(582 days)
No
The device description and performance studies focus on mechanical filtration and aerosol dynamics, with no mention of AI/ML algorithms or data processing.
No.
The device is an accessory to a nebulizer that minimizes exhaled medical aerosol, functioning as an emission control device rather than directly treating a medical condition.
No
The device is described as a filter kit intended to minimize exhaled medical aerosol, indicating a therapeutic or protective function rather than a diagnostic one. It doesn't mention detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly outlines physical components like a tube, check valve, filter element, plastic body, mechanical filter pad, and connectors. The performance studies also focus on physical characteristics like aerosol characterization, biocompatibility, and filter efficiency, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "minimize the amount of medical aerosol exhaled into the air" during nebulizer therapy. This is a therapeutic or environmental control function, not a diagnostic one.
- Device Description: The device is a filter designed to capture exhaled aerosol particles. This is a mechanical filtration process, not a test performed on a biological sample to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, DNA, chemicals, etc.)
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of a biological sample.
- Performance Studies: The performance studies focus on aerosol characterization, biocompatibility, and filter efficiency (BFE and VFE). These are relevant to the device's function as a filter for exhaled air, not as a diagnostic tool.
The device is clearly intended to be an accessory to a nebulizer for controlling the release of exhaled aerosols, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The filter kit is intended for single patient use as an accessory to a small volume nebulizer. The device can be used in a hospital, home, or clinic environment with patients 5 years and above to minimize the amount of medical aerosol exhaled into the air.
Product codes (comma separated list FDA assigned to the subject device)
CAH, CAF
Device Description
The Filtered Mouthpiece is an accessory to the AeroEclipse® BANTM nebulizer. The filtered mouthpiece kit will be sold as a stand-alone filter kit or as part of a kit with the AeroEclipse® BAN™ nebulizer. The replacement filters can be purchased in bulk pack.
The device is a tube with a port to a check valve and a filter element. On inhalation the flow is straight through the tube from the nebulizer to the patient with a check valve preventing air from the filter exhaust from backflowing and diluting the delivered aerosol. On exhalation the check valve opens and all flow is directed through a filter to capture exhaled aerosol particles. This minimizes fugitive emissions from therapies such a methacholine challenge test or the delivery of antibiotics.
In line with FDA's definition of a "medical device accessory" the Filtered Mouthpiece is intended to supplement the performance of the parent device. AeroEclipse® Durable BANTM nebulizer (K080926).
The principle of operation of the Filtered Mouthpiece with nebulizer remains the same as the cleared AeroEclipse® Durable BANTM nebulizer.
Another Nebulizer that includes a filter has been identified and is listed as the primary predicate.
The filter consists of a plastic body, which incorporates a mechanical filter pad (Synthetic Fibers and Foam) and connectors (male / female).
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
5 years and above
Intended User / Care Setting
hospital, home, or clinic environment
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)
7.1 Aerosol Characterization
Aerosol characterization testing was performed in accordance with relevant sections of the CDRH Guidance Document "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH - 1993). The test results demonstrated substantially equivalent in-vitro performance between the subject device (filtered mouthpiece) used with AeroEclipse® Durable BANTM nebulizer, and the predicate device, AeroEclipse® Durable BAN"™ nebulizer (K080926).
7.2 Biocompatibility Testing
Biological endpoints applicable to the filtered mouthpiece accessory are listed below. Materials were tested in accordance with ISO 10993-1 (2018) and the results satisfied the requirements. All in vitro and in vivo studies were performed and included the following battery of tests: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Pyrogenicity. Acute Systemic Toxicity, Genotoxicity, Chemical Characterization with a Biological Risk Assessment.
| ISO Standard | Test/ Assessment |
|---|---|
| 10993-1 | Biological Risk Assessment |
| 10993-5 | Cytotoxicity Study Using the ISO Elution Method |
| 10993-5 | Cytotoxicity Study Using the ISO Elution Method (After Cidex exposure / high level disinfection) |
| 10993-3 | Genotoxicity: Bacterial Reverse Mutation Study |
| 10993-10 | Intracutaneous Study in Rabbits |
| 10993-10 | Guinea Pig Maximization Sensitization |
| 10993-11 | Acute Systemic Toxicity Study in Mice |
| 10993-11 | Pyrogenicity in Rabbits |
| 10993-17 | Establishment of allowable limits for leachable substances |
| 10993-12 | Solvent and Extraction Condition Verification for ISO 10993- 18 Chemical Characterization Program |
| 10993-18 | Chemical characterization of materials |
7.3 Dry Gas Pathway Testing
To support the safe use of the filtered mouthpiece accessory in dry gas conditions. a worst-case assessment of volatile organic compounds (VOCs) and fine particles (particulate matter PM2.5) was conducted. Testing results and risk assessment demonstrated that exposure during use of the filtered mouthpiece accessory is unlikely to result in toxicological effects.
7.4 Filter Efficiency
The Filtered Mouthpiece was independently tested and meets the Bacterial Filtration Efficiency (BFE) of 99.999% and Virus Filtration Efficiency (VFE) of 99.99% were confirmed.
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
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August 24, 2023
Monaghan Medical Corporation % Joseph Azary Consultant Aztech Regulatory & Quality LLC 543 Long Hill Avenue Shelton, Connecticut 06484
Re: K220145
Trade/Device Name: Monaghan medical filtered mouthpiece kit Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II Product Code: CAH, CAF Dated: August 24, 2023 Received: August 24, 2023
Dear Joseph Azary:
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. 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 located 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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 OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220145
Device Name
Monaghan Medical Filtered Mouthpiece Kit
Indications for Use (Describe)
The filter kit is intended for single patient use as an accessory to a small volume nebulizer. The device can be used in a hospital, home, or clinic environment with patients 5 years and above to minimize the amount of medical aerosol exhaled into the air.
| 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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3
510(k) Summary FILTERED MOUTHPIECE
SUBMITTER/510(K) HOLDER 1.
Monaghan Medical Corporation 153 Industrial Boulevard Plattsburgh, NY 12901
Contact Name: Joseph Azary (Aztech Regulatory & Quality LLC) Email: jazary@erols.com Telephone: (203) 242-6670
Updated: August 17, 2023
2. DEVICE NAME
| Proprietary Name: | None |
|---|---|
| Common/Usual Name: | Mouthpiece / Exhalation Filter |
| Classification Name: | Nebulizer (Direct Patient Interface |
| Classification Regulation: | 21 CFR 868.5630 |
| Product code: | CAF |
| Classification: | Class 2 |
| Medical Specialty (Panel): | Anesthesiology |
3. PREDICATE DEVICES
Primary Predicate Device
-
Salter Nebulizer Exhalation Aerosol Filter / Nebutech (Salter / Sunmed) -K983403
Secondary Predicate Device -
AeroEclipse® Durable BAN™ nebulizer (Trudell Medical International) . K080926
Reference -
The filter used in the subject device is identical to the filter in the Heat and ● Moisture Exchanger and Filter, which was cleared under 510(k) K132709
4
4. DEVICE DESCRIPTION AND PRINCIPLE OF OPERATION
The Filtered Mouthpiece is an accessory to the AeroEclipse® BANTM nebulizer. The filtered mouthpiece kit will be sold as a stand-alone filter kit or as part of a kit with the AeroEclipse® BAN™ nebulizer. The replacement filters can be purchased in bulk pack.
The device is a tube with a port to a check valve and a filter element. On inhalation the flow is straight through the tube from the nebulizer to the patient with a check valve preventing air from the filter exhaust from backflowing and diluting the delivered aerosol. On exhalation the check valve opens and all flow is directed through a filter to capture exhaled aerosol particles. This minimizes fugitive emissions from therapies such a methacholine challenge test or the delivery of antibiotics.
In line with FDA's definition of a "medical device accessory" the Filtered Mouthpiece is intended to supplement the performance of the parent device. AeroEclipse® Durable BANTM nebulizer (K080926).
The principle of operation of the Filtered Mouthpiece with nebulizer remains the same as the cleared AeroEclipse® Durable BANTM nebulizer.
Another Nebulizer that includes a filter has been identified and is listed as the primary predicate.
The filter consists of a plastic body, which incorporates a mechanical filter pad (Synthetic Fibers and Foam) and connectors (male / female).
ട. INTENDED USE
The filter kit is intended for single patient use as an accessory to a small volume nebulizer. The device can be used in a hospital, home or clinic with patients 5 years and above to minimize the amount of medical aerosol exhaled into the air.
5
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The subject device is to be used as an accessory to the AeroEclipse® Durable BANTM nebulizer (K080926). The AeroEclipse® Durable BANTM Nebulizer is provided with a mouthpiece. The subject device is composed of identical materials as the mouthpiece provided with the predicate device, except that it contains a filter and exhaust connector. The filter materials used in the subject device are identical the reference device subject to 510(k) K132709.
The subject device has similar / equivalent properties as the primary predicate device including a) Use Environment, b) Rx Only, c) Non-Sterile, d) Single Patient Use, e) Similar Medical Grade Polymers, f) Filter Material, Filter Rating and Type, g) Filter Efficiency VFE and BFE, and h) Intended use to be used with nebulizer to minimize the amount of medical aerosol exhaled into the air.
The differences include a) primary predicate does not have a reuse claim and b) the primary predicate has a smaller size filter area. These differences in technology for the device raise no new questions of safety and effectiveness. Testing data demonstrates these technological characteristics are substantially equivalent to the predicate device.
| Characteristic | Monaghan Medical
Corporation
Filtered Mouthpiece | Salter Nebulizer Exhalation
Aerosol Filter
Aka Nebutech (K983403) | Trudell Medical International
AeroEclipse® Durable BAN™
Nebulizer (K080926) |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used with a nebulizer to reduce
emissions | Used with a nebulizer to
reduce emissions | Administer aerosolized
medication |
| Indications for
Use
(partial excerpt) | The filter kit is intended for
single patient use as an accessory
to a small volume nebulizer. The
device can be used in a hospital,
home or clinic with patients 5
years and above to provide
filtration to minimize the amount
of medical aerosol exhaled into
the air. | Indicated for use whenever the
physician or healthcare
professional administering or
prescribing medical aerosol
products to a patient with a
Salter Labs nebulizer wishes
to minimize the amount of
medical aerosol exhaled into
the air. | The AeroEclipse® Durable
BAN™ Nebulizer is a single
patient reusable device,
intended to be used by patients
who are under the care or
treatment of a licensed health
care provider or physician. The
device is intended to be used by
these patients to administer
aerosolized medication
prescribed by a physician or
health care professional. The
intended environments for use
include the home, hospitals and
clinics. |
| Use Environment | Home, Hospitals or Clinics | Home, Hospitals or Clinics | Home, Hospitals or Clinics |
6
| Used with
Nebulizer | Used with small volume
nebulizer | Used with Nebulizer (Salter -
Nebutech) | Not Applicable |
|------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------|-------------------------------------------|
| Prescription | Rx only | Rx only | Rx only |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile |
| Single Patient Use | Yes | Yes | Yes |
| Reusable | Yes (for single patient) | No reuse claims | Yes (for single patient) |
| Materials | Medical Grade Polymers
(Polypropylene)
Filter (identical materials to
K132709) | Medical Grade Polymers
(Polypropylene, Polystyrene) | Medical Grade Polymers
(Polypropylene) |
| Disposable | Yes Disposable | Yes Disposable | Yes Disposable |
| Filter Media Area | Approx 6360 mm² | >3871 mm² | No Filter |
| Filter Type | Hydrophobic | Hydrophobic | No Filter |
| Mouthpiece | Yes | Yes | Yes |
| Filter Rating | 0.3um filtration | 0.3um filtration | No Filter |
| Filter Efficiency | 99.999% BFE
99.99% VFE | 99.99% BFE
99.99% VFE | No Filter |
| Valve for Filter | One Way Valve Mouthpiece | One Way Valve Mouthpiece | Not Applicable |
| Connector Size | 22mm conical connector. | 20mm connector | 22mm conical connector. |
7. PERFORMANCE TESTING
7.1 Aerosol Characterization
Aerosol characterization testing was performed in accordance with relevant sections of the CDRH Guidance Document "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH - 1993). The test results demonstrated substantially equivalent in-vitro performance between the subject device (filtered mouthpiece) used with AeroEclipse® Durable BANTM nebulizer, and the predicate device, AeroEclipse® Durable BAN"™ nebulizer (K080926).
7.2 Biocompatibility Testing
Biological endpoints applicable to the filtered mouthpiece accessory are listed below. Materials were tested in accordance with ISO 10993-1 (2018) and the results satisfied the requirements. All in vitro and in vivo studies were performed and included the following battery of tests: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Pyrogenicity. Acute Systemic Toxicity, Genotoxicity, Chemical Characterization with a Biological Risk Assessment.
7
| ISO Standard | Test/ Assessment |
|---|---|
| 10993-1 | Biological Risk Assessment |
| 10993-5 | Cytotoxicity Study Using the ISO Elution Method |
| 10993-5 | Cytotoxicity Study Using the ISO Elution Method |
| (After Cidex exposure / high level disinfection) | |
| 10993-3 | Genotoxicity: Bacterial Reverse Mutation Study |
| 10993-10 | Intracutaneous Study in Rabbits |
| 10993-10 | Guinea Pig Maximization Sensitization |
| 10993-11 | Acute Systemic Toxicity Study in Mice |
| 10993-11 | Pyrogenicity in Rabbits |
| 10993-17 | Establishment of allowable limits for leachable substances |
| 10993-12 | Solvent and Extraction Condition Verification for ISO 10993- |
| 18 Chemical Characterization Program | |
| 10993-18 | Chemical characterization of materials |
Table 1. Summary of Biocompatibility Testing Conducted
7.3 Dry Gas Pathway Testing
To support the safe use of the filtered mouthpiece accessory in dry gas conditions. a worst-case assessment of volatile organic compounds (VOCs) and fine particles (particulate matter PM2.5) was conducted. Testing results and risk assessment demonstrated that exposure during use of the filtered mouthpiece accessory is unlikely to result in toxicological effects.
7.4 Filter Efficiency
The Filtered Mouthpiece was independently tested and meets the Bacterial Filtration Efficiency (BFE) of 99.999% and Virus Filtration Efficiency (VFE) of 99.99% were confirmed.
8
8. CLINICAL PERFORMANCE SUMMARY
Not applicable. The determination of substantial equivalence is not based on Clinical Performance data.
9. CONCLUSION
Based upon the non-clinical data it has been demonstrated that the proposed device compared to the predicates can be found to be substantially equivalent. The subject device does not raise new issues of safety or effectiveness compared to the predicate devices.