DEY VIAL SODIUM CHLORIDE 3% by DEY LABORATORIES, INC.

Dey Vial Sodium Chloride 3% and 10% are used in conjunction with a nebulizer for the induction of sputum production where specimen collection is indicated.

Device Description

DEY-PAK® Sodium Chloride Solution 3% and 10% solutions are contained in a 15 mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lot number and expiration date. One side of the vial has pressure sensitive label and the other side is blank. The vials are supplied in cartons of 50 vials.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (DEY-PAK® Sodium Chloride Solution 3% and 10%). This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical studies. Therefore, the document does not contain the information requested for a detailed study description or acceptance criteria and reported device performance in the context of an algorithm or AI system.

Here's a breakdown of why the requested information cannot be extracted from this document:

Type of Device: The device is a sodium chloride solution used with a nebulizer, a pharmaceutical product, not an AI/algorithm-based diagnostic or treatment system.
Regulatory Pathway: A 510(k) submission primarily establishes that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, chemical composition, energy source, manufacturing processes, and performance (if applicable, through bench testing or non-clinical data) to the predicate. It does not generally require or present the type of clinical trial data with acceptance criteria, ground truth, and reader studies that would be associated with AI or imaging devices.
Lack of AI/Algorithm: There is no mention of any AI component, algorithm, or software in the device description or intended use.

Therefore, I cannot provide the requested information from this document.

If this were a document for an AI-powered medical device, the following information would typically be present and could be extracted:

Table of Acceptance Criteria and Reported Device Performance: This would specify metrics like sensitivity, specificity, AUC, or F1-score with corresponding thresholds and the device's actual performance against those thresholds in a test set.
Sample Size and Data Provenance for Test Set: Details on the number of cases (e.g., images, patient records) used for testing, their origin (e.g., specific hospitals, geographical regions), and whether the data was collected retrospectively or prospectively.
Number and Qualifications of Experts for Ground Truth: Information about how many human experts (e.g., radiologists, pathologists) reviewed the test cases to establish the definitive diagnosis, and their experience levels (e.g., board-certified, years of experience).
Adjudication Method: How disagreements among experts were resolved (e.g., majority vote, senior expert arbitration).
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: If human reader performance with and without AI assistance was evaluated, and the statistical effect size of improvement.
Standalone Performance: Data on the algorithm's performance without any human intervention.
Type of Ground Truth: Whether the truth was established by expert consensus, histological pathology, long-term patient outcomes, or another definitive method.
Sample Size for Training Set: The total number of cases used to train and validate the AI model.
Ground Truth Establishment for Training Set: How the labels or diagnoses for the training data were determined.

None of these elements are present in the provided 510(k) summary for the DEY-PAK® Sodium Chloride Solution.

Summary

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K972778

OCT - 8 1997 PREMARKET NOTIFICATION [510(K)} SUMMARY

Dev Laboratories LP 2751 Napa Valley Corporate Drive Napa, CA 94558 (707) 224-3200 Fax: (707) 224-0791 Contact Person: Allan S. Kaplan, R.P., Ph.D., Vice President of Technical Affairs Date Summary Prepared: July 18, 1997

DEY-PAK® Sodium Chloride Solution 3% Trade Name: DEY-PAK® Sodium Chloride Solution 10%
Sodium Chloride Solution 3% Common Name: Sodium Chloride Solution 10%
Classification: Class II
DEY-VIAL® Sodium Chloride, USP Sterile 10 mL (K880411) Equivalence Claim: Arm-A-Vial (Armour, K841988, K841988-A, K841989, K841989-A) Dis-Pos-Vial (Parke-Davis) Redipak (Wyeth)
Device Description: DEY-PAK® Sodium Chloride Solution 3% and 10% solutions are contained in a 15 mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lot number and expiration date. One side of the vial has pressure sensitive label and the other side is blank. The vials are supplied in cartons of 50 vials.

Intended Use: DEY-PAK® Sodium Chloride Solution 3% and 10% are used in conjunction with a nebulizer. The contents of the vial is to be dispensed, as prescribed, into a nebulizer cup. The solution is then inhaled to induce sputum.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT - 8 1997

Allan S. Kaplan, R.P., Ph.D. Dey Laboratories 2751 Napa Valley Corporate Drive Napa, California 94558

Re: K972778 DEY-PAK® Sodium Chloride Solution, USP, Sterile, 3% and 10% Regulatory Class: II (two) Product Code: 73 CAF Dated: July 24, 1997 Received: July 25, 1997

Dear Dr. Kaplan:

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, Druq, 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, listinq 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) 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: 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 - Allan S. Kaplan, R.P., Ph.D.

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. Collelon

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) Number (if known): __ K972778

Device Name: Dey Vial Sodium Chloride 3% and 10%

Indications For Use:

Dey Vial Sodium Chloride 3% and 10% are used in conjunction with a nebulizer for the induction of sputum production where specimen collection is indicated.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	__________________________

Prescription Use_v OR Over-The-Counter Use_

(Per 21 CFR 801.109) (Optional Format 1-2-96)

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).