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This document provides a comprehensive summary of safety and effectiveness for the SonoSite Hand-Carried Ultrasound System submitted for FDA clearance under the 510(k) process, detailing device classification,

How to fill out d04538a - 510k premarket

How to fill out D04538A - 510(K) PREMARKET NOTIFICATION-SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (Cl Series)

1. Obtain the D04538A form from the FDA website or relevant regulatory authority.
2. Read the instructions provided with the form carefully to understand the requirements.
3. Fill in the applicant's details including name, address, and contact information.
4. Provide a detailed description of the Sonosite Hand-Carried Ultrasound System, including its intended use and indications for use.
5. Include any necessary device labeling and promotional materials.
6. Summarize prior submissions of similar devices to establish a basis for substantial equivalence.
7. Complete the section relating to any performance testing or clinical data that supports the application.
8. Sign and date the application form.
9. Submit the completed form along with the required fee to the FDA or relevant regulatory body.

Who needs D04538A - 510(K) PREMARKET NOTIFICATION-SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (Cl Series)?

1. Manufacturers of the Sonosite Hand-Carried Ultrasound System seeking market clearance.
2. Healthcare providers needing a cleared device for clinical use.
3. Regulatory professionals managing submissions for medical devices.
4. Quality assurance teams ensuring compliance with regulatory requirements.

People Also Ask about

How much does a SonoSite ultrasound cost?

It's important to note that clearance under the 510(k) pathway does not indicate that the FDA has approved the device but rather that the FDA has determined the device is equivalent to a similar device already on the market.

What is a SonoSite ultrasound used for?

A 510(k) Premarket Notification is required for low to moderate risk medical devices classified as either Class I or Class II and not exempt from 510(k). Companies are unable to market their products to health care providers, patients and other consumers until they are given 510(k) clearance by the FDA.

What is an exemption from the 510k premarket notification requirements?

Most class I and class II devices are exempt from 510(k) requirements. Devices that may be 510(k) exempt include: Preamendment devices (devices legally marketed in the US prior to May 28, 1976) Class I devices specifically exempted by FDA or classified as class I under section 513 (with certain exceptions)

What is premarket notification 510k?

Price Range: $25,000 - $35,000.

What is pre-market submission?

510(k) Pre-market Notification: A 510(k) submission is a pre-market submission made to the US FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (predicate device) that is not subject to PMA.

What is the meaning of premarket approval?

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

What is a 510k premarket notification?

A 510(k) Premarket Notification is required for low to moderate risk medical devices classified as either Class I or Class II and not exempt from 510(k). Companies are unable to market their products to health care providers, patients and other consumers until they are given 510(k) clearance by the FDA.

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What is D04538A - 510(K) PREMARKET NOTIFICATION-SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (Cl Series)?

D04538A - 510(K) PREMARKET NOTIFICATION refers to the regulatory submission required by the FDA for the Sonosite Hand-Carried Ultrasound System (Cl Series), which is a portable ultrasound device intended for medical use.

Who is required to file D04538A - 510(K) PREMARKET NOTIFICATION-SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (Cl Series)?

Manufacturers or importers of medical devices, such as the Sonosite Hand-Carried Ultrasound System (Cl Series), are required to file the 510(K) premarket notification to gain FDA clearance before marketing the device.

How to fill out D04538A - 510(K) PREMARKET NOTIFICATION-SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (Cl Series)?

To fill out the 510(K) premarket notification for D04538A, you must gather evidence that the device is safe and effective, complete the required forms, include detailed descriptions of the device, its intended use, and any relevant testing data, and submit the application to the FDA.

What is the purpose of D04538A - 510(K) PREMARKET NOTIFICATION-SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (Cl Series)?

The purpose of D04538A - 510(K) PREMARKET NOTIFICATION is to demonstrate to the FDA that the Sonosite Hand-Carried Ultrasound System (Cl Series) is substantially equivalent to a legally marketed device, ensuring its safety and effectiveness for its intended use before it can be marketed.

What information must be reported on D04538A - 510(K) PREMARKET NOTIFICATION-SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (Cl Series)?

The information that must be reported includes the device's name, description, indications for use, labeling, performance data, and any clinical or non-clinical studies that support the claim of substantial equivalence to a predicate device.