(246 days)
Not Found
No
The document describes an upgrade to a microcomputer control system for steam sterilizers, focusing on a more modern microprocessor/software and interactive interface. There is no mention of AI, ML, or related concepts.
No.
The device is a sterilizer intended for sterilizing medical instruments, linens, and liquids, not for treating patients.
No
The device is a steam sterilizer, used for reprocessing medical equipment, not for diagnosing medical conditions.
No
The device description explicitly states that the PACS 2000 controls are applied to the Getinge/Castle (Straightline) line of steam sterilizer models, which are physical sterilizers with chambers and piping. While the PACS 2000 is an upgrade to the control system (which includes software), it is integrated into and controls a physical hardware device (the sterilizer). Therefore, it is 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 to sterilize medical devices (surgical instruments, linens) and laboratory/industrial items using steam. This is a process performed on objects, not on biological specimens from the human body for diagnostic purposes.
- Device Description: The device is a steam sterilizer with a control system. It's designed to kill microorganisms on items, not to analyze 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 information for diagnosis, monitoring, or treatment decisions based on biological analysis.
- Using reagents or assays.
The device is clearly intended for the reprocessing of medical and laboratory equipment to ensure they are sterile for subsequent use. This falls under the category of medical device reprocessing equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Getinge/Castle Series 100 Steam Sterilizers (Straightline) with the PACS 2000 controls is an upgrade of an existing microcomputer control system for a comprehensive line of health care reusable medical reprocessing equipment. The PACS 2000 controls an intended to be used for the control of a variety of equipment including washers, 5 washing/disinfectors, washer/sterilizers and sterilizers. This submittal is made for the PACS 2000 controls applied to the Getinge/Castle (Straightline) line of steam sterilizer models (see attachment Section 18 - Competitive Comparison). The Series 100 (Straightline) sterilizer line includes two sizes, A 16" x 16" x 26" chamber having a volume 3.9 cubic feet and a 20" x 20" x 38" chamber having a volume 8.8 cubic feet. Both chamber sizes include single and double door sterilizers with a power door offered on the single door model only. The Series 100 Steam Sterilizer (Straightline) includes gravity (Model 122) and prevacuum (Model 133) steam sterilizers for healthcare facilities and moist heat (Model 123) sterilizes for laboratories and industrial uses. The latter applications are addressed in this submittal for the rare occasion health care facilities may use them. The to be cleared for each of the models are as follows:
For the Model 122
- P 1 GRAV WRAP 1 Gravity Cycle 30 minute exposure at 250°F and 30 minute dry
- P2 GRAV WRAP 2 Gravity Cycle 10 minute exposure at 275°F and 30 minute dry
- P3 FLASH 3+ Gravity Cycle with 3 minute exposure at 275°F and 0 minute dry
- P4 FLASH 10+ Gravity Cycle with 10 minute exposure at 275°F and 0 minute dry For the Model 123
- P 1 GRAV WRAP 1 Gravity Cycle 30 minute exposure at 250°F and 30 minute dry
- P4 FLASH 3+ Gravity Cycle 3 minute exposure at 275°F and o minutes dry For the Model 133
- P1 PREVA WRAP Prevacuum Cycle 3 minute exposure at 275°F and 16 minute dry
- P2 PREVA WRP1 Prevacuum Cycle 3 minute exposure at 275°F and 3 minute dry
- P3 FLASH 3+ Gravity Cycle 3 minute exposure at 275°F and 0 minute dry
- P4 FLASH 10+ Gravity Cycle 10 minute exposure at 275°F and 0 minute dry
- P5 VAC LEAK TST Air leak Test 3 minute exposure at 268°F and 15 min. leak test
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The Castle Series 100 Sterilizers (Straightline) is an upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. Specifically, PACS 2000 controls applied to the Series 100 (Straightline) Steam Sterilizer are to be used with "Castle" brand sterilizers manufactured by Getinge/Castle, Inc. for use in industrial, laboratory, and health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids not intended for direct patient contact).
The difference between predicate sterilizer controls and the PACS 2000 controls is that the PACS 2000 controls are provided with more modern microprocessor/software, and interactive operator interface. The chamber vessel and piping remain unchanged.
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 steam sterilizers, industrial, laboratory, and health care facility environments.
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
Evaluation studies consisting of fabric and instrument loads (wrapped and unwrapped) have been completed to validate the safety and effectiveness of the Series 100 Steam Sterilizer (Straightline). 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Evaluation studies consisting of fabric and instrument loads (wrapped and unwrapped) have been completed to validate the safety and effectiveness of the Series 100 Steam Sterilizer (Straightline). 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. No clinical testing is required for this submittal.
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
§ 880.6880 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
Per 21 CFR 807.92(a)(2)
This summary is for the:
NOV 1 2 1997
| Trade Name | Castle Series 100 Steam Sterilizers (Straightline) |
|---|---|
| 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 Contros and Sterilizers K820783.
Per 21CFR 807.92(a)(4), (5) & (6)
The Castle Series 100 Sterilizers (Straightline) is an upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. Specifically, PACS 2000 controls applied to the Series 100 (Straightline) Steam Sterilizer are to be used with "Castle" brand sterilizers manufactured by Getinge/Castle, Inc. for use in industrial, laboratory, and health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids not intended for direct patient contact)
The difference between predicate sterilizer controls and the PACS 2000 controls is that the PACS 2000 controls are provided with more modern microprocessor/software, and interactive operator interface. The chamber vessel and piping remain unchanged.
Per 21CFR 807.92(b)(1), (2) & (3)
The ANSI/AAMI ST-8 - 1994 American National Standard for Hospital Steam Sterilizers, AAMI ST37-1996 Flash Sterilization: Steam Sterilization of Patient Care Items for Immediate Use, 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) was used to establish the minimum construction and performance requirements for this product.
Evaluation studies consisting of fabric and instrument loads (wrapped and unwrapped) have been completed to validate the safety and effectiveness of the Series 100 Steam Sterilizer (Straightline). The plan for this was derived from AAMI ST8 1994 and the accepted industrial standards listed above. Validation testing was performed using
1
accepted half cycle analysis and results consistent with a sterility assurance level of at least 10 were obtained. The cycles cleared for each of the models are listed in the following table:
| Sterilizer
Model | Cycle
Type | Exposure
Time | Exposure
Time* | Drying
Time | Loads |
|---------------------|---------------|------------------|-------------------|----------------|-----------------------------------------|
| 122 | Gravity | 30 | 250 | 30 | Wrapped Linen Packs |
| | Gravity | 10 | 275 | 30 | Wrapped Hard Goods |
| | Gravity/Flash | 3 | 275 | 0 | Unwrapped Nonporous Instruments |
| | Gravity/Flash | 10 | 275 | 0 | Unwrapped Porous Instruments |
| 123 | Gravity Cycle | 30 | 250 | 30 | Wrapped Linen Packs and Hard Goods |
| | Gravity/Flash | 3 | 275 | 0 | Unwrapped Nonporous Instruments |
| 133 | Prevacuum | 3 | 275 | 16 | Wrapped Hard Goods |
| | Prevacuum | 3 | 275 | 3 | Linen Packs & Single Wrapped Hard Goods |
| | Gravity/Flash | 3 | 275 | 0 | Unwrapped Nonporous Instruments |
| | Gravity/Flash | 10 | 275 | 0 | Unwrapped Porous Instruments |
| | Air leak Test | 3 | 268 | 15 | No Load - Vacuum Leak test |
- Exposure times listed are actual times of the cleared cycles 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 vessel 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.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a staff entwined by two snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus, indicating the name of the department and its country.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 1997
Mr. Michael J. Palladino Getinge/Castle, Incorporated C/O MET Laboratories 914 West Patapsco Avenue Baltimore, Maryland 21230-3432
Re: K970907 Castle Series 100 Steam Sterilizers Trade Name: (Straightline) Requlatory Class: II Product Code: FLE Dated: October 28, 1997 October 29, 1997 Received:
Dear Mr. Palladino:
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 Regulation (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 requlation 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 miqht have under sections 531
3
Page 2 - Mr. Palladino
through 542 of the Act for devices under the Electronic chrough 512 or the novel 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 deberized in your six equivalence of your device to a legally rinding of babbeandlar of 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 ene promotion and (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.fpa.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
A. Ulatowski Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
4
KI 10707/A
510(k) Number (if Known):
Device Name: Castle Series 100 Steam Sterilizer (Straightline)
Indications For Use:
The Getinge/Castle Series 100 Steam Sterilizers (Straightline) with the PACS 2000 controls is an upgrade of an existing microcomputer control system for a comprehensive line of health care reusable medical reprocessing equipment. The PACS 2000 controls an intended to be used for the control of a variety of equipment including washers, 5 washing/disinfectors, washer/sterilizers and sterilizers. This submittal is made for the PACS 2000 controls applied to the Getinge/Castle (Straightline) line of steam sterilizer models (see attachment Section 18 - Competitive Comparison). The Series 100 (Straightline) sterilizer line includes two sizes, A 16" x 16" x 26" chamber having a volume 3.9 cubic feet and a 20" x 20" x 38" chamber having a volume 8.8 cubic feet. Both chamber sizes include single and double door sterilizers with a power door offered on the single door model only. The Series 100 Steam Sterilizer (Straightline) includes gravity (Model 122) and prevacuum (Model 133) steam sterilizers for healthcare facilities and moist heat (Model 123) sterilizes for laboratories and industrial uses. The latter applications are addressed in this submittal for the rare occasion health care facilities may use them. The to be cleared for each of the models are as follows:
For the Model 122
- P 1 GRAV WRAP 1 Gravity Cycle 30 minute exposure at 250°F and 30 minute dry
- P2 GRAV WRAP 2 Gravity Cycle 10 minute exposure at 275°F and 30 minute dry
- P3 FLASH 3+ Gravity Cycle with 3 minute exposure at 275°F and 0 minute dry
- P4 FLASH 10+ Gravity Cycle with 10 minute exposure at 275°F and 0 minute dry For the Model 123
- P 1 GRAV WRAP 1 Gravity Cycle 30 minute exposure at 250°F and 30 minute dry
- P4 FLASH 3+ Gravity Cycle 3 minute exposure at 275°F and o minutes dry For the Model 133
- P1 PREVA WRAP Prevacuum Cycle 3 minute exposure at 275°F and 16 minute dry
- P2 PREVA WRP1 Prevacuum Cycle 3 minute exposure at 275°F and 3 minute dry
- P3 FLASH 3+ Gravity Cycle 3 minute exposure at 275°F and 0 minute dry
- P4 FLASH 10+ Gravity Cycle 10 minute exposure at 275°F and 0 minute dry
- P5 VAC LEAK TST Air leak Test 3 minute exposure at 268°F and 15 min. leak test
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Offoncurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number ---------------------------------------------------------------------------------------------------------------------------------------------------------------- |
OR
Over-The Counter Use_