(88 days)
Not Found
Not Found
No
The device description and performance studies focus on the chemical composition and clinical efficacy of a contact lens cleaning solution, with no mention of AI or ML.
No
This device is a multi-purpose solution for cleaning and disinfecting contact lenses, which are medical devices, but the solution itself is not directly applied to a patient to treat or diagnose a disease or condition. While it maintains the cleanliness and safety of contact lenses, preventing potential harm to the eye, its primary function is not therapeutic in the sense of directly treating a medical condition of the user.
No
This device is a multi-purpose solution for cleaning, disinfecting, and storing soft contact lenses. It does not perform any diagnostic function.
No
The device description clearly states it is a sterile isotatic, phosphate buffered saline solution, which is a physical substance, not software. The performance studies also relate to the clinical effects of this solution.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cleaning, disinfecting, and storing contact lenses. This is a direct interaction with a medical device (contact lens) and not a diagnostic test performed on a sample from the human body.
- Device Description: The description details a solution for treating contact lenses, not for analyzing biological samples.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health.
- Clinical Studies: The clinical studies focus on the performance of the solution in maintaining contact lens cleanliness and the impact on the eye, not on the accuracy of a diagnostic test.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The STORE NAME Multi-Purpose Solution is indicated for use in cleaning, chemical (NOT HEAT) disinfection, and storing of soft (hydrophilic) contact leases.
Product codes
LPN
Device Description
A sterile isotatic, phosphate buffered saline solution containing polyoxyethylens polyoxypropylane block copolymer, preserved with 0.128% EDTA and 0.0001% Cosmocil CQ (polyhexamethylene biguanide).
Contains no chiorhaxidine or thimerosal.
Cleans, loosens and removes accurations of films, deposits and dabris from soft consist. Innissa, Destroys harmful microorganisms on the surface of the lens. Rinses, stores and rewels lenses before the lansas are placed on the eye.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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: Clinical Studies
SAMPLE SIZE:
Test group: 419 completed, 72 discontinued, 491 total.
Control (Multipurpose): 107 completed, 10 discontinued, 117 total.
Control (Peroxide): 94 completed, 22 discontinued, 116 total.
Visual Acuity:
Test: 20/15 (30 eyes), 20/20 (344 eyes), 20/25 (74 eyes), 20/30 (21 eyes), 20/40 (5 eyes), 20/50 or greater (1 eye), Not reported (16 eyes).
Control (Multipurpose): 20/15 (7 eyes), 20/20 (92 eyes), 20/25 (13 eyes), 20/30 (1 eye), 20/40 (1 eye), 20/50 or greater (1 eye), Not reported (3 eyes).
Control (Peroxide): 20/15 (8 eyes), 20/20 (83 eyes), 20/25 (17 eyes), 20/30 (0 eyes), 20/40 (0 eyes), 20/50 or greater (0 eyes), Not reported (8 eyes).
Adverse Reactions: 2 adverse reactions in the test group, both resolved with no sequelae.
Slit Lamp Findings (reports/eye examinations):
Test: Edema (5/2,990), Neovas (102/2,990), Stain (85/2,990), Hyperemia (320/2,990), Palpebral (335/2,990), Other (16/2,990).
Control (Multipurpose): Edema (6/750), Neovas (48/750), Stain (119/750), Hyperemia (93/750), Palpebral (199/750), Other (7/750).
Control (Peroxide): Edema (4/672), Neovas (62/672), Stain (60/672), Hyperemia (40/672), Palpebral (123/672), Other (3/672).
Symptoms, Problems and Complaints (Total Visits: Test 2,990, Multipurpose 750, Peroxide 672):
No symptoms: Test (2,503), Multipurpose (597), Peroxide (573).
Total symptoms: Test (691), Multipurpose (244), Peroxide (168).
Lens Cleanliness (Clinically clean/total):
Test: 2,919/2,990
Multipurpose: 695/750
Peroxide: 630/672
KEY RESULTS:
The compatibility of the Store Name Multi-purpose Solution was shown for cleaning, rinsing, disinfecting and storing soft hydrophilic contact leases.
Toxicology: The solution and bottle were shown to be non-toxic in all tests.
Microbiology: Sterile, passed preservative efficacy, passed stand-alone disinfection test, stability to date approximately one year.
Clinical studies show adverse reactions were minimal and resolved. Visual acuity results were comparable between test and control groups. Slit lamp findings and reported symptoms provided detailed safety profiles. Lens cleanliness was high across all groups.
Key Metrics
Not Found
Predicate Device(s)
Complete brand Multi-Purpose Solution
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
K980147
K980147 Summary
510(k) SUMMARY
Company: SUBMITTER 1. Address:
Automatic Liquid Packaging, Inc 2200 W. Lake Shore Dr Woodstock, IL 60098-7498
CONTACT PERSON 2. Address: John Brda 2200 W. Lake Shore Dr Woodstock, IL 60098-7498 (815) 338-9500
- DEVICE IDENTIFICATION તે જ Common Name Multipurpose Contact Leus Solution Store Name Multi-purpose Sciution Trade Name
CLASSIFICATION 4.
Class II (Performance Standards) 21 CFR 886,5928 Soft (hydrophilic) contact leas solution
PREMARKET NOTIFICATION NUMBER K980147 રે.
Telephone:
INDICATIONS FOR USE 6.
The STORE NAME Multi-Purpose Solution is indicated for use in cleaning, chemical (NOT HEAT) disinfection, and storing of soft (hydrophilic) contact leases.
DEVICE DESCRIPTION 7.
A sterile isotatic, phosphate buffered saline solution containing polyoxyethylens polyoxypropylane block copolymer, preserved with 0.128% EDTA and 0.0001% Cosmocil CQ (polyhexamethylene biguanide).
Contains no chiorhaxidine or thimerosal.
Cleans, loosens and removes accurations of films, deposits and dabris from soft consist. Innissa, Destroys harmful microorganisms on the surface of the lens. Rinses, stores and rewels lenses before the lansas are placed on the eye.
SUBSTANTIAL EQUIVALENCE ಳು
This product is substantially equivalent to the currently marketed product, Complete brand Multi-Purpose Solution. The device has the same basic technological characteristics as the predicate
device, relative to design, packaging and composition.
Summary Page 1
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۱۰ ۱۰ ۱۰ ۱۳ ۰۰ ۱۳
K980147 Summary
SAFETY AND EFFICACY ರಿ.
A Chemistry
STORE NAME Multi-Purpose Solution is a starile isotonic, phosphate buffered saline s I OK Notaining polyonyethylene polyoxypropylene Block copolymer; preserved with 0.128% EDTA and 0.0001% Cosmocil CQ (polyhexamethylene bignanide).
The competibility of the Store Name Multi-purpose Solution was shown for cleaning, rinsing, disinfecting and storing soft hydrophilic contact leases.
a, eyeling
b. critical micalle concentration
B. Toxicology
The solution and bortle were shown to be non-loxic in all tests as listed balow.
- Agar Ovarlay Cytoloxicity (Direct Contact Autian/Oceas Method): ਕ non-cytoloxic
- Systemic Toxicity (USPASO Method): no difference, test/contro} ﺗﻘ
- Acute Oral Toxicity (FDA Draft Guidelines for Class III Sell Hydrophilic ப் Contact Lens Solutions, July 1985 revision): no acute oral toxicity.
- Acure Ocular Irritation (FDA Guidelines for Class III Introcular and Contact d. Lenses and Ophthalmic Solutions, Federal Register Volume 50, No. 183): no acute ocular irritation
- Full USP Class VI Testing for Coutainers for Ophthalmie Products. હ.
C. Microbiology
- Sterility: Sterile ਕੇ.
- Preservative efficacy: passed challenge/rechallenge ت
- Disinfection Efficacy: passed stand-alone disinfection Lest d.
- d. Stability. to date, approximately one your
Summary Page 2
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ແມ່ນ ບຸນ 4
K980147 Summary
10. CLINICAL STUDIES
A. Accountability
| Test | Control | ||
|---|---|---|---|
| Multipurpose | Peroxide | ||
| Completed | 419* | 107 | 94 |
| Discontinued | 72 | 10 | 22 |
| Total | 491 | 117 | 116 |
*Number of cyer
B. Final Visual Acuity
| Test | Control | |||
|---|---|---|---|---|
| Multipurpose | Peroxide | |||
| 20/15 | 30* | 7 | 8 | |
| 20/20 | 344 | 92 | 83 | |
| 20/25 | 74 | 13 | 17 | |
| 20/30 | 21 | 1 | 0 | |
| 20/40 | 5 | 1 | 0 | |
| 20/50 or | ||||
| greater | 1 | 1 | 0 | |
| Not reported | 16 | 3 | 8 |
*Number of eyes
ப் Adverse Reactions
2 adverse reactions in the test group, both resolved with no sequelac
D. Slit Lamp Findings
| Test | Control | ||
|---|---|---|---|
| Multipurpose | Peroxide | ||
| Edema | 5/2,990* | 6/750 | 4/672 |
| Neovas . | 102/2,990 | 48/750 | 62/672 |
| Stain | 85/2,990 | 119/750 | 60/672 |
| Hyperemia | 320/2,990 | 93/750 | 40/672 |
| Palpebral | 335/2,990 | 199/750 | 123/672 |
| Other | 16/2,990 | 7/750 | 3/672 |
· Number of reports/number of cyc cxaminations at scheduled visits
Summary Page 3
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K980147 Sunmary
E. Symptoms, Problems and Complaints
| Test | Control | ||
|---|---|---|---|
| Multipurpose | Peroxide | ||
| Total Visits | 2,990 | 750 | 672 |
| No symptoms | 2,503 | 597 | 573 |
| 1.Discomfort | 88 | 26 | 24 |
| 2.Movement | 12 | 2 | 6 |
| 3.Tearing | 10 | 6 | 10 |
| 4.Photophobia | 17 | 4 | 4 |
| 5.Pain, etc | 61 | 22 | 18 |
| 6.Spectacle blur | 15 | 10 | 0 |
| 7.Secretions | 16 | 12 | 10 |
| 8.Lens awareness | 121 | 25 | 26 |
| 9.Blinking | 19 | 4 | 3 |
| 10.Variable vision | 46 | 34 | 11 |
| 11.Handling | 2 | 2 | 0 |
| 12.Poor dist. Vision | 25 | 19 | 2 |
| 13.Cleaning | 55 | 39 | 12 |
| 14.Reading problems | 7 | 2 | 5 |
| 15.Medications | 2 | 2 | 2 |
| 16.Sol'n sensitivity | 32 | 3 | 6 |
| 17.Other | 163 | 32 | 29 |
| Total symptoms | 691 | 244 | 168 |
F. Lens Cleanliness
| Test | Control | ||
|---|---|---|---|
| Multipurpose | Peroxide | ||
| Clinically clean | 2,919/2,990 | 695/750 | 630/672 |
Summary Page 4
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Image /page/4/Picture/0 description: The image shows the letterhead for the Department of Health & Human Services. The letterhead includes the department's logo, name, and the names of two of its agencies: the Public Health Service and the Food and Drug Administration. The address "9200 Corporate Boulevard" is also included on the letterhead.
JUL - 1 1998
Rockville MD 20850
Mr. John Brda Regulatory Affairs Manager Automatic Liquid Packaging 2200 Lake Shore Drive Woodstock, Illinois 60098-7498
Re: K980147
Trade Name: Store Name Multi-Purpose Soft (hydrophilic ) Contact Lens Solution Regulatory Class: II Product Code: 86 LPN Dated: January 14, 1998 Received: January 15,1998
Dear Mr. Brda:
This letter corrects our substantially equivalent letter of April 13, 1998 regarding the above referenced device to change the addressee.
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval) it may be subject to such additional controls. Existing major (2 remains affecting 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will yerify such assumptions. Failure to comply with the GMP regulation may result in regulatory
5
Page 2- Mr. John Brda
action. In addition, the Food and Drug Administration (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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) I rail letter " " " 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-1744. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
David M. Whipple
Sos A. Ralph Rosenthal Director Office of Device Evaluation Center for Devices and Radiological Health
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510(k) NUMBER (IF KNOWN) K980147
STORE NAME MULTI-PURPOSE SOLUTION DEVICE NAME
INDICATIONS FOR USE
STORE NAME Multi-Purpose Solution is indicated for use in cleaning, cinsing, chemical (NOT HEAT) disinfection, and storing of soft (hydrophilic) contact lenses.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ 21 CFR 801.109)
(Per Over-The-Counter-Use _ OR (Optional Format 1-2-96)
.. . . . . . . . . . . . . .
Nira Smith
$
(Division Sign-Off) (Division of Ophthalmic Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________