eyes, with no evidence of ocular irritation.
- USP Class VI Testing (for bottles manufactured of PETROTHENE LR 7320-01 high density polyethylene):
- Cytotoxicity Test: SC test extract showed no evidence of causing cell lysis or toxicity. Not cytotoxic and passed ISO study.
- Systemic Toxicity Test: No mortality or evidence of significant systemic toxicity from the extracts. Met USP requirements.
- Ocular Irritation Study: No evidence of significant irritation in the test or control eye of any rabbit. SC and CSO test article extracts would not be considered irritants to the ocular tissue of the rabbits.
- Microbiology:
- Sterility: Sterility data included.
- Preservative efficacy: Passed requirements of the preservative efficacy test.
- Disinfection Efficacy: Passed the requirements of the stand-alone and multi-item testing.
- Stability: Stability data included.
- Clinical Data:
- Six months usage by 246 subjects wearing representative soft (hydrophilic) contact lenses, compared to control groups using currently marketed care products. Showed substantial equivalence to current solutions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.”
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 8 2005
John M. Szabocsik, Ph.D. SZABOCSIK AND ASSOCIATES Suite 1200 203 North Wabash Avenue Chicago, IL 60601
Re: K050517 Trade/Device Name: JSZ Multipurpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated (Date on orig SE 1tr): February 18, 2005 Received (Date on orig SE Itr): March 1, 2005
Dear Dr. Szabocsik:
This letter corrects our substantially equivalent letter of April 13, 2005 regarding the trade name section of the reference block.
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 (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 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
1
Page 2 - John M. Szabocsik, Ph.D.
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.
This letter will allow you to continue 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 (301) 827-8910. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
David M. Whipple
David M. Whipple Acting Director Division of Ophthalmic 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) K 05 05 05 17
Device Name: İSZ Multipurpose Solution
- ﻧ
Indications for Use The JSZ Multipurpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage of soft (hydrophilic) contact lenses as recommended by the eye care practitioner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K050517 |
|---|---|
| Prescription Use | OR Over-The-Counter-Use |
| (Per 21 CFR 801.109) | |
| (Optional Format 1-2-96) |
ﺔ ﺍﻟﻤﺘ
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APR 1 3 2005
1050517
JSZ-Multipurpose Solution 510(k) FOI Summary
510(k) SUMMARY
JSZ-MULTIPURPOSE SOLUTION FOR SOFT (HYDROPHILIC) CONTACT LENSES
This summary uses the format provided in 21 CFR 807.92:
| (a)(1). Submitter: | John M. Szabocsik, PhD
President
SZABOCSIK AND ASSOCIATES INC
203 N WABASH AVE STE 1200
CHICAGO IL 60601
Phone 312-553-0828
FAX 312-553-0611 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary prepared: | February 18, 2005 |
| (a)(2) Device Trade Name: | JSZ-Multipurpose Solution |
| Device Common Name: | Soft (hydrophilic) contact lens solution |
Device Classification Name:
Accessories to Contact Lens Solution (86LPN)
(a)(3) Identification of Predicate Device:
This product is substantially equivalent to other currently marketed contact lens care multipurpose solutions.
(a)(4) Device Description:
The JSZ-Multipurpose Solution is a sterile, isotonic solution that contains poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorhexidine or thimerosal.
This product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
(a)(5) Intended Use (Indications for Use):
The JSZ Multipurpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage of soft (hydrophilic) contact lenses as recommended by the eye care practitioner.
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(a)(6) Comparison of Technological Characteristics:
No changes have been made to the product formulation subject to this application.
Discussion of Nonclinical: b)(1)
- I. Chemistry
A. Solution compatibility
The compatibility of the JSZ-Multipurpose Solution was demonstrated by cycling lenses through 30 cycles of simulated use, using the JSZ-Multipurpose Solution for cleaning, rinsing, disinfecting and storing. Parameters of lenses were measured before and after the 30 cycles, and no differences were found.
B. Cleaning effectiveness
The efficacy of the JSZ-Multipurpose Solution as a daily cleaner was shown by determining the critical micelle concentration.
II. Toxicology
The toxicological testing is summarized below, and reports are attached. The solution was shown to be non-toxic in all tests. Additional toxicity testing (cytotoxicity, systemic toxicity and ocular irritation) was done to verify the safety of the solution in the contract manufacturer's bottle.
Agar Overlay Cytotoxicity: A.
Representative lenses from all four groups of soft (hydrophilic) lens types were exposed to the JSZ-Multipurpose Solution for 24 hours, then tested in a direct contact cytotoxicity assay. All test lens types were noncytotoxic.
Systemic Toxicity: B.
The JSZ-Multipurpose Solution was evaluated for systemic toxicity by intraperitoneal (ip) injection in healthy mice, 50ml/kg body weight. The animals were observed over a 72 hour period, and showed no difference from control animals injected with saline. The solution passed the test requirements, that there be no difference between the response of test and control animals.
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C. Acute Oral Toxicity
The JSZ-Multipurpose Solution was evaluated for acute oral toxicity by intubation in healthy rats, 5ml/kg body weight. The animals were observed immediately after intubation, after 2 and 4 hours, then daily for fourteen days. The animals were weighed prior to intubation, at 7 days, and at 14 days. All animals showed no clinical signs of toxicity from test initiation to Day 14, therefore the JSZ-Multipurpose Solution passed the test requirements of no acute oral toxicity.
Acute Ocular Irritation: D.
The JSZ-Multipurpose Solution was instilled directly into one eye of each of three rabbits, the other eye receiving sterile water as a control. Examinations over 72 hours showed no differences between test and control eyes, with no evidence of ocular irritation with either the test or control solutions. The JSZ-Multipurpose Solution therefore meets the requirements of the acute ocular irritation test, that it does not cause ocular irritation.
- Full USP Class VI Testing of JSZ-Multipurpose Solution in bottles E. manufactured of PETROTHENE® LR 7320-01 high density polyethylene.
- Cytotoxicity Test: 1.
Under the conditions of this study, the SC test extract showed no evidence of causing cell lysis or toxicity. The negative controls, reagent controls, and the positive controls performed as anticipated. The SC test extract was not cytotoxic and passed this ISO study.
Systemic Toxicity Test: 2. Under the conditions of this study, there was no mortality or evidence of significant systemic toxicity from the extracts. Each test article extract met with
USP requirements.
Ocular Irritation Study: 3.
Under the conditions of this study, there was no evidence of significant irritation in the test or control eye of any rabbit. The SC and CSO test article extracts would not be considered irritants to the ocular tissue of the rabbits.
Microbiology III.
Sterility A.
Sterility data is included from the contract manufacturer.
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Preservative efficacy B.
The JSZ-Multipurpose Solution solution passed the requirements of the preservative efficacy test.
..
Disinfection Efficacy C.
The JSZ-Multipurpose Solution passed the requirements of the stand-alone of The JSZ-Multipurpose Solution passed the requirements for the multi-item testing.
Stability D.
Stability data is included from the contract manufacturer.
(b)(2) Discussion of Clinical Data:
A clinical trial of 6 months usage of the JSZ-Multipurpose Solution by A clinical trial of 6 monuls usage of the 382 mount of soft (hydrophilic)
246 subjects, wearing representative lenses from all marked care 246 subjects, wearing representative rouses using currently marketed care
contact lenses, compared to control groups using currently marketed care contact lenses, compared to control groups asing our unstally
products, showed that the product is substantially equivalent to those current solutions.
(b)(3) Conclusions Drawn from Data Supporting Equivalence Determination:
Conclusions Drawn Barns of States of divised studies supporting the application. sions Drawn from Data Supporting Equites supporting the application, the In view of the in Vitto and cinical starter starter oppose Solution is substantially
safety, efficacy and comfort of the JSZ-Multipurpose Solution is substions safety, efficacy and comfort of the JSZ-Multipurpose Bountillers of any and