(187 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical aspects of an aerosol holding chamber and do not mention any AI or ML components.
No
The device is a valved aerosol holding chamber, which assists in the delivery of aerosolized medications from an MDI, rather than providing therapy itself. It is a delivery aid, not a therapeutic device.
No
The device is described as an aerosol holding chamber intended to assist with the delivery of aerosolized medications, not to diagnose a condition.
No
The device description clearly describes a physical, cylindrical tube with a one-way valve, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for assisting with the delivery of aerosolized medications to patients with lung disease. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a physical device designed to hold and deliver medication, not to analyze biological samples or provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic results.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device's function is to facilitate the delivery of medication, which is a treatment modality.
N/A
Intended Use / 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.
Product codes
73 CAF
Device Description
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.
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
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
1
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.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/3 description: The image shows a black and white abstract design. The design features three curved lines that appear to be stacked on top of each other. The lines are thick and bold, and they create a sense of movement and flow. The overall impression of the image is one of simplicity and elegance.
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.
3
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
4
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)