(263 days)
The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia, and dyskinesia. It includes a medication reminder, an event marker and is intended to monitor activity associated with movement during sleep. The device is indicated for use in individuals 46 to 83 years of age.
The Personal Kinetigraph (PKG) Gen 2 Plus utilizes a PKG Watch (movement data logger) worn by the patient on their wrist over 6-to-10 day recording cycles. The PKG Watch continuously records and quantifies the kinematics of movement disorder symptoms such as bradykinesia (BK), dyskinesia (DK), tremor, immobility, and dyskinesia fluctuations, in movement disorder conditions such as Parkinson's disease. Proprietary PKG Analysis Algorithms are used to analyze the movement data and generate a PKG-2A Report, which provides the clinical provider with a summary of these movement disorder symptoms, plotted over the full recording period. The PKG-2A Report includes an additional feature that allows the plots to be annotated by a qualified PKG Reporter. The PKG Watch includes a medication reminder to notify the patient when it is time to take their medication, and an event marker for the patient to record when they have taken their prescribed medication. The Personal Kinetigraph (PKG) Gen 2 Plus System includes the GKCM Cloud Platform (PKG Clinic Server), a cloud-based service for receiving and processing the movement data files and generating PKG-2A Reports. The Personal Kinetigraph (PKG) Gen 2 Plus is a modified version of the predicate Personal Kinetigraph (PKG) System Model GKC-2000 (Gen 2) cleared under K161717, incorporating several new or enhanced features, including a Docking Station for charging the PKG Watch and uploading movement data files to the GKCM Cloud Platform, and a Clinic Portal (housed in the GKCM Cloud Platform), providing customer facing functions such as creating and editing patient details, scheduling medication reminders, raising PKG orders and viewing the PKG-2A Report. The Personal Kinetigraph (PKG) Gen 2 Plus also includes a PKG Tablet and PKG Dock Cable, cleared previously under K161717. The PKG Tablet is an off-the-shelf Android based tablet that runs a custom software application to configure the PKG Watch before a recording session, extract recorded data after a recording session, and upload this data to the GKCM Cloud Platform. The PKG Dock Cable connects the PKG Watch to the PKG Tablet for configuration before a recording session, and allows for uploading of the movement data to the PKG Clinic Server after the recording session. The PKG Tablet and PKG Dock Cable are not required when using the Docking Station and Clinic Portal. The Personal Kinetigraph (PKG) Gen 2 Plus system consists of the following key components: PKG Watch (movement data logger) including wrist bands; PKG Docking Station; PKG Clinic Portal; GKCM Cloud Platform (PKG Clinic Server); PKG Analysis Algorithms; PKG-2A Report; PKG Tablet; PKG Dock Cable; and 5-Bay charger.
This document describes the regulatory clearance of the Personal Kinetigraph (PKG) System Gen 2 Plus. Based on the provided text, the device is a modified version of a previously cleared device (K161717) and primarily focuses on hardware and software enhancements rather than changes to core diagnostic algorithms or indications for use. Therefore, the performance data provided focuses heavily on engineering validations (electrical safety, mechanical safety, software V&V, cybersecurity, biocompatibility, human factors) and explicitly states that clinical data was not required for this submission.
Consequently, a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or a detailed description of ground truth establishment for a diagnostic test set, which are typical for AI/ML-based diagnostic devices, are not applicable in this context. The device's primary function remains to "quantify kinematics of movement disorder symptoms" using "Proprietary PKG Analysis Algorithms" which appear to have been validated in the prior submission or are considered substantially equivalent in their underlying function.
Given this, the requested information will be presented as per available details, with explicit notes about what is not applicable based on the provided FDA document.
Device: Personal Kinetigraph (PKG) System Gen 2 Plus (K211887)
Purpose: To quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia, and dyskinesia.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes engineering verification and validation testing for the modified device components rather than specific diagnostic accuracy metrics. The "acceptance criteria" are implied by compliance with the listed standards and successful completion of the tests.
| Acceptance Criteria (Implied by Standards/Testing) | Reported Device Performance (Summary from Document) |
|---|---|
| Electrical Safety & EMC Compliance | Underwent electrical safety and EMC evaluation and testing according to IEC 60601-1:2005+AMD1:2012, IEC 60601-1-2:2014, and IEC 60601-1-11:2015. |
| Mechanical Safety Compliance | Underwent mechanical safety evaluation and testing in accordance with IEC 60601-1:2005+A1:2012 and IEC 601-1-11:2015. Testing included: Shock & Vibration, Continuous Operation (Thermal Cycling), Transport and Storage, Impact Testing, Ingress Protection (IP21), Drop testing, Push testing, and Molding Stress Relief. |
| Software Verification & Validation (V&V) | Conducted in accordance with IEC 62304:2006 + AMD1:2015 and FDA's Guidance for Industry and "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005. |
| Cybersecurity Compliance | Designed and developed in accordance with applicable requirements outlined in "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff OCTOBER 2018". |
| Biocompatibility | Evaluation conducted according to FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process' September 4, 2020", specifically for modified Wrist Strap materials. Testing performed: ISO10993-5:2009 Cytotoxicity, ISO10993-10:2010 Sensitization, and ISO10993-10:2010 Irritation. Testing performed in an FDA recognized GLP testing facility. |
| Human Factors Engineering / Usability | Performed during design and development in accordance with IEC 62366-1:2015 and FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices. Guidance for Industry and Food and Drug Administration Staff. February 3, 2016". |
Note: The document explicitly states: "Clinical data was not required for this submission as the changes to the Personal Kinetigraph (PKG) - Gen 2 Plus did not introduce any significant new risks, or changes to known risks, that would require clinical evaluation." This means there was no new clinical study specifically for this 510(k) submission to demonstrate the performance of the core "PKG Analysis Algorithms" in quantifying movement disorder symptoms. The substantial equivalence argument relies on the predicate device's prior clearance and the fact that the modifications are not considered to significantly alter the device's fundamental diagnostic function or safety profile.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a clinical performance study. The "test sets" referenced for performance data (e.g., electrical, mechanical, software, biocompatibility) are material or system test articles, not patient data for diagnostic accuracy.
- Data Provenance: Not applicable for a clinical performance study for this specific submission as no new clinical data was collected.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable as no new clinical data was collected or analyzed for this submission where expert ground truth would be established. The device's "Proprietary PKG Analysis Algorithms" rely on quantitative kinematics, and their prior validation/equivalence is assumed.
4. Adjudication Method for the Test Set
- Not applicable as no new clinical data was collected requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The submission states that "Clinical data was not required for this submission." Therefore, no assessment of human readers improving with or without AI assistance was performed. The device quantifies kinematics using algorithms, it's not described as an AI-assistance tool for human readers interpreting images.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly described as a new standalone performance study. While the device contains "Proprietary PKG Analysis Algorithms" which would inherently operate in a standalone manner to quantify kinematics, the document does not report new standalone performance metrics or studies in this submission. Its functional equivalence is tied to the predicate device whose algorithms would have been assessed previously.
7. The Type of Ground Truth Used
- For the engineering validation studies (e.g., electrical, mechanical, software, biocompatibility, cybersecurity, human factors), the "ground truth" is defined by the technical specifications, standards (e.g., IEC 60601, ISO 10993, IEC 62304), and regulatory guidance documents listed. For instance, for electrical safety, the ground truth is compliance with the limits set by IEC 60601-1.
- For the device's intended clinical function (quantifying movement disorders), the "ground truth" for the original validation of the PKG Analysis Algorithms (presumably done for the predicate device K161717) would typically involve comparison to clinical assessments by movement disorder specialists, standardized motor evaluations, or other objective measures (though this is not detailed in the current submission).
8. The Sample Size for the Training Set
- Not applicable for this 510(k) submission, as it focuses on modifications and substantial equivalence to a predicate device, rather than the initial development and training of new AI/ML algorithms requiring a "training set." The proprietary algorithms were developed previously.
9. How the Ground Truth for the Training Set was Established
- Not applicable for this 510(k) submission. Information on how the ground truth was established for the original development of the "Proprietary PKG Analysis Algorithms" is not provided in this document.
§ 882.1950 Tremor transducer.
(a)
Identification. A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.(b)
Classification. Class II (performance standards).