Get the free 510(k) Summary for TERATECH Model 10V5 Smart Probe - accessdata fda

This document summarizes the regulatory details and intended uses of the TERATECH Model 10V5 Smart Probe, a diagnostic ultrasound transducer, and outlines its equivalence to existing devices.

How to fill out 510k summary for teratech

How to fill out 510(k) Summary for TERATECH Model 10V5 Smart Probe

1. Begin with the product identification including the model name and number.
2. Provide a description of the TERATECH Model 10V5 Smart Probe, including its intended use.
3. List all relevant regulatory standards that the product complies with.
4. Detail the technological characteristics of the device, including materials, design, and functionality.
5. Compare the device to a legally marketed predicate device, highlighting similarities and differences.
6. Include performance testing data that demonstrates safety and effectiveness.
7. Provide labeling information including instructions for use and any risk information.
8. Submit a summary of any clinical data if applicable, outlining the study design and results.
9. Ensure that all submissions comply with FDA guidelines and include necessary signatures.
10. Review the completed summary for accuracy before submission.

Who needs 510(k) Summary for TERATECH Model 10V5 Smart Probe?

1. Manufacturers of the TERATECH Model 10V5 Smart Probe, as it is required for marketing clearance.
2. Regulatory affairs professionals involved in managing product compliance.
3. Healthcare providers and institutions looking to purchase or use the device, as they require assurance of its safety and efficacy.

People Also Ask about

What is the 510k pathway?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

What are the three types of 510k?

If so, then the 510(k) pathway is not appropriate, and instead, a De Novo or PMA is needed. There are three types of 510(k) submissions: Traditional, Abbreviated, and Special. Each type has its own requirements and may be appropriate for different types of medical devices.

What is the FDA 510k summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

What are the requirements for 510k clearance?

The FDA 510k submission requirements include extensive technical documentation such as proposed labeling, sterilization and shelf life data, biocompatibility research, animal, clinical and bench performance testing and other technical evidence needed to establish substantial equivalence and receive FDA 510k clearance.

What is the difference between FDA and FDA 510k?

The Primary Difference Between FDA And FDA 510k The main distinction between the FDA vs FDA 510(k) is that the FDA oversees total product safety, whereas FDA 510(k) is a premarket submission procedure for medical device clearance based on equivalence.

What is the FDA brief summary requirement?

The law requires that print ads making claims about a drug (product claim ads) include a "brief summary" with all the risks listed in the drug's "prescribing information" and at least one FDA-approved use of the drug. The brief summary generally includes: Who should not take the drug.

What is 510 K to the FDA?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

What is the 510k FDA summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

For pdfFiller’s FAQs

What is 510(k) Summary for TERATECH Model 10V5 Smart Probe?

The 510(k) Summary for TERATECH Model 10V5 Smart Probe is a document submitted to the FDA that demonstrates the device is substantially equivalent to a legally marketed device. It includes details about the device's intended use, technological characteristics, and performance data.

Who is required to file 510(k) Summary for TERATECH Model 10V5 Smart Probe?

The manufacturer or importer of the TERATECH Model 10V5 Smart Probe is required to file the 510(k) Summary with the FDA to obtain clearance to market the device.

How to fill out 510(k) Summary for TERATECH Model 10V5 Smart Probe?

To fill out the 510(k) Summary, manufacturers must provide information such as the device description, indications for use, comparison to predicate devices, performance testing results, and labeling details. The FDA provides a guidance document that outlines the necessary sections to include.

What is the purpose of 510(k) Summary for TERATECH Model 10V5 Smart Probe?

The purpose of the 510(k) Summary is to inform the FDA and the public about the device's safety and effectiveness, ensuring it meets required regulations before entering the market.

What information must be reported on 510(k) Summary for TERATECH Model 10V5 Smart Probe?

The 510(k) Summary must report information such as the device name, manufacturer's name, device classification, intended use, technological characteristics, summary of substantial equivalence, and any clinical data or performance testing results.