TOPSEAL HEMOSTATIC DRESSING, MODEL 11150

• K Number: K033291
• Device Name: TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
• Manufacturer: RADI MEDICAL SYSTEMS AB
• Date Cleared: 2004-03-17 ( 155 days)
• Product Code: QSY , FRO , PRE
• Regulation Number: N/A
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K024107 , K021678 , K021581

Intended Use

TopSeal™ Hemostatic Dressing is indicated for control of minor bleeding from wounds and lacerations or minor bleeding from skin incisions or punctures following percutaneous medical procedures.

Device Description

TopSeal™ Hemostatic Dressing is a sterile dressing impregnated with the hemostatic agent m.docTM (calcium/sodium salt of micro-dispersed oxidized cellulose). The active hemostatic agent promotes the topical control of bleeding. The dressing comes as a pad which is impermeable to water and acts as a bacterial barrier.

AI/ML Overview

The provided text describes a 510(k) submission for the TopSeal™ Hemostatic Dressing and its substantial equivalence determination by the FDA. However, the text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

The document is a regulatory letter and a 510(k) summary, which focuses on:

• The administrative change regarding the product code.
• The determination of substantial equivalence to predicate devices.
• The description and intended use of the device.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details because it is not present in the provided text.

Regulation Number and Section

N/A