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.

AI/ML Overview

This 510(k) premarket notification is for Sterile Water for Inhalation, USP. This product is a Class II medical device, specifically an accessory to medicinal non-ventilatory nebulizers and a nebulizer accessory.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (What they aimed to demonstrate)	Reported Device Performance (How the device performs)
Safety and Efficacy: Substantial equivalence to predicate devices for intended use.	* "Analytical testing to the stated specifications demonstrates that these devices will have comparable safety and efficacy in use." (Section 8. Summary Conclusions)
USP Monograph Criteria for Sterile Water for Inhalation, USP:	* "The formulation components of the filled device solution have been substantiated to each meet their respective USP monograph criteria." (Section 7. Non-Clinical and Clinical Testing) * "Each of the finished devices undergoes testing to meet the stated USP monograph and container criteria." (Section 7. Non-Clinical and Clinical Testing)
Container Integrity: Meet container criteria and direct food and drug contact standards.	* "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. Non-Clinical and Clinical Testing) * "Each of the finished devices undergoes testing to meet the stated USP monograph and container criteria." (Section 7. Non-Clinical and Clinical Testing)
Sterility: Device is sterile.	* "The single-use devices... are sterile and pyrogen-free." (Section 4. Description of the Devices) * One of the in vitro analytical methods used to demonstrate equivalence is "sterility." (Section 7. Non-Clinical and Clinical Testing)
Pyrogen-free: Device is pyrogen-free.	* "The single-use devices... are sterile and pyrogen-free." (Section 4. Description of the Devices)
Fill Uniformity: Consistent fill volume.	* One of the in vitro analytical methods used to demonstrate equivalence is "fill uniformity." (Section 7. Non-Clinical and Clinical Testing)
Water Purity: Meet purity standards.	* "The water raw material source is Water for Injection, USP produced at Holopack." (Section 6. Technological Characteristics) * One of the in vitro analytical methods used to demonstrate equivalence is "water purity." (Section 7. Non-Clinical and Clinical Testing)
Physical-Chemical Characteristics: (e.g., water properties, unit configuration)	* These characteristics were used in "various in vitro analytical methods" to demonstrate equivalence. (Section 7. Non-Clinical and Clinical Testing)

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

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 several various in vitro analytical methods (water purity, fill uniformity; sterility; container integrity) and physical-chemical characteristics (water properties; unit configuration) available which demonstrate this equivalence." (Section 7. Non-Clinical and Clinical Testing)

Therefore, there appears to be no "test set" in the traditional sense of a clinical study involving human subjects or a defined dataset for AI model evaluation. The assessment was based on analytical and physical-chemical testing of the manufactured product. The data provenance is internal to the manufacturer's quality control and testing processes.

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

Given that no clinical "test set" was used, the concept of experts establishing ground truth for such a set is not applicable here. The ground truth for the product specifications (e.g., USP monograph criteria) would have been established by the United States Pharmacopeia (USP) and other relevant regulatory bodies.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This device is a sterile solution (Sterile Water for Inhalation, USP). It is not an imaging or diagnostic device that would typically involve human readers or an AI algorithm requiring an MRMC study.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Performance:

Not applicable. This device is a physical product (sterile water), not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" used for this device's acceptance was:

USP Monograph Criteria: The legally defined specifications for Sterile Water for Inhalation, USP.
Manufacturer's Internal Quality Control Specifications: Based on the USP and good manufacturing practices.
Predicate Device Characteristics: The known and established characteristics of legally marketed predicate devices.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The manufacturing processes and quality checks are based on established scientific principles and regulatory standards, not on data-driven learning models.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

Michel

		510(k) Notification
		Section 2: 510(k) Summary
		SUMMARY CONTENTS
AUG 28 1997		Sterile Water for Inhalation, USP
	1.	Applicants NameAddressContact PersonDate of Submission
	2.	Device Name and Classification
	3.	The Predicate Devices to which Equivalence is Claimed
	4.	Description of the Device
	5.	Intended Use
	6.	Technological Characteristics of the Device and the Predicate Device
	7.	Non-Clinical and Clinical Testing

1. Summary Conclusion
  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.

{1}------------------------------------------------

510(k) Notification

June, 1997

Section 2: 510(k) Summary

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

Contact Persons:

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

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

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

1. Device Name and Classification:
. Trade Name of Devices:
- 2.1 Sterile Water for Inhalation, USP
. Common Name of the Devices:
- 2.2 Sterile Water for Inhalation, USP
. Classification: Class II, Anesthesiology 514 Compliance: Standard
- 2.3 Class Code: 73 CCQ 73 BTT Accessory to medicinal non-ventilatory nebulizer

Class Code: 73 CAF Nebulizer accessory

{2}------------------------------------------------

Holopack

510(k) Notification

Section 2: 510(k) Summary

1. 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.
K871618 Prefilled Sterile Water for Inhalation, USP Automatic Liquid Packaging, Inc. 2200 W. Lake Shore Drive Woodstock, IL 60096
K870332 Travenol Laboratories ( pre-1976) Wyeth Laboratories, Inc. (pre-1976) Respiratory Therapy Vials
K881184 Sterile Water for Inhalation Delmed-Intertech

Sterile Water for Inhalation, USP Dey Laboratories, Inc. Concord, CA 94518

1. 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
Sterile Water for Inhalation, USP	3mL fill	Blue / Embossed label
Sterile Water for Inhalation, USP	5mL fill	Blue / Embossed label

{3}------------------------------------------------

Holopack

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.

Technological Characteristics of the Device and the Predicate Devices ട.

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 water raw material source is Water for Injection, USP produced at Holopack.

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 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.

{4}------------------------------------------------

---International L.A.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	510/k) Notification	- COO-
AND AND AND CONSULTION OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAI	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	LINE MELECT CONN. L

Section 2: 510(k) Summary

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 (water purity, fill uniformity; sterility; container integrity) and physical-chemical characteristics (water properties; unit configuration) available which demonstrate this equivalence.

8. Summary Conclusions

The subject devices:

Sterile Water for Inhalation, 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.

••

{5}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

AUG 28

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

K972467 Re: Prefilled Units containing Sterile for Inhalation, USP Requlatory 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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.

{6}------------------------------------------------

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. 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

{7}------------------------------------------------

lolopack

510(k) Notification-

June, 1997

STATEMENT OF INTENDED USE

AUG 28 1997

Devices:

Sterile Water for Inhalation, USP

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

Ath. A. Ciarlush.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K972467 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).