(262 days)
The Intelliflo Spacer is intended to be used in combination with Metered Dose Inhaler's (MDI) to assist in respiratory steroid drug delivery. The target population includes all patients using MDI's i.e., children, elderly, and adults.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Intelliflo Spacer." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about a standalone algorithm study or an MRMC comparative effectiveness study.
The letter only provides:
- Device Name: Intelliflo Spacer
- Regulatory Class: II
- Product Code: CAF
- Indications for Use: "The Intelliflo Spacer is intended to be used in combination with Metered Dose Inhaler's (MDI) to assist in respiratory steroid drug delivery. The target population includes all patients using MDI's i.e., children, elderly, and adults."
Therefore, I cannot provide the requested table and study details based solely on the input provided. The document is a clearance letter, not a study report or a summary of performance data.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 5 1898
Allan M. Wachter, M.D. Aeromax Technologies, Inc. 12020 S. Warner-Elliot Loop #124 Phoenix, AZ 85044
Re: K984085 Intelliflo Spacer Requlatory Class: II (two) Product Code: CAF July 6, 1999 Dated: Received: July 6, 1999
Dear Dr. Wachter:
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 leqally 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 aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 regulation may result in In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Reqister. 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 requlations.
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Page 2 - Allan M. Wachter, M.D.
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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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(K984085)
Item #1
Indications for use:
The Intelliflo Spacer is intended to be used in combination with Metered Dose Inhaler's (MDI) to assist in respiratory steroid drug delivery. The target population includes all patients using MDI's i.e., children, elderly, and adults.
LoA. Westerhausen
DTC
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological De 510(k) Number
Prescription use √
§ 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).