Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4110](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4110) → SDG — Brain Intraparenchymal Infusion Cannula

# SDG · Brain Intraparenchymal Infusion Cannula

_Neurology · 21 CFR 882.4110 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SDG

## Overview

- **Product Code:** SDG
- **Device Name:** Brain Intraparenchymal Infusion Cannula
- **Regulation:** [21 CFR 882.4110](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4110)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

A brain intraparenchymal infusion cannula is a non-powered, hollow tube-like device with a rigid component for stereotaxic-aided temporary placement in brain parenchyma tissue to deliver a therapy. The SmartFlow Neuro Cannula, when used with compatible stereotaxic and therapeutic delivery devices, is indicated for intraputaminal administration of eladocagene exuparvovec-tneq for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency.

## Classification Rationale

FDA has determined that, for the previously stated indications for use, the SmartFlow Neuro Cannula can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

## Special Controls

In combination with the general controls of the FD&C Act, the brain intraparenchymal infusion cannula is subject to the following special controls:

(1) In vivo performance testing must demonstrate that the device performs as intended to deliver the intended dosage of the therapy and evaluate all adverse effects, including adverse tissue reaction and tissue injury.

(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 evaluated:

(i) A characterization of the therapy distribution profile in the intended brain parenchyma location, including infusate reflux and dose accuracy;

(ii) Device compatibility with the therapy or analog, including:

(A) Leachables characterization of the device;
(B) Particulate testing of the device;
(C) Characterization of therapy or analog adsorption and aggregation by the device;
(D) Therapy potency and quality testing; and
(E) Functional compatibility with other devices intended to be used during the procedure;

(iii) A characterization of the brain intraparenchymal target placement accuracy in a clinically-relevant phantom compared to a pre-procedure plan; and

(iv) Mechanical testing:

(A) Tensile strength;
(B) Compressive strength;
(C) Maximum infusion pressure (burst); and
(D) Leakage.

(3) Human factors/usability testing must demonstrate that the intended user(s) in the intended use environment can correctly and safely use the device in a clinically-relevant workflow following the instructions for use.

(4) The patient-contacting components of the device must be demonstrated to be biocompatible.

(5) Performance data must demonstrate the sterility of all patient-contacting components of the device.

(6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(7) Labeling must include:

(i) Detailed description of the device technical parameters, including physical dimensions and priming volume; and
(ii) A shelf life.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN240023](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SDG/DEN240023.md) | SmartFlow Neuro Cannula | ClearPoint Neuro, Inc. | Nov 13, 2024 | DENG |

## Top Applicants

- ClearPoint Neuro, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SDG](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SDG)

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