(189 days)
Not Found
No
The description focuses on data recording and transmission, with no mention of AI/ML for analysis or interpretation of the data.
No
The device monitors and records MDI medication usage and technique, but it does not directly treat a disease or condition. Its purpose is to assess compliance and technique for healthcare professionals, not to deliver therapy.
Yes
Explanation: The device assesses patients' techniques in using MDIs and helps the physician "assess patients' techniques." It records and transmits "certain properties of the patient's technique," which indicates it gathers information about the patient's condition (their technique) for assessment.
No
The device description explicitly states the system consists of hardware components including an electronic monitor, adapter, and docking station, in addition to software.
Based on the provided information, the MDILog system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The MDILog system does not analyze any biological samples like blood, urine, tissue, etc.
- The purpose of the MDILog is to monitor patient compliance and technique in using a medical device (MDI). It collects data about the usage of the inhaler itself, not about the patient's internal biological state or disease.
- The device description clearly outlines its function as an electronic monitor that attaches to the MDI and records usage data. This is a device that interacts with and monitors the use of another medical device, not a diagnostic test performed on a biological sample.
The MDILog falls under the category of a medical device used for monitoring and assessment of patient behavior related to their treatment.
N/A
Intended Use / Indications for Use
The MDILog system monitors the compliance of asthma and chronic respiratory patients with metered dose inhalers (MDIs) and allows for the physician to assess patients' techniques in using MDIs. The MDILog is intended for outpatient use by a single individual under the care or treatment of a physician or licensed health care professional. The device is to be used whenever patient compliance monitoring is indicated. The health care professional prescribes the patient medication treatment plan and MDILog monitors and records MDI medication usage.
The MDILog is intended for use by a single patient under the care or treatment of a physician or licensed the atth care professional The MDILog is prescribed by the doctor when decated MDI usage monitoring is indicated The MDILog can be used by any patient who regularly uses MDIs as prescribed by a physician.
Product codes (comma separated list FDA assigned to the subject device)
73 CAF
Device Description
The MDILog system monitors the compliance of asthma and chronic respiratory patients with metered dose inhalers (MDIs) and allows the physician to assesses patients' technique in using MDIs. The system consists of the MDLog electronic monitor, an adapter, a docking station to communicate to an IBM compatible personal computer, and software. The MDILog monitor is a small electronics module operating on a 3-volt battery that attaches to the dispensing boot of a metered dose inhaler (MDI). It records the time and date when a patient uses an MDI, measures certain properties of the patient's technique, and transmits these data to a docking station, which transmits the data to a computer.
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
outpatient use by a single individual under the care or treatment of a physician or licensed 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)
The tests that supported the determination of substantial equivalence were performance testing in a simulated-use condition, environmental tests, and software validation testing.
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.
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
AU: -
510(k) SUMMARY
| Device Trade Name | MDILog, Model MDC-511 |
|---|---|
| Common Name: | Monitoring accessory for Metered Dose Inhalers |
| Classification Name: | Unknown, but accessory to metered dose inhalers which are |
| classified as nebulizers | |
| Contact Person: | Linda Nelson |
| Medtrac Technologies, Inc. | |
| 12364 Alameda Parkway | |
| Suite 115 | |
| Lakewood, CO 80228 | |
| 303-985-0252 | |
| Date Prepared: | January 27, 1997 |
Substantial Equivalence Statement: MDILog is substantially equivalent to the predicate devices NewMed Doser (K935955), Medtrac Peaklog (K940835) and Nebulizer Chronolog (K823423).
Description: The MDILog system monitors the compliance of asthma and chronic respiratory patients with metered dose inhalers (MDIs) and allows the physician to assesses patients' technique in using MDIs. The system consists of the MDLog electronic monitor, an adapter, a docking station to communicate to an IBM compatible personal computer, and software. The MDILog monitor is a small electronics module operating on a 3-volt battery that attaches to the dispensing boot of a metered dose inhaler (MDI). It records the time and date when a patient uses an MDI, measures certain properties of the patient's technique, and transmits these data to a docking station, which transmits the data to a computer.
Intended Use : The MDILog system monitors the compliance of asthma and chronic respiratory patients with metered dose inhalers (MDIs) and allows for the physician to assess patients' techniques in using MDIs. The MDILog is intended for outpatient use by a single individual under the care or treatment of a physician or licensed health care professional. The device is to be used whenever patient compliance monitoring is indicated. The health care professional prescribes the patient medication treatment plan and MDILog monitors and records MDI medication usage.
003 35
1
The summary of technological characteristics of this new device compared to predicate devices is described in the matrix in Table of Comparison to Legally Marketed Devices included in this section.
The tests that supported the determination of substantial equivalence were performance testing in a simulated-use condition, environmental tests, and software validation testing. These tests are in accordance with the Reviewer Guidance for Premarket Notification Submissions, Anesthesiology and Respiratory Device Branch and the Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(K) Review.
2
Table of Comparison to Legally Marketed Devices
机制
I
ﯩﺖ
ここで000
: =
| Characteristic | Nebulizer Chronolog
System (K823423) | PeakLog System
(K940835) | Doser
(K935955) | MDILog System |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Monitor medication usage and
compliance. | Measures spirometric functions
and monitors compliance. | Monitor medication usage. | Monitor medication usage and
compliance. |
| Principle of Operation | MDI canister placed in
Chronolog body. Mechanical
switch used to detect canister
actuation. Data stored in device
memory for later retrieval. | Hot wire technology used to
detect air flow & firmware
algorithms used to extrapolate
measurements. Data stored in
device memory for later retrieval. | Attaches onto MDI canister in
dispenser. Pressure activated
when the Doser is pushed down
thus pushing the MDI to dispense
medication. Counts stored in
device memory | Attached onto outside of
dispenser body. Heated
thermister used to detect air flow,
mechanical beam with strain gage
used to detect canister actuation
and moving magnet used to
detect shake. Data stored in
device memory for later retrieval. |
| Output Port and Computer
Interface | Direct connection to stand-alone
hardware via etched card and
socket. | RS232 connector and interface
cable | None | Infrared cells to Infrared reader
Docking Station and interface
cable. |
| Data Collection | Records data and time of each
MDI canister actuation. | Measures PEFR and FEV1.
Records date and time of each
measurement. | Records number of MDI canister
actuations. | Records date and time of shake,
canister actuation and inhale. |
| Internal Clock | Yes (4 minute resolution) | Yes (1 second resolution) | Yes (30 minute resolution) | Yes (1 second resolution) |
| Digital Display | None | Yes (2 X 16 LCD) | Yes (1 X 6 LCD) | Yes (2 X 8 LCD) |
| Keyboard | None | Yes (4 key membrane switch) | Yes (2-push buttons, 1-pin set
button) | Yes (2 key membrane switch) |
| Memory Size | 8K | 64K | Unknown | 8K |
| Maximum Maneuvers
Stored | 256 | 500 | 300 (approximately) | 1300 |
| Power Source | 3 - 1.4 volt zinc-air cells (User
replaceable) | 2 AAA alkaline batteries (User
replaceable) | Battery (Non-replaceable) | 1 - 3 volt lithium cell (Factory
replaceable) |
| Battery Life | Over 1 year | 4 weeks | 1 year | Six months |
| Low Battery Indicator | None | Yes (message on display) | Yes (message on display) | Yes (message on display) |
| Patient Reminder | None | Yes - Beeps (reminds patient
when to perform a measurement) | Yes - Beeps (reminds patient
when 20 doses are left in
canister) | Yes - Beeps (reminds patient
when to take medication and
when canister is empty) |
| Auto Power Saver | Yes | Yes | Yes | Yes |
| Support Software | Yes (stand-alone hardware) | Yes (IBM compatible) | None | Yes (IBM compatible) |
| Device Initialization and Re-
initialization w/ Software | Yes | Yes | No | Yes |
| Patient Data Storage w/
Software | Yes | Yes | No | Yes |
| Patient Data Report | Yes | Yes | No | Yes |
| Characteristic | Nebulizer Chronolog System (K823423) | PeakLog System (K940835) | Doser (K935955) | MDILog System |
| Generation w/ Software
Patient Data Graphs Generation | No | Yes | No | Yes |
| Data Retrieval from Device w/ Software | Yes | Yes | No | Yes |
| Read and report battery level w/ Software | Yes | Yes | No | Yes |
| Size | 4 L X 2.5 W X 1.5 D (inches) | 3 L X 2 W X 1 D (inches) | 1.4 inch diameter | 1.8 L X 1.1 W X 0.85 D (inches approximately) |
| Case Material | Carbon-filled polypropylene | K-resin (KR01) | Plastic (unknown) | Isoplast (2510) |
3
and the comments of the comments of the country of
■ .
"
——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
播剧 |
l
4
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Linda Nelson Medtrac Technologies 12364 W. Alameda Parkway, Suite 115 Lakewood, Colorado 80228
AUG - 6 1997
Re: K970344 MDILog, Model MDC-511 Regulatory Class: II (two) Product Code: 73 CAF Dated: May 6, 1997 Received: May 8, 1997
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 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 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 ((2) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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.
5
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 requlation (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 qeneral 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
6
Page 7 of 329
510(k) Number (If known): K970344
Device Name: MDILog, model MDC-511
Indications For Use:
The MDILog is intended for use by a single patient under the care or treatment of a physician or licensed the atth care professional The MDILog is prescribed by the doctor when decated MDI usage monitoring is indicated The MDILog can be used by any patient who regularly uses MDIs as prescribed by a physician.
It will be the physician or health care professional's responsibility to contact and coordinate with Meduae I echnologies the auschment of the MMLog adupter and device onto the MDI actuator. MDIs with attached MINLog idapters and devices will be distributed to patients by a physician or health care 11.18048. 11.3
E DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER F NEDDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
to A. Waterhaus
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Prescription Use X
(Per 21 CFR 801,109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)