(92 days)
The DPILog is intended for use by a single patient under the care or treatment of a physician or licensed healthcare professional. The DPILog is prescribed by the doctor when detailed Dry Powder Inhaler (DPI) usage monitoring is indicated. The DPILog can be used by any patient who regularly uses DPIs as prescribed by a physician.
The DPILog DPC-512 is comprised of a reusable electronics module and a disposable battery sleeve that snaps together around an already cleared/marketed dry power inhaler. The device utilizes previously cleared/marketed accessories, i.e., an infrared docking station to communicate the collected data to a computer via an interface cable and software. The DPILog System has direct application to physicians involved in clinical trial disease management and training patients in proper use of DPIs. The objective data collected by the DPILog allows researchers improved quality of information in clinical trials and increased precision of statistical analysis.
The provided document (K062811) for the DPILog DPC-512 is a 510(k) premarket notification with a summary of its safety and effectiveness. This type of document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting detailed studies with specific acceptance criteria and performance metrics for a novel technology. Therefore, much of the requested information (such as specific performance metrics, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance) is not typically found in a 510(k) summary for a device like this, which is an accessory to a medical device and relies on showing equivalence.
The DPILog DPC-512 is described as a device that "utilizes previously cleared/marketed accessories" and its "proposed device is equivalent to the identified predicate devices with respect to technological characteristics and function." This indicates that the regulatory pathway relies on demonstrating that the new device is functionally the same as existing, cleared devices, rather than proving new performance claims through extensive clinical studies.
However, I can extract information related to the device description, intended use, and equivalence claims.
Here's a breakdown of the available information in response to your request, with an emphasis on what is not provided due to the nature of the submission:
Acceptance Criteria and Study for DPILog DPC-512 (K062811)
The provided document (K062811) describes the DPILog DPC-512 as an accessory to metered dose inhalers (MDI), emphasizing its equivalence to predicate devices rather than presenting novel performance studies with specific acceptance criteria and reported performance metrics. The submission focuses on demonstrating substantial equivalence in technological characteristics and function to already cleared devices. Therefore, direct "acceptance criteria" for novel device performance and detailed "reported device performance" in a quantitative table are not provided in this 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for an accessory device based on substantial equivalence, explicit quantitative acceptance criteria and reported device performance in the manner of a clinical study for a novel diagnostic algorithm are not present in the provided text. The "acceptance criteria" here are implicitly related to meeting the general safety and effectiveness standards by demonstrating equivalence to predicate devices. The "reported device performance" is essentially that it functions equivalently to the predicate devices.
The submission states: "The proposed device is equivalent to the identified predicate devices with respect to technological characteristics and function." This statement serves as the primary "performance claim" and the basis for regulatory acceptance.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. Given that the device is an accessory that monitors DPI usage and relies on existing technologies, a "test set" in the context of an AI or diagnostic algorithm study is not applicable here. The submission does not detail any specific data collection for performance validation.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the 510(k) summary. Establishing ground truth by experts is typically relevant for diagnostic or AI-driven devices. The DPILog DPC-512 is a usage monitoring device, not a diagnostic one.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary, as there is no described test set or adjudication process for diagnostic performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed, or at least not described in this 510(k) summary. MRMC studies are relevant for diagnostic devices that involve human interpretation, often with AI assistance. The DPILog DPC-512 is a data collection and monitoring device.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study for an algorithm was not performed, or at least not described in this 510(k) summary. The device's primary function is described as collecting data from Dry Powder Inhalers. While it uses "electronics module" and "software" to communicate data, it is not presented as an AI-driven or diagnostic algorithm in the sense requested.
7. Type of Ground Truth Used
This information is not applicable/not provided in the context of this device being an accessory for usage monitoring, rather than a diagnostic tool requiring ground truth for accuracy validation. The "ground truth" for this device would likely relate to the accurate recording of inhaler activations, which is implicitly covered by demonstrating technological equivalence to predicate devices.
8. Sample Size for the Training Set
This information is not applicable/not provided. The device is not described as involving machine learning or a training set in the context of an algorithm.
9. How Ground Truth for the Training Set Was Established
This information is not applicable/not provided, as there is no described training set or ground truth establishment process.
In summary, the K062811 document for the DPILog DPC-512 is a 510(k) premarket notification demonstrating substantial equivalence to existing predicate devices. It is an accessory designed for monitoring the usage of Dry Powder Inhalers. As such, it does not contain the detailed performance studies, acceptance criteria, test/training set information, expert involvement, or ground truth establishment typically found for novel diagnostic algorithms or AI-powered devices. The "study" proving it meets acceptance criteria is the demonstration that its technological characteristics and function are equivalent to those of the predicate devices.
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Life Outcomes, Incorporated 510(k) Premarket Notification
| Summary of Safety and Effectiveness | |||||
|---|---|---|---|---|---|
| Submitted by: | Life Outcomes, Inc.5696 Peachtree Parkway, Suite ANorcross, GA 30092 USATelephone: (770) 622-4427Facsimile: (770) 622-9021Website: www.lifeoutcomes.com | DEC 20 2006 | |||
| Contact Person: | Thomas TacciniDirector, Research & DevelopmentWestmed, Inc.109 Inverness Drive East, Suite AEnglewood, CO 80112 USATelephone: (303) 783-0011 ext. 1132Facsimile: (303) 708-8631Email: ttaccini@westmedinc.com | ||||
| Date Prepared: | September 15, 2006 | ||||
| Proprietary Name: | DPILog DPC-512 | ||||
| Common Name: | Accessory to Metered Dose Inhalers | ||||
| Classification Name: | Anesthesiology 21 CFR 868.5630 73 CAF | ||||
| Predicate Device: | MedTrac MDILog MDC-512, K990185, cleared April 1, 1999MedTrac MDILog MDC-511, K970344, cleared August 6, 1997NewMed Doser, K935955, cleared September 516, 1994 |
Device Description: The DPILog DPC-512 is comprised of a reusable electronics module and a disposable battery sleeve that snaps together around an already cleared/marketed dry power inhaler. The device utilizes previously cleared/marketed accessories, i.e., an infrared docking station to communicate the collected data to a computer via an interface cable and software. The DPILog System has direct application to physicians involved in clinical trial disease management and training patients in proper use of DPIs. The objective data collected by the DPILog allows researchers improved quality of information in clinical trials and increased precision of statistical analysis.
lntended Use of Device: The DPILog DPC-512 is intended for use by a single patient under the care or treatment of a physician or licensed healthcare professional. The DPLLog is prescribed by the doctor when detailed Dry Powder Inhaler (DPI) usage monitoring is indicated. The DPILog can be used by any patient who regularly uses DPIs as prescribed by a physician.
ll will be the physician or healthcare professional's responsibility to contact and coordinate with Life Outcomes to acquire and attach the PPLog electronics module, disposable sleeve bodies onto the DPI actuator. DPIs with attached DPILog electronic modules and disposable sleeve bodies will be distributed to patients by a physician or healthcare professional.
Technological Characteristics: The proposed device is equivalent to the identified predicate devices with respect to technological characteristics and function. The device has been designed to comply with the applicable sections of International Electrotechnical Commission Standards for Medical Devices, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8 plus International Standards Organization Standards for Risk Management ISO 14971 and Biocompatibility ISO 10993.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2006
Life Outcomes. Incorporated C/O Mr. Charles M. Hart Principle Consultant HART Consulting 3957 Blue Pine Circle Highlands Ranch, Colorado 80126-8077
Re: K062811
Trade/Device Name: DPILog, Model DPC-512 Regulation Number: 868.5630 Regulation Name: Nebulizer Anesthesiology Regulatory Class: II Product Code: CAF Dated: December 7, 2006 Received: December 8, 2006
Dear Mr. Hart:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -Mr. Hart
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
11 062811
DPILog DPC-512 Device Name:
Indications for Use:
The DPILog is intended for use by a single patient under the care or treatment of a physician or licensed healthcare professional. The DPILog is prescribed by the doctor when detailed Dry Powder Inhaler (DPI) usage monitoring is indicated. The DPILog can be used by any patient who regularly uses DPIs as prescribed by a physician.
It will be the physician or healthcare professional's responsibility to contact and coordinate with Life Outcomes to acquire and attach the DPILog electronics module, disposable sleeve bodies onto the DPI actuator. DPIs with attached DPILog electronic modules and disposable sleeve bodies will be distributed to patients by a physician or healthcare professional.
(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
OR
(Per 21 CFR 801.109)
Over-The-Counter _____________________________________________________________________________________________________________________________________________________________
§ 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).