Hudson RCI® AddiPak® Unit Dose Vial
Device Facts
| Record ID | K231058 |
|---|---|
| Device Name | Hudson RCI® AddiPak® Unit Dose Vial |
| Applicant | Medline Industries, LP |
| Product Code | CAF · Anesthesiology |
| Decision Date | Jan 4, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5630 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
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.
Device Story
AddiPak® Unit Dose Vials are pre-filled, single-use, disposable containers holding sterile water or 0.45% sodium chloride solution. Used in home, hospital, and sub-acute facilities, these vials are intended for use with non-ventilator nebulizers for lavage therapy or tracheal irrigation. The clinician twists the perforated, break-away cap to open the vial, which features inverted graduations for volume measurement. The device provides a sterile liquid medium for inhalation therapy. It benefits patients by facilitating airway hydration or irrigation as part of respiratory care.
Clinical Evidence
No clinical testing was performed. Substantial equivalence is supported by bench testing, including biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, material-mediated pyrogenicity), chemical characterization with toxicological risk assessment, and compliance with USP 661 and USP 788 standards. Stability and sterility testing were also conducted.
Technological Characteristics
Vials are constructed of Low-Density Polyethylene (LDPE). They are manufactured via an aseptic Blow-Fill-Seal process. Available in 3mL and 5mL sizes. The device is a sterile, single-use, non-electronic, passive container. It conforms to USP monographs for Sterile Water for Inhalation and Sterile Sodium Chloride for Inhalation.
Indications for Use
Indicated for patients (infants ≥ 10kg, children, adolescents, adults) requiring lavage therapy or tracheal irrigation.
Regulatory Classification
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.
Predicate Devices
- Hudson RCI® AddiPak® Unit Dose Vials (K142153)
Reference Devices
Submission Summary (Full Text)
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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) | |
|-----------------------------------------------------------------------------------------------------------------|--|
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |
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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.
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
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Image /page/5/Picture/0 description: The image features the Medline logo, set against a blue square background. The logo consists of the word "MEDLINE" in bold, white sans-serif font, positioned to the left of a stylized white starburst symbol. The starburst is composed of four pointed shapes converging at a central point, creating a dynamic and modern design.
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).
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.
## 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
| Device<br>Characteristic | Proposed Device<br>Addipak® | Primary Predicate<br>Device Addipak®<br>K142153 | References<br>Holopack<br>K972466<br>K972467 | Comparison<br>Analysis |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Manufacturer | Medline Industries (formerly<br>Teleflex) | Teleflex | Holopack | |
| Product Code | CAF | CAF | CAF | Same |
| Indications for<br>Use | The AddiPak® Unit Dose Vial<br>may be used in conjunction<br>with a non-ventilator<br>nebulizer for lavage therapy,<br>or for tracheal irrigation. | The Hudson RCI®<br>AddiPak® Unit Dose<br>Vial, 0.9% Full Normal<br>saline Solution may be<br>used in conjunction with a<br>non-ventilator nebulizer<br>for lavage therapy, or for<br>tracheal irrigation. | The intended use of<br>these<br>sterile single use<br>devices is as<br>accessories to<br>medicinal<br>nonventilatory<br>nebulizers in<br>respiratory therapy<br>or for<br>tracheal irrigation or<br>lavage. | Same |
| Regulation<br>Number | 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 water<br>0.45% Half Normal Saline | --<br>0.9% Full Normal Saline | Sterile water<br>(K972467)<br>0.45% Half Normal<br>Saline (K972466) | Same as<br>references |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------|
| Packaging Size | 3 mL, 5 mL | 3 mL, 5 mL, 15 mL | 3 mL, 5 mL | Same size as<br>references |
| Shelf Life | 2 years from date of<br>manufacture | 2 years from date of<br>manufacture | Not specified | Same |
| Materials in fluid<br>contact | Vial LDPE | Vial LDPE | Vial LDPE | Same |
| Prescription vs.<br>OTC | Prescription | Prescription | Prescription | Same |
| Contraindications | No known contraindications | No known<br>contraindications | No known<br>contraindications | Same |
| Sterile vs. Non-<br>Sterile | Sterile – Reverse Osmosis per<br>USP <71> | Sterile – Reverse Osmosis<br>per USP <71> | Sterile – Reverse<br>Osmosis per USP<br><71> | Same |
| Vial Design | Pinched seam between vial<br>and cap for opening<br>Nozzle opening design to keep | Pinched seam between<br>vial and cap for opening<br>Nozzle opening design to<br>keep contents within | Pinched seam between<br>vial and cap for<br>opening<br>Nozzle opening<br>design to keep | Same |
| | contents within when inverted<br>Raised inverted graduations | when inverted<br>Raised inverted<br>graduations | contents within when<br>inverted<br>Raised inverted<br>graduations | |
| Single Use vs.<br>Reusable | Single Use | Single Use | Single Use | Same |
| Biocompatibility | • Cytotoxicity<br>• Sensitization<br>• Intracutaneous<br>Reactivity<br>• Material Mediated<br>Pyrogenicity<br>• Chemical<br>Characterization with<br>Toxicological Risk<br>Assessment<br>• USP 661<br>• USP 788 | • Cytotoxicity<br>• Sensitization<br>• Intracutaneous<br>Reactivity<br>• Material Mediated<br>Pyrogenicity<br>• Chemical<br>Characterization<br>with Toxicological<br>Risk Assessment<br>• USP 661<br>• USP 788 | • Not specified | Same |
| Patient<br>Population | Any patients requiring lavage<br>therapy or tracheal irrigation. | Any patients requiring<br>lavage therapy or tracheal<br>irrigation. | Any patients requiring<br>lavage therapy or<br>tracheal irrigation. | Same |
| Used with<br>Nebulizers | 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 |
| Manufacturing<br>Process | Per USP Monograph<br>Blow-Fill-Seal aseptic process | Per USP Monograph<br>Blow-Fill-Seal aseptic<br>process | Per USP Monograph<br>Blow-Fill-Seal aseptic<br>process | Same |
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Image /page/7/Picture/0 description: The image shows the Medline logo. The logo is white text on a blue background. The text "MEDLINE" is in a sans-serif font. Above the text is a white symbol that resembles a stylized cross or star.
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.
