---
kind: "section"
citation: "21 C.F.R. § 870.1345"
title: "21"
number: "870.1345"
heading: "Intravascular bleed monitor."
url: "https://uscodex.org/cfr/21/870.1345"
---

# §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.**

## Notes

### Amendments

[87 FR 34778, June 8, 2022]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

### Amendments

[87 FR 34778, June 8, 2022]