(167 days)
Model 222: The Castle Model 222 Gravity Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped hard goods and linens. Wrapped-goods cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. Unwrapped goods cycles (flash) are used to process unwrapped hard goods such as instruments and utensils. Steam stenlization by the unwrapped (flash) method is employed when time does not permit the use of the preferable, wrapped sterilization procedure. Implantables should never be sterilized by the unwrapped (flash) method. All cycles employ gravity or downward displacement with positive pulsing conditioning for dynamic air removal. Processing temperatures range from 250°F to 275°F (121°C to 135°C)
Model 233: The Castle Model 233 Vacuum Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped hard goods and linens. Wrapped-goods (Hi Vac) cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. A gravity cycle is provided for processing wrapped dry goods and/or hard goods. Additionally, a Vacuum Leak Test cycle, not intended for sterilization, and an Air-Removal-Test-Pack (Bowie-Dick) cycle, not intended for sterilization is provided. The wrapped-goods (Hi Vac) cycles employ vacuum-and-positive pulsing to condition a load before processing at the selected exposure temperature. The gravity cycle employs the gravity, or downward displacement method of air removal. Processing temperatures for wrapped goods cycles range from 250°F (121°C to 135°C).
Model 223: The Castle Model 223 Gravity Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped and unwrapped hard goods and linens. Wrapped-goods cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. The cycles employ gravity or downward displacement with positive pulsing conditioning for dynamic air removal. Processing temperatures for wrapped goods cycles range from 250°F to 275°F (121°C to 135°C).
All Models: Castle Series 200 Steam Sterilizers are programmed with factory recommended sterilization parameters (cycle settings) which have been verified and validated for efficacy. By using a supervisory password, the controls allow for flexibility in selecting exposure temperature, exposure time, and drying time. It is possible, with that password, to select cycle settings that will not necessarily achieve the desired sterlity assurance level. Users with password access are responsible for the efficacy of any cycle settings other than the factory recommended settings.
The Castle Series 200 Sterilizers (Powerclave) is a control system upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. Specifically, PACS 2000 controls applied to the Series 200 (Powerclave) Steam Sterilizer are to be used with "Castle" brand sterilizers manufactured by Getinge/Castle, Inc for use in health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, hard goods, and linens. The difference between the predicate sterilizer controls and the PACS 2000 controls is that the PACS 2000 controls are provided with a more modern microprocessor, software, and an interactive operator interface. The piping remains relatively unchanged, with the addition of a chamber drain float switch to signal possible water-in-chamber conditions and a thermostatic drain discharge temperature control. A minor change on each chamber vessel size has changed the interior chamber width from 24 inches to 26 inches; the length on the mid-sized vessel has changed from 49 inches to 50 inches.
Here's a breakdown of the acceptance criteria and the study information for the Castle Series 200 Steam Sterilizers (Powerclave) based on the provided text, structured to answer your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for the sterilizer's performance are the established sterilization cycles and their effectiveness in achieving a specified sterility assurance level (SAL). The reported device performance is that these cycles were validated to meet a SAL of at least $10^{-6}$.
| Sterilizer Model | Cycle Type | Exposure Time (Minutes)* | Exposure Temperature | Drying Time (Minutes) | Loads | Reported Performance (SAL) |
|---|---|---|---|---|---|---|
| 222 | Gravity | 30 | 250 °F | 30 | Wrapped Linen Packs | $\geq 10^{-6}$ |
| 222 | Gravity | 10 | 275 °F | 30 | Wrapped Hard Goods | $\geq 10^{-6}$ |
| 222 | Gravity/Flash | 3 | 275 °F | 0 | Unwrapped Nonporous Instruments | $\geq 10^{-6}$ |
| 222 | Gravity/Flash | 10 | 275 °F | 0 | Unwrapped Porous Instruments | $\geq 10^{-6}$ |
| 223 | Gravity | 30 | 250 °F | 30 | Wrapped Linen Packs and Hard Goods | $\geq 10^{-6}$ |
| 223 | Gravity | 10 | 275 °F | 30 | Wrapped Hard and Dry Goods | $\geq 10^{-6}$ |
| 233 | Prevacuum | 3 | 275 °F | 16 | Wrapped Hard and Dry Goods | $\geq 10^{-6}$ |
| 233 | Prevacuum | 3 | 275 °F | 3 | Linen Packs & Single Wrapped Hard Goods | $\geq 10^{-6}$ |
| 233 | Gravity | 30 | 250 °F | 30 | Wrapped Linen Packs and Hard Goods | $\geq 10^{-6}$ |
| 233 | Bowie-Dick Test | 3.5 | 273 °F | 0 | Air Removal Test Pack | Meets test requirements |
| 233 | Air Leak Test | 3 | 268 °F | 15 | No Load - Vacuum Leak test | Meets test requirements |
*Exposure times listed are actual times of the cycles to be cleared and are not half times.
Beyond sterilization efficacy, the device also meets the following requirements:
- Safety Standards: UL544 and CSA C22.2 Nº 151 product safety standards for medical devices.
- Pressure Vessel Code: Section VIII of the ASME pressure vessel code.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document mentions "Evaluation studies consisting of fabric and instrument loads (wrapped and unwrapped)". However, it does not specify the exact number or sample size of these loads used for the validation testing.
- Data Provenance: The studies were conducted internally by Getinge/Castle, Inc. and are retrospective in nature (testing of the developed device). The country of origin of the data is implicitly the USA, where Getinge/Castle, Inc. is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- The document does not mention the use of experts to establish the ground truth for the sterilization testing. Sterilization efficacy is typically validated through microbiological challenge tests and physical measurements, rather than expert consensus on images or diagnoses.
4. Adjudication Method for the Test Set:
- Given that the validation relied on established industrial standards and the measurement of sterility assurance levels through "half cycle analysis," no human adjudication method (like 2+1, 3+1) was used or is relevant for this type of device testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, often with and without AI assistance. This document pertains to a steam sterilizer, which is a therapeutic/device processing tool, not a diagnostic one.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable to a steam sterilizer. The "device" in question is the sterilizer itself, which operates autonomously to sterilize items based on pre-programmed cycles. Its performance is inherent to the machine, not an algorithm that assists human interpretation.
7. The Type of Ground Truth Used:
- The ground truth for the sterilization efficacy was established through microbiological challenge tests resulting in a sterility assurance level (SAL) of at least $10^{-6}$. This is inferred from the statement "Validation testing was performed using accepted half cycle analysis and results consistent with a sterility assurance level of at least $10^{-6}$ were obtained." This type of ground truth is based on a quantifiable reduction of microbial life, a standard method for sterilizer validation.
8. The Sample Size for the Training Set:
- This question is not applicable to this device. A steam sterilizer does not involve a "training set" in the context of machine learning or AI algorithms. The sterilizer operates based on engineered physics, control systems, and pre-defined parameters, not learned data sets.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable for the same reasons as #8. There is no training set or corresponding ground truth in the context of this traditional medical device. The "ground truth" for its operation is the established science of sterilization (heat, pressure, time) and the engineering principles applied in its design.
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FEB 1 0 1998
510(k) SAFETY AND EFECTIVENESS SUMMARY
for
Castle Series 200 Steam Sterilizers (Powerclave)
Submitted by
Getinge/Castle, Inc. 1777 East Henrietta Road Rochester, NY 14623
Phone (716) 475-1400 (716) 272-5033 Fax
November 24, 1997
Oz Osborne Senior Quality Assurance Engineer Quality Assurance/Regulatory Affairs Phone 716-272-5129 FAX 716-272-5033
Michael J. Palladino Senior Quality Assurance Engineer Quality Assurance/Regulatory Affairs Phone 716-272-5016 FAX 716-272-5033
Per 21 CFR 807.92(a)(1) & (a)
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This summary is for the:
| Trade Name | Castle Series 200 Steam Sterilizers (Powerclave) |
|---|---|
| Common Name | Steam Sterilizer (greater than 2 cubic feet) |
| Classification Name | Steam Sterilizer (per 21 CFR 880.6880) |
Per 21CFR 807.92(a)(3)
We believe this product to be substantially equivalent to our Castle Microcomputer Controls and Sterilizers K820783.
Per 21CFR 807.92(a)(4), (5) & (6)
The Castle Series 200 Sterilizers (Powerclave) is a control system upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. Specifically, PACS 2000 controls applied to the Series 200 (Powerclave) Steam Sterilizer are to be used with "Castle" brand sterilizers manufactured by Getinge/Castle, Inc for use in health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, hard goods, and linens.
The difference between the predicate sterilizer controls and the PACS 2000 controls is that the PACS 2000 controls are provided with a more modern microprocessor, software, and an interactive operator interface. The piping remains relatively unchanged, with the addition of a chamber drain float switch to signal possible water-in-chamber conditions and a thermostatic drain discharge temperature control. A minor change on each chamber vessel size has changed the interior chamber width from 24 inches to 26 inches; the length on the mid-sized vessel has changed from 49 inches to 50 inches.
Per 21CFR 807.92(b)(1), (2) & (3)
The following standards were used to establish the minimum construction and performance requirements for this product:
ANSI/AAMI ST-8 - 1994 American National Standard for Hospital Steam Sterilizers,
CAN/CSA-Z314.7-M91 Effective Sterilization in Hospitals by the Steam Process (ref. AAMI ST8-1988), GGS-1340A November 24, 1975 Federal Specification Sterilizer, Surgical Instrument and Supply Gravity Air Removal, Non-Portable (Heat and Moisture Stable),
GGS-1343A November 26, 1975 Federal Specification Sterilizer, Surgical Instrument and Supply Mechanical Air Removal, Non-Portable (Heat and Moisture Stable)
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Evaluation studies consisting of fabric and instrument loads (wrapped and unwrapped) have been completed to validate the safety and effectiveness of the Series 200 Steam Sterilizer (Powerclave). The plan for this was derived from AAMI ST8 1994 and the accepted industrial standards listed above. Validation testing was performed using accepted half cycle analysis and results consistent with a sterility assurance level of at least 10 were obtained.
| SterilizerModel | Cycle Type | ExposureTimeMinutes* | ExposureTemperature | DryingTimeMinutes | Loads |
|---|---|---|---|---|---|
| 222 | Gravity | 30 | 250 °F | 30 | Wrapped Linen Packs |
| 222 | Gravity | 10 | 275 °F | 30 | Wrapped Hard Goods |
| 222 | Gravity/Flash | 3 | 275 °F | 0 | Unwrapped Nonporous Instruments |
| 222 | Gravity/Flash | 10 | 275 °F | 0 | Unwrapped Porous Instruments |
| 223 | Gravity | 30 | 250 °F | 30 | Wrapped Linen Packs and Hard Goods |
| 223 | Gravity | 10 | 275 °F | 30 | Wrapped Hard and Dry Goods |
| 233 | Prevacuum | 3 | 275 °F | 16 | Wrapped Hard and Dry Goods |
| 233 | Prevacuum | 3 | 275 °F | 3 | Linen Packs & Single Wrapped Hard Goods |
| 233 | Gravity | 30 | 250 °F | 30 | Wrapped Linen Packs and Hard Goods |
| 233 | Bowie-Dick Test | 3.5 | 273 °F | 0 | Air Removal Test Pack |
| 233 | Air leak Test | 3 | 268 °F | 15 | No Load - Vacuum Leak test |
The cycles to be cleared for each of the models are listed in the following table:
- Exposure times listed are actual times of the cycles to be cleared and are not half times.
This product has been also designed to meet the requirements of UL544 and CSA C22.2 Nº 151 product 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 conform to the above requirements.
No clinical testing is required for this submittal.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1998 Gettinge/Castle, Incorporated C/O Mr. Gordon Gillerman Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
Re : K973225 Castle Series 200 Steam Sterilizer Trade Name: (Straightline) Regulatory Class: II Product Code: FLE Dated: February 2, 1998 February 3, 1998 Received:
Dear Mr. Gillerman:
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, Drug, 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 regulations 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Gillerman
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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,
Timothy A. Ulatowski
Timothy A Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if Known):
Device Name: Castle Series 200 Steam Sterilizer (Powerclave)
Indications For Use:
Model 222:
The Castle Model 222 Gravity Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped hard goods and linens.
Wrapped-goods cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. Unwrapped goods cycles (flash) are used to process unwrapped hard goods such as instruments and utensils. Steam stenlization by the unwrapped (flash) method is employed when time does not permit the use of the preferable, wrapped sterilization procedure. Implantables should never be sterilized by the unwrapped (flash) method. All cycles employ gravity or downward displacement with positive pulsing conditioning for dynamic air removal. Processing temperatures range from 250°F to 275°F (121°C to 135°C)
The cycles to be cleared for this model (Model 222) are:
| Cycle | Name | Type | Exposure Temp | Minutes | Dry Minutes |
|---|---|---|---|---|---|
| P1 | GRAV WRAP 1 | Gravity 250°F | 250°F | 30 | 30 |
| P2 | GRAV WRAP 2 | Gravity 275°F | 275°F | 10 | 30 |
| P3 | FLASH 3 + | Gravity 3 Minutes | 275°F | 3 | 0 |
| P4 | FLASH 10 + | Gravity 10 Minutes | 275°F | 10 | 0 |
Model 233:
The Castle Model 233 Vacuum Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped hard goods and linens.
Wrapped-goods (Hi Vac) cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. A gravity cycle is provided for processing wrapped dry goods and/or hard goods. Additionally, a Vacuum Leak Test cycle, not intended for sterilization, and an Air-Removal-Test-Pack (Bowie-Dick) cycle, not intended for sterilization is provided. The wrapped-goods (Hi Vac) cycles employ vacuum-and-positive pulsing to condition a load before processing at the selected exposure temperature. The gravity cycle employs the gravity, or downward displacement method of air removal. Processing temperatures for wrapped goods cycles range from 250°F (121°C to 135°C).
The cycles to be cleared for this model (Model 233) are:
| Cycle | Name | Type | ExposureTemp | Minutes | DryMinutes |
|---|---|---|---|---|---|
| P1 | PREVAC ONE | Prevac 275°F | 275°F | 3 | 16 |
| P2 | PREVAC TWO | Prevac 275°F | 275°F | 3 | 3 |
| P3 | GRAVITY WRAP | Gravity 250°F | 250°F | 30 | 30 |
| P5 | B-D TEST | Air Removal | 273°F | 3.5 | 0 |
| P6 | VAC LEAK TST | Vacuum Leak | 268°F | 3 | 15(dry)+5(dwell)+15(test) |
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Model 223:
The Castle Model 223 Gravity Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped and unwrapped hard goods and linens.
Wrapped-goods cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. The cycles employ gravity or downward displacement with positive pulsing conditioning for dynamic air removal. Processing temperatures for wrapped goods cycles range from 250°F to 275°F (121°C to 135°C).
The cycles to be cleared for this model (Model 223) are:
| Cycle | Name | Type | ExposureTemp | Minutes | DryMinutes |
|---|---|---|---|---|---|
| P1 | GRAV WRAP 1 | Gravity 250°F | 250°F | 30 | 30 |
| P2 | GRAV WRAP 2 | Gravity 275°F | 275°F | 10 | 30 |
All Models:
Castle Series 200 Steam Sterilizers are programmed with factory recommended sterilization parameters (cycle settings) which have been verified and validated for efficacy. By using a supervisory password, the controls allow for flexibility in selecting exposure temperature, exposure time, and drying time. It is possible, with that password, to select cycle settings that will not necessarily achieve the desired sterlity assurance level. Users with password access are responsible for the efficacy of any cycle settings other than the factory recommended settings.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lillian
(Division Sign-Off)
Division of Dental Infection Control, and General Hospital Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
§ 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).