(567 days)
Not Found
No
The description focuses on a PLC-based control system with a PC user interface for automating sterilization cycles, with no mention of AI or ML technologies.
No
This device is an accessory control system for ethylene oxide sterilizers, intended to retrofit existing sterilizers and assure repeatability and performance of the sterilization process. It does not directly treat or diagnose medical conditions, which are characteristics of a therapeutic device.
No
Explanation: The device is an electronic control system for ethylene oxide sterilizers, designed to retrofit existing sterilizers and ensure the repeatability of the sterilization process. It controls and monitors the sterilization cycle, rather than diagnosing a medical condition.
No
The device description explicitly states it is a "programmable logic controller (PLC)-based system" and uses a "PLC for control," indicating the presence of hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory for retrofitting existing ethylene oxide sterilizers used in hospitals. Its purpose is to provide operator and information monitoring capabilities and improve the reliability and safety of the sterilization process.
- Device Description: The description reinforces that it's a control system for sterilizers, utilizing a PLC and PC interface.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment.
- Being used in a laboratory setting for diagnostic purposes.
The device's function is to control and monitor a sterilization process, which is a method for disinfecting medical equipment, not for diagnosing or treating patients directly through analysis of biological samples.
N/A
Intended Use / Indications for Use
The H & W Hospital Ethylene Oxide Sterilizer Control System is an accessory in the form of an electronic control system for the retrofit of existing sterilizers to provide operator and information monitoring capabilities of a personal computer (PC) together with the functional reliability, safety, and dependability of control obtained through the use of a programmable logic controller (PLC). The H & W Hospital Ethylene Oxide Sterilizer Control System is intended to retrofit existing Steris (Amsco) Eagle Model 2000 & 3000 series and Getinge (Castle) Model M/C 3500, 3600 or 4200 series Hospital EO Sterilizers only. The automated cycle performs in such a manner as to assure the repeatability of the process. The predetermined cycles duplicate the cycles provided by the original equipment manufacturer and are demonstrated to deliver the biological performance as stipulated in the consensus standard ANSI/AAMI ST-24.
Product codes (comma separated list FDA assigned to the subject device)
FLF
Device Description
This device is an accessory to an electronic ethylene oxide sterilizer control system. This control system is a modern, programmable logic controller (PLC)-based system with Personal Computer (PC) user interface. This accessory control system uses a PLC and a Visual Basic/Windows user interface. These two features, a PLC for control and a Windows -based user interface provide multiple advantages. First being the inherent safety and reliability of the PLC and second the operator's ease of use of the Windows "based user interface. This accessory control system kit is intended for the retrofit of existing sterilizers or for use on sterilizers remanufactured by original equipment manufacturers, third party remanufacturers or their licensees.
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
Hospital
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance is assured in both the predicate system and the H&W system by validating the performance of the system, on-site in a sterilizer with known and already defined characteristics. These characteristics are addressed in the reference standard. The bench mark to be used was and is the sterilizer retrofitted. That sterilizer chamber, by design, is capable of well-defined physical characteristics. The hospital sterilizer system as configured after retrofit demonstrates equal or better performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).
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510(k) Summary
Applicant's Name and Address
H&W Technologies, LLC P.O. Box 20281 Rochester, New York 14602-0281
Contact Person, Telephone, FAX
Charles O. Hancock, RAC Director, Regulatory Affairs
Tel : (585) 223-1850 FAX : (585) 223-6855
Submission Date
November 29, 2001
Trade Name
H & W Technology Hospital Ethylene Oxide Sterilizer Control System
Common Name
Hospital Ethylene Oxide Sterilizer Control System
Classification Name
Hospital Ethylene Oxide Sterilizer
Device Classification
Class II (performance standards) (as per 21CFR, part 880.6860 equivalent device)
Legally Marketed Equivalent Device Name(s)
Joslyn EO Sterilizer/EO Modernization Kit (K901146)
Description of Device
This device is an accessory to an electronic ethylene oxide sterilizer control system. This control system is a modern, programmable logic controller (PLC)-based system with
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Personal Computer (PC) user interface. This accessory control system uses a PLC and a Visual Basic/Windows user interface. These two features, a PLC for control and a Windows -based user interface provide multiple advantages. First being the inherent safety and reliability of the PLC and second the operator's ease of use of the Windows "based user interface. This accessory control system kit is intended for the retrofit of existing sterilizers or for use on sterilizers remanufactured by original equipment manufacturers, third party remanufacturers or their licensees.
1014013
:255
Image /page/1/Figure/1 description: The image shows a block diagram of a sterilizer system. The system consists of an EO supply, a sterilizer chamber, a PLC portion, a PC portion, a printer, and a network. The EO supply is connected to the sterilizer chamber, which is connected to the PLC portion. The PLC portion is connected to the PC portion and the printer. The PC portion is connected to the network.
Statement of Intended Use
The H & W Hospital Ethylene Oxide Sterilizer Control System is an electronic control system accessory for the retrofit of existing sterilizers to provide operator and information monitoring capabilities of a Personal Computer (PC) together with the functional reliability, safety, and dependability of a programmable logic controller (PLC). Hospital EO sterilizers are dedicated purpose sterilizers with preselected process parameters programmed to allow operation only within very stringent limits in a fixed cycle. The automated cycle performs in such a manner as to assure the repeatability of the process. The predetermined cycles duplicate the cycles provided by the original equipment manufacturer and are demonstrated to deliver the biological performance as stipulated in the consensus standard ANSI/AAMI ST-24.
The H&W system is shown to be developed using a Product Development Life Cycle (PDLC) procedure assuring the integrity of the design process to vield predetermined results. H&W employs a PDLC intended to assure that requirements are defined; design
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is controlled; fabrication is in accordance with documentation; testing in conducted so as to validate that the requirements have been met; the product is installed properly; the product is operated per instructions; the product is maintained properly; and the documentation system is maintained over the life of the product. Conformity to the consensus standard is one of the requirements.
3 J 5
Effectiveness
Discussion:
This control system accessory is an electronic control system for the retrofit of existing sterilizers. These controls were originally designed for use with industrial sterilizers where the flexibility to program a number of different process parameters was important. Hospital EO sterilizers are dedicated purpose sterilizers with preselected process parameters programmed to allow operation only within very stringent limits in a fixed cycle. The automated cycle performs in such a manner as to assure the repeatability of the process. The predetermined cycles duplicate the cycles provided by the original equipment manufacturer and are demonstrated to deliver the biological performance as stipulated in the consensus standard.
The predicate Joslyn accessory kit system was shown to be designed to render the same biological kill performance as that of the sterilizer systems it was designed to replace as evidenced by testing in conformance with the requirements of AAMI standard. The H&W system is shown to be developed using a rigorous Product Development Life Cycle (PDLC) procedure assuring the integrity of the design process to yield predetermined results. H&W employs a PDLC procedure intended to assure that: requirements are defined; design is controlled; fabrication is in accordance with documentation; testing in conducted so as to validate that the requirements have been met; the product is installed properly; the product is operated per instructions; the product is maintained properly; and the documentation system is maintained over the life of the product. Conformity to the consensus standard is one of the requirements.
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K014013
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Human factors were not an explicit requirement of the predicate device. However, good hospital practice did dictate ease of use. The state of maturity of the user market for hospital sterilizer controls dictated minimally expected operator interface capability. The H&W system includes not only user expectations in the requirements criteria but also includes the satisfaction of the consensus standard elements along with the flexible features available by employing a PC as the operator control interface. (Information can be presented effectively according to the appropriateness of a given operator response. (For example - attention may be gained by a combination of sound, color, animation or frequency of display as appropriate to the importance and necessity of action.)
Performance is assured in both the predicate system and the H&W system by validating the performance of the system, on-site in a sterilizer with known and already defined characteristics. These characteristics are addressed in the reference standard. The bench mark to be used was and is the sterilizer retrofitted. That sterilizer chamber, by design, is capable of well-defined physical characteristics. The hospital sterilizer system as configured after retrofit demonstrates equal or better performance.
Emission controls, whether or an integral part of the sterilizer or not, are accommodated in both predicate and H&W systems. (Amsco EO sterilizer, dependent on vintage, may or may not have the integral Envirogard® emission control system. Castle EO sterilizers employ external means for emission control.)
A AMI/ANSI ST24: Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3nd edition, AAMI/ANSI, 1999 is the consensus standard to which the H&W system was designed for conformance. The predicate system was design to an earlier edition of the same standard. While not identical, because each edition reflects the then current thinking regarding the best practice at the time of revision, both predicate and H&W systems do reflect the same conformance to the state of the art regarding control systems at the time of their introduction. When allowance is made for that consideration, the two systems meet the same criteria for acceptance.
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Safety
Mechanical Safety is assured in both the predicate and H&W systems by using the original equipment manufacturer or qualified third part remanufacturer to inspect and qualify the suitability of the vessel to meet the requirements of the ASME Boiler and Pressure Vessel Code referenced in the consensus standard. Further mechanical safety is assured be conformity to IEC 1010-2-042 requirements.
Electrical Safety is assured in the H&W system by conformance to IEC 1010-2-042 Particular Requirements for Toxic Gas Sterilizers. The predicate device met only the general electrical requirements of UL 3101-1 Part 1 for laboratory equipment. The IEC requirements are more comprehensive and specifically address all aspects of EO sterilizer safety as opposed to the more general and less stringent considerations for the broad category of laboratory equipment contained in the UL document.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 2003
Mr. Charles O. Hancock Director, Regulatory Affairs H & W Technologies, LLC P.O. Box 20281 Rochester, New York 14602-0281
Re: K014013
Trade/Device Name: H & W Hospital Ethylene Oxide Sterilizer Control System Regulation Number: 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: FLF Dated: April 23, 2003 Received: April 25, 2003
Dear Mr. Hancock:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Hancock
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Rarr
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) K014013 Number
Device Name
H & W Hospital Ethylene Oxide Sterilizer Control System
The H & W Hospital Ethylene Oxide Sterilizer Control System is Indications for Use an accessory in the form of an electronic control system for the retrofit of existing sterilizers to provide operator and information monitoring capabilities of a personal computer (PC) together with the functional reliability, safety, and dependability of control obtained through the use of a programmable logic controller (PLC). The H & W Hospital Ethylene Oxide Sterilizer Control System is intended to retrofit existing Steris (Amsco) Eagle Model 2000 & 3000 series and Getinge (Castle) Model M/C 3500, 3600 or 4200 series Hospital EO Sterilizers only. The automated cycle performs in such a manner as to assure the repeatability of the process. The predetermined cycles duplicate the cycles provided by the original equipment manufacturer and are demonstrated to deliver the biological performance as stipulated in the consensus standard ANSI/AAMI ST-24.
Qiu S. Lim
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number: K014013