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K Number
K960486
Device Name
KSEA MODEL 383320 20 ANGIOMAT
Manufacturer
KARL STORZ ENDOSCOPY
Date Cleared
1996-10-25

(266 days)

Product Code
DQI
Regulation Number
870.1800
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The KSEA model 38320 20 Angiomat pump is designed to provide a clear field of view during percutaneous and intra-operative endoscopy of the peripheral vascular system. Please consult your angloscope manual for specific indications and contraindications for use.

Device Description

The KSEA model 383320 20 Angiomat for endoscopy of the peripheral vascular system is a microprocessor-based infusion pump, with user adjustable flow rates and pressure adjustment. The unit incorporates a wide variety of safety features including: bubble detection, pressure monitoring, volume monitoring and flow control. The Angiomat has two operating modes and also incorporates a bolus infusion function.

AI/ML Overview

This document is a 510(k) summary for a medical device submitted to the FDA in 1996. It describes an infusion pump and asserts its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, study data, sample sizes, expert involvement, or any of the other specific details requested in your prompt.

The document primarily focuses on:

  • Applicant and contact information
  • Device identification (Common Name: Infusion Pump, Trade Name: KSEA Model 383320 20 Angiomat)
  • Indication for Use (to provide a clear field of view during percutaneous and intra-operative endoscopy of the peripheral vascular system)
  • Device Description (microprocessor-based infusion pump with user-adjustable flow rates, pressure adjustment, safety features like bubble detection, pressure monitoring, volume monitoring, flow control, two operating modes, and bolus infusion function)
  • A statement of Substantial Equivalence to predicate devices.

Therefore, I cannot fulfill your request as the provided text does not contain the necessary information.

To answer your prompt, I would need a different document that details the studies conducted, their methodology, results, and acceptance criteria for the KSEA Model 383320 20 Angiomat.

§ 870.1800 Withdrawal-infusion pump.

(a)
Identification. A withdrawal-infusion pump is a device designed to inject accurately drugs into the bloodstream and to withdraw blood samples for use in determining cardiac output.(b)
Classification. Class II (performance standards).