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 devices are color-coded unit blow-fill-sealed containers with liquid contents as labeled for inhalation therapy. The devices contain no preservative. They are sterile and pyrogen-free.

CONTENTS	VOLUME	CONTAINER
0.45% Sodium Chloride Inhalation Solution, USP	3mL fill	Green / Embossed label
0.45% Sodium Chloride Inhalation Solution, USP	5mL fill	Green / Embossed label
0.9% Sodium Chloride Inhalation Solution, USP	3mL fill	Pink / Embossed label
0.9% Sodium Chloride Inhalation Solution, USP	5mL fill	Pink / Embossed label

AI/ML Overview

The provided document is a 510(k) Premarket Notification for Sodium Chloride Inhalation Solutions. This type of submission is for medical devices that are substantially equivalent to a predicate device already on the market. It does not typically involve clinical trials or a study to prove performance against specific acceptance criteria in the way a novel AI/software device would. Instead, substantial equivalence is demonstrated through comparative analysis of technological characteristics and non-clinical testing.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable to this particular submission type and product.

Here's a breakdown based on the provided text, indicating where information is not applicable:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred)	Reported Device Performance
Intended Use: As accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage.	"The intended use of these sterile devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage." (Section 5) This is identical to predicate devices.
Composition (Solution): Meets USP monograph requirements for Sodium Chloride Inhalation Solution at 0.45% and 0.9%.	"The solutions component, at the stated concentration of Sodium Chloride Inhalation Solution, meet the USP monograph requirements." (Section 6) "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." (Section 7) "These devices are designed to meet the current USP specifications." (Summary Conclusions 8)
Composition (Container): Formed of polyethylene resins meeting direct food and drug contact criteria.	"The subject unit dose devices of this premarket notification are formed of polyethylene resins meeting the direct food and drug contact criteria. The formed units meet the criteria for direct food and drug contact as prefilled unit containers." (Section 6) "The component materials of the accessory device container have been substantiated to each meet criteria for direct food and drug contact or additive respectively." (Section 7)
Sterility: Sterile and pyrogen-free.	"They are sterile and pyrogen-free." (Section 4) "Analytical testing to the stated specifications demonstrates that these devices will have comparable safety and efficacy in use." (Summary Conclusions 8) ("Sterility" is mentioned as an in vitro analytical method in Section 7 as evidence of equivalence.)
Preservative-free: Contains no preservative.	"The devices contain no preservative." (Section 4)
Container Integrity: Maintained.	("Container integrity" is mentioned as an in vitro analytical method in Section 7 as evidence of equivalence.)
Fill Uniformity: Maintained.	("Fill uniformity" is mentioned as an in vitro analytical method in Section 7 as evidence of equivalence.)
Technological Characteristics: Similar to predicate devices, leveraging advanced blow-fill-seal technology.	"The finished device product configuration characteristics of these inhalation devices are similar to those of the predicate devices." (Section 6) "The technological improvements relate to the method of manufacture... The blow-fill-seal systems... represent technological advances in this type of production and in the control of the manufacturing environment." (Section 6) "Performance characteristics of the devices... are identical or better than the predicate devices." (Section 6) "Analytical testing to the stated specifications demonstrates that these devices will have comparable safety and efficacy in use." (Summary Conclusions 8)
Manufacturing Standards: Manufactured under current Good Manufacturing Practices (cGMP) and aseptic conditions.	"The devices are manufactured under conditions of current Good Manufacturing Practices (cGMP)." (Section 6) "The devices, as manufactured by Holopack, are produced using dark-side/white-side blow-fill-seal technology on rommeLag® machines specifically designed for aseptic filling operations." (Summary Conclusions 8)
Labeling/Identification: Embossed with identifying product text, level markings, and color-coded.	"The single-use containers are embossed with identifying product text and level markings." (Section 6) "The single-use devices are color-coded unit blow-fill-sealed containers with liquid contents as labeled..." (Section 4) "The device containers have embossed unit identification and shelf carton labeling so that label requirements are met." (Summary Conclusions 8)
Limitations: Not for parenteral use; requires prescription.	"These devices are not for parenteral use nor for preparations intended for parenteral use." (Section 5.1 & Statement of Intended Use) "The use of these devices requires prescription." (Section 5.1) "Sale of the device is restricted by or on the order of a physician." (Statement of Intended Use)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable (N/A): This submission is for a pharmaceutical/delivery device (inhalation solution), not an AI/software device that would use a "test set" in this manner. Substantial equivalence was demonstrated through non-clinical laboratory testing and adherence to USP standards. No clinical trials or patient data sets (retrospective/prospective) are mentioned.

3. 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)

N/A: No "ground truth" for a test set in the context of an AI/software device. The compliance is against established USP monographs and industry standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A: Not applicable to this type of device and submission.

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

N/A: This is not an AI-assisted diagnostic device, so an MRMC study is not relevant.

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

N/A: This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Standard Specifications and Monograph Requirements: The "ground truth" (or benchmark for performance) for this device is based on established USP (United States Pharmacopeia) monograph requirements for Sodium Chloride Inhalation Solution and criteria for direct food and drug contact for the container materials. It also relies on the performance characteristics of predicate devices (K884359, K870332, Travenol Laboratories pre-1976, Wyeth Laboratories pre-1976).

8. The sample size for the training set

N/A: This is not an AI/software device that uses a "training set."

9. How the ground truth for the training set was established

N/A: Not applicable to this type of device and submission.

Summary

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olopack

510(k) Notification

June, 1997

2-100

Section 2: 510(k) Summary

AUG 7 7 7 SUMMARY CONTENTS

Sodium Chloride Inhalation Solutions, USP 0.45% ; 0.9%

Applicants Name 1. Address Contact Person Date of Submission
1. Device Name and Classification
The Predicate Devices to which Equivalence is Claimed 3.
Description of the Device 4.
1. Intended Use
Technological Characteristics of the Device and the Predicate Device 6.
Non-Clinical and Clinical Testing 7.
Summary Conclusion 8.

This 510(k) Premarket Notification summary information following is provided with respect to requests for information on this submission under Freedom of Information. Copy of this summary, which excludes Confidential Information, will be made available on request as required under Freedom of Information.

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510(k) Notification

Section 2: 510(k) Summary

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

Contact Persons:

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

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

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

1. Device Name and Classification:
. Trade Name of Devices:
- Sodium Chloride Inhalation Solution, USP 2.1 [labeled concentration at ] 0.45% and 0.9%
. Common Name of the Devices:
- Sodium Chloride Inhalation Solution 2.2 0.45% and 0.9%
Class II, Anesthesiology . Classification: 514 Compliance: Standard
- 2.3 73 CCQ Class Code: 73 BTT Accessory to medicinal non-ventilatory nebulizer

Class Code: 73 CAF Nebulizer accessory

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Holopack
------------------------------------------------------------------------------------------------------------------------------------------------------------------------
15 - hoursehold L.P.

510(k) Notification

Section 2: 510(k) Summary

The Predicate Devices to which Equivalence is Claimed

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 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 Solution for Inhalation Dey Laboratories, Inc. Concord, CA 94518

4. Description of the Devices

The single-use devices are color-coded unit blow-fill-sealed containers with liquid contents as labeled for inhalation therapy. The devices contain no preservative. They are sterile and pyrogen-free.

CONTENTS	VOLUME	CONTAINER
0.45% Sodium Chloride Inhalation Solution, USP	3mL fill	Green / Embossed label
0.45% Sodium Chloride Inhalation Solution, USP	5mL fill	Green / Embossed label
0.9% Sodium Chloride Inhalation Solution, USP	3mL fill	Pink / Embossed label
0.9% Sodium Chloride Inhalation Solution, USP	5mL fill	Pink / Embossed label

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Section 2: 510(k) Summary

ട. Intended Use

The intended use of these sterile 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 as accessories 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 requires prescription.

6. Technological Characteristics of the Device and the Predicate Devices

The subject unit dose devices of this premarket notification are formed of polyethylene resins meeting the direct food and drug contact criteria. The formed units meet the criteria for direct food and drug contact as prefilled unit containers. The solutions component , at the stated concentration of Sodium Chloride Inhalation Solution, meet the 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, L.P in the production of these devices for inhalation therapy utilize dark-side/white-side machine technology. The blow-fill-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
Business and the designation for the designed to and

Section 2: 510(k) Summary

7. Non-Clinical and Clinical Testing

The component materials of the accessory device container have been substantiated to each meet criteria for direct food and drug contact or additive respectively. 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 several 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 8.

The subject devices:

0.45% and 0.9% Sodium Chloride Inhalation Solution, USP

as manufactured by Holopack International, LP of Columbia, SC claim 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.

These devices are designed to meet the current USP specifications. The device containers have embossed unit identification and shelf carton labeling so that label requirements are met.

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/white-side blow-fill-seal technology on rommeLag® machines specifically designed for aseptic filling operations. These manufacturing systems represent a technological advance for the production of these types of devices. The details of the aseptic manufacturing processes and environment are referenced under confidentiality.

••

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

AUG 28 1997

Mr. Walter Zahn Holopack International, LP Carolina Research Park 1 Technology Circle Columbia, South Carolina 29203

K972466 Re : Prefilled Units containing Sodium Chloride Inhalation Solutions, USP Regulatory Class: II (two) Product Code: 73 CAF Dated: June 30, 1997 Received: July 1, 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 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. Callehan

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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lolopaci

510(k) Notification

June, 1997

STATEMENT OF INTENDED USE

Sodium Chloride Inhalation Solution, USP Devices: [labeled concentration at] 0.45% [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 well-established.

Limitations

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

The use of these devices requires physician order (prescription). Sale of the device is restricted by or on the order of a physician.

Prescription Device

A. Cirlousli.

(Division Sign-Off) Division of Cardiovascular, Respiratory, 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).