(266 days)
No
The device is a simple pre-filled vial of saline or sterile water for inhalation, with no mention of any computational or analytical capabilities that would involve AI/ML.
No
The device is a pre-filled vial of bland liquids for inhalation therapy, intended for lavage therapy or tracheal irrigation. It is not a therapeutic device itself, but rather contains substances used in therapeutic procedures.
No
This device is described as pre-filled vials of bland liquids (sterile water or 0.45% sodium chloride solution) intended for inhalation therapy for lavage or tracheal irrigation. It does not perform any kind of diagnostic function; instead, it is a consumable used in therapy.
No
The device is a physical product (pre-filled vials of liquid) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "lavage therapy, or for tracheal irrigation" using a non-ventilator nebulizer. This involves introducing a substance into the body for therapeutic or cleaning purposes.
- Device Description: The device is a pre-filled vial of sterile water or saline solution for inhalation therapy.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to gain diagnostic information. This device is a therapeutic/procedural aid for inhalation therapy.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CAF
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
This includes infants (weighing ≥ 10kg), children, adolescents, and adults.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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"
1
(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
2
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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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
5
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
Characteristic | Proposed Device
Addipak® | Primary Predicate
Device Addipak®
K142153 | References
Holopack
K972466
K972467 | Comparison
Analysis |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Manufacturer | Medline Industries (formerly
Teleflex) | Teleflex | Holopack | |
| Product Code | CAF | CAF | CAF | Same |
| 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. | The Hudson RCI®
AddiPak® Unit Dose
Vial, 0.9% Full Normal
saline Solution may be
used in conjunction with a
non-ventilator nebulizer
for lavage therapy, or for
tracheal irrigation. | The intended use of
these
sterile single use
devices is as
accessories to
medicinal
nonventilatory
nebulizers in
respiratory therapy
or for
tracheal irrigation or
lavage. | Same |
| Regulation
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
0.45% Half Normal Saline | --
0.9% Full Normal Saline | Sterile water
(K972467)
0.45% Half Normal
Saline (K972466) | Same as
references |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------|
| Packaging Size | 3 mL, 5 mL | 3 mL, 5 mL, 15 mL | 3 mL, 5 mL | Same size as
references |
| Shelf Life | 2 years from date of
manufacture | 2 years from date of
manufacture | Not specified | Same |
| Materials in fluid
contact | Vial LDPE | Vial LDPE | Vial LDPE | Same |
| Prescription vs.
OTC | Prescription | Prescription | Prescription | Same |
| Contraindications | No known contraindications | No known
contraindications | No known
contraindications | Same |
| Sterile vs. Non-
Sterile | Sterile – Reverse Osmosis per
USP | Sterile – Reverse Osmosis
per USP | Sterile – Reverse
Osmosis per USP
| Same |
| Vial Design | Pinched seam between vial
and cap for opening
Nozzle opening design to keep | Pinched seam between
vial and cap for opening
Nozzle opening design to
keep contents within | Pinched seam between
vial and cap for
opening
Nozzle opening
design to keep | Same |
| | contents within when inverted
Raised inverted graduations | when inverted
Raised inverted
graduations | contents within when
inverted
Raised inverted
graduations | |
| Single Use vs.
Reusable | Single Use | Single Use | Single Use | Same |
| Biocompatibility | • Cytotoxicity
• Sensitization
• Intracutaneous
Reactivity
• Material Mediated
Pyrogenicity
• Chemical
Characterization with
Toxicological Risk
Assessment
• USP 661
• USP 788 | • Cytotoxicity
• Sensitization
• Intracutaneous
Reactivity
• Material Mediated
Pyrogenicity
• Chemical
Characterization
with Toxicological
Risk Assessment
• USP 661
• USP 788 | • Not specified | Same |
| Patient
Population | Any patients requiring lavage
therapy or tracheal irrigation. | Any patients requiring
lavage therapy or tracheal
irrigation. | Any patients requiring
lavage therapy or
tracheal irrigation. | Same |
| Used with
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
Process | Per USP Monograph
Blow-Fill-Seal aseptic process | Per USP Monograph
Blow-Fill-Seal aseptic
process | Per USP Monograph
Blow-Fill-Seal aseptic
process | Same |
7
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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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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.