(528 days)
None
No
The description mentions a microprocessor controlling programmed parameters and software providing information for control, but there is no mention of AI or ML capabilities, learning, or adaptive algorithms.
No
The device is a sterilizer for medical and dental instruments, not a device used for treating patients.
No
Explanation: The device is described as a "table top steam sterilizer" used for "sterilization of standard loads of medical and dental instruments." Its function is to sterilize equipment, not to diagnose medical conditions or analyze biological samples.
No
The device is a table top steam sterilizer with a water reservoir, heat source, sealed chamber, and physical components like a stainless steel chamber and aluminum door. While it uses a microprocessor and software to control cycles, it is fundamentally a hardware device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "sterilization of standard loads of medical and dental instruments." This is a process performed on medical devices, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details a steam sterilizer, which is a piece of equipment used for sterilization, not for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The device is clearly a sterilizer for medical and dental instruments, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The "Sterilemax" provides sterilization of standard loads of medical and dental instruments, as do the predicate units.
Product codes
Not Found
Device Description
The B/T "Sterilemax" is a table top steam sterilizer. As in the case of the predicate units, the Sterilemax has a water reservoir, a heat source and a sealed chamber.
The unit is designed with four standard cycles and one optional cycle. The standard cycles are: wrapped instruments (10 min at 135 C.), unwrapped instruments (3 min at 135 C), packs (30 minutes at 121 C.), the optional cycle for dental handpieces (10 min at 132 C.) and liquids for non-clinical applications (15 min at 121 C.).
The chamber is constructed of stainless steel with a cast aluminum door and a silicone sealing gasket. The pressure chamber and components are designed, tested and stamped for conformance to ASME code.
A microprocessor controls the cycle parameters. The software provides the microprocessor with the necessary information to control the process per the programmed parameters. The software has been validated and documented under the requirements outlined in the "Reviewer Guide for Computer Controlled Medical Devices."
The unit has an 80 character alpha-numeric display. This display provides program and process information to the user, as well as fault condition messages. The display also provides the user with instructions regarding device operation.
The unit meets the requirements of UL/CUL3101-1, IEC 1010-1-92 safety standards. The unit is designed with additional user safety features such as, door interlocks and over temperature controls.
The chamber is 12″ diameter by 18″ deep. This chamber is somewhat larger than the predicate units. The general construction and operation is similar to the claimed predicate units.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Evaluations have been completed to validate the safety and effectiveness of the unit. The plan for this testing was derived from AAMI and accepted industry standards. Validation testing was performed using the half cycle analysis and total kill endpoint for each of the four standard cycles and the optional cycle for dental handpieces. The unit rendered all recommended loads sterile on half cycles.
The liquid cycle is not recommended for clinical applications.
Key Metrics
Not Found
Predicate Device(s)
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
JAN 29 1997
510(k) Safety and Effectiveness Summary
Manufacturer:
Barnstead/Thermolyne Corporation 2555 Kerper Boulevard Dubuque, Iowa 52001 Phone (319) 556-2241 Fax (319) 556-0695
Craig Case, Product Manager Contact Name:
Date Prepared: January 17, 1997
Common Name: Autoclave, table top steam Sterilizer
Trade Name: "Sterilemax"
Classification Name: Steam Sterilizer (per 21 CFR 880.6880) (size category less than two cubic feet)
Substantial Equivalence:
The B/T (Barnstead/Thermolyne) "Sterilemax" is claimed to be substantially equivalent in safety and effectiveness to the following two steam sterilizers currently approved and legally marketed; the Tuttenauer American Gold - 510(k) No. K833837 and the MDT S-8 - 510(k) No. K910777.
General Description:
The B/T "Sterilemax" is a table top steam sterilizer. As in the case of the predicate units, the Sterilemax has a water reservoir, a heat source and a sealed chamber.
The unit is designed with four standard cycles and one optional cycle. The standard cycles are: wrapped instruments (10 min at 135 C.), unwrapped instruments (3 min at 135 C), packs (30 minutes at 121 C.), the optional cycle for dental handpieces (10 min at 132 C.) and liquids for non-clinical applications (15 min at 121 C.).
Design and Materials:
The chamber is constructed of stainless steel with a cast aluminum door and a silicone sealing gasket. The pressure chamber and components are designed, tested and stamped for conformance to ASME code.
A microprocessor controls the cycle parameters. The software provides the microprocessor with the necessary information to control the process per the programmed parameters. The software has been validated and documented under the requirements outlined in the "Reviewer Guide for Computer Controlled Medical Devices."
Intended Use:
The "Sterilemax" provides sterilization of standard loads of
1
medical and dental instruments, as do the predicate units.
Technology Considerations:
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. . . .
The unit has an 80 character alpha-numeric display. This display provides program and process information to the user, as well as fault condition messages. The display also provides the user with instructions regarding device operation.
The unit meets the requirements of UL/CUL3101-1, IEC 1010-1-92 safety standards. The unit is designed with additional user safety features such as, door interlocks and over temperature controls.
The chamber is 12″ diameter by 18″ deep. This chamber is somewhat larger than the predicate units. The general construction and operation is similar to the claimed predicate units.
Safety and Effectiveness:
Evaluations have been completed to validate the safety and effectiveness of the unit. The plan for this testing was derived from AAMI and accepted industry standards. Validation testing was performed using the half cycle analysis and total kill endpoint for each of the four standard cycles and the optional cycle for dental handpieces. The unit rendered all recommended loads sterile on half cycles.
The liquid cycle is not recommended for clinical applications.
Conclusion:
It is the conclusion of Barnstead/Thermolyne that the Sterilemax is substantially equivalent to the predicate devices; the Tuttenauer American Gold - 510(k) No. K833837 and the MDT S-8 -510(k) No. K910777. Based on the test data submitted the Sterilemax provides effective sterilization of recommended loads with recommended cycles.