(220 days)
Hudson RCI® AquaPak® Prefilled Nebulizer adds sterile water or saline solution in aerosol form to a patient's breathing gases. It may be used with pediatric (ages 2 years and above) and adult patients.
Hudson RCI® AquaPak® Prefilled Nebulizers provide sterile water or sterile saline for inhalation therapy. Nebulizers generate aerosol, a fine mist of liquid water (or sodium chloride solution) that is suspended in the gas to be inhaled by the patient.
The Hudson RCI® AquaPak® Prefilled Nebulizers are designed to aerosolize and provide a fine mist of sterile water or saline solution to inspired gas during aerosol therapy.
Prefilled sterile reservoirs for AquaPak® Nebulizers come in three sizes; 440ml, 760ml and 1070ml. Each reservoir must be used with a suitable adaptor component, which connects the system to a flow-metered gas source and provides nebulizer functionality.
Adaptor types available for the Hudson RCI® AquaPak® Prefilled Nebulizers include the 028 and the 033 Nebulizer Adaptors. Both the standard model with the yellow collar (type 028) and the quiet model with the blue collar (type 033) feature an adjustable air entrainment window, which provides a specific oxygen concentration by entraining room air into the oxygen stream.
The provided document is a 510(k) summary for the Hudson RCI® AquaPak® Prefilled Nebulizer. It outlines the device's characteristics, intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, it does not contain information about a study that uses a device to meet acceptance criteria in the way typically expected for AI/CADe devices described in the prompt's requirements.
Instead, this document describes non-clinical comparative performance testing to demonstrate substantial equivalence for a medical device (a nebulizer), not to prove the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity with a test set. This is a crucial distinction.
Therefore, I cannot fulfill most of your requested points as they are designed for studies evaluating the performance of AI/CADe systems or diagnostic devices against a defined ground truth.
Here's what I can extract and infer based on the provided text, while explicitly stating what information is not available:
Acceptance Criteria and Study for Hudson RCI® AquaPak® Prefilled Nebulizers
This document describes a 510(k) premarket notification for a medical device, the Hudson RCI® AquaPak® Prefilled Nebulizer. The "study" described is primarily non-clinical bench testing to demonstrate substantial equivalence to a legally marketed predicate device, rather than a clinical trial or performance study against specific, quantified acceptance criteria for an AI/CADe system.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with numerical targets for accuracy, sensitivity, or specificity. Instead, it describes "comparative characteristics" to a predicate device and "non-clinical comparative performance testing" to demonstrate substantial equivalence. The "performance" is implicitly deemed acceptable if it is substantially equivalent to the predicate.
| Comparative Characteristic / Test Performed | Proposed Device: Hudson RCI® AquaPak® Prefilled Nebulizer | Predicate Device: Smiths Medical Portex™ Thera-Mist® Large Volume Nebulizer | Outcome (Implicit "Acceptance") |
|---|---|---|---|
| Indications for Use | Adds sterile water or saline solution in aerosol form to a patient's breathing gases. | Delivers particulate humidity in the 3 to 5 micron range for chronic secretion patients. | Substantially Equivalent |
| Principle of Operation | Jet nebulizer with adjustable air entrainment | Jet nebulizer with adjustable air entrainment | Substantially Equivalent |
| Gas source | 50 Psi oxygen regulated via a flow meter | 50 Psi oxygen regulated via a flow meter | Substantially Equivalent |
| Flow rate and FiO2 Control Capabilities | 028 Model: 28% at 5 LPM, 35% at 8 LPM, 40%-98% at 10 LPM. 033 Model: 28%-35% at 8 LPM, 40%-98% at 10 LPM. | Normal Flow LVN: 28%-60%. High Flow LVN: 36%-95% at 14-15 LPM. | Substantially Equivalent |
| Aerosol Particle Size Delivery | 1.5 to 3 micron range | 3 to 5 micron range | Acknowledged difference, noted as minor and raising no new safety/efficacy issues. |
| Sterilization | Adaptors - Non-sterile; Sterile Water/Saline Reservoirs - Reverse osmosis, distillation, and aseptic fill. | Adaptors - Non-sterile; Sterile Water/Saline Reservoirs - Reverse osmosis, distillation, and aseptic fill. | Substantially Equivalent |
| Single Use | Yes | Yes | Substantially Equivalent |
| Shelf Life | Adaptors - N/A; Sterile Water/Saline – 2 years from date of manufacture. | Adaptors - N/A; Sterile Water/Saline – 2 years from date of manufacture. | Substantially Equivalent |
| Lift Pressure (Test) | Not explicitly reported in numbers, but "performed." | Not explicitly reported in numbers, but "performed." | Demonstrated Substantial Equivalence |
| Oxygen Entrainment (Test) | Not explicitly reported in numbers, but "performed." | Not explicitly reported in numbers, but "performed." | Demonstrated Substantial Equivalence |
| Nebulization Rate (Test) | Not explicitly reported in numbers, but "performed." | Not explicitly reported in numbers, but "performed." | Demonstrated Substantial Equivalence |
| Particle Size Distribution (Test) | Not explicitly reported in numbers, but "performed." (Note: Range already listed in comparison table) | Not explicitly reported in numbers, but "performed." (Note: Range already listed in comparison table) | Demonstrated Substantial Equivalence |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "bench testing" but does not provide the number of units tested.
- Data Provenance: Not applicable in the context of typical AI/CADe data. The testing is non-clinical bench testing of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This concept is not applicable here. Ground truth is not established by experts for this type of non-clinical device testing. Instead, the performance is measured against engineering specifications or compared directly to a predicate device.
4. Adjudication method for the test set
- Not applicable. There is no expert adjudication for this type of non-clinical bench testing.
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
- No. This is not an AI/CADe device, and no MRMC study was performed or is relevant for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the AI/CADe sense. For bench testing, the "ground truth" would be established by validated measurement equipment and adherence to engineering specifications for device function (e.g., flow rates, particle size, lift pressure). The primary "ground truth" for regulatory submission is substantial equivalence to the predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device, and no training set was used.
Summary of Device and Evidence:
The Teleflex Medical Hudson RCI® AquaPak® Prefilled Nebulizer sought 510(k) clearance by demonstrating "substantial equivalence" to the Smiths Medical Portex™ Thera-Mist® Large Volume Nebulizer. This was achieved through a comparison of "comparative characteristics" and "non-clinical comparative performance testing." The tests performed included Lift Pressure, Oxygen Entrainment, Nebulization Rate, and Particle Size Distribution. The document states that the differences between the proposed device and the predicate are "minor and raise no new issues of safety and efficacy." The detailed numerical results of these bench tests are not provided in this summary, only that they were performed to verify the performance and substantial equivalence.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
Teleflex Medical Incorporated c/o Mr. Jim Cochie Sr. Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709
Re: K141214
Trade/Device Name: Hudson RCI® AquaPak® Prefilled Nebulizers Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: Class II Product Code: CAF Dated: November 14, 2014 Received: November 20, 2014
Dear Mr. Cochie:
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 (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. 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.
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Page 2 - Mr. Cochie
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141214
Device Name
Hudson RCI® AquaPak® Prefilled Nebulizer
Indications for Use (Describe)
Hudson RCI® AquaPak® Prefilled Nebulizer adds sterile water or saline solution in aerosol form to a patient's breathing gases. It may be used with pediatric (ages 2 years and above) and adult patients.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Section 29 - 510(k) Summary - Updated
510(k) SUMMARY
Hudson RCI® AquaPak® Prefilled Nebulizers
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8083 919-433-4996 Fax:
B. Contact Person
James Cochie Sr. Regulatory Affairs Specialist
C. Date Prepared
August 26, 2014
D. Device Name
Trade Name: Hudson RCI® AquaPak® Prefilled Nebulizers
Common Name: Nebulizer
Classification Name: Nebulizer (Direct Patient Interface), CFR - 868.5630, Class II
E. Device Description
Hudson RCI® AquaPak® Prefilled Nebulizers provide sterile water or sterile saline for inhalation therapy. Nebulizers generate aerosol, a fine mist of liquid water (or sodium chloride solution) that is suspended in the gas to be inhaled by the patient.
The Hudson RCI® AquaPak® Prefilled Nebulizers are designed to aerosolize and provide a fine mist of sterile water or saline solution to inspired gas during aerosol therapy.
Prefilled sterile reservoirs for AquaPak® Nebulizers come in three sizes; 440ml, 760ml and 1070ml. Each reservoir must be used with a suitable adaptor component, which connects the system to a flow-metered gas source and provides nebulizer functionality.
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Section 29 - 510(k) Summary - Updated
Adaptor types available for the Hudson RCI® AquaPak® Prefilled Nebulizers include the 028 and the 033 Nebulizer Adaptors. Both the standard model with the yellow collar (type 028) and the quiet model with the blue collar (type 033) feature an adjustable air entrainment window, which provides a specific oxygen concentration by entraining room air into the oxygen stream.
F. Indications for Use
The Hudson RCI® AquaPak® Prefilled Nebulizer adds sterile water or saline solution in aerosol form to a patient's breathing gases.
G. Target Population
The Hudson RCI® AquaPak® Prefilled Nebulizer may be used with pediatric (ages 2 years and above) and adults.
H. Environments of Use
This device is intended for hospital, sub-acute facilities, long-term care facilities and in a home care environment.
This product is single use only.
I. Contraindications
There are no known contraindications.
J. Comparative Characteristics
The proposed Hudson RCI® AquaPak® Prefilled Nebulizer is substantially equivalent to the predicate device:
| ComparativeCharacteristics | Proposed Device:Hudson RCI® AquaPak®Prefilled Nebulizer | Predicate Device:Smiths Medical Portex™MThera-Mist® Large VolumeNebulizer |
|---|---|---|
| Manufacturer | Teleflex Medical, Inc. | Smiths Medical ASD, Inc. |
| 510(k) Number | TBD | K962534 |
| Indications for Use | The Hudson RCI®AquaPak® PrefilledNebulizer adds sterilewater or saline solution inaerosol form to a patient'sbreathing gases. | The Smiths MedicalPortex™ Thera-Mist®Large Volume Nebulizerdelivers particulatehumidity in the 3 to 5micron range for chronicsecretion patients. |
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| Section 29 - 510(k) Summary - Updated | ||||||
|---|---|---|---|---|---|---|
| --------------------------------------- | -- | -- | -- | -- | -- | -- |
| Principle ofOperation | Jet nebulizer withadjustable air entrainment | Jet nebulizer withadjustable air entrainment |
|---|---|---|
| Gas source | 50 Psi oxygen regulated viaa flow meter | 50 Psi oxygen regulated viaa flow meter |
| Flow rate and FiO2ControlCapabilities | 028 Model:28% at 5 LPM35% at 8 LPM40% - 98% at 10 LPM033 Model:28% - 35% at 8 LPM40% - 98% at 10 LPM | Normal Flow LVN:28% - 60 %High Flow LVN:36% - 95% at 14 - 15 LPM |
| Aerosol ParticleSize Delivery | 1.5 to 3 micron range | 3 to 5 micron range |
| Sterilization | Adaptors - Non-sterileSterile Water/SalineReservoirs - Reverseosmosis, distillation, andaseptic fill | Adaptors - Non-sterileSterile Water/SalineReservoirs - Reverseosmosis, distillation, andaseptic fill |
| Single Use | Yes | Yes |
| Shelf Life | Adaptors - N/ASterile Water/Saline – 2years from date ofmanufacture | Adaptors - N/ASterile Water/Saline – 2years from date ofmanufacture |
| Packaging | Adaptors - 50/case, 10 or20/case when packaged withwater/ salineSterile water/saline - 10 or20/case | LVN Adaptors - 40/case,12/case when packaged withwaterSterile Water - 12/caseSaline - Made-to-Order |
K. Non-clinical Comparative Performance Testing
Bench testing has been performed to verify that the performance of the proposed Hudson RCI® AquaPak® Prefilled Nebulizer is substantially equivalent to the predicate device, and that the Hudson RCI® AquaPak® Prefilled Nebulizer will perform as intended.
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| TestPerformed | Reference to Standard (ifapplicable) | Principle of Test |
|---|---|---|
| Lift Pressure | N/A | Measures the amount of negativepressure required to pull liquid up fornebulization |
| OxygenEntrainment | N/A | Measures the percentage of oxygen/airmixture when adjusted to preset oxygenpercentage |
| NebulizationRate | N/A | Determines the basic rate at which theliquid is aerosolized and emitted inmL/min |
| Particle SizeDistribution | N/A | Determines the particle size (MMAD)and geometric standard deviation (GSD)of the aerosolized liquid |
Section 29 – 510(k) Summary - Updated
L. Substantial Equivalence
The proposed Hudson RCI® AquaPak® Prefilled Nebulizer is substantially equivalent in intended use, design, performance and principles of operation to the identified predicate device cleared under 510(k) K962534. The differences between the proposed Hudson RCI® AquaPak® Prefilled Nebulizer and the predicate device are minor and raise no new issues of safety and efficacy. The proposed Hudson RCI® AquaPak® Prefilled Nebulizer is substantially equivalent to the currently marketed predicate device.
§ 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).