21 CFR 892.1590 — Ultrasound Imaging System For Acquiring Images At Home By Lay Users

Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1590

Identification

The Pulsenmore ES is an ultrasound imaging system intended to enable the acquisition of ultrasound images that allow interpreting healthcare providers to determine fetal heart rate. It is intended for limited diagnostic ultrasound imaging in B-Mode and M-Mode in Fetal/Obstetric applications for pregnant women with a singleton pregnancy at the gestational age of 14-38 weeks, in non-clinical environments. The device consists of hardware and software that provides guidance to lay users to aid image acquisition, which can be performed in an app-guided mode or clinician-guided mode.

Classification Rationale

FDA has determined that the device can be classified in Class II with the establishment of special controls for Class II, which provide reasonable assurance of the safety and effectiveness of the device type.

Product Codes

Special Controls

SGJ — Ultrasound Imaging System For Acquiring Images At Home By Lay Users

In combination with the general controls of the FD&C Act, the ultrasound imaging system for acquiring images at home by lay users is subject to the following special controls: (1) Clinical performance testing of software with representative compatible hardware must demonstrate that the device system performs as intended under anticipated conditions of use in the intended patient population. Testing must include the following: (i) An evaluation of device performance in a representative user and patient population; (ii) An evaluation of the diagnostic utility and quality of images/data acquired using the device; (iii) Results comparing device performance to a clinically justified clinical comparator with established clinical performance; and (iv) An evaluation of all adverse events. (2) Non-clinical performance testing must demonstrate that the device system and its components perform as intended under anticipated conditions of use. Testing must include the following: (i) Validation of pre-acquisition quality control checks by software; (ii) Evaluation of the function of device software and hardware control safety features; (iii) Validation of device system guidance functionality in a simulated use environment; (iv) For ultrasound hardware, testing including: (A) Acoustic output measurement; (B) Image quality evaluation; and (C) Clinical measurement accuracy. (3) Performance testing must demonstrate the electromagnetic compatibility (EMC), electrical safety, thermal safety, mechanical safety, and wireless coexistence of the device system hardware in the intended use environment. (4) Performance testing must validate the reprocessing instructions for reusable components of the device system hardware. (5) Performance testing must demonstrate that all patient-contacting components of the device system hardware are biocompatible. (6) Software verification, validation and hazard analysis must be performed. (7) Device technological characteristics must incorporate design features to limit the number of scans and duration of device system use by the lay user to mitigate unnecessary ultrasound exposure. (8) A training program must be included with sufficient educational elements so that upon completion of the training program, the user can operate the device system in the intended use environment. (9) Human factors assessment must demonstrate the following: (i) The user can correctly use the device system in the intended use environment with the provided instructions and training materials; and (ii) The user understands situations in which the device system should not be used. (10) Labeling must be included for the patient and healthcare professional that includes the following: (i) A summary of clinical performance testing written for the intended reader; (ii) For software labeling, hardware compatibility information; (iii) The following statements: (A) A statement that the images and data acquired using the software are to be interpreted by qualified healthcare professionals; (B) A statement that the device system should not be used to replace or delay in-office/in-clinic assessment when needed; (C) A statement that users of the device system must complete the device-specific user training program prior to performing their first scan; and (D) A statement on adherence to the As Low As Reasonably Achievable (ALARA) principle and the device controls available to minimize ultrasound bioeffects. (iv) For healthcare professional labeling, instructions for configuring the limits on device system use; and (v) For patient labeling: (A) Hardware platform requirements; (B) A warning that the device system is not intended to be used outside of what has been prescribed, and to be aware of limits placed upon device system use by their healthcare professional; (C) Instructions for reprocessing of any reusable components; and (D) Instructions for proper handling of the device hardware when it is no longer needed, including disposal methods, and/or return requirements.

De Novo Order DEN240074