21 CFR § 870.1345 ("Intravascular bleed monitor")

Enacted 2022-06-08 | Official source

Summary

Requires that an intravascular bleed monitor -- which uses measurements of the body's electrical conductivity and an algorithm to monitor potential internal bleeding complications -- be subject to special controls from the U.S. Food and Drug Administration. Those controls require performance testing for efficacy, usability, and safety; software verification, validation, and hazard analysis; and detailed labeling.

Key facts

🏛️ This document has been enacted by the U.S. Food and Drug Administration. For authoritative text and metadata, visit the official source.

🎯 This document primarily applies to the private sector, rather than the government.

📜 This document's name is 21 CFR § 870.1345 ("Intravascular bleed monitor").

Themes AI risks, applications, governance strategies, and other themes addressed in AGORA documents.

Risk factors (1)

Reliability This tag applies to documents that address the ability of an AI system to perform as required, without failure, under the conditions of expected use and over a given period of time, including the entire lifetime of the system.

Harms (1)

Harm to health/safety This tag applies to documents addressing AI-related health and safety harms, including death, injury, or reduction in lifespan.

Governance strategies (4)

AI application areas (1)

Medicine, life sciences and public health

Full text

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§ 870.1345 Intravascular bleed monitor. (a) Identification. An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications.

(b) Classification. Class II (special controls). The special controls for this device are: (1) In vivo animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use and evaluate the following: (i) Device performance characteristics; (ii) Adverse effects, including gross necropsy and histopathology; and (iii) Device usability, including device preparation, device handling, and user interface. (2) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Tensile testing of joints and materials; (ii) Mechanical integrity testing; (iii) Friction testing; (iv) Flush testing; (v) Air leakage and liquid leakage testing; (vi) Latching and unlatching testing; (vii) Kink and bend testing; (viii) Insertion force testing; (ix) Torque testing; (x) Corrosion testing; and (xi) Dimensional tolerance testing.

(3) Performance data must support the sterility and pyrogenicity of the device components intended to be provided sterile. (4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (5) The patient contacting components of the device must be demonstrated to be biocompatible. (6) Software verification, validation, and hazard analysis must be performed. (7) Performance data must demonstrate electromagnetic compatibility (EMC), electrical safety, thermal safety, and mechanical safety. (8) Human factors performance evaluation must demonstrate that the user can correctly use the device, based solely on reading the directions for use. (9) Labeling must include: (i) Instructions for use; (ii) A shelf life and storage conditions; (iii) Compatible procedures; (iv) A sizing table; and (v) Quantification of blood detected.