Pinetics Icon

Case study

A 510(k)-cleared cardiovascular diagnostic system, built end to end

How Pinetics designed a four-device cardiovascular diagnostic system, end to end, that went on to receive US FDA 510(k) clearance.

Talk to our engineers

At a glance

Client

A European medical device company

Product

A cardiovascular diagnostic, screening and research system

Pinetics' scope

The full product, end to end: electronics, firmware, edge software, the PPG watch, and the design and test documentation for the 510(k)

Timeline

From concept to a system ready for 510(k) submission in under 18 months

Outcome

US FDA 510(k) clearance

What did the client need?

The client needed one system that measures several markers of cardiovascular health in a single session: pulse wave analysis (PWA), central blood pressure (cBP), pulse wave velocity (PWV) and the ankle-brachial index (ABI). It had to be accurate enough for clinical use, built to medical device standards, and documented for a US FDA 510(k) submission.

What did Pinetics build?

Pinetics designed a system of four devices that work together:

  • Main hub on an NXP processor and an 8-layer high-speed board, handling the pneumatic (cuff), ultrasound and photoplethysmography (PPG) sensors, with four PPG and pressure channels and a 4.3 inch capacitive touch display. Blood pressure is measured by oscillometric, PPG and ultrasound methods.
  • Doppler sensor, a small unit that connects to the main hub.
  • Edge device on an NXP processor, running a multi-module application built with Qt, Node.js and React, on a 4-layer high-speed board with USB 3.0, HDMI and gigabit Ethernet.
  • PPG watch on a Nordic processor with a dedicated analogue front end, on a 6-layer board with blind vias, 0.4 mm pitch BGA and 3 mil track spacing.

Fast Fourier Transform (FFT) processing of the ultrasound signal gives blood flow velocity. The devices connect over dual-band Wi-Fi and Bluetooth.

What was the hardest part of the project?

Making four devices behave as one medical system. Each device has its own electronics and firmware, but the clinician sees one measurement session and one result. Every reading has to arrive in the right place, at the right time, with nothing lost between devices, and the whole system has to be verified as a single product for the 510(k).

How did the team make four devices work as one?

  • A clear role for every device. The Doppler sensor connects to the main hub, the PPG wearable connects to the edge device, and the edge device runs the multi-module application, with the devices linked over Wi-Fi and Bluetooth.
  • One set of requirements and one risk file. System requirements and a single ISO 14971 risk file covered all four devices, traced down to the requirements of each one.
  • Testing on the complete system. Verification and validation were run on the full system, not only on each device in isolation.
  • One team across every layer. The same Pinetics team built the hardware, firmware and software for all four devices, so no interface fell between two suppliers.

Which standards did the design meet?

  • IEC 60601 (electrical safety and essential performance of medical electrical equipment)
  • CISPR 11 (electromagnetic emissions)
  • ISO 14971 (risk management)
  • IEC 62304 (medical device software life cycle)
  • IEC 62366 (usability engineering)
  • EU MDR
  • Design outputs delivered inside the client’s ISO 13485 quality system, following US FDA design controls (21 CFR 820.30)
  • Devices and data flows designed to meet HIPAA and GDPR requirements

What was the result?

The system received US FDA 510(k) clearance. Pinetics took it from concept to a system ready for 510(k) submission in under 18 months.

“Pinetics took our cardiovascular diagnostic concept from paper to a fully functional, FDA-compliant system in under 18 months. Their firmware and hardware teams worked in lockstep, something we hadn’t experienced with previous vendors.”

CTO, European medical device company

See all case studies

Building a multi-device medical system?

Pinetics designs medical devices end to end, from concept and architecture to the design and test documentation a regulatory submission needs. Tell us what you are building.