---
kind: "section"
citation: "21 C.F.R. § 870.4510"
title: "21"
number: "870.4510"
heading: "Apical closure device."
url: "https://uscodex.org/cfr/21/870.4510"
---

# §870.4510. Apical closure device.

- (a) **Identification.** An apical closure device is a prescription device consisting of a delivery system and implant component that is used for soft tissue approximation of cardiac apical tissue during transcatheter valve replacement procedures.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The patient contacting materials must be evaluated to be biocompatible.
  - (2) Performance data must validate the sterility of the patient-contacting components of the device.
  - (3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
  - (4) 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) Consistent and reliable implant deployment;
    - (ii) Assessment of implant pull-out force; and
    - (iii) **Sheath size compatibility with implant.**
  - (5) In vivo evaluation of the device must demonstrate device performance, including device operation resulting in closure of the myocardial wound.
  - (6) Labeling must include the following:
    - (i) Detailed information explaining how the device operates;
    - (ii) Sheath size that device can accommodate;
    - (iii) Identification of the minimum myocardial wall thickness to ensure optimal device function; and
    - (iv) **A shelf life.**

## Notes

### Amendments

[81 FR 71371, Oct. 17, 2016]

### 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

[81 FR 71371, Oct. 17, 2016]