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K Number
K230668
Device Name
Disposable High-pressure Extension Lines
Manufacturer
Precision Medical Plastics Ltd.
Date Cleared
2024-06-14

(462 days)

Product Code
DXT
Regulation Number
870.1650
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Disposable High-pressure Extension Lines is indicated for use as a connecting line for injection of contrast media or saline during coronary angiographic procedures.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Disposable High-pressure Extension Lines," which is a medical device. This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the text does not include:

  • Details about acceptance criteria for device performance.
  • Results of a study proving the device meets acceptance criteria.
  • Information on sample sizes for test sets (or training sets, for that matter).
  • Any mention of data provenance (country of origin, retrospective/prospective).
  • Details about experts used for ground truth establishment or their qualifications.
  • Adjudication methods.
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect sizes related to human reader improvement with AI assistance.
  • Whether a standalone algorithm performance study was done.
  • The type of ground truth used (expert consensus, pathology, etc.).
  • How ground truth for a training set was established.

This document specifically concerns a physical medical device (extension lines for angiographic injectors), not an AI/Software as a Medical Device (SaMD) that would typically involve the types of studies and criteria you've asked about (e.g., performance metrics, ground truth, expert readers, training sets).

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.