Castle® Series 100HC Steam Sterilizers are intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids not intended for direct patient contact) by means of pressurized steam.

Device Description

The 100HC Steam Sterilizers represent a series of sterilizers intended for use in hospital and health care facilities. The product provides an update to the control system that provides additional functionality and ease of use to the end user that includes the added flexibility to adjust cycle parameters (as on previous sterilizer models), rename, and reassign (re-sequence) the designated sterilization cycles.

AI/ML Overview

Here's an analysis of the provided text regarding the Castle® Series 100HC Steam Sterilizers, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the way one might expect for software or diagnostic devices (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria for this medical device (steam sterilizer) are tied to its ability to meet established industry standards for sterilization and its substantial equivalence to a predicate device.

The reported device performance is described by its various sterilization cycles, which are designed to achieve specific sterilization parameters for different load configurations. The implicit acceptance criteria are that these cycles, when executed by the device, achieve the necessary conditions for sterility.

Acceptance Criteria (Implicit)	Reported Device Performance
Compliance with AAMI ST8, ST37 & ST46 Standards and Guidelines	The sterilizers meet the applicable requirements of AAMI ST8, CSA-Z314.7, and GGS-1340A standards. The "Load configurations are based on AAMI ST8, ST37 & ST46 Standards and Guidelines." Various cycles (Gravity, Liquids, Flash, Prevacuum, Bowie-Dick Test, Leak Test) are detailed with specific temperatures, times, and load capacities designed for effective sterilization according to these standards.
Substantial Equivalence to Predicate Device (Castle® Series 100 Steam Sterilizers [K970907])	"Castle® Series 100HC Steam Sterilizers provide substantially equivalent product as those of our predicate device. There have been no substantial changes in technology, intended use, or labeling of this device." The modifications are described as improvements to the control system and user flexibility, not fundamental changes to the sterilization efficacy.
Effective Sterilization for Intended Use	Intended for "use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids not intended for direct patient contact) by means of pressurized steam." The detailed cycle table specifies parameters for these uses.

2. Sample Size Used for the Test Set and the Data Provenance

This document does not describe a "test set" in the context of data for an algorithm or diagnostic. The device in question is a steam sterilizer, a piece of hardware designed to perform a physical process.

Sample Size: Not applicable in the context of data for an algorithm. The testing would involve physical load configurations and sterility assurance levels, typically standardized by regulatory bodies and industry rather than a statistical "test set" of data.
Data Provenance: Not applicable. The document refers to compliance with standards (e.g., AAMI, CSA) which represent established scientific and industry best practices for sterilization, not data collected from a specific patient population or geographical region.
Retrospective/Prospective: Not applicable. Testing for a sterilizer's efficacy is typically conducted through controlled laboratory and real-world simulations to ensure it meets performance standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable to this type of device submission. For a steam sterilizer, "ground truth" is established by scientific principles of microbiology and engineering, and validated through standardized testing protocols (e.g., using biological indicators, thermocouples) that demonstrate the destruction of microorganisms. The document refers to compliance with standards established by organizations like AAMI, which involve experts in sterilization, microbiology, and healthcare, but does not detail the specific experts or their qualifications for this particular submission's ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. There is no human adjudication process described for the performance of a steam sterilizer. The performance is assessed against physical and biological parameters defined by recognized standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is not an AI-assisted diagnostic or imaging device. It is a steam sterilizer.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device does not involve an algorithm for diagnostic or interpretative purposes. The "algorithms" in this context refer to the programming of the sterilization cycles, which operate autonomously once initiated according to pre-validated parameters.

7. The Type of Ground Truth Used

The ground truth for the efficacy of the sterilizer is based on:

Scientific Principles of Sterilization: The complete destruction of all viable microorganisms, typically confirmed through biological indicators (spores) and physical monitoring (temperature, pressure, time).
Industry Standards: Compliance with established sterilization standards and guidelines such as AAMI ST8, ST37, ST46, CSA-Z314.7, and GGS-1340A. These standards define the parameters (temperature, pressure, time exposures for specific loads) required to achieve sterilization.
Engineering Validation: Verification that the device can consistently deliver the specified physical conditions (temperature, pressure, vacuum) within the sterilization chamber.

8. The Sample Size for the Training Set

Not applicable. This device does not use an "AI" training set. Its operational parameters (cycles) are designed based on scientific principles and extensive validation testing of sterilization processes, not machine learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the AI sense. The "ground truth" for developing the sterilizer's parameters (temperature, time, pressure for various loads) would be established through a combination of:

Microbiological Studies: Determining the D-value (decimal reduction time) of highly resistant microorganisms (e.g., Geobacillus stearothermophilus) at specific temperatures and humidities.
Engineering and Thermal Mapping Studies: Extensive testing with thermocouples and biological indicators within simulated load configurations to ensure that every point within the load reaches and maintains the required sterilizing conditions for the specified duration.
Compliance with Recognized Sterilization Standards: These standards (e.g., AAMI, ISO) provide scientifically validated guidelines for effective sterilization cycles.

In summary, this document describes a traditional medical device (a steam sterilizer) where performance is evaluated against established physical and biological standards for sterilization, rather than through empirical data analysis of an algorithm's output or human reader performance.

Summary

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Getinge/Castle, Inc. FDA 510(k) Summary - Castle® Series 100HC Steam Sterilizers Re: K994314 January 25, 2000 994314 FEB 16 2000 Page 1 of 3

510(k) SUMMARY

Castle® Series 100HC Steam Sterilizers

Submitted by:	Getinge/Castle Inc.1777 E Henrietta RoadRochester, NY 14623-3133
Contact Person:	Frederick R. CattSenior, Regulatory Affairs and Code Compliance EngineerPhone: (716) 272-5013Fax:(716) 272-5299
Date prepared:	January 25, 2000
Proprietary Name:	Castle® Series 100HC Steam Sterilizers
Common Name:	Steam Sterilizer
Device Classification:	Steam Sterilizer (80FLE)
	Class II, as listed under Title 21 CFR 880.6880
Predicate Device:	Castle® Series 100 Steam Sterilizers (Straightline) [K970907]

Description of Device:

(continued....)

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								Full List of Available Cycles for Series 100HC - up to 19 Total Cycles (w/ P1 - P6 Active)
Ref.No.	Cycle Type	ExposureTemperature[°F/°C]	ExposureTime(Min.)	Drying Time[Min.]	AvailableandFactorySet P#Cycles[122HC]	AvailableandFactorySet P#Cycles[133HC]		Load Configuration
1	Gravity 1	250/121	30	30	P1	Available
2	Gravity 1	250/121	30	30	Available	Available		Double Wrapped Instrument Trays, 16lbs. (2 max.)
3	Gravity 2	275/135	10	30	P2	Available		Fabric Packs (2 max. in 16"x16" chamber)(12 max. in 20"x20" chamber)
4	Gravity 2	275/135	10	30	Available	Available
5	Liquids 1*	250/121	30	0.75psi/min.	Available	Available	●	Up to 250 mL Containers (40 max. in16" chamber)(168 max. in 20" chamber)
ర్	Liquids 2*	250/121	45	0.75psi/min.	Available	Available		Up to 1000 mL Containers (15 max. in 16" chamber)(32 max. in 20" chamber)
7	Flash 3+	275/135	3	0	P3	Available
8	Flash 3+	275/135	3	0	P4	P3	Unwrapped Single InstrumentUnwrapped Non-Porous Instrument Trays up to 16lbs.(2 max.)
9	Flash 3+	275/135	3	0	Available	Available
10	Flash 3+	275/135	3	0	Available	Available
11	Flash 10+	275/135	10	0	િર	P4
12	Flash 10+	275/135	10	0	PS	Available		Unwrapped Single InstrumentUnwrapped Porous and Non-Porous Instrument Trays
13	Flash 10+	275/135	10	0	Available	Available		up to 16lbs. (2 max.)
14	Flash 10+	275/135	10	0	Available	Available
15	Prevacuum 1	275/135	3	16	NA	P1	�	Double Wrapped Instrument Trays 16lbs. (2 max.)Fabric Packs (2 max. in 16"x16" chamber)(12 max. in 20"x20" chamber)
16	Prevacuum 2	275/135	3	3	NA NA	P2		Single Wrapped Single Instrument
17	Prevacuum 2	275/135	3	3	NA	Available		Single Wrapped Instrument Trays 16lbs. (2 max.)Fabric Packs (2 max. in 16"x16" chamber)(12 max. in 20"x20" chamber)
18	Bowie-Dick Test	273/134	3.5	0	I NA NA	છેર	●	S.M.A.R.T. Pack (Bowie-Dick Pack.) (1 max.)
19	Leak Test	268/131	3	15/5/15**	NA NA	ଚିଚ୍ଚ	●	Empty Chamber Test
	Note 1: Qualified Getinge/Castle personnel may reassign (re-sequence) "Available" cycles to P1-P6.
	Note 2: Load configurations are based on AAMI ST8, ST37 & ST46 Standards and Guidelines.
		time as factory set parameter and indicated dry time is slow exhaust rate.						Note 3: "The Liquids cycle is not intented for the sterlizztion of liquid catient contact. Liguid cycles have 8 minute liguid dwell
								Note 4: ** 15 minute dry, 5 minute timed vacuum leak rate test for change in pressure (differential).
	NA: Cycle Not Available

Intended Use:

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Getinge/Castle, Inc. FDA 510(k) Summary - Castle® Series 100HC Steam Sterilizers Re: K994314 January 25, 2000 Page 3 of 3

Predicate Device

Castle® Series 100 Steam Sterilizer (Straightline) [K970907].

Nonclinical Comparisons to Predicate Devices

Castle® Series 100HC Steam Sterilizers is a new model designation to identify incorporation of design improvements. These sterilizers are very similar to the Series 100 Steam Sterilizers (predicate device). Modifications made to the predicate device include:

Addition of the "HC" suffix (Health Care facility type intended use) .
Software change to provide a more modular structure .
Customer ability to select, from 19 pre-validated cycles to be configured by a qualified . Getinge/Castle representative for the P1 - P6 control settings
Ability for qualified Getinge/Castle representatives to modify a customized cycle description (up . to 8 digits) in addition to the fixed cycle type designation for the P1 - P6 control settings
Customer ability for user to modify cycle parameters (time and temperature), through password . access, to accommodate specific device sterilization cycle requirements
Selectable temperature (ºF or ºC) and pressure (psi, kPa, or bars) units .
Minor piping changes to accommodate manufacturing .
Adjustments to password features ●
Power door option made available for double door vessels ●
Power failure and recovery times lengthened .

Clinical Data:

No clinical data is required for this submission.

Conclusion:

Castle® Series 100HC Steam Sterilizers provide substantially equivalent product as those of our predicate device. There have been no substantial changes in technology, intended use, or labeling of this device. The sterilizers meet the applicable requirements of AAMI ST8, CSA-Z314.7, and GGS-1340A standards.

Based on the provided information in this premarket notification, it can be concluded that the subject device is substantial equivalent to the predicate devices and is safe and effective when used as intended.

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Public Health Service

FEB 1 6 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mark N. Smith, P.E. Director Regulatory Affairs/Quality Assurance Getinge/Castle, Incorporated 1777 East Henrietta Road Rochester, New York 14623-3133

Re : K994314 Castle® Series 100HC Steam Sterilizers Trade Name: Regulatory Class: II Product Code: FLE Dated: January 25, 2000 Received: January 27, 2000

Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Smith

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,

Valtrist

mothy A. Ulatowski Difector Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number:

K994314

Device Name:

Castle® Series 100HC Steam Sterilizers

Indications for Use:

Castle® Series 100HC Steam Sterilizers are intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids not intended for direct patient contact) by means of pressurized steam.

Ref.No.	Cycle Type	ExposureTemperature[°F/°C]	ExposureTime[Min.]	Drying Time[Min.]	AvailableandFactorySet P#Cycles[122HC]	AvailableandFactorySet P#Cycles[133HC]	Load Configuration
1	Gravity 1	250/121	30	30	P1	Available
2	Gravity 1	250/121	30	30	Available	Available	Double Wrapped Instrument Trays, 16lbs. (2 max.)
3	Gravity 2	275/135	10	30	P2	Available	Fabric Packs (2 max. in 16"x16" chamber)(12 max. in 20"x20" chamber)
4	Gravity 2	275/135	10	30	Available	Available
5	Liquids 1*	250/121	30	0.75psi/min.	Available	Available	Up to 250 mL Containers (40 max. in16" chamber)(168 max. in 20" chamber)
6	Liquids 2*	250/121	45	0.75psi/min.	Available	Available	Up to 1000 mL Containers (15 max. in 16" chamber)(32 max. in 20" chamber)
7	Flash 3+	275/135	3	0	P3	Available
8	Flash 3+	275/135	3	0	P4	P3	Unwrapped Single Instrument
9	Flash 3+	275/135	3	0	Available	Available	Unwrapped Non-Porous Instrument Trays up to 16lbs.(2 max.)
10	Flash 3+	275/135	3	0	Available	Available
11	Flash 10+	275/135	10	0	P5	P4
12	Flash 10+	275/135	10	0	P6	Available	Unwrapped Single Instrument
13	Flash 10+	275/135	10	0	Available	Available	Unwrapped Porous and Non-Porous Instrument Traysup to 16lbs. (2 max.)
14	Flash 10+	275/135	10	0	Available	Available
15	Prevacuum 1	275/135	3	16	NA	P1	Double Wrapped Instrument Trays 16lbs. (2 max.)Fabric Packs (2 max. in 16"x16" chamber)(12 max. in 20"x20" chamber)
16	Prevacuum 2	275/135	3	3	NA	P2	Single Wrapped Single Instrument
17	Prevacuum 2	275/135	3	3	NA	Available	Single Wrapped Instrument Trays 16lbs. (2 max.)Fabric Packs (2 max. in 16"x16" chamber)(12 max. in 20"x20" chamber)
18	Bowie-Dick Test	273/134	3.5	0	NA	P5	S.M.A.R.T. Pack (Bowie-Dick Pack.) (1 max.)
19	Leak Test	268/131	3	15/5/15**	NA	P6	Empty Chamber Test
Note 1: Qualified Getinge/Castle personnel may reassign (re-sequence) "Available" cycles to P1-P6.
Note 2: Load configurations are based on AAMI ST8, ST37 & ST46 Standards and Guidelines.
Note 3: The Liquids cycle is not intended for the sterilization of liquids intended for direct patient contact. Liquid cycles have 8 minute liquid dwelltime as factory set parameter and indicated dry time is slow exhaust rate.Note 4: *15 minute dry, 5 minute dwell, 15 minute timed vacuum leak rate test for change in pressure (differential).
NA: Cycle Not Available

Regulation Number and Section

§ 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).