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14min
Posted by The Zewski Report
On Jun 28, 2024
Blood Pressure Cuff
Device Type: Cardiovascular - Diagnostic
FDA Description:
A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.
How do we generate reports on undeveloped technology compared to known technologies?
To generate reports at The Zewski Report, we use a variety of sources for inputs. When analyzing an existing device, we will review the following items and create a Ballpark report on what we believe the development pathway would be in today's market for a device similar to the one known.
- FDA Records
- Recognized Standards
- Other Known Testing
- Review of Existing Design
- Review of Existing Assembly
In order to generate a report for a device that is not approved or designed, it takes a little more effort. However, we still can create a report with limited information. In this scenario, we will help identify your indications for use and review your patent. This allows us to home in on critical data including:
- FDA Records with Similar Intent
- Associated Recognized Standards
- Experience Based Test Knowledge
- Patent Review for Design Intent
- Known Technology Needed for Manufacturing
Device Classification
| Device Name | Blood Pressure Cuff |
| Regulation Description | Blood Pressure Cuff |
| Regulation Medical Specialty | Cardiology |
| Product Code | DXQ |
| Submission Type | 510(K) |
| Regulation Number | 870.1120 |
| Device Class | 2 |
| Implanted Device | No |
| Life Sustaining Device | No |
| Third Party Eligible | Yes |
FDA Approved Devices
Design Assumptions
The blood pressure cuff is a non-sterile, multi-patient use, reusable device and is designed to be used by a clinician to measure a patient’s blood pressure. It's typical duration of use is less than 1hr.
The device comprises an inflatable bladder that fills with air to apply pressure to the artery, an inflation bulb that is used to manually inflate the bladder, a valve to control the release of air from the bladder, and a tubing which connects the bladder to the bulb. The cuff is typically made of nylon with Velcro strips to allow the cuff to adhere to itself, so it remains in place during use. The blood pressure cuff is not exempt from good manufacturing practices, including design controls requiring design traceability documentation to be compliant with regulations.
Regulatory Assumptions
The blood pressure cuff is a moderate-risk Class II device categorized under regulation number 870.1120, which covers several product codes – DXQ being the focus of this report. The device is intended for facility use and has a 510(k) submission type and is eligible for third party review. It can also be noted that the FDA has fees for small businesses that may range between ~$8k (for a 510(k)) ~$35k (for De Novo) for adult indicated devices.
Testing Assumptions & Consensus Standards
The device is subject to various mechanical performance tests such as pressure, force, leak, kink, and drop tests. In addition to conditional and shipping tests. Below is the recognized consensus standards listed on the FDA website for this device:
- 3-96 ISO 81060-1 First edition 2007-12-01 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type.
Manufacturing Intent
The device does not employ any area of manufacturing technology that is not well established.
Custom Reports
Custom Reports include detailed visual and interactive tools:
Feasibility Score: The Feasibility Score, or Zewski Score, is a number between 1-100 that identifies how difficult of a program your project is to initiate and maintain a plan and budget for relative to other projects on the scale. The higher the risk of the project, the lower the score. Average Class II projects fall between 40 and 60. Projects above 75 are generally straightforward. Those below 25 are complex and extremely high risk.
Compliance Score: Similar to the Feasibility Score, the Compliance Score runs between 1 and 100. However, this score only looks at the difficulty of the FDA approval process. Its values focus more on patient risk and testing challenges than business feasibility. Your Compliance Score may differ depending on the overall project details. For example, a project with a small market but little risk will have a lower Feasibility Score than Compliance Score.
Indications Assessment: Detailed breakdown of the typical indications for product code BZE and the impact on risk, cost, and time related to the development and delivery of this project.
Milestone Data: Breaking the project into approximately 50 activities over 5 phases helps identify the most critical items that will impact time and cost on a macro level. Depending on the project's complexity, fewer or more items may be involved.
Manufacturing Study: Expert assessment of the technology needed to bring your product idea to fruition. Through research and experience, we will lay out a likely path from your product's production methods and the fields of expertise needed to make it happen.
Financial Assessment: Includes cost scenarios based on the manufacturing process and location, with the necessary quality level for each aspect of your project. It will also look at low- and high-volume scenarios plus any needed labor and automation to assess possible cost efficiencies.
