STORE NAME Multi-Purpose Solution is indicated for use in cleaning, chemical (NOT HEAT) disinfection, and storing of soft (hydrophilic) contact leases.

Device Description

A sterile isotatic, phosphate buffered saline solution containing polyoxyethylens polyoxypropylene 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.

AI/ML Overview

Here's an analysis of the provided text regarding K980147, outlining the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance (STORE NAME Multi-Purpose Solution)
Chemistry	Compatibility (cleaning, rinsing, disinfecting, storing)	Shown for cleaning, rinsing, disinfecting, and storing soft hydrophilic contact lenses.
	Cycling	Not explicitly detailed as a pass/fail criterion, but implied under "compatibility".
	Critical micelle concentration	Not explicitly detailed as a pass/fail criterion, but implied under "compatibility".
Toxicology	Agar Overlay Cytotoxicity (Direct Contact)	Non-cytotoxic
	Systemic Toxicity (USP/ISO Method)	No difference (test/control)
	Acute Oral Toxicity (FDA Draft Guidelines)	No acute oral toxicity
	Acute Ocular Irritation (FDA Guidelines)	No acute ocular irritation
	Full USP Class VI Testing for Containers	Passed
Microbiology	Sterility	Sterile
	Preservative Efficacy	Passed challenge/rechallenge
	Disinfection Efficacy	Passed stand-alone disinfection test
	Stability	To date, approximately one year (this seems to be an ongoing observation rather than a fixed "pass" at the time of submission)
Clinical Performance	Visual Acuity	94% of test eyes maintained 20/25 or better (30+344+74 = 448 out of 476 reported with VA, Note: Missing 16 not reported, if these are excluded, the percentage is higher. If they are assumed worse, the percentage could be lower. For similar controls, Multipurpose had 93% and Peroxide had 96% in this range. The document doesn't define a specific acceptance criterion for VA, but demonstrates comparable performance to controls.
	Adverse Reactions	2 adverse reactions in the test group, both resolved with no sequelae. (Implied acceptance criteria: low incidence and resolvability, comparable to or better than controls.)
	Slit Lamp Findings (Edema, Neovas, Stain, Hyperemia, Palpebral, Other)	Proportional incidence rates for the test group (e.g., Edema: 5/2,990, Neovas: 102/2,990) are presented. These are compared to control groups (Multipurpose and Peroxide). (Implied acceptance criteria: incidence rates are clinically acceptable and comparable to the predicate or other marketed solutions.)
	Symptoms, Problems, Complaints	Incidence rates for various symptoms (e.g., Discomfort: 88/2,990 visits, Lens awareness: 121/2,990 visits) are presented for the test group vs. controls. Total symptoms for test group: 691/2,990 visits (23.1%). Controls: Multipurpose 244/750 (32.5%), Peroxide 168/672 (25.0%). (Implied acceptance criteria: incidence rates are clinically acceptable and comparable to the predicate or other marketed solutions. The test group actually had a lower symptom rate per visit than one control and comparable to the other.)
	Lens Cleanliness	2,919/2,990 (97.6%) of test group examinations showed clinically clean lenses. Controls: Multipurpose 695/750 (92.7%), Peroxide 630/672 (93.75%). (Implied acceptance criteria: a high percentage of clinically clean lenses, comparable to or better than controls. The test device performed better than both controls here.)

2. Sample Size for the Test Set and Data Provenance

Clinical Study Test Set (Eyes):
- Test group: 491 eyes (419 completed, 72 discontinued)
- Control (Multipurpose): 117 eyes (107 completed, 10 discontinued)
- Control (Peroxide): 116 eyes (94 completed, 22 discontinued)
- Total Eyes in Study (Clinical): 724 eyes
Clinical Study Test Set (Examinations/Visits):
- Test group: 2,990 eye examinations/scheduled visits
- Control (Multipurpose): 750 eye examinations/scheduled visits
- Control (Peroxide): 672 eye examinations/scheduled visits
Data Provenance: The document does not explicitly state the country of origin. Given the FDA 510(k) submission, it is highly likely the study was conducted in the United States. The study appears to be prospective, as it involves tracking clinical outcomes and adverse events in subjects over time using the solution.
Other Test Sets (for Chemistry, Toxicology, Microbiology): Sample sizes are not specified for these laboratory tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth within the clinical study. Given the nature of a clinical trial for contact lens solutions, "ground truth" would be established by the examining practitioners (e.g., ophthalmologists, optometrists, or trained study coordinators under their supervision) based on standardized clinical assessments (visual acuity tests, slit lamp examinations, patient symptom reports). No explicit "expert consensus" for specific case-by-case ground truth determination is mentioned beyond the standard clinical examination protocols.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (like 2+1, 3+1, none) for the clinical test set data. Clinical trials typically follow pre-defined protocols for data collection and assessment by trained investigators. Any disagreements or ambiguities in data interpretation would ideally be resolved according to the study protocol, but a formal adjudication process by external experts is not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to compare the diagnostic performance of different readers (e.g., radiologists) on a set of cases, often in the context of imaging. This submission concerns a contact lens solution, and the clinical study evaluates the solution's performance in real-world use on patients, not diagnostic interpretation by multiple readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

Yes, in essence. The Chemistry, Toxicology, and Microbiology sections represent "standalone" performance evaluations of the device (the solution itself) without human-in-the-loop interaction in the context of clinical decision-making. These tests evaluate the intrinsic properties of the solution (sterility, disinfection efficacy, toxicity, etc.) in a controlled laboratory setting. The clinical study then evaluates the device's performance with human-in-the-loop (patients using the solution, and clinicians evaluating the outcomes).

7. The Type of Ground Truth Used

Chemistry, Toxicology, Microbiology: The ground truth is established through laboratory test results against predefined chemical, biological, and safety standards (e.g., "non-cytotoxic," "passed stand-alone disinfection test," "sterile," "no acute ocular irritation").
Clinical Studies: The ground truth is primarily based on clinical observations and patient-reported outcomes. This includes:
- Clinical assessments: Visual acuity measurements, slit lamp findings (e.g., presence/absence of edema, staining, hyperemia), and assessment of lens cleanliness by clinicians.
- Patient-reported data: Symptoms, problems, and complaints provided by the patients during visits.
- Adverse events: Clinically verified adverse reactions.

8. The Sample Size for the Training Set

The document does not mention a training set. This is a 510(k) submission for a medical device (contact lens solution), not an AI/Machine Learning device or a diagnostic test where a "training set" in the computational sense would be required. The data presented is from a clinical study and laboratory evaluations conducted to demonstrate safety and efficacy.

9. How the Ground Truth for the Training Set Was Established

As no training set (in the context of AI/ML) is mentioned or implied, this question is not applicable. The "ground truth" for the various tests (chemistry, toxicology, microbiology, and clinical outcomes) was established as described in point 7.

Summary

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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.

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 orgreater	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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۲ , 05/09

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

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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 ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.”