(187 days)
The Pocket Chamber Valved Aerosol Holding Chamber is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized MDI canisters with the associated activator elbow. The spacer device is indicated to assist in the treatment of patients with lung disease such as, but not limited to, asthma, emphysema, chronic bronchitis, and cystic fibrosis.
The Pocket Chamber Valved Aerosol Holding Chamber is a cylindrical tube, approximately 3.1 inches long by 4.5 cm wide, and accepts the MDI manufacturer's mouthpiece. The MDI receptacle has an orifice of size and shape similar to the MDI mouthpiece. The device is designed to prevent offcenter actuations. A one-way valve is located at the juncture between the mouthpiece and the body.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Ferraris Medical, Inc. Pocket Chamber Valved Aerosol Holding Chamber:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance (Pocket Chamber) | Compared Against |
|---|---|---|
| Total Dose | Performed comparably | AeroChamber, MDI actuator without spacer |
| Respirable Dose | Performed comparably | AeroChamber, MDI actuator without spacer |
| Mass Median Aerodynamic Diameter (MMAD) | Performed comparably | AeroChamber, MDI actuator without spacer |
| Geometric Standard Deviation (GSD) | Performed comparably | AeroChamber, MDI actuator without spacer |
| Resistance to Flow | Performs in accordance with specifications | Not explicitly stated; implied internal specifications |
| Cleaning Instructions Validation | Performs in accordance with specifications | Not explicitly stated; implied internal specifications |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the Cascade Impactor Test.
The data provenance is retrospective, as it describes a study that has already been performed.
The country of origin for the data is not explicitly stated, but given the submitter and FDA contact information, it is likely the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
This information is not applicable as the study described is a performance test on a device, not a diagnostic or image-based assessment requiring expert interpretation for ground truth. The "ground truth" here is the objective measurement obtained through the Cascade Impactor Test, measuring physical characteristics of the aerosol.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3. There is no human interpretation or consensus required for the physical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance:
This is not applicable. The device is an aerosol holding chamber, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI or human reader improvement is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device, not an algorithm. The "performance" described is the device's ability to facilitate aerosol delivery, which is an inherent mechanical function, not an algorithmic output.
7. The type of ground truth used:
The ground truth for the performance study was objective physical measurements obtained through the Cascade Impactor Test. These measurements directly quantify the characteristics of the aerosol produced by the device, such as total dose, respirable dose, mass median aerodynamic diameter, and geometric standard deviation. For resistance to flow and cleaning instructions, it's based on device specifications and validation testing.
8. The Sample Size for the Training Set:
This information is not applicable as there is no "training set" in the context of this device's performance study. Physical devices do not typically undergo "training" in the way an AI algorithm would.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reasons as point 8.
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MAR 2 8 2000
510(k) SUMMARY
Ferraris Medical. Inc. Pocket Chamber Valved Aerosol Holding Chamber
Submitter's Name. Address. Telephone Number. Contact Person and Date Prepared
| Mr. David R. Malys | Jonathan S. Kahan, Esq. |
|---|---|
| President | Hogan & Hartson L.L.P. |
| Ferraris Medical, Inc. | 555 Thirteenth Street, N.W. |
| 9681 Wagner Road | Washington, DC 20004-1109 |
| Post Office Box 344 | Telephone: (202) 637-5794 |
| Holland, New York 14080 | Facsimile: (202) 637-5910 |
Date Prepared:
September 23, 1999
Name of Device and Name/Address of Sponsor
Ferraris Medical, Inc. Pocket Chamber Valved Aerosol Holding Chamber
Mr. David R. Malys President Ferraris Medical, Inc. 9681 Wagner Road Post Office Box 344 Holland, New York 14080
Common or Usual Name
Spacer; Aerosol Holding Chamber
Classification Name
Accessory to a nebulizer
Predicate Devices
Monaghan Medical Corporation's AeroChamber Aerosol Holding Chamber
Intended Use
The Pocket Chamber Valved Aerosol Holding Chamber is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized MDI canisters with the associated activator elbow. The spacer device is indicated to assist in the treatment of patients with lung disease such as, but not limited to, asthma, emphysema, chronic bronchitis, and cystic fibrosis.
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Technological Characteristics and Substantial Equivalence
The Pocket Chamber Valved Aerosol Holding Chamber is a cvlindrical tube. approximately 3.1 inches long by 4.5 cm wide, and accepts the MDI manufacturer's mouthpiece. The MDI receptacle has an orifice of size and shape similar to the MDI mouthpiece. The device is designed to prevent offcenter actuations. A one-way valve is located at the juncture between the mouthpiece and the body. The Pocket Chamber Valved Aerosol Holding Chamber is substantially equivalent to the AeroChamber.
Performance Data
Ferraris performed the Cascade Impactor Test comparing the Pocket Chamber Valved Aerosol Holding Chamber with the AeroChamber and an MDI actuator without a spacer device for four categories of drugs. The Pocket Chamber Valved Aerosol Holding Chamber performed comparably in terms of total dose, respirable dose, mass median aerodynamic diameter; and geometric standard deviation. In addition, resistance to flow testing on the one-way valve, and validation of the cleaning instructions demonstrate that the Pocket Chamber performs in accordance with the device's specifications.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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MAR 2 8 2000
Mr. Jonathan S. Kahan Ferraris Medical, Inc. c/o Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109
Re : K993199 Pocket Chamber Valved Aerosol Holding Chamber Regulatory Class: II (two) 73 CAF Product Code: Dated: December 30, 1999 Received: December 30, 1999
Dear Mr. Kahan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Jonathan S. Kahan
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Jean-Nicholas fer,
James E. Dillard III Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Ferraris Medical, Inc.'s Pocket Chamber Valved Aerosol Device Name: Holding Chamber
Indications for Use:
The Pocket Chamber Valved Aerosol Holding Chamber is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized MDI canisters with the associated activator elbow. The spacer device is indicated to assist in the treatment of patients with lung disease such as, but not limited to, asthma, emphysema, chronic bronchitis, and cystic fibrosis.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. A. Whitten
Prescription Use (Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 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).