(34 days)
Obstetrical: This product will be used to detect fetal heart beats as an aid for determining fetal viability. Vascular: This product will also be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
The LifeDop 350 Doppler is a portable, battery-powered ultrasound device used for detecting fetal heart beats and also for blood flow detection in veins and arteries. Primarily intended to be table-top, stand or wall mounted.
The provided document is a 510(k) premarket notification for the Summit Doppler Systems, Inc. LifeDop 350 Doppler. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria and corresponding performance studies, as would be required for novel devices or higher-risk classifications.
Therefore, the document does not contain the detailed information typically requested for acceptance criteria and study data proving a device meets these criteria. Instead, it asserts substantial equivalence based on comparable technology, materials, and intended use as a previously cleared device (K024197).
Here's a breakdown of the requested information based on the provided text, highlighting what is not available within this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The submission does not specify numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it relies on the device being "substantially equivalent" in technology and intended use to a previously cleared device.
2. Sample Size Used for the Test Set and Data Provenance
No dedicated test set or clinical study for the LifeDop 350 Doppler is described. The submission states "Clinical Testing: None provided," indicating that no new clinical data was generated for this 510(k). The device is cleared based on its similarity to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No ground truth was established as no new clinical study was conducted for this submission.
4. Adjudication Method for the Test Set
Not applicable. No clinical study or test set requiring adjudication was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a doppler ultrasound system, not an AI-powered diagnostic tool. No MRMC studies or AI involvement are mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm, and no standalone performance study was conducted.
7. The Type of Ground Truth Used
Not applicable. As no new clinical testing was performed, no ground truth was established for the LifeDop 350 Doppler in this submission. The substantial equivalence argument relies on the predicate device's existing clearance and the established safety and effectiveness of the underlying Doppler ultrasound technology.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment.
Conclusion based on the provided document:
The K090499 submission for the Summit Doppler Systems, Inc. LifeDop 350 Doppler is a Traditional 510(k). For this type of submission, extensive new clinical data or performance studies against predefined acceptance criteria are often not required if the device demonstrates substantial equivalence to a predicate device.
The basis for clearance is that the LifeDop 350 Doppler is "substantially equivalent to the commercially available and legally marketed device indicated above [Summit Doppler Systems Golden, CO LifeDop Doppler Ultrasound System K024197, Cleared 1/3/03]." The document explicitly states "Clinical Testing: None provided" for the LifeDop 350 Doppler. This means the safety and effectiveness are supported by the existing clearance of the predicate device and the recognized principles of Doppler ultrasound technology.
§ 884.2660 Fetal ultrasonic monitor and accessories.
(a)
Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.(b)
Classification. Class II (performance standards).