(71 days)
Not Found
Not Found
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and there is no description of training or test sets, which are typical for AI/ML devices.
No
The description states the device is "intended for use by a single patient under the care or treatment of a physician," but it does not specify any therapeutic action or treatment provided by the device itself. It appears to be a tool used in conjunction with MDIs for managing patient care, rather than a device that provides therapy.
No
The provided text does not describe the MDILog as acquiring, processing, or analyzing physiological data to diagnose a condition, but rather as a device intended for use with MDIs by patients under physician care.
No
The device description mentions "MDIs with attached MDILog and attach the MDILog Titel adapter, sice v adapter bodies," which indicates the device includes physical hardware components (adapters and bodies) that attach to MDIs, not just software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes the MDILog as being used by a single patient under the care of a physician for the purpose of being prescribed. This indicates a device used directly on or by a patient for treatment or monitoring, not for examining specimens in vitro (outside the body).
- Device Description: The description "MDILog, model MDC-512" doesn't provide details that suggest an IVD.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Mentioning reagents, assays, or laboratory procedures
The description points towards a device used in the context of patient care and medication delivery (likely related to MDIs - Metered Dose Inhalers), which falls outside the scope of IVDs.
N/A
Intended Use / Indications for Use
The MDILog is intended for use by a single patient under the care or treatment of a physician or licensed he any The MDILog is intended for use by a single patient under the care of themient of a pirposition of the MDLog can be used by any THC MDIEog is preseribed by as prescribed by a physician.
Product codes
73 CAF
Device Description
MDILog, model MDC-512
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
Not Found
Intended User / Care Setting
physician or licensed he any The MDILog; physician or health care professional
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1999
Ms. Linda Nelson Medtrac Technoloqies, Inc. 6950 Jefferson Avenue, Suite 210 Lakewood, CO 80235
Re: K990185 MDILog, Model MDC-512 Regulatory Class: II (two) Product Code: 73 CAF January 15, 1999 Dated: Received: January 20, 1999
Dear Ms. Nelson:
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 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 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.
1
Page 2 - Ms. Linda Nelson
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,
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
2
510(k) Number (If known): (unknown)
Device Name: MDILog, model MDC-512
Indications For Use:
The MDILog is intended for use by a single patient under the care or treatment of a physician or licensed he any The MDILog is intended for use by a single patient under the care of themient of a pirposition of the MDLog can be used by any THC MDIEog is preseribed by as prescribed by a physician.
It will be the physician or health care professionality to contact and coordinate with Medirac Technologies to acquire It will be the physician of health care protessonal s responsibility of tonactions. MDIs with attached MDILog and attach the MDILog Titel adapter, sice v adapter bodies and hiscian or health care professional.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R.H. A. La. Lowsli
(Division Sign or)
liovascular, Respirato
Prescription Use
Over-The-Counter Use _
(Per 21CFR 801.109)
(Optional Format 1-2-96)