Search Results

1P-16 infiltration/suction pump is indicated for fluid infiltration and aspiration

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "Peristaltic Infiltration/Suction Pump" (also referred to as IP-16 Infiltration/Suction Pump).

This document does not contain any information about acceptance criteria for device performance, a study to prove meeting those criteria, or details regarding the methodologies of such a study.

The FDA letter confirms that the device is "substantially equivalent" to predicate devices already on the market, signifying its regulatory clearance based on that comparison, not necessarily on a direct performance study detailed within this letter.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

Ask a specific question about this device

The SCULPTURE is designed for use in fragmentation, emulsification and aspiration of soft ussue in the following Surgical Specialties: plastic and reconstructive surgery, general surgery

Not Found

This appears to be a 510(k) clearance letter from the FDA for a device called "Sculpture." The letter confirms that SMEI, Inc. can market the device because it has been determined to be substantially equivalent to devices marketed prior to May 28, 1976.

However, the provided text does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. This document is a regulatory approval letter, not a clinical study report.

Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need access to the actual 510(k) submission document or a clinical study report for the Sculpture device.

Ask a specific question about this device