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K Number
K190292
Device Name
Passio Pump Drainage System
Manufacturer
Bearpac Medical
Date Cleared
2019-07-25

(164 days)

Product Code
DWM
Regulation Number
870.5050
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Passio Pump Drainage System is indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access to the pleural cavity in order to relieve symptoms such as dyspnea and chest discomfort associated with malignant pleural effusion and other recurrent effusions.

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the Passio Pump Drainage System. It grants clearance for a medical device used for draining pleural effusions.

Crucially, this document is a regulatory clearance letter and does NOT contain information about acceptance criteria or a study that proves the device meets those criteria, as typically found in a clinical study report or a pre-market submission summary for AI/ML-based devices.

The letter confirms substantial equivalence to a predicate device and discusses regulatory requirements, but it does not detail:

  • Performance metrics (e.g., sensitivity, specificity, accuracy, precision).
  • Sample sizes for test or training sets.
  • Data provenance.
  • Expert qualifications or adjudication methods for ground truth establishment.
  • Multi-reader multi-case studies or standalone algorithm performance.
  • The type of ground truth used.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text. This device is a physical pump drainage system, not an AI/ML-based diagnostic or assistive software, which is typically where the types of acceptance criteria and study designs you've listed would be relevant.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report for an AI/ML-driven medical device, not a 510(k) clearance letter for a mechanical device.

§ 870.5050 Patient care suction apparatus.

(a)
Identification. A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.(b)
Classification. Class II (performance standards).