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For the collection of cervical cytology specimens for Pap test analysis. The SoftPAP™ Cervical Sample Collector should not be used after the first 10 weeks of gestation in pregnant patients.

The CytoCore, Inc. SoftPAP™ Collector is a multicomponent assembly for the collection of exfoliated cervical epithelial cells. Its major components are a disposable Balloon assembly (Balloon and rod), and a reusable Handle. The Balloon provides the conformal surface upon which the cells are collected. The Handle provides a means of manipulating and expanding the Balloon during the sampling process. The Balloon inflates against the cervix and conformally contacts the entire areas to be sampled, namely the ectocervical, the transformation zone, and the endocervical surfaces.

The provided text is a 510(k) premarket notification for a medical device called the "CytoCore SoftPAP™ Collector." This document focuses on demonstrating substantial equivalence to a predicate device, the CytoCore e2™ Collector (K013285), following modifications to the e2 Collector for physician ease-of-use and manufacturability while not affecting the intended use, indications for use, or patient contact components.

Therefore, this document does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria against scientific metrics.

Instead, the core of this submission is to show that the new device is as safe and effective as the previously cleared predicate device. This is primarily done by:

1. Stating the modifications: The document details changes between the e2 Collector and the SoftPAP Collector, such as the transition from a single integrated unit to a separate reusable handle and single-use collection device, and changes in the balloon collapse and inflation mechanisms.
2. Affirming no impact on critical aspects: The document explicitly states that "The modifications did not affect the Intended Use, Indications for Use, balloon material, balloon inflation profile, or any components that come in contact with the patient or patient cells."

Based on the provided text, I cannot provide the requested information regarding acceptance criteria and a study proving their attainment because such information is not present in this 510(k) submission document.

Here's why the requested information is absent:

• 510(k) Substantial Equivalence: A 510(k) is primarily intended to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness. It doesn't typically require new clinical studies or new acceptance criteria if the changes are minor and do not alter the fundamental performance or safety aspects.
• Predicate Device Relies on Prior Approval: The predicate device, CytoCore e2™ Collector (K013285), would have been cleared based on its own set of performance data and acceptance criteria. Since the SoftPAP™ Collector is deemed substantially equivalent and the modifications did not affect critical performance aspects, the FDA does not require new performance studies to re-prove the device's efficacy or safety against new acceptance criteria in this specific context.

In summary, the provided document does not contain the information you requested because it's a 510(k) submission focused on demonstrating substantial equivalence, not on establishing and meeting new performance acceptance criteria through a novel study.

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