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K Number
K980087
Device Name
PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330
Manufacturer
PRESSURE PRODUCTS, INC.
Date Cleared
1998-07-01

(173 days)

Product Code
DXC
Regulation Number
870.4450
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use of the Pressure Products Pressure Pad is to temporarily occlude the femoral artery when used in conjunction with the appropriate femoral artery clamp.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, I cannot extract the acceptance criteria and the details of a study proving device performance. The document is an FDA letter regarding a 510(k) premarket notification for "Pressure Pads" and primarily discusses the device's substantial equivalence to a predicate device and regulatory compliance. It does not contain information about:

  1. Acceptance criteria or device performance data.
  2. Sample sizes for test or training sets.
  3. Details about expert involvement (number, qualifications, adjudication methods).
  4. Multi-reader multi-case (MRMC) comparative effectiveness studies.
  5. Standalone algorithm performance.
  6. Types of ground truth used.

The letter confirms the device's classification and allows it to be marketed, but does not delve into the technical study results or validation parameters.

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).