The intended use of these sterile single use devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage. The intended use indication is identical to those devices to which substantial equivalence is claimed. The use of these devices for inhalation therapy is well-established.

Device Description

The single-use device is in a color-coded unit blow-fill-sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen-free. The single-use containers are embossed with identifying product text and level markings. The finished device product configuration characteristics of these inhalation devices are similar to those of the predicate devices.

AI/ML Overview

The provided document is a 510(k) summary for a medical device: "0.9% Sodium Chloride Inhalation Solution, USP". This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel performance or efficacy through extensive clinical studies like those for new drug applications or high-risk devices.

Therefore, the document does not contain the requested information regarding:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance, or details about ground truth establishment for a test set.
Information on expert adjudication methods or multi-reader multi-case studies.
Results of standalone algorithm performance.
Sample sizes for a training set or ground truth establishment for a training set.

Instead, the document focuses on demonstrating substantial equivalence to existing devices through:

Comparison of intended use: The intended use of the device ("as accessory to medicinal nonventilatory nebulizers; in respiratory therapy; for tracheal irrigation or lavage") is stated to be identical to the predicate devices.
Technological characteristics: The device's container materials, solution components (0.9% USP Sodium Chloride), and manufacturing process (blow-fill-seal technology) are described and compared to predicate devices. It emphasizes compliance with USP monograph requirements for the solution.
Non-Clinical and Clinical Testing: The document explicitly states: "Clinical testing is not necessary to show substantial equivalence for either safety or efficacy of intended use to the predicate devices as there are various in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physical-chemical characteristics (solution properties; unit configuration) available which demonstrate this equivalence."

Key Takeaways from the Document Regarding "Acceptance Criteria" (Implicit for 510(k) Submission):

The acceptance criteria are implicitly tied to demonstrating that the device is as safe and effective as its predicate devices, primarily through meeting established standards and specifications for its components and manufacturing.

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit from text):
  - Compliance with USP monograph requirements for 0.9% Sodium Chloride Inhalation Solution.
  - Container materials meet criteria for direct food and drug contact and USP container testing.
  - Finished devices undergo testing to meet stated USP monograph and container criteria (e.g., assay, fill uniformity, sterility, container integrity, solution properties, unit configuration).
  - Sterile and pyrogen-free.
  - No preservative.
  - Manufactured under current Good Manufacturing Practices (cGMP).
  - Technological characteristics are "identical or better" than predicate devices.
- Reported Device Performance: The document states that the device "meets the current USP specifications" and "Analytical testing to the stated specifications demonstrates that these devices will have comparable safety and efficacy in use." No specific performance metrics or values are provided; rather, it refers to compliance with established standards.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. The document explicitly states that clinical testing (which would typically involve test sets) was not necessary. The evaluation relied on in vitro analytical methods and physical-chemical characteristics.
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):
- Not Applicable. No ground truth established through expert review for a test set was mentioned, as clinical testing was not performed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or expert adjudication was performed.
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. This device is a medical solution (0.9% Sodium Chloride) used with nebulizers, not an AI or imaging diagnostic device. MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" here is the established USP (United States Pharmacopeia) monograph criteria and other regulatory standards for Sodium Chloride Inhalation Solution and its container components. This is verified through "in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physical-chemical characteristics (solution properties; unit configuration)."
The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not Applicable. No training set exists for this type of device submission.

Summary

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K974056

Holopack	510(k) Notification	October, 1997
----------	---------------------	---------------

Section 2: 510(k) Summary

Applicant Name & Address: 1.
Holopack International, LP Carolina Research Park 1 Technology Circle Columbia, SC 29203

JAN 2 | 1998

Contact Persons:

Walter Zahn President 803-806-3300 Phone: 803-806-3301 Fax:

Marianna Cronrath Regulatory Agent Phone: 732-888-6278 Fax: 732-888-2917

This 510(k) premarket notification summary was prepared October, 1997 in conjunction with the notification.

1. Device Name and Classification:
. Trade Name of Device:
- 2.1 0.9% Sodium Chloride Inhalation Solution, USP [labeled concentration at 0.9%]
Common Name of the Device: .
- 2.2 0.9% Sodium Chloride Inhalation Solution
Classification: Class II, Anesthesiology . 514 Compliance: Standard
- 2.3 Class Code: 73 CAF

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	1000

Section 2: 510(k) Summary

The Predicate Devices to which Equivalence is Claimed 3.

There are several comparable devices manufactured prior to 1976 and/or those to which Substantial Equivalence is claimed.

K884359	Unit Dose 0.45%; 0.9%; 3% Sodium Chloride Solution for
	Inhalation in 3, 5 and 15mL containers
K870332	Automatic Liquid Packaging, Inc.
	2200 W. Lake Shore Drive
	Woodstock, IL 60096

K8703320 Travenol Laboratories ( pre-1976) Wyeth Laboratories, Inc. (pre-1976) Respiratory Therapy Vials

Sodium Chloride Inhalation Solution Dey Laboratories, Inc. Concord, CA 94518

Description of the Devices 4.
The single-use device is in a color-coded unit blow-fill-sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen-free.

CONTENTS	VOLUME	CONTAINER
0.9% Sodium Chloride Inhalation Solution, USP	15mL fill	Pink
		Embossed label

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Section 2: 510(k) Summary

5. Intended Use

The intended use of this sterile device is as accessory to medicinal nonventilatory nebulizers; in respiratory therapy; for tracheal irrigation or lavage.

The intended use indication is identical to those devices to which substantial equivalence is claimed. The use of these devices as respiratory therapy accessories and for inhalation therapy is well-established.

5.1 Limitations

These devices are not for parenteral use nor for preparations intended for parenteral use. The use of these devices is on order of physician or licensed practitioner.

Technological Characteristics of the Device and the Predicate Devices

The subject unit dose device containers of this premarket notification are formed of polyethylene resins meeting the direct food and drug contact criteria. The formed units likewise meet the criteria for direct food and drug contact as prefilled unit containers. The solution component at the stated concentration in Sodium Chloride Inhalation Solution meets the current USP monograph requirements.

The single-use containers are embossed with identifying product text and level markings. The finished device product configuration characteristics of these inhalation devices are similar to those of the predicate devices.

The technological improvements relate to the method of manufacture of the devices which are the subject of this premarket notification. The blow-fill-seal systems used by Holopack International, LP in the production of these devices for inhalation therapy utilize dark-side/white-side machine technology. The blowfill-seal systems on which the devices are manufactured represent technological advances in this type of production and in the control of the manufacturing environment. The devices are manufactured under conditions of current Good Manufacturing Practices (cGMP).

Performance characteristics of the devices that are the subject of this notification are identical or better than the predicate devices. Proprietary details of the aseptic manufacturing environment and blow-fill-seal technology are referenced under confidentiality.

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Holopack

510(k) Notification	October, 1997
Section 2: 510(k) Summary

7. Non-Clinical and Clinical Testing

The component materials of the accessory device container have each been substantiated to meet criteria for direct food and drug contact or additive respectively and to comply with USP container testing. The formulation components of the filled device solution have been substantiated to each meet their respective USP monograph criteria. Each of the finished devices undergoes testing to meet the stated USP monograph and container criteria.

Clinical testing is not necessary to show substantial equivalence for either safety or efficacy of intended use to the predicate devices as there are various in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physical-chemical characteristics (solution properties; unit configuration) available which demonstrate this equivalence.

Summary Conclusions

The subject device:

0.9% Sodium Chloride Inhalation Solution. USP

as manufactured by Holopack International, LP of Columbia, SC claims substantial equivalence, with the same intended use, to several devices which were manufactured prior to 1976 or which have received market clearance through established equivalence.

This device is designed to meet the current USP specifications. The device containers have embossed unit identification and shelf carton labeling.

Analytical testing to the stated specifications demonstrates that these devices will have comparable safety and efficacy in use.

The devices, as manufactured by Holopack, are produced using dark-side/whiteside blow-fill-seal technology on rommeLag® machines specifically designed for aseptic filling operations. These manufacturing systems represent a technological advance for the production of this type of device. The details of the aseptic manufacturing processes and environment are referenced under confidentiality.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 1998

Mr. Walter Zahn Holopack International, L.P. Carolina Research Park 1 Technology Circle Columbia, SC 29203

Re : K974056 0.9% Sodium Chloride Solution for Inhalation, USP Requlatory Class: II (two) Product Code: 73 CAF October 20, 1997 Dated: Received: October 27, 1997

Dear Mr. Zahn:

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 regulations 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 - Mr. Walter Zahn

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 requlation 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. Callahon

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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Holopack
	1 23 40
	Parcellinously &

510(k) Notification

October, 1997

STATEMENT OF INTENDED USE

Sodium Chloride Inhalation Solution, USP Devices: [labeled concentration at] 0.9%

Intended Use

The intended use of these sterile single use devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage.

The intended use indication is identical to those devices to which substantial equivalence is claimed. The use of these devices for inhalation therapy is wellestablished.

Limitations

These devices are not for parenteral use nor for preparations intended for parenteral use.

The use of these devices is on order of physician or licensed practictioner.

Prescription Device 1

M. Ruyc

(Division Sign-Off) Division of Cardiovascular and Neurological Devices 510(k) Number

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).