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5min
Device Type: Cardiovascular - Diagnostic
FDA Description:
A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.
Regulation Number: 870.1230
The Code of Federal Regulations (CFR) classifies and organizes over 1,700 devices into 16 medical specialty “panels” (such as Anesthesiology Devices or General Hospital and Personal Use Devices). Within these broad categories are 7-digit regulation numbers and associated device descriptions, including intended use, classification, and information about marketing requirements.
Product Code: DQE
This is a 3-letter code assigned to a product based on identified predicate devices with similar device descriptions and intended use. Product codes were introduced as a way for regulators to accurately monitor and track medical devices on the market. For developers, product codes can often provide a framework to their product’s intended use and how it would be regulated by the FDA.
Device Class: II
The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Class I devices generally pose the lowest risk to the patient and/or user and Class III devices pose the highest risk.
Premarket Notification: Not Exempt
The premarket notification 510(k) process requires a medical device manufacturer to 'notify' the FDA 90 days before they propose to begin marketing a new or modified device. This notification submission allows the FDA to determine whether a device is substantially equivalent to one or more predicate devices.
Eligible for Third Party Review: Yes
The 510(k) Third Party Review Program provides medical device manufacturers with a voluntary alternative review process, in which accredited Third Party Review Organizations are allowed to review certain low-to-moderate risk medical devices. The program is intended to help yield more rapid 510(k) decisions and to allow the FDA to focus its resources on higher risk devices, while still maintaining oversight of the review of lower risk devices eligible for third party review.
510(k) Associated with Regulation No. 870.1250 | DQE - Catheter, Oximeter, Fiber-Optic
K160645: PreSep Oligon Oximetry Catheter
K140129: PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter
K110167: PreSep Oligon Oximetry Catheters
K091268: Hospira Critical Care and Advanced Sensor Catheter
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.
