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510(k) Data Aggregation
(144 days)
EZSURGICAL
The A-Lap™ set has application for use in the creation and maintenance of an operative cavity such as the gynecologic, general, urologic and thoracic procedures. The set may be used in procedures to create and maintain a port of entry and for temporary retracting of tissue.
The A-Lap™ retractor has application for use in the creation and maintenance of an operative cavity such as the gynecologic. general, urologic and thoracic procedures. The device may be used in procedures requiring temporary retracting of tissue.
The EZaxess is intended for use in creating and for maintaining a port of entry in gynecologic, general, urologic and thoracic procedures.
The A Lap™ set is laparoscopic surgical device compose of two components:
A-Lap™ Retractor - a surgical retraction instrument used to move, retain or hold back internal organs in the operative region during laparoscopic surgery. The device purposes is to widen the access area to the treatment site (the surgical field), to grasp and retract the surrounding tissues, to maintain the resultant size of the access area and to secure the retracted tissue or organs by holding it away from the surgical site. The retraction is achieved by a 12 cm X 12 cm polyester mesh connected to stainless steel wires.
EZaxess - a laparoscopic port included a 170 mm long and 10mm in diameter bladeless trocar and flexible cannula (10cm long and 10mm in diameter). The device is used to create and maintain a port of entry during laparoscopic surgery. The A Lap™ set is intended to be use for various laparoscopic surgical procedures, such as gynecologic, general, urologic and thoracic procedures. It is fully disposable and is intended for single use only.
Here's an analysis of the provided text regarding the A-Lap™ Set, A-Lap™ Retractor, and EZaxess devices, focusing on acceptance criteria and the study that proves the devices meet them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format with corresponding reported device performance metrics. Instead, it refers to general compliance with standards and equivalence to predicate devices. The "performance" is primarily assessed through design analysis, in vitro, and in vivo data to confirm safety and effectiveness, and substantial equivalence.
Based on the text, the implicit acceptance criteria and reported performance relate to:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility | Verified: Materials confirmed biocompatible according to ISO 10993-1 for external communicating, blood contact, short duration ( |
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(39 days)
EZSURGICAL
The DASH™ is a deformable shape memory padded retractor, which is intended to retain or hold back organs and tissue in the course of surgical procedure. At the same time it serves as means of cushioning and absorption to the surgical area.
The DASH™ is a deformable shape memory padded retractor
The provided text is a 510(k) clearance letter from the FDA for a manual surgical instrument named DASH™. It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria, study data, sample sizes, expert qualifications, or ground truth establishment for device performance. It is a regulatory clearance document, not a clinical or performance study report.
Therefore, I cannot provide the requested information based on the input text.
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