(170 days)
FemSpec, LLC, FemECC™ Endocervical Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis.
FemSpec, LLC, FemECC™ Endocervical Curette is a sterile, disposable curette.
This looks like a 510(k) clearance letter from the FDA for a medical device called the "FemECC™ Endocervical Curette." This type of document is a regulatory approval, not a clinical study report. Therefore, it does not contain the specific information requested about acceptance criteria, study design, or performance metrics.
The letter explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... "
This means the device was cleared based on its substantial equivalence to an already approved predicate device, not on a new clinical study demonstrating performance against specific acceptance criteria. The 510(k) process often relies on non-clinical testing (e.g., biocompatibility, sterilization validation, mechanical testing) and comparison to a predicate device's design and indications for use.
Therefore, I cannot provide the requested information based on this document.
To provide an answer to your prompt, a document detailing a clinical trial or performance study would be required.
§ 884.1050 Endocervical aspirator.
(a)
Identification. An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.(b)
Classification. Class II (performance standards).