Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart C — General Hospital and Personal Use Monitoring Devices](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices) → [21 CFR 880.2801](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2801) → SBE — Digital Physical/Chemical Sterilization Process Sensor

# SBE · Digital Physical/Chemical Sterilization Process Sensor

_General Hospital · 21 CFR 880.2801 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/SBE

## Overview

- **Product Code:** SBE
- **Device Name:** Digital Physical/Chemical Sterilization Process Sensor
- **Regulation:** [21 CFR 880.2801](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2801)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

A digital physical/chemical sterilization process sensor is a device intended to monitor one or more parameter(s) of the sterilization process. The adequacy of the sterilization conditions as measured by the parameter(s) is/are indicated by a digital readout of the result. The 3M™ Attest™ eBowie-Dick Test system (consisting of a Test Card, Card Holder, and Auto-reader) is used to monitor the equipment performance of steam sterilizers by detecting steam penetration as a means of measuring air removal efficiency in dynamic-air-removal steam sterilizers.

## Classification Rationale

Class II (special controls). The device is granted De Novo classification as a digital physical/chemical sterilization process sensor (21 CFR 880.2801).

## Special Controls

In combination with the general controls of the FD&C Act, the digital physical/chemical sterilization process sensor is subject to the following special controls:

- (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must fulfill the following:
	- Testing must compare performance with a scientifically justified comparator; (i)
	- (ii) Testing must demonstrate that the measured response is dependent on the sterilization cycle parameter(s);
	- Testing must identify relevant validation parameters (analytical performance (iii) characteristics) and include scientifically justified samples, conditions, and data analysis to evaluate said parameters with established acceptance criteria for each. parameter:
	- (iv) Testing must evaluate sensitivity and specificity to determine conditions for passing and failing results:
	- Testing must determine and validate accuracy, precision, and range of the (v) measuring device:
	- Testing must evaluate end point stability; and (vi)
	- (vii) Testing must demonstrate that the reader maintains a defined range of accuracy over a defined time interval.
- (2) Performance data must support the shelf life of the device by demonstrating continued device functionality over the labeled shelf life under the proposed storage conditions. Transport stability testing must demonstrate device resilience to transport conditions.
- Software verification, validation, and hazard analysis must be performed for any (3) software components.
- (4) Performance data must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/SBE](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/SBE)

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