(82 days)
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Not Found
No
The device description and intended use clearly describe a mechanical spacer for MDIs, with no mention of software, data processing, or AI/ML terms.
Yes.
The device is intended to aid in the proper inhalation of asthmatic medication, which directly relates to the treatment of a medical condition.
No
Explanation: The device, BreatheRite MDI Spacer, is described as aiding in the proper inhalation of asthmatic medication using an MDI, acting as a dispersion chamber. It does not mention any function for diagnosing conditions or diseases.
No
The device description clearly outlines physical components (chamber, flange adapter, valve adapter, exhalation adapter) which are hardware.
Based on the provided information, the VENTLAB Corporation's BreatheRite MDI Spacer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid in the proper inhalation of asthmatic medication from a metered dose inhaler. This is a device used in vivo (on a living person) to deliver medication, not to perform tests on samples taken from the body in vitro (in a lab setting).
- Device Description: The description details a physical chamber and valve system for medication delivery, not equipment for analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
Therefore, the BreatheRite MDI Spacer is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
VENTLAB Corporation's BreatheRite MDI Spacer is designed to work in conjunction with a metered dose inhaler (MDI) to provide a dispersion chamber that will aid the sufferer in inhaling a suitable asthmatic medication properly.
Product codes
73 CAF
Device Description
The BreatheRite MDI Spacer consists of a chamber that secures the metered dose inhalers mouthpiece with an elastomeric flange adapter at one end, a chamber connected to a one-way valve adapter, which opens on inhalation, and an exhalation adapter that allows the air to exhaust to the atmosphere both of which are housed within the mouthpiece.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 24 1998
Mr. E.J. Smith Ventlab Corporation c/o Smith Associates P.O. Box 4341 Crofton, MD 21114-4341
Re: K981944 BreatheRite Regulatory Class: II (two) Product Code: 73 CAF Undated Dated: Received: June 3, 1998
Dear Mr. Smith:
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 registration, 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 Existing major regulations affecting your device additional controls. can be found in the Code of Federal Requlations, 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 requlations.
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Page 2 - Mr. E.J. Smith
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. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Device Name: BreatheRite MDI Spacer
Classification Panel: 73 CAF
Indications for Use:
VENTLAB Corporation's BreatheRite MDI Spacer is designed to work in conjunction with a metered dose inhaler (MDI) to provide a dispersion chamber that will aid the sufferer in inhaling a suitable asthmatic medication properly. The BreatheRite MDI Spacer consists of a chamber that secures the metered dose inhalers mouthpiece with an elastomeric flange adapter at one end, a chamber connected to a one-way valve adapter, which opens on inhalation, and an exhalation adapter that allows the air to exhaust to the atmosphere both of which are housed within the mouthpiece.
Federal (USA) law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | or | Over-the-Counter Use |
|---|---|---|---|
| ------------------ | --------------------------------------------------- | ---- | ----------------------------------------------------------------------- |
| Lank W. Wedos 8-18-99 | |
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| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number |