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K Number
K982136
Device Name
JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200
Manufacturer
SCHIFF & CO.
Date Cleared
1999-03-24

(280 days)

Product Code
DTN
Regulation Number
870.4400
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Jostra Venous Hardshell Cardiotomy Resevoir VHK 4200 is intended for use in adult cardiopulmonary bypass procedures of short duration of 6 hours or less.

Device Description

Not Found

AI/ML Overview

Based on the provided text, the document is a 510(k) clearance letter for the "Jostra Venous Hardshell Cardiotomy Reservoir VHK 4200." This document primarily addresses regulatory clearance and substantial equivalence to a predicate device, rather than a detailed study report demonstrating performance against specific acceptance criteria for an AI/ML powered medical device.

Therefore, the requested information regarding acceptance criteria and a study proving device performance (especially in the context of AI/ML devices) is not available in the provided text.

Specifically, the document does not contain:

  1. A table of acceptance criteria and reported device performance.
  2. Information on sample sizes, data provenance, or test sets.
  3. Details on experts used for ground truth, adjudication methods, or ground truth types.
  4. Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
  5. Details on training set sample size or how ground truth for training was established.

The document asserts that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than presenting a de novo performance study against new acceptance criteria.

§ 870.4400 Cardiopulmonary bypass blood reservoir.

(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.