(134 days)
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Not Found
No
The summary does not contain any keywords or descriptions related to AI or ML technology. The device appears to be a simple mechanical space chamber for MDI delivery.
Yes
The device "improves delivery to lungs and reduces the amount of drug deposited in the throat" from an M.D.I. (Metered Dose Inhaler), indicating it impacts the functionality or performance of a drug delivery system for therapeutic benefit.
No
Explanation: The device is described as improving drug delivery to the lungs and reducing drug deposition in the throat, which indicates a therapeutic or drug delivery function, not a diagnostic one. It helps in the treatment process rather than identifying a condition.
No
The description clearly indicates a "space chamber," which is a physical device used with an MDI. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that improves the delivery of medication from an MDI (Metered Dose Inhaler) to the lungs. This is a therapeutic or drug delivery function, not a diagnostic one.
- No mention of in vitro testing: IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of this device does not involve any such testing.
- Anatomical Site: The anatomical sites mentioned (lungs, throat) are where the medication is delivered and acts, not where samples are taken for analysis.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The space chamber obtains maximum benefit from your M.D.I. It improves delivery to lungs and reduces the amount of drug deposited in the throat.
The space chamber can be used by all patients from the youngest neonate to an adult. The device can be used in hospital, home and is portable and can be carried by the patient.
The space chamber is a multipatient use device. Please follow cleaning instructions between patient use.
Product codes
73 CAF
Device Description
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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
lungs, throat
Indicated Patient Age Range
The space chamber can be used by all patients from the youngest neonate to an adult.
Intended User / Care Setting
hospital, home
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are abstract and formed by flowing lines. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 1997
Mr. Mo Shariff Monarch Medical, Inc. 4550 Birch Bay/Lynden Road Suite B138 Blaine, Washington 98230
Re: K971808 Space Chamber™ Requlatory Class: II (two) Product Code: 73 CAF August 14, 1997 Dated: Received: August 20, 1997
Dear Mr. Shariff:
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 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). Yoll 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 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 Requlation (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 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. Mo Shariff
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/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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Page / of _/
510(k) Number (if known): K971808
Davica Name:
Indications For Us
The space chamber obtains maximum benefit from your M.D.I. It improves delivery to lungs and reduces the amount of drug deposited in the throat.
The space chamber can be used by all patients from the youngest neonate to an adult. The device can be used in hospital, home and is portable and can be carried by the patient.
The space chamber is a multipatient use device. Please follow cleaning instructions between patient use.
(PLEASE DO NOT WRITE BELOW THIS UNE-CONTINUE ON ANOTHER PAGE IF NEEDED!
(Division Sign-Off)
Division of Cardiovascular
(Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _
OR
Over-The-Counter Us
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)