Automated Liquid Packaging, Inc. Sterile Water and Saline Solutions are products that have been used in the medical community for decades. The only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers.

The irrigation bottle is manufactured of 100% low density polyethylene (LDPE) and contains no color or chemical additives.

The two solutions are sterile, aseptically filled and are hermetically sealed for single use only.

AI/ML Overview

The provided document is limited to a 510(k) summary for Sterile Water and Saline Bottles for Irrigation. This type of document is for a medical device and typically does not contain the detailed clinical study information such as acceptance criteria, statistical analysis, and expert adjudication that would be found in a submission for an AI/ML-driven diagnostic device.

Here's an analysis based on the lack of this information in the provided document, addressing each point:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the document. For a product like sterile water and saline solutions, acceptance criteria would likely relate to sterility, chemical composition (e.g., sodium chloride concentration), pH, particulate matter, and container integrity, as well as biological compatibility with ISO 10993 standards. However, specific thresholds are not provided.
- Reported Device Performance: The document states, "All materials used in the fabrication of Sterile Water and Saline Solutions were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use." No specific performance metrics (e.g., success rates, purity levels, sterility assurance levels) or quantitative results are provided.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This information is not applicable and not present in the document. The testing described is material qualification and product performance testing (e.g., sterility, biological safety), not a clinical trial with a test set of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This information is not applicable and not present. Ground truth, in the context of diagnostic AI/ML, refers to a definitive diagnosis or outcome. For this device, "ground truth" would relate to laboratory test results (e.g., sterility tests, chemical analysis) rather than expert clinical interpretation of patient data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable and not present. Adjudication methods are used in clinical studies where multiple human readers or experts disagree on an outcome. The testing performed for this device would involve laboratory methods with pre-defined pass/fail criteria.
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 and not present. This type of study is relevant for AI-powered diagnostic tools that assist human interpretation. The sterile water and saline solutions are not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable and not present. This refers to the performance of an AI algorithm independently. The device in question is a physical product (sterile solutions), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance would be established through laboratory testing results (e.g., microbiological cultures for sterility, chemical assays for composition, physical testing for container integrity) against established standards (e.g., USP monographs, ISO 10993 for biocompatibility). The document vaguely refers to "biological qualification safety tests as outlined in ISO 10993 Part-1" and "industry recognized test methods."
The sample size for the training set:
- Not applicable and not present. Training sets are used for machine learning models. The manufacturer performed product performance and material safety testing, not AI model training.
How the ground truth for the training set was established:
- Not applicable and not present. As there is no AI model or training set, this question is not relevant to the provided document.

Summary for the given document:

The provided 510(k) summary for Sterile Water and Saline Bottles for Irrigation, USP, describes a conventional medical device. It focuses on demonstrating substantial equivalence to a predicate device based on intended use and performance attributes. The "study" mentioned is the "Summary of testing" which involved:

Evaluating materials through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices."
Testing materials "in accordance with industry recognized test methods."

The objective of these tests was to confirm that the materials and the final product were "acceptable for the intended use" (device cleaning and irrigation) and met safety standards, rather than proving diagnostic accuracy or human reader improvement for an AI/ML product. The document does not provide specific data, acceptance criteria thresholds, sample sizes for these tests, or details about how the ground truth for these tests was established beyond adherence to "industry recognized test methods" and ISO 10993.

Summary

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OCT 2 5 2000

K994321

SMDA REQUIREMENTS

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Sterile Water and Saline Bottles for Irrigation, USP

Manufacturer:

Automated Liquid Packaging, Inc. 2200 West Lake Shore Drive Woodstock, IL 60098

Regulatory Affairs Contact: John Brda

Telephone:

815/338-9500

December, 1999

Date Summary Prepared:

Common Name:

Classification:

Predicate Device:

Description:

Sterile Water and Saline Bottle for Irrigation, USP

Class II per 21CFR § 868.

Sterile Water and Saline for Irrigation

The irrigation bottle is manufactured of 100% low density polyethylene (LDPE) and contains no color or chemical additives.

The two solutions are sterile, aseptically filled and are hermetically sealed for single use only.

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SMDA REQUIREMENTS (continued)

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Sterile Water and Saline Bottles for Irrigation

Intended Use:

Sterile Water and Saline Solutions are defined as an accessory to a device that is intended For Device Cleaning and Irrigation.

Substantial Equivalence:

The Sterile Water and Saline Solutions are substantially equivalent to the Sterile Water and Saline Solutions in that:

the intended use is the same
the performance attributes are the same

Summary of testing:

All materials used in the fabrication of Sterile Water and Saline Solutions were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing hair or movement. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 2000

Mr. John Brda Regulatory Affairs Manager Automatic Liquid Packaging, Incorporated 2200 Lake Shore Drive Woodstock, Illinois 60098

Re : K994321 Sterile Water and Saline Solutions Trade Name: Requlatory Class: II Product Code: JOL Dated: July 27, 2000 Received: July 31, 2000

Dear Mr. Brda:

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, -- @r---- o 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class Ti (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:

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Page 2 -- Mr. Brda

this response to your premarket notification submission does chis response to your promosou might have under sections 531 through 542 of the Act for devices under the Electronic Chrough 542 Of the net 201 rovisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as Info iceed in your 510(k) premarket notification. The FDA described in your sie in privalence of your device to a legally finding of bubbandaaice results in a classification for your marketed predicate active robably in the market.

If you desire specific advice for your device on our labeling If you debire bpoort 801 and additionally 809.10 for in regaractor ( Compliance at (301) 594-4692. Additionally, for questions on Compilance at (501) sertising of your device, please contact i the Office of Compliance at (301) 594-4639. Also, please note "Misbranding by reference to the regulation entitled, premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obtained from the biving (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):

Unknown

Device Name:

Indications For Use:

Sterile Water and Saline Solutions are defined as an accessory to a device that is intended For Device Cleaning and Irrigation.

Sterile Water and Saline Solutions

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-The Counter Use V

(Division Sign-Off) Jaurek. Shill for Pat Criceni
sion of Cardiovascular, Respiratory,
Neurological Devices
510(k) Number 994321

Οι

Regulation Number and Section

§ 880.6740 Vacuum-powered body fluid suction apparatus.

(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.