(304 days)
Not Found
No
The summary describes a control system upgrade with a modern microprocessor and software, but there is no mention of AI or ML capabilities.
No.
This device is a control system for steam sterilizers, used to sterilize surgical instruments and liquids, not for direct therapeutic application to a patient.
No
The device is an upgrade to a microcomputer control system for hospital steam sterilizers, intended to sterilize surgical instruments and liquids, not to diagnose medical conditions.
No
The device is described as an upgrade to an existing microcomputer control system for steam sterilizers, including a microprocessor/software and a touch screen interface. While it includes software, it is part of a larger hardware system (the sterilizer controls and interface) and is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control hospital steam sterilizers used for sterilizing surgical instruments and liquids. This is a sterilization process, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The device is a control system for a sterilizer, focusing on the microprocessor, software, and user interface. It does not involve analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or treatment decisions based on biological samples.
The device's function is to ensure the proper operation of a sterilizer, which is a process used to make medical devices safe for use, not to diagnose a condition.
N/A
Intended Use / Indications for Use
The MDT Biologic Company Access (Powerclave) is an upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. Specifically, Access (Powerclave) Steam Sterilizer Controls are to be used with "Castle" brand sterilizers manufacutered by MDT Biologic Company for use in industrial, laboratory, and health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, and liquids.
Product codes
Not Found
Device Description
The MDT Biologic Company Access (Powerclave) is an upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. Specifically, Access (Powerclave) Steam Sterilizer Controls are to be used with "Castle" brand sterilizers manufacutered by MDT Biologic Company for use in industrial, laboratory, and health care facility environments. These sterilizers are intended to be used to sterilize wrapped and un-wrapped surgical instruments, and liquids.
The difference between predicate sterilizer controls and the Access controls is that the Access controls are provided with more modern microprocessor/software. and interactive graphic touch screen operator interface. The chamber vessel and piping remain unchanged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
industrial, laboratory, and health care facility environments.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
No clinical testing is required for this submittal
Key Metrics
Not Found
Predicate Device(s)
Castle Microcomputer Control K820783.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).
0
000033
This summary is for the:
MDT Biologic Company ACCESS (Powerclave) Trade name
sterilizer controls Common name
Classification name steam sterilizer (per 21 CFR 880.6880)
ref. 21 CFR 807.92(a)(2)
We believe this product to be substantially equivalent to Castle Microcomputer Control K820783.
ref. 21 CFR 807.92(a)(3)
The MDT Biologic Company Access (Powerclave) is an upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. Specifically, Access (Powerclave) Steam Sterilizer Controls are to be used with "Castle" brand sterilizers manufacutered by MDT Biologic Company for use in industrial, laboratory, and health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, and liquids.
The difference between predicate sterilizer controls and the Access controls is that the Access controls are provided with more modern microprocessor/software. and interactive graphic touch screen operator interface. The chamber vessel and piping remain unchanged.
ref. 21 CFR 807.92 (a)(4), (5) & (6)
The ANSI/AAMI ST-8 - 1994 American National Standard for Hospital Steam Sterilizers was used to establish the minimum construction and performance requirements for this product.
This product has also been designed to meet the requirements of UL-544, CSA C22.2, and IEC 601.1 safety standards for medical devices. The vessels are designed and constructed to Section VIII of the ASME pressure vessel code and each vessel is so certified.
We believe the product to confrom to the above requirements.
No clinical testing is required for this submittal
ref. 21 CFR 807.92(b)(1), (2) & (3)