(189 days)
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 health care professional. The MDILog is prescribed by the doctor when MDI usage monitoring is indicated. The MDILog can be used by any patient who regularly uses MDIs as prescribed by a physician.
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.
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.
This looks like a 510(k) premarket notification document for a medical device called MDILog, Model MDC-511. This type of document is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than proving its effectiveness through clinical trials with specific acceptance criteria in the same way a new drug or high-risk device might.
Therefore, the requested information about "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with performance metrics like sensitivity, specificity, accuracy, and detailed statistical analysis is not present in this document. The submission focuses on demonstrating equivalency based on technological characteristics and performance in simulated-use conditions rather than a comparative effectiveness study involving human readers or a standalone algorithm performance study.
Here's a breakdown of the available information based on your request, highlighting what is not covered by this type of submission:
1. A table of acceptance criteria and the reported device performance:
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Acceptance Criteria (Not applicable in the traditional sense for this 510(k)): This document does not define specific clinical performance "acceptance criteria" like sensitivity or specificity. Instead, the "acceptance" is based on demonstrating substantial equivalence to predicate devices through technical characteristic comparison and performance testing.
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Reported Device Performance: The document describes "performance testing in a simulated-use condition" and "environmental tests," but it does not provide any specific quantitative results or metrics from these tests. The "Table of Comparison to Legally Marketed Devices" (excerpted below) highlights features and technical specifications rather than performance outcomes against predefined clinical criteria.
Characteristic Nebulizer Chronolog System (K823423) PeakLog System (K940835) Doser (K93555) 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 thermistor 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. Data Collection Records date 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) Maximum Maneuvers Stored 256 500 300 (approximately) 1300 Battery Life Over 1 year 4 weeks 1 year Six months Patient Reminder None Yes - Beeps Yes - Beeps Yes - Beeps (reminds patient when to take medication and when canister is empty) (and other characteristics listed in the provided document)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided. The document mentions "performance testing in a simulated-use condition" but does not detail the sample size (e.g., number of uses, devices, or individuals involved in the simulation), data provenance, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable/provided. The 510(k) submission does not describe a test set with human-established ground truth in a clinical context. The performance testing was in a "simulated-use condition," which would likely involve engineering or technical verification rather than expert clinical assessment of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable/provided for the reason stated above.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable. The MDILog is a compliance monitoring device for MDIs, not an AI-powered diagnostic tool that assists human readers. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable in the context of an "algorithm" as commonly understood in AI. The device itself is standalone in its monitoring function, but the "performance testing in a simulated-use condition" doesn't detail performance metrics that would typically apply to algorithm-only evaluations (e.g., specific accuracy, precision, recall for an AI task).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not provided. Given the nature of "simulated-use condition" performance testing for a monitoring device, the "ground truth" would likely be based on controlled experimental conditions and known mechanical/electronic outputs, rather than clinical ground truth like pathology or expert consensus. For example, if the device is testing MDI actuation detection, the ground truth would be the actual actuation events under controlled settings.
8. The sample size for the training set:
- This information is not provided. This device is a hardware monitoring system with embedded software, not a machine learning model that undergoes "training" on a dataset in the AI sense.
9. How the ground truth for the training set was established:
- This information is not applicable for the reason stated above (not an AI training set).
In summary:
This 510(k) notification focuses on establishing substantial equivalence based on the device's technological characteristics and intended use compared to existing predicate devices. It briefly mentions "performance testing in a simulated-use condition" and "environmental tests" as support, but it does not provide the detailed study information, acceptance criteria, or quantitative performance results that would be expected for a device proving clinical effectiveness or an AI model's performance. The review process for such a device is primarily concerned with safety and the demonstration of equivalent functionality to already cleared devices.
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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 areclassified as nebulizers |
| Contact Person: | Linda NelsonMedtrac Technologies, Inc.12364 Alameda ParkwaySuite 115Lakewood, CO 80228303-985-0252 |
| 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.
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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.
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Table of Comparison to Legally Marketed Devices
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| Characteristic | Nebulizer ChronologSystem (K823423) | PeakLog System(K940835) | Doser(K935955) | MDILog System |
|---|---|---|---|---|
| Intended Use | Monitor medication usage andcompliance. | Measures spirometric functionsand monitors compliance. | Monitor medication usage. | Monitor medication usage andcompliance. |
| Principle of Operation | MDI canister placed inChronolog body. Mechanicalswitch used to detect canisteractuation. Data stored in devicememory for later retrieval. | Hot wire technology used todetect air flow & firmwarealgorithms used to extrapolatemeasurements. Data stored indevice memory for later retrieval. | Attaches onto MDI canister indispenser. Pressure activatedwhen the Doser is pushed downthus pushing the MDI to dispensemedication. Counts stored indevice memory | Attached onto outside ofdispenser body. Heatedthermister used to detect air flow,mechanical beam with strain gageused to detect canister actuationand moving magnet used todetect shake. Data stored indevice memory for later retrieval. |
| Output Port and ComputerInterface | Direct connection to stand-alonehardware via etched card andsocket. | RS232 connector and interfacecable | None | Infrared cells to Infrared readerDocking Station and interfacecable. |
| Data Collection | Records data and time of eachMDI canister actuation. | Measures PEFR and FEV1.Records date and time of eachmeasurement. | Records number of MDI canisteractuations. | 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 setbutton) | Yes (2 key membrane switch) |
| Memory Size | 8K | 64K | Unknown | 8K |
| Maximum ManeuversStored | 256 | 500 | 300 (approximately) | 1300 |
| Power Source | 3 - 1.4 volt zinc-air cells (Userreplaceable) | 2 AAA alkaline batteries (Userreplaceable) | Battery (Non-replaceable) | 1 - 3 volt lithium cell (Factoryreplaceable) |
| 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 patientwhen to perform a measurement) | Yes - Beeps (reminds patientwhen 20 doses are left incanister) | Yes - Beeps (reminds patientwhen to take medication andwhen 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/ SoftwarePatient 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) |
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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.
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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
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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
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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)
§ 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).