The subject device is 3 mL Steri-Neb Saline, 0.9% "/v Sodium Chioride Inhalation Solution USP. Steri-Neb Saline is used for respiratory therapy and tracheal lavage. For respiratory therapy, Steri-Neb Saline is used for dilution of solutions used in nebulizers. Steri-Neb Saline is a unit dose low density polyethylene vial containing sterile, preservative-free, clear, colourless, aqueous solution. The Steri-Neb Saline product contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "3mL Steri-Neb Saline, 0.9% w/v Sodium Chloride Inhalation Solution USP." It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria for device performance as would be expected for a novel device or software.

Therefore, many of the requested elements regarding acceptance criteria and study design (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not typically included in a 510(k) summary for a product of this nature. This document primarily emphasizes the technological characteristics and intended use comparison to an already cleared predicate device.

However, I can extract information related to the comparison to the predicate, which serves as the "study" for establishing substantial equivalence.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of 510(k), acceptance criteria are not in the form of performance metrics (like sensitivity/specificity for an AI model) but rather revolve around demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness.

Acceptance Criteria (Implied for 510(k) Substantial Equivalence)	Reported Device Performance (Comparison to Predicate)
Intended Use Equivalence: The subject device must have the same intended use as the predicate device.	The subject device, 3 mL Steri-Neb Saline, 0.9% w/v Sodium Chloride Inhalation Solution USP, is used for respiratory therapy and tracheal lavage, including dilution of solutions in nebulizers. The predicate device, Dey's 3 mL 0.9% w/v Sodium Chloride Inhalation Solution USP, is also used for respiratory therapy and tracheal lavage. Both have the same intended use.
Technological Characteristics Equivalence: The subject device must have the same technological characteristics, or any differences must not raise new questions of safety or effectiveness.	Both devices are plastic unit-dose vials containing 0.9% Sodium Chloride Inhalation Solution USP. Both are sterile, preservative-free, clear, colorless, aqueous solutions. The subject device contains 0.9% w/v Sodium Chloride USP in Water for Injection USP, with no additives. No technological differences identified that raise new questions of safety and effectiveness. (Details stated to be in Attachments 3-8, which are not provided here).
Formulation Equivalence: The active ingredients and key properties should be the same.	Both contain 0.9% w/v Sodium Chloride Inhalation Solution USP. Both are single-use products.
Sterility/Preservation Equivalence: Both devices should be sterile and preservative-free.	Both the predicate and subject device are sterile and preservative-free.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of this 510(k). This is a comparison of product specifications and intended use, not a clinical trial or performance evaluation with a "test set" of patients or data.
Data Provenance: The data is based on the description and specifications of the subject device and the predicate device. No specific "country of origin" for data or "retrospective/prospective" study design is mentioned, as it's not a data-driven performance study.

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

Number of Experts: Not applicable. Ground truth for device performance in a clinical or AI context is not established for this type of submission. The judgment of substantial equivalence is made by the FDA based on the provided technical documentation and comparison to the predicate.
Qualifications of Experts: The submission was prepared by Steripak Limited, with John William Holloway B.Sc. CChem MRSC MBIRA, Head of Product Development and Regulatory Affairs, signing the document. The FDA, specifically the Division of Cardiovascular, Respiratory, and Neurological Devices, evaluates the submission.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no "test set" requiring adjudication. The process is a regulatory review by the FDA.

5. 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

MRMC Study: No. This is a saline solution, not an AI device or diagnostic imaging tool.

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

Standalone Performance Study: No. This is not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate device, as accepted by the FDA. The subject device is deemed "substantially equivalent" to this established predicate. The parameters for comparison are the device's intended use, technological characteristics (physical form, chemical composition), and labeling.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. There is no algorithm or AI model involved that would require a training set.

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

How Ground Truth for Training Set was Established: Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the text "JUN 2 1998" on the left side of the image. To the right of the date is the word "Steripak" in a large, bold font. Below the word "Steripak" is the text "510(k) Summary".

"This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92".

"The assigned 510 (k) number is 1980 929 11

1. Submitter Information

Steripak Limited Goddard Road, Astmoor Runcorn , Cheshire WA7 1QF England

Contact Person: Steve Forrester-Coles Site Operations Director

Phone: 44-1-928-579110 44-1-928-579540 FAX:

2. Name of Device

Trade/Proprietary Name:	3mL Steri-Neb Saline, 0.9% w/v Sodium ChlorideInhalation Solution USP
Common/Usual Name:	Pre-filled Vial for Respiratory Therapy, 0.9% w/vSodium Chloride Inhalation Solution USP
Classified Name:	Accessory for Nebulizer, Direct Patient Interface

3. Predicate Device

The predicate device identified for the substantial equivalence claim is Dey's 3 mL 0.9% Sodium Chloride Inhalation Solution USP. This product is distributed by Dey under Automatic Liquid Packaging, Incorporated's 510 (k) K840943, Pre-filled Respiratory Therapy Vial, cleared on April 24, 1983. Dey's Sodium Chloride Inhalation Solution USP 0.9% product is a plastic single-use vial containing sterile preservative-free solution for respiratory therapy and tracheal lavage.

Description of the Subject Device 4.

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Intended Use of the Subject Device

The Steri-Neb Saline product is 0.9% Sodium Chloride Inhalation Solution USP in a plastic unit-dose vial. The Steri-Neb Saline plastic unit-dose vial is first separated from the strip of vials and then opened by twisting off the top of the vial. The Steri-Neb Saline is used for respiratory therapy and tracheal lavage. For respiratory therapy, the Steri-Neb Saline vial is emptied into the nebulizer reservoir by squeezing the solution from the opened vial. The Steri-Neb Saline product is a sterile single use product. Any solution remaining in the plastic unit-dose vial should be discarded.

Technological Characteristics of the Subject Device Compared to the Predicate ર. Device

The predicate device identified for the substantial equivalence claim is Dey's 3 mL 0.9% w/v Sodium Chloride Inhalation Solution USP. Dey's product is substantially equivalent to the Steri-Neb Saline product in that both products are plastic unitdose vials containing 0.9% Sodium Chloride Inhalation Solution USP for single-use in respiratory therapy and tracheal lavage. The solution for both the predicate and subject device is sterile and preservative-free. Comparison of the predicate device and the subject device indicate that there are no technological differences between the two products that raise new questions of safety and effectiveness. Details of the substantial equivalence claim are included in Attachments 3 through 8.

7. Signature of Applicant

Steripak Limited,

John William Holloway BSc. CChem MRSC MBIRA Head of Product Development and Regulatory Affairs

Signature

03/03/98

Date

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1998

Mr. Jason A. Gross Zenith Goldline Pharmaceuticals Inc. 140 Legrand Avenue Northvale, NY 07647

Re : K980829 0.9% w/v Sodium Chloride Inhalation Solution USP Regulatory Class: II (two) Product Code: 73 CAF March 3, 1998 Dated: Received: March 4, 1998

Dear Mr. Gross:

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 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 requlations 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 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) (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. 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.

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Page 2 - Mr. Jason A. Gross

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (K) Notification 3rd March 1998

Indications For Use Statement

1980829 510(k) Number (if known): J

Device Name : ___ 0.9%w/v Sodium Chloride Inhalation Solution USP

Indications For Use:

For respiratory therapy and tracheal lavage

(Please Do Not Write Below This Line - Continue On another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation

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M. Singh -

(Division Sign-Off) Division of Cardiova and Neurological De 510(k) Number

Prescription Use

Over-The-Counter Use_

(Per 21 CFR § 801.109)

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).