(567 days)
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.
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.
The provided text describes an ethylene oxide sterilizer control system, an accessory for existing sterilizers, and its compliance with standards and safety. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance with numerical metrics, nor does it detail a clinical study with elements like sample sizes, expert ground truth establishment, or multi-reader multi-case studies as typically expected for medical imaging or diagnostic AI devices.
The submission is for a control system for a sterilizer, not a diagnostic or imaging device, which explains the absence of the typical "study" information. The "study" here refers to validation against engineering and performance standards for sterilizers.
Here's an attempt to answer based on the provided text, highlighting the limitations due to the nature of the device and the available information:
Acceptance Criteria and Device Performance Study for H & W Hospital Ethylene Oxide Sterilizer Control System
The H & W Hospital Ethylene Oxide Sterilizer Control System is an electronic control system accessory designed to retrofit existing hospital ethylene oxide (EO) sterilizers. The primary objective is to maintain or improve the reliability, safety, and performance of the sterilizer, particularly its biological performance, according to established consensus standards.
Given that this is a control system for sterilizers and not a diagnostic or imaging device, the "acceptance criteria" and "study" details differ significantly from what would be expected for AI-powered diagnostic tools. The "performance" largely revolves around adherence to industry standards, safety regulations, and functional equivalence to predicate devices, rather than statistical metrics like sensitivity, specificity, or AUC from a clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Comments / Reference |
|---|---|---|---|
| Biological Performance | Deliver biological performance as stipulated in ANSI/AAMI ST-24 (3rd edition, 1999). | Predetermined cycles duplicate original equipment manufacturer (OEM) cycles and are "demonstrated to deliver the biological performance as stipulated in the consensus standard." | The H&W system conforms to this standard. The predicate system conformed to an earlier edition, but both met "the same criteria for acceptance" when considering the state of the art at their respective introductions. |
| Functional Reliability, Safety & Dependability | Ensure functional reliability, safety, and dependability of a Programmable Logic Controller (PLC) and PC user interface. | Utilizes a PLC for inherent safety and reliability, and a Windows-based user interface for ease of use. A rigorous Product Development Life Cycle (PDLC) assures integrity of design, controlled fabrication, and testing. | PDLC procedure is intended to assure requirements are met and validation is conducted. |
| Reproducibility | Assure repeatability of the automated sterilization process. | "The automated cycle performs in such a manner as to assure the repeatability of the process." | Duplicate OEM parameters. |
| Mechanical Safety | Meet requirements of ASME Boiler and Pressure Vessel Code; conform to IEC 1010-2-042. | Original equipment manufacturer or qualified third-party remanufacturer inspects and qualifies the vessel suitability to ASME code. H&W system conforms to IEC 1010-2-042. | Predicate device's mechanical safety also assured similarly. |
| Electrical Safety | Conform to IEC 1010-2-042 Particular Requirements for Toxic Gas Sterilizers. | H&W system conforms to IEC 1010-2-042, which is described as more comprehensive and specific than the predicate's UL 3101-1 Part 1 general requirements. | Emphasized as an improvement over the predicate device. |
| Human Factors/Ease of Use | Incorporate user expectations and consensus standard elements for operator interface. | Utilizes a PC as the operator control interface, allowing for effective information presentation (sound, color, animation) to gain attention as appropriate. | Acknowledged as an improvement/specific consideration beyond the predicate. |
| On-site Performance Validation | Validate system performance on-site in a sterilizer with known and defined characteristics as per reference standard. | The "bench mark to be used was and is the sterilizer retrofitted." The retrofitted system "demonstrates equal or better performance." | Performance is validated on-site. |
| Emission Controls | Accommodate emission controls. | Accommodated in both predicate and H&W systems, whether integral or external to the sterilizer. | Addressed. |
| Compatibility | Intended for specific sterilizer models. | 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. | Specific statement of intended use. (K014013 Indications for Use Statement) |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of data for an algorithm. Instead, the validation appears to be centered on the system itself when installed on existing sterilizers.
- The "test set" is implied to be actual sterilizers where the system is retrofitted and its performance validated on-site.
- Sample Size: Not explicitly stated as a number of devices. The validation process refers to "a sterilizer" (singular) but implies this process is to be followed for each retrofitted unit: "Performance is assured... by validating the performance of the system, on-site in a sterilizer with known and already defined characteristics."
- Data Provenance: This is an industrial control system, not a data-driven AI. "Data provenance" as typically understood (e.g., country of origin of patient data) is not applicable. The performance is validated against the physical characteristics and operational output of the sterilizer itself. The context is practical engineering validation rather than clinical data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not explicitly provided. The "ground truth" for the biological performance is the successful sterilization outcomes as stipulated by consensus standard ANSI/AAMI ST-24. This standard itself is developed by experts in the field. The operational validation (on-site testing) would likely involve qualified technicians or engineers, but their number and specific qualifications are not detailed in this submission.
4. Adjudication method for the test set
Not applicable. There is no mention of "adjudication" in the context of panel reviews or conflict resolution for expert opinions, since the "test set" is the biological and mechanical performance of the sterilizer, measured against established standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This type of study is typically performed for diagnostic devices (e.g., medical imaging AI) to compare human reader performance with and without AI assistance. This device is an industrial control system accessory, not a diagnostic tool, so an MRMC study is not relevant or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a control system, which functions "standalone" once programmed, but always within the context of physically controlling a sterilizer. The "algorithm" here refers to the PLC-based control logic, which operates independently to execute sterilization cycles. The validation focuses on whether these automated cycles achieve the required biological performance and safety standards, which is essentially its standalone or automated performance. Human interaction is primarily for monitoring and initiation through the PC interface.
7. The type of ground truth used
The primary ground truth is compliance with consensus standards and demonstrated biological performance as stipulated by ANSI/AAMI ST-24. This includes the successful inactivation of biological indicators, which is an objective measure of sterilization efficacy. Other ground truths include adherence to engineering and electrical safety standards (ASME, IEC).
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model in the sense of requiring a "training set" of data to learn from. Its logic is programmed based on engineering principles and industry standards, not data-driven model training.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of machine learning. The "ground truth" for the design and programming of the control system is based on the requirements defined by the Product Development Life Cycle (PDLC) procedure, industry best practices, and the consensus standard ANSI/AAMI ST-24. These requirements are established by experts and regulatory bodies in the field of sterilization.
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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
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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.
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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
§ 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).