Contents of these products may be sterile water or a 0.45% sodium chloride solution (half-normal saline). Vials are factory-sealed, made of translucent, color-coded polyethylene, and are available in two sizes (3mL and 5mL). These products are single-use, and intended for inhalation only. Color-coded vials identify contents as sterile water (blue) and half-normal 0.45% saline (green).

The pre-filled vials have a perforated, break-away twist cap for dispensing solution. When twisted by the user, cap breaks away and open a small hole for solution to pass through. Vials are designed with inverted graduations to allow the clinician to read volume while dispensing solution. Addipak unit dose vials conforms to the specifications of United States Pharmacopeia – National Formulary, Sterile Water for Inhalation and Sterile Sodium Chloride for Inhalation monograph.

AI/ML Overview

This document pertains to the clearance of a medical device (Hudson RCI® AddiPak® Unit Dose Vial) and does not describe artificial intelligence (AI) or machine learning (ML) device performance. Therefore, many of the requested categories related to AI/ML device studies are not applicable.

Acceptance Criteria and Device Performance

The acceptance criteria for the Hudson RCI® AddiPak® Unit Dose Vial are based on demonstrating substantial equivalence to a predicate device (Hudson RCI® AddiPak® Unit Dose Vials K142153) and satisfying various non-clinical testing requirements. The reported device performance is presented through a comparison of the proposed device's characteristics against the predicate and reference devices, along with summaries of non-clinical testing.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance	Comments
Intended Use	The device should be used in conjunction with a non-ventilator nebulizer for lavage therapy or tracheal irrigation. Single-use, disposable, and intended for inhalation only.	Same as predicate and reference devices.	The proposed device (Sterile Water and 0.45% Half Normal Saline) covers the same intended uses as the predicate (0.9% Full Normal Saline) and reference devices (Sterile Water and 0.45% Half Normal Saline).
Technological Characteristics	Matching or being substantially equivalent in key characteristics to the predicate and reference devices.	See "Summary of Technological Characteristics" table on pages 5-7. All characteristics (Product Code, Regulation Number, Materials in fluid contact, Prescription vs. OTC, Contraindications, Sterile vs. Non-Sterile, Vial Design, Single Use vs. Reusable, Patient Population, Used with Nebulizers, Inhalation Only, Manufacturing Process) were found to be the "Same" as the predicate or reference devices. Differences in solution type, packaging size, and the inclusion of a nebulizer were addressed by reference devices.	Demonstrates equivalence in fundamental design and operational principles.
Biocompatibility	Meeting specified biocompatibility standards.	Passed all listed tests: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Material Mediated Pyrogenicity, Chemical Characterization with Toxicological Risk Assessment, USP 661, USP 788.	No adverse findings reported, indicating the materials are safe for intended use.
Performance Testing (Bench)	Meeting specified stability and sterility standards.	Passed Stability and Sterility tests.	Confirms the product maintains its integrity and purity over its shelf life.
Shelf Life	A specified duration from the date of manufacture.	2 years from date of manufacture.	Matches the predicate device's shelf life.
Packaging Size	Available in specified volumes.	3mL, 5mL.	Matches sizes available in reference devices. Predicate included a 15mL option, which is not part of the proposed device.
Solution Type	Sterile water and 0.45% Half Normal Saline.	Matches the solutions available in reference devices. Predicate specifically contained 0.9% Full Normal Saline.	The range of solutions is effectively covered by combining the predicate and reference devices.

Study Details (Not Applicable for this Device Type)

The provided document describes the FDA clearance for a physical medical device (unit dose vials containing saline or sterile water) and its equivalence to a predicate device. It does not involve any artificial intelligence (AI) or machine learning (ML) components. Therefore, the following information fields, which are specific to AI/ML device studies, are not applicable to this submission:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, no ML test set.
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 for ML.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, no ML test set.
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, no AI component.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, no ground truth for ML.
The sample size for the training set: Not applicable, no ML training set.
How the ground truth for the training set was established: Not applicable, no ML training set.

In summary, the FDA clearance for the Hudson RCI® AddiPak® Unit Dose Vial was based on demonstrating substantial equivalence through non-clinical testing of material properties, performance, and comparison to existing predicate and reference devices, not on AI/ML performance studies.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 4, 2024

Medline Industries, LP Phyllis Kondor Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093

Re: K231058

Trade/Device Name: Hudson RCI® AddiPak® Unit Dose Vial Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: December 5, 2023 Received: December 6, 2023

Dear Phyllis Kondor:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Ethan L. Nyberg -S

Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices

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OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231058

Device Name AddiPak® Unit Dose Vial

Indications for Use (Describe)

The AddiPak® Unit Dose Vial may be used in conjunction with a non-ventilator nebulizer for lavage therapy, or for tracheal irrigation.

These products are single-use, disposable, and intended for inhalation only.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image is a logo for Medline. The logo features the word "MEDLINE" in a bold, sans-serif font, with the letters stacked vertically. A white, four-pointed star-like shape is positioned above the text, with one point extending downward between the letters. The background is a solid blue color.

Traditional 510(k) Premarket Notification Hudson RCI® AddiPak® Unit Dose Vials All information on this page is confidential.

510(k) Summary

Submitter / 510(k) Sponsor

Medline Industries, LP Three Lakes Drive Northfield, IL 60093

Registration Number: 1417592

Submission Correspondent

Phyllis Kondor Regulatory Affairs Specialist pkondor@medline.com 1-800-633-5463

Summary Preparation Date January 3, 2024

Type of 510(k) Submission Traditional

Device Name / Classification

Trade Name: AddiPak® Unit Dose Vials Classification Name: Nebulizer (Direct Patient Interface) Product Code: CAF Classification Panel: Anesthesiology (Respiratory) Regulatory Class: Class II Regulation Number: 21 CFR 868.5630

Predicate Device

Hudson RCI® AddiPak® Unit Dose Vials K142153

Reference Devices

Holopack K972466 – Sodium Chloride Inhalation Solution K972467 - Sterile Water for Inhalation

Device Description

AddiPak® unit dose solutions are pre-filled vials of bland liquids for inhalation therapy.

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Traditional 510(k) Premarket Notification Hudson RCI® AddiPak® Unit Dose Vials All information on this page is confidential.

water (blue) and half-normal 0.45% saline (green).

Indications for Use

The AddiPak® Unit Dose Vial may be used in conjunction with a non-ventilator nebulizer for lavage therapy, or for tracheal irrigation.

These products are single-use, disposable, and intended for inhalation only.

Principle of Operation

These products are used with a nebulizer for lavage and tracheal lavage.

Environment of Use

The AddiPak® Unit Dose Vials are intended for use in home, hospital, and sub-acute facilities.

Patient Population

The AddiPak® Unit Dose Vials are intents requiring lavage therapy or tracheal irrigation. This includes infants (weighing ≥ 10kg), children, adolescents, and adults.

Summary of Technological Characteristics

DeviceCharacteristic	Proposed DeviceAddipak®	Primary PredicateDevice Addipak®K142153	ReferencesHolopackK972466 K972467	ComparisonAnalysis
Manufacturer	Medline Industries (formerlyTeleflex)	Teleflex	Holopack
Product Code	CAF	CAF	CAF	Same
Indications forUse	The AddiPak® Unit Dose Vialmay be used in conjunctionwith a non-ventilatornebulizer for lavage therapy,or for tracheal irrigation.	The Hudson RCI®AddiPak® Unit DoseVial, 0.9% Full Normalsaline Solution may beused in conjunction with anon-ventilator nebulizerfor lavage therapy, or fortracheal irrigation.	The intended use ofthesesterile single usedevices is asaccessories tomedicinalnonventilatorynebulizers inrespiratory therapyor fortracheal irrigation orlavage.	Same
RegulationNumber	21 CFR 868.5630	21 CFR 868.5630	21 CFR 868.5630	Same

TABLE 9-1: COMPARISON OF PROPOSED AND PREDICATE DEVICES

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Traditional 510(k) Premarket Notification Hudson RCI® AddiPak® Unit Dose Vials All information on this page is

Solutions	Sterile water0.45% Half Normal Saline	--0.9% Full Normal Saline	Sterile water(K972467)0.45% Half NormalSaline (K972466)	Same asreferences
Packaging Size	3 mL, 5 mL	3 mL, 5 mL, 15 mL	3 mL, 5 mL	Same size asreferences
Shelf Life	2 years from date ofmanufacture	2 years from date ofmanufacture	Not specified	Same
Materials in fluidcontact	Vial LDPE	Vial LDPE	Vial LDPE	Same
Prescription vs.OTC	Prescription	Prescription	Prescription	Same
Contraindications	No known contraindications	No knowncontraindications	No knowncontraindications	Same
Sterile vs. Non-Sterile	Sterile – Reverse Osmosis perUSP <71>	Sterile – Reverse Osmosisper USP <71>	Sterile – ReverseOsmosis per USP<71>	Same
Vial Design	Pinched seam between vialand cap for openingNozzle opening design to keep	Pinched seam betweenvial and cap for openingNozzle opening design tokeep contents within	Pinched seam betweenvial and cap foropeningNozzle openingdesign to keep	Same
	contents within when invertedRaised inverted graduations	when invertedRaised invertedgraduations	contents within wheninvertedRaised invertedgraduations
Single Use vs.Reusable	Single Use	Single Use	Single Use	Same
Biocompatibility	• Cytotoxicity• Sensitization• IntracutaneousReactivity• Material MediatedPyrogenicity• ChemicalCharacterization withToxicological RiskAssessment• USP 661• USP 788	• Cytotoxicity• Sensitization• IntracutaneousReactivity• Material MediatedPyrogenicity• ChemicalCharacterizationwith ToxicologicalRisk Assessment• USP 661• USP 788	• Not specified	Same
PatientPopulation	Any patients requiring lavagetherapy or tracheal irrigation.	Any patients requiringlavage therapy or trachealirrigation.	Any patients requiringlavage therapy ortracheal irrigation.	Same
Used withNebulizers	Yes	Yes	Yes	Same
Environment of	Home, hospital, and sub-acute	Home, hospital, and sub-acute	Not specified	Similar
Use	facilities	acute facilities
Inhalation Only	Yes	Yes	Yes	Same
ManufacturingProcess	Per USP MonographBlow-Fill-Seal aseptic process	Per USP MonographBlow-Fill-Seal asepticprocess	Per USP MonographBlow-Fill-Seal asepticprocess	Same

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Traditional 510(k) Premarket Notification Hudson RCI® AddiPak® Unit Dose Vials All information on this page is confidential.

Summary of Non-Clinical Testing

Biocompatibility Testing

Cytotoxicity
Sensitization
Intracutaneous Reactivity ●
Material Mediated Pyrogenicity ●
Chemical Characterization with Toxicological Risk Assessment ●
USP 661
USP 788 ●

Performance Testing (Bench)

Stability .
. Sterility

Performance Testing (Animal)

This section does not apply. No animal testing was performed.

Performance Testing (Clinical)

This section does not apply. No clinical testing was performed.

Summary of Clinical Testing

Not applicable.

Conclusion

The proposed AddiPak® Unit Dose Vial, Sterile Water and 0.45% Half Normal Saline Solution is substantially equivalent in

Intended use for adding sterile water or saline solution with a nebulizer for tracheal irrigation or lavage ●
. Design - used with a nebulizer and disposable prefilled container
. Principles of operation and solutions similar to the predicate and the same as the references

The differences between the AddiPak® Unit Dose Vial. Sterile Water and 0.45% Half Normal Saline Solution and the predicate devices are:

. Solution type – sterile water and 0.45% saline
Size of the packaged solution
Provided nebulizer - the proposed device does not include a nebulizer
. Predicate can provide supplemental oxygen during aerosol therapy

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Image /page/8/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, sans-serif font, positioned to the left of a white starburst symbol. The starburst has four points, with the top and bottom points being longer than the side points. The background of the logo is a solid dark blue color.

Traditional 510(k) Premarket Notification Hudson RCI® AddiPak® Unit Dose Vials All information on this page is confidential.

The reference devices address each difference of the predicate namely, the indications for use, solutions, technological characteristics, and principle of operation to support substantial equivalence.

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).