(129 days)
The AeroVent Plus™ CHC is a single patient use collapsible holding chamber that provides the means of delivering MDI packaged drugs into a ventilator breathing circuit. The intended environments for use include the home, hospitals and clinics.
The AeroVent Plus™ Collapsible Holding Chamber (CHC) is a single patient use device used for the administration of MDI packaged drugs to mechanically ventilated patients without the need to compromise the integrity of the breathing circuit by having to open the circuit to administer the medication. The AeroVent Plus™ CHC remains collapsed in the breathing circuit until such time that a treatment is required. The AeroVent Plus™ CHC is then expanded while remaining in the circuit and treatment is given. Upon completion of the treatment the AeroVent Plus™ CHC is then once again collapsed in the circuit.
It is designed only for use in the inspiratory limb of a breathing circuit, to accommodate conventional pMDI canisters as well as most pMDI canisters with integrated dose counters (GSK type) while maintaining the counter function.
The medical device, AeroVent Plus™ Collapsible Holding Chamber (CHC), is a single-patient-use device for administering MDI packaged drugs to mechanically ventilated patients without compromising the breathing circuit. It is designed for use in the inspiratory limb of a breathing circuit and accommodates conventional pMDI canisters and most pMDI canisters with integrated dose counters.
This summary describes the device's acceptance criteria and the study that indicates it meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Compared to Predicate Device AeroVent® CHC) | Reported Device Performance (AeroVent Plus™ CHC) |
|---|---|---|
| MMAD (Mass Median Aerodynamic Diameter) | Comparable performance | Comparable to AeroVent® CHC |
| Pressure Leak Testing | Comparable performance | Comparable to AeroVent® CHC |
| Environmental Testing | Comparable performance | Comparable to AeroVent® CHC |
| Mechanical Life Cycle | Comparable performance | Comparable to AeroVent® CHC |
| Use with Integrated Dose Counters | Maintain counter function for pMDI products with integrated dose counters | Allows for activation of the counter (unlike predicate devices) |
| Fittings | Comply with ISO5356-1 standard | Complies with ISO5356-1 standard |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the non-clinical tests (MMAD, Pressure Leak Testing, Environmental Testing, Mechanical Life Cycle). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective.
3. Number of Experts and Their Qualifications for Ground Truth
No experts were used to establish ground truth for a test set, as this device's performance was evaluated through non-clinical laboratory testing comparing it to a predicate device, not by diagnostic accuracy or interpretation by human experts.
4. Adjudication Method for the Test Set
No adjudication method was used for a test set involving human interpretation, as the evaluation relied on non-clinical engineering and performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted. The device is not an AI-assisted diagnostic tool, and its effectiveness was demonstrated through non-clinical comparison to a predicate device.
6. Standalone Performance Study
Yes, a standalone performance was done in the sense that the device itself was subjected to several non-clinical tests (MMAD, Pressure Leak Testing, Environmental Testing, Mechanical Life Cycle) and its performance was compared to a predicate device.
7. Type of Ground Truth Used
The ground truth or benchmark for the performance tests was established by comparison to a legally marketed predicate device (AeroVent® Collapsible Holding Chamber) and compliance with an industry standard (ISO5356-1). This is a form of device performance comparison against a known standard/predicate, rather than expert consensus, pathology, or outcomes data typically associated with diagnostic devices.
8. Sample Size for the Training Set
No training set was described or utilized, as this device relies on mechanical and material properties rather than machine learning algorithms.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
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K110273
JUN - 9 2011
510(k) SUMMAR Y
Date Prepared: June 9, 2011
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
-
- Submitter Information
| Name: | Monaghan Medical Corporation | |
|---|---|---|
| Address: | 5 Latour Avenue; Suite 1600Plattsburgh, New York 12901 | |
| Telephone#: | 518-561-7330 | |
| Fax#: | 518-561-5660 | |
| Contact Person: | Cari J. Reil | Regulatory Affairs Manager |
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- Device Information
| Device Trade Name: | AeroVent Plus™ Collapsible Holding Chamber |
|---|---|
| Common Name: | Aerosol Holding Chamber/Spacer |
| Classification Name: | Nebulizer (Direct Patient Interface) |
| Classification Number: | 868.5630 |
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- Legally Marketed Predicate Devices
| Device Trade Name: | AeroVent ® Collapsible Holding Chamber |
|---|---|
| 510(k) Number: | K894969 |
| Manufacturer: | Monaghan Medical Corporation |
| Device Trade Name: | AeroVent II ™ Collapsible Holding Chamber |
| 510(k) Number: | K012939 |
| Manufacturer: | Monaghan Medical Corporation |
-
- Device Description
The AeroVent Plus™ Collapsible Holding Chamber (CHC) is a single patient use device used for the administration of MDI packaged drugs to mechanically ventilated patients without the need to compromise the integrity of the breathing circuit by having to open the circuit to administer the medication. The AeroVent Plus™ CHC remains collapsed in the breathing circuit until such time that a treatment is required. The AeroVent Plus™ CHC is then expanded while
- Device Description
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remaining in the circuit and treatment is given. Upon completion of the treatment the AeroVent Plus™ CHC is then once again collapsed in the circuit.
It is designed only for use in the inspiratory limb of a breathing circuit, to accommodate conventional pMDI canisters as well as most pMDI canisters with integrated dose counters (GSK type) while maintaining the counter function.
-
- Intended Use
The AeroVent Plus™ CHC is a single patient use collapsible holding chamber that provides the means of delivering MDI packaged drugs into a ventilator breathing circuit. The intended environments for use include the home, hospitals and clinics.
- Intended Use
-
- Technological Characteristics
The AeroVent PlusTM CHC has the same function and intended use as the predicate devices, AeroVent® CHC and Aerovent IITM CHC. It is also approximately the same size.
- Technological Characteristics
The AeroVent Plus™ CHC allows for use of pMDI products with integrated dose counters, allowing the activation of the counter. The AeroVent™ CHC or Aerovent ITM CHC did not have this ability.
The fittings on the AeroVent Plus™ CHC have been standardized to comply with the ISO5356-1 standard as on the predicate of the Aerovent IITM CHC.
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- Non-Clinical Test Summary
The AeroVent Plus™ CHC was tested to compare performance to the predicate device of AeroVent® CHC, including:
- Non-Clinical Test Summary
-
MMAD Mass Median Aerodynamic Diameter -
-
-Pressure Leak Testing
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Environmental Testing -
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Mechanical Life Cycle -
In all cases the AeroVent Plus™ CHC was comparable to the AeroVent @ CHC.
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- Clinical Performance Summary
Clinical testing was not completed as it is not required to show substantial equivalence.
- Clinical Performance Summary
-
- Conclusions
The AeroVent Plus™ CHC meets performance requirements and raises no new issues of safety or effectiveness.
- Conclusions
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Cari J. Reil Regulatory Affairs Manager Monaghan Medical Corporation 5 Latour Avenue, Suite 1600 Plattsburgh, New York 12901
JUN - 9 2011
Re: K110273
Trade/Device Name: AeroVent Plus™ Collapsible Holding Chamber (CHC) Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: May 26, 2011 Received: May 27, 2011
Dear Ms. Reil:
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- Ms. Reil
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
hh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure -
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510(k) Number (if known): |< | | | 2 7 3
Device Name: _ AeroVent Plus™ Collapsible Holding Chamber (CHC)
Indications for Use:
The AeroVent Plus™ CHC is a single patient use collapsible holding chamber that provides the means of delivering MDI packaged drugs into a ventilator breathing circuit. The intended environments for use include the home, hospitals and clinics.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | ||
| Division of Anesthesiology, General Hospital | ||
| Infection Control, Dental Devices | ||
| 510(k) Number: | K110273 | |
| Prescription Use √(Per 21 CFR 801.109) | or | Over-The-Counter Use |
Monaghan Medical Corporation · 5 Latour Avenue, Suite 1600 · Plattsburgh, NY 12901 · Toll Free 800-B33-9653 · Fax 518-561-5088 · www.monaghanmed.com
§ 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).