(582 days)
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.
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. The filter consists of a plastic body, which incorporates a mechanical filter pad (Synthetic Fibers and Foam) and connectors (male / female).
The provided text is an FDA 510(k) summary for a medical device called the "Monaghan Medical Filtered Mouthpiece Kit." This document focuses on demonstrating the substantial equivalence of this device to existing predicate devices based on non-clinical performance testing, rather than clinical performance data or AI/algorithm performance.
Therefore, many of the requested points regarding AI/algorithm acceptance criteria, study methodologies, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this document as they pertain to the evaluation of AI-driven medical devices.
However, I can extract the relevant acceptance criteria and performance data for the physical device based on the provided text.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Derived from predicate/standards) | Reported Device Performance (Monaghan Medical Filtered Mouthpiece Kit) |
|---|---|---|
| Aerosol Characterization | Substantially equivalent in-vitro performance to predicate nebulizer (AeroEclipse® Durable BAN™ nebulizer K080926) when used together. | Demonstrated substantially equivalent in-vitro performance. |
| Biocompatibility | Compliance with ISO 10993-1 (2018) for biological endpoints. | All tested biological endpoints (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Pyrogenicity, Acute Systemic Toxicity, Genotoxicity, Chemical Characterization with a Biological Risk Assessment) satisfied requirements. |
| Dry Gas Pathway Testing | Exposure to volatile organic compounds (VOCs) and fine particles (PM2.5) during use is unlikely to result in toxicological effects in worst-case dry gas conditions. | Testing results and risk assessment demonstrated exposure is unlikely to result in toxicological effects. |
| Filter Efficiency | Bacterial Filtration Efficiency (BFE) and Viral Filtration Efficiency (VFE) performance. (Specific numerical targets implied by predicate/standards). | BFE: 99.999% confirmed. VFE: 99.99% confirmed. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the numerical sample sizes for each non-clinical test (e.g., how many filters were tested for efficiency, how many batches for biocompatibility). It describes the types of tests performed.
- Data Provenance: The tests are described as in-vitro (lab-based) or in-vivo (animal studies for biocompatibility, e.g., rabbits, mice, guinea pigs). The document does not specify the country of origin of the data or whether it was retrospective or prospective, though performance testing is by nature prospective for a new device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For non-clinical performance testing of a physical device, "ground truth" and "experts" in the context of human readability or AI performance are not relevant. The "ground truth" is established by the validated test methodologies and measurement instruments (e.g., filter efficiency testing protocols, chemical analysis for biocompatibility).
4. Adjudication method for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 typically refer to human expert consensus in image interpretation or diagnostic tasks, which is not relevant to non-clinical device performance 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:
- Not Applicable. No MRMC or human-in-the-loop study was conducted or is relevant to this physical device's non-clinical performance evaluation. The document explicitly states: "The determination of substantial equivalence is not based on Clinical Performance data."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical medical accessory, not an AI algorithm.
7. The type of ground truth used:
- For Aerosol Characterization: Ground truth is established by the performance of the predicate device (AeroEclipse® Durable BAN™ nebulizer K080926) using standardized test methods.
- For Biocompatibility: Ground truth is established by the specified ISO 10993 series of standards and their acceptable limits for various biological responses (e.g., no cytotoxicity, no sensitization).
- For Dry Gas Pathway Testing: Ground truth is established by toxicological risk assessments and acceptable exposure limits for VOCs and PM2.5, based on established scientific principles.
- For Filter Efficiency: Ground truth is established by independent laboratory testing using standardized methods for Bacterial Filtration Efficiency (BFE) and Viral Filtration Efficiency (VFE).
8. The sample size for the training set:
- Not Applicable. This is a physical device, and the evaluation is based on non-clinical performance testing, not machine learning model training.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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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.
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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
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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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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
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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.
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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 MedicalCorporationFiltered Mouthpiece | Salter Nebulizer ExhalationAerosol FilterAka Nebutech (K983403) | Trudell Medical InternationalAeroEclipse® Durable BAN™Nebulizer (K080926) |
|---|---|---|---|
| Intended Use | Used with a nebulizer to reduceemissions | Used with a nebulizer toreduce emissions | Administer aerosolizedmedication |
| Indications forUse(partial excerpt) | The filter kit is intended forsingle patient use as an accessoryto a small volume nebulizer. Thedevice can be used in a hospital,home or clinic with patients 5years and above to providefiltration to minimize the amountof medical aerosol exhaled intothe air. | Indicated for use whenever thephysician or healthcareprofessional administering orprescribing medical aerosolproducts to a patient with aSalter Labs nebulizer wishesto minimize the amount ofmedical aerosol exhaled intothe air. | The AeroEclipse® DurableBAN™ Nebulizer is a singlepatient reusable device,intended to be used by patientswho are under the care ortreatment of a licensed healthcare provider or physician. Thedevice is intended to be used bythese patients to administeraerosolized medicationprescribed by a physician orhealth care professional. Theintended environments for useinclude the home, hospitals andclinics. |
| Use Environment | Home, Hospitals or Clinics | Home, Hospitals or Clinics | Home, Hospitals or Clinics |
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| Used withNebulizer | Used with small volumenebulizer | 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 toK132709) | 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% BFE99.99% VFE | 99.99% BFE99.99% 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.
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| 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.
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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.
§ 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).