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K Number
K973132
Device Name
EZ HOLD 1 LBS., EZ HOLD 2 LBS
Manufacturer
TZ MEDICAL, INC.
Date Cleared
1998-01-12

(144 days)

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

The EZ Hold is a weighted (1.0 and 2.0 pound) stainless steel (304) device used to assist a vascular technician or RN to hold pressure on the femoral artery post-cardiac catheriterization.

Device Description

The EZ Hold is a weighted (1.0 and 2.0 pound) stainless steel (304) device used to assist a vascular technician or RN to hold pressure on the femoral artery post-cardiac catheriterization. Currently the technician uses either their hand or fingers to compress the artery or they use a mechanical clamp. The EZ Hold uses disks, as used with the mechanical clamps, but is held in place by the technician until hemostasis is obtained.

The EZ Hold is: 1) designed to reduce the risk for the RN of direct prolonged contact with body fluids (blood), and 2) alleviate bio-mechanical stress which occurs during traditional digital compression of the femoral artery post-cardiac catheritization. The devices work with currently marketed compatiblepressure disks (DisCo PNO-R or PNO-1 or equivalent bal and socket fit), fits the palm of the hand and is weighted to provide pressure at the site.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) clearance letter for the "EZ Hold Device," stating that it has been deemed substantially equivalent to a legally marketed predicate device.

The letter primarily covers:

  • Device Name: EZ Hold
  • Regulatory Class: II (two)
  • Product Code: DXC
  • Indications For Use: To assist a vascular technician or RN in holding pressure on the femoral artery post-cardiac catheterization.
    • Designed to reduce the risk of direct, prolonged contact with body fluids (blood) for the RN.
    • Designed to alleviate biomechanical stress during traditional digital compression.
  • Substantial Equivalence: The FDA has determined the device is substantially equivalent to devices marketed prior to May 28, 1976.
  • General Controls: The device is subject to general controls provisions of the Act, including annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

There is no mention of specific performance data, acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement in this document.

§ 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).