Achieving 510(k) Clearance for a First-of-Its-Kind AI-Enabled Wearable

Client Overview

Perin Health Devices is a medical device company built through a partnership between Phase Margin, an engineering consulting firm, and Potawatomi Ventures Federal Group. Together they developed the Perin Health Patch, a first-of-its-kind wearable that captures more than 15 physiological metrics in a single, water-resistant device that never needs charging. It was designed to simplify monitoring for complex diseases across in-patient, remote, and other care settings.

The device was ambitious by design, and that ambition came with a difficult regulatory path. Bringing hardware, software, and machine learning to market in a single 510(k) submission is one of the most demanding paths the FDA offers. Perin Health was a young company with a small technical team, and the people who understood the device best were the same people who needed to keep building it. Pulling them into a year-long regulatory process was not a feasible option.

The Challenge

Perin Health faced a 510(k) journey that was difficult on almost every front. The device itself was novel, with few comparable products on the market to point to, and some of the hardest setbacks came from third parties the company did not control.

Four things made this especially hard:

• A novel, multi-technology device. Combining hardware, software, and machine learning made classification, predicate selection, and documentation far more complex than a typical submission.
  

• Moving regulatory expectations. The FDA released new guidance twice in the months before submission, each requiring last-minute implementation, and the agency was particularly exacting about software documentation.
  

• Third-party testing failures. An independent third-party biocompatibility lab improperly stored samples and failed the study three times, forcing a complete retest, a roughly seven-week delay, and ultimately a full resubmission.
  

• Real business pressure. Investor deadlines were fixed, and a small technical team meant Perin Health could not afford to move engineers into managing regulatory work.
  

They needed experienced quality and regulatory support that could handle the complicated work load, without slowing the product down.

Why Rook Quality Systems

Perin Health engaged Rook Quality Systems (RQS) as an embedded quality partner.  Rook's Ally Reichart, Quality Engineer, and Lee Brewer, Software Quality Engineer, spearheaded the effort, providing hands-on execution, regulatory strategy, and seasoned oversight while working directly alongside the internal team.

Rather than advising from a distance, RQS owned the regulatory strategy, submission compilation, and quality system implementation, so Perin Health’s engineers could stay on the technical development of the device. For a small team facing a submission this complex, that division of labor was the whole point: one group focused on building the product, another focused on getting it cleared.

Rook’s Approach

Because Perin Health needed both execution and judgment, RQS took a structured, hands-on role across the entire submission.

Over the course of the engagement, RQS:

• Implemented a QMS in SharePoint, sized to the company’s team and resources

   

• Delivered end-to-end 510(k) submission support, compiling an eSTAR submission exceeding 380+ pages, which took over 150 hours of compilation work alone

   

• Led regulatory strategy and FDA engagement, including a face-to-face meeting with the agency and two submission issue requests (Q-Subs) to resolve questions around classification and the respiratory clinical study

   

• Managed the response to a 44-page FDA hold letter, the largest the RQS team had ever seen, working through it systematically

   

• Made a hard scope call, recommending that the blood pressure function be pulled from the initial submission to protect the clearance timeline and deferred to a future filing

   

• Answered every FDA interactive review request within days during the final weeks of review

When the review came down to speed, RQS was able to turn around each request quickly enough to keep the clearance on track. Throughout the engagement, RQS operated as an extension of the Perin Health team, bringing both the expertise to do the work and the judgment to guide the calls that shaped the outcome.

The Results

With RQS support, Perin Health received FDA 510(k) clearance for the Perin Health Patch in January 2026. It took 13 months and included a 44-page hold letter, three failed rounds of third-party lab testing, and mid-process changes to FDA guidance, any one of which could have thwarted the device’s success.

What that clearance represented:

• A first-of-its-kind AI-enabled wearable cleared through one of the FDA’s most demanding pathways
  

• A full resubmission navigated successfully, with every piece of FDA feedback addressed in a second 510(k) and every interactive review request answered quickly in the final weeks
  

• An engineering team that stayed on the product the entire time, with RQS carrying the QMS and regulatory workload
  

• A clear path forward, with the hold letter feedback on blood pressure already mapped into the strategy for the next submission
  

The company reached market clearance for a genuinely novel device while ending the process with a quality system that is compliant, audit-ready, and built to support future growth.

Ongoing Partnership

Rook Quality Systems continues to work with Perin Health as an embedded quality partner, managing the QMS and regulatory strategy day to day, including preparation of the next 510(k) to add blood pressure functionality. As the organization and its product evolve, the relationship gives Perin Health experienced quality and regulatory support without having to build that function internally, which for a company at this stage is often the difference between sustainable growth and stagnation.