(27 days)
Not Found
No
The summary describes a steam sterilizer with an updated control system and display, but there is no mention of AI or ML technology.
No
The device is a steam sterilizer intended for use in health care facilities to sterilize medical instruments and supplies, not to treat patients.
No
This device is a steam sterilizer used to sterilize surgical instruments, linens, and liquids. Its purpose is to prepare medical equipment for use, not to diagnose medical conditions.
No
The device is a steam sterilizer, which is a piece of hardware used to sterilize medical instruments. While it includes a software update to the control system, the core device is not software-only.
Based on the provided information, 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, liquids) using pressurized steam. This is a process performed on medical devices, not a test performed on biological samples to diagnose a condition.
- Device Description: The description focuses on the sterilization process and the control system for that process. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic or prognostic information
- Measuring analytes or biomarkers
- Using reagents or assays
Therefore, the Castle® 400HC/500HC Series Steam Sterilizer is a medical device used for sterilization, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Castle® 400HC/500HC Series Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids to be used to tienties mappes contact) by means of pressurized steam.
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The 400HC/500HC Series Steam Sterilizer is intended for use in hospital and health care facilities. The product incorporates an update to the control system that provides additional functionality and ease of use to the end user. It includes a larger color display that will allow the user to choose from the entire list of available cycles. Similar features to those on the Series 100HC include renaming and re-sequencing of sterilization cycles. The full lists of available cycles are provided in Table 1 for vacuum sterilizers (Models 433HC and 533HC) and Table 2 for gravity sterilizers (Models 422HC and 522HC).
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
health care facilities
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)
No clinical data is required for this submission.
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
SEP - 5 2001
510(k) SUMMARY
KO12573
Castle® 400HC/500HC Series Steam Sterilizer Models: 422HC, 433HC, 522HC, and 533HC
| Submitted by: | Getinge/Castle Inc.
1777 E Henrietta Road
Rochester, NY 14623-3133 |
|------------------------|-------------------------------------------------------------------------------------------------------------|
| Contact Person: | Frederick R. Catt
Senior, Regulatory Compliance Engineer
Phone: (716) 272-5013
Fax: (716) 272-5299 |
| Date prepared: | August 31, 2001 |
| Proprietary Name: | Castle® 400HC/500HC Series Steam Sterilizer
Models: 422HC, 433HC, 522HC and 533HC |
| Common Name: | Steam Sterilizer |
| Device Classification: | Steam Sterilizer (80 FLE)
Class II, as listed per 21 CFR 880.6880 |
| Predicate Device: | Castle® Series 100HC Steam Sterilizer [K994314] |
Description of Device:
The 400HC/500HC Series Steam Sterilizer is intended for use in hospital and health care facilities. The product incorporates an update to the control system that provides additional functionality and ease of use to the end user. It includes a larger color display that will allow the user to choose from the entire list of available cycles. Similar features to those on the Series 100HC include renaming and re-sequencing of sterilization cycles. The full lists of available cycles are provided in Table 1 for vacuum sterilizers (Models 433HC and 533HC) and Table 2 for gravity sterilizers (Models 422HC and 522HC).
(Continued ... )
1
Model 433HC and 533HC Vacuum Steam Sterilizer Cycles and Load Chart Table 1.
| Cycle Type | No. of
Available
Cycles | Factory Settings | | | Load Configuration2 | Maximum Items per
Chamber Size | |
|------------------------------|-------------------------------|------------------|-------------------|---------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------|----------------|
| | | Exp.
Temp. | Exp.
Time | Dry Time1 | | 433HC | 533HC |
| GRAVITY 1
(grv) | 3 | 250°F
(121°C) | 30 min. | 30 min. | • Double-wrapped Instrument trays,
up to 16 lbs. per tray. | 2 | 3 |
| | | | | | • Fabric packs | 4 | 12 |
| GRAVITY 2
(grv) | 3 | 275°F
(135°C) | 10 min. | 30 min. | • Double-wrapped Instrument trays,
up to 16 lbs. per tray. | 2 | 3 |
| | | | | | • Fabric packs | 4 | 12 |
| Flash 3+
(f 3) | 4 | 275°F
(135°C) | 3 min. | 10 sec.5 | • Unwrapped non-porous single
instrument | 1 | 1 |
| | | | | | • Unwrapped non-porous instrument trays, up to 16 lbs. per tray. | 2 | 2 |
| Flash 10+
(f10) | 2 | 275°F
(135°C) | 10 min. | 10 sec.5 | • Unwrapped porous or non-porous
single instrument | 1 | 1 |
| | | | | | • Unwrapped porous and non-porous instrument trays, up to 16 lbs. per
tray. | 2 | 2 |
| PREVAC 1
(vac) | 3 | 275°F
(135°C) | 3 min. | 16 min. | • Double-wrapped instrument trays,
up to 16 lbs. per tray. | 2 | 3 |
| | | | | | • Fabric packs | 4 | 12 |
| PREVAC 2
(vac) | 2 | 275°F
(135°C) | 3 min. | 3 min. | • Single wrapped single instrument | 1 | 1 |
| | | | | | • Single wrapped instrument trays,
up to 16 lbs. per tray. | 2 | 3 |
| | | | | | • Fabric packs | 4 | 12 |
| PREVAC 3
(vac) | 1 | 275°F
(135°C) | 3 min. | 0 min.5 | • Unwrapped porous or non-porous
single instrument | 1 | 1 |
| | | | | | • Unwrapped porous and non-porous instrument trays, up to 16 lbs. per
tray. | 2 | 2 |
| Bowie-Dick
Test (vac) | 1 | 273°F
(134°C) | 3 min.
30 sec. | 0 min. | S.M.A.R.T. Pack or equivalent (1 max.)
in an EMPTY chamber | 1 Test
Pack | 1 Test
Pack |
| Vacuum
Leak Test
(Ikt) | 1 | 268°F
(131°C) | 3 min. | 15 min. dry
5 min. dwell
15 min. test | Empty chamber | -- | -- |
| LIQUIDS 1
(liq) | 1 | 250°F
(121°C) | 30 min. | 0.75
psi/min.4 | Up to 250 mL containers | 80 | 168 |
| LIQUIDS2
(liq) | 1 | 250°F
(121°C) | 45 min. | 0.75
psi/min.4 | Up to 1000 mL containers | 15 | 32 |
Load configurations follow AAM Standards ST8 Hospital Steem Sterilizers where applicable.
Factory set drying time is the recommended minimum drying time may be required depending on local conditions. Gravity cycle drying time may be reduced by selecting vacuum drying phase.
Refer to AAM Standards ST46 Good Hospitel Practice: Steam Sterility Assurance and ST37 Good Hospital Practice: Flash Sterilization - Steam Storilization of Patient Care Items for Immediate Use.
3Vacuum leak test cycle parameters are not adjustable.
4Cooldown rate
Sitems may NOT be dry. Dry time may be added if required.
2
| Table 2. Model 422HC and 522HC Gravity Steam Sterilizer Cycles an Load Chan | ||
|---|---|---|
| -- | -- | ------------------------------------------------------------------------------- |
| Cycle Type | No. of
Available
Cycles | Factory Settings | | | Load Configuration2 | Maximum Items per
Chamber Size | |
|--------------------|-------------------------------|------------------|--------------|-------------------|-------------------------------------------------------------------------|-----------------------------------|-------|
| | | Exp.
Temp. | Exp.
Time | Dry Time1 | | 422HC | 522HC |
| GRAVITY 1
(grv) | 3 | 250°F
(121°C) | 30 min. | 30 min. | Double-wrapped instrument trays,
up to 16 lbs. per tray. | 2 | 3 |
| | | | | | Fabric packs | 4 | 12 |
| GRAVITY 2
(grv) | 3 | 275°F
(135°C) | 10 min. | 30 min. | Double-wrapped instrument trays,
up to 16 lbs. per tray. | 2 | 3 |
| | | | | | Fabric packs | 4 | 12 |
| Flash 3+
(f 3) | 4 | 275°F
(135°C) | 3 min. | 10 sec.4 | Unwrapped non-porous single instrument | 1 | 1 |
| | | | | | Unwrapped non-porous instrument trays, up to 16 lbs. per tray. | 2 | 2 |
| Flash 10+
(f10) | 2 | 275°F
(135°C) | 10 min. | 10 sec.4 | Unwrapped porous or non-porous single instrument | 1 | 1 |
| | | | | | Unwrapped porous & non-porous Instrument trays, up to 16 lbs. per tray. | 2 | 2 |
| LIQUIDS 1
(liq) | 1 | 250°F
(121°C) | 30 min. | 0.75
psi/min.3 | Up to 250 mL containers | 80 | 168 |
| LIQUIDS2
(liq) | 1 | 250°F
(121°C) | 45 min. | 0.75
psi/min.3 | Up to 1000 mL containers | 15 | 32 |
Load configurations follow AAMI Standards ST8 Hospital Steam Sterlilzers where applicable.
1Factory set drying time is the recommended minimum drying time. Extended drying time may be Factory set drying time is the recomments of himment crying time may be reduced by selecting vacuum drying phase.
2 Refer to AAMI Standards ST46 Good Hospital Practice: Steam Sterilly Assurance and Refer ID AAMI Stambards 3140 Good Hoopiler Proses Sterilization of Pationt Care Items for Immediate Use.
3Cooldown rate
4 Items may NOT be dry. Dry time may be added if required.
Intended Use:
Castle® 400HC/500HC Series 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.
Predicate Device
Castle® Series 100HC Steam Sterilizer [K994314].
3
Nonclinical Comparisons to Predicate Device
The 400HC/500HC Series Steam Sterilizer is a family name and includes new model The 400HO/30010 Ocean Steam Steam of various design improvements and number designations to fuentify inociration similar to the Series 100HC predicate device. Modifications made from the predicate device include:
- Control System is updated to use an improved CPU and user interface. The new . Control System's updated to soo an in display that provides information to be user intenace includes a larger color also, and in a clear format. Adjustments have also been made to password features.
- Software is updated for use within the new control system. �
- Sterilizer chamber has changed from having a full jacket to a partial jacket with a . material change from nickel clad to stainless steel.
- Increased the number of available pre-validated cycles. .
- morodos modified for incorporation with new pressure vessel design. .
Clinical Data:
No clinical data is required for this submission.
Conclusion:
The Castle® 400HC/500HC Series Steam Sterilizer is a substantially equivalent device The Castle 400110/50010 Gollou Stounn Connection Changes in technology,
to that of the predicate device. There have been no substantial of AAAA to that of this device. There nave peoplicable requirements of AAMI ST8, CSA-Z314.7, GGS-1340A and GGS-1343A Standards.
Based on the provided information in this premarket notification, it can be concluded Based on the provided information in this promation were and is safe and effective when used as intended.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2001
Mr. Frederick R. Catt Sr. Requlatory Compliance Engineer Getinge/Castle, Incorporated 1777 East Henrietta Road Rochester, New York 14623-3133
K012573 Re : Castle 400HC/500HC Series Steam Trade/Device Name: Sterilzer, Models 422HC, 433HC, 522HC and 533HC 880.6880 Requlation Number: Regulatory Class: II Product Code: FLE Dated: August 8, 2001 August 9, 2001 Received:
Dear Mr. Catt:
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 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). 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 reqistration, 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 Regulations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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.
5
Page 2 - Mr. Catt
concerning your device in the Federal Register. Please note i concerning your device in the reactification submission does this response to your premarked hove under sections 531 not affect any obligation for may under the m Electronic through 542 of the Act for devices ander one of ther Federal laws or requlations.
This letter will allow you to begin marketing your device as This letter will allow you co xbgt motification. The FDA described in your 510(x) promazice of your device to a legally
finding of substantial equivalence of your device for your marketed predicate device results in a classification for your marketed predicate device rebares in the to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific advice 15. Is additionally 809.10 for in regulation (21 crk Fare ovi anase contact the Office of Compliance at (301) 594-4618. Additionally, for questions on Compliance at (301) 354 issing of your device, please contact the promocion and advertibing on Journal (301) Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). _ Other general premation on your responsibilities under the Act may be Intormation of your of Small Manufacturers, obtained from the Britision on amandaling toll-free number International and Comballer 11527 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
6
INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
K012573
Castle® 400HC/500HC Series Steam Sterilizer Models: 422HC, 433HC, 522HC and 533HC
Indications for Use:
Castle® 400HC/500HC Series Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids to be used to tienties mappes contact) by means of pressurized steam.
Model 433HC and 533HC Vacuum Steam Sterilizer Cycles and Load Chart Table 1.
| Cycle Type | No. of
Available
Cycles | Factory Settings | | | Load Configuration2 | Maximum Items per
Chamber Size | |
|------------------------------|-------------------------------|------------------|-------------------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|----------------|
| | | Exp.
Temp. | Exp.
Time | Dry Time1 | | 433HC | 533HC |
| GRAVITY 1
(grv) | 3 | 250°F
(121°C) | 30 min. | 30 min. | • Double-wrapped instrument trays,
up to 16 lbs. per tray.
• Fabric packs | 2 | 3 |
| GRAVITY 2
(grv) | 3 | 275°F
(135°C) | 10 min. | 30 min. | • Double-wrapped instrument trays,
up to 16 lbs. per tray.
• Fabric packs | 2 | 3 |
| Flash 3+
(f 3) | 4 | 275°F
(135°C) | 3 min. | 10 sec.5 | • Unwrapped non-porous single
instrument
• Unwrapped non-porous instru
ment trays, up to 16 lbs. per tray. | 1 | 1 |
| Flash 10+
(f10) | 2 | 275°F
(135°C) | 10 min. | 10 sec.6 | • Unwrapped porous or non-porous
single instrument
• Unwrapped porous & non-porous
Instrument trays, up to 16 lbs. per
tray. | 1 | 1 |
| PREVAC 1
(vac) | 3 | 275°F
(135°C) | 3 min. | 16 min. | • Double-wrapped instrument trays,
up to 16 lbs. per tray.
• Fabric packs | 2 | 3 |
| PREVAC 2
(vac) | 2 | 275°F
(135°C) | 3 min. | 3 min. | • Single wrapped single instrument
• Single wrapped Instrument trays,
up to 16 lbs. per tray.
• Fabric packs | 1 | 1 |
| PREVAC 3
(vac) | 1 | 275°F
(135°C) | 3 min. | 0 min.5 | • Unwrapped porous or non-porous
single Instrument
• Unwrapped porous & non-porous
instrument trays, up to 16 lbs. per
tray. | 1 | 1 |
| Bowie-Dick
Test (vac) | 1 | 273°F
(134°C) | 3 min.
30 sec. | 0 min. | S.M.A.R.T. Pack or equivalent (1 max.)
in an EMPTY chamber | 1 Test
Pack | 1 Test
Pack |
| Vacuum
Leak Test
(lkt) | 1 | 268°F
(131°C) | 3 min. | 15 min. dry
5 min. dwell
15 min. test | Empty chamber | -- | -- |
| LIQUIDS 1
(liq) | 1 | 250°F
(121°C) | 30 min. | 0.75
psi/min.4 | Up to 250 mL containers | 80 | 168 |
| LIQUIDS2
(liq) | 1 | 250°F
(121°C) | 45 min. | 0.75
psi/min.4 | Up to 1000 mL containers | 15 | 32 |
7
Notes for Table 1:
Load configurations follow AAMI Standards ST8 Hospital Steam Sterilizers where applicable.
- 2 Refer to AAMI Standards ST46 Good Hosphal Practice: Steam Sterlilty Assurance and ST37 Good Relet to ARMI Standards 3140 Octor Prospital Practice: Croom Sterilized of Patlent Care Increation of Patlent Care In
3 Vacuum leak tost cycle parameters are not adjustable.
4Cooldown rate
5 Items may NOT be dry. Dry time may be added if required.
Model 422HC and 522HC Gravity Steam Sterilizer Cycles and Load Chart Table 2.
| Cycle Type | No. of
Available
Cycles | Factory Settings | | | Load Configuration2 | Maximum Items per
Chamber Size | |
|--------------------|-------------------------------|------------------|--------------|-------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|-------|
| | | Exp.
Temp. | Exp.
Time | Dry Time1 | | 422HC | 522HC |
| GRAVITY 1
(grv) | 3 | 250°F
(121°C) | 30 min. | 30 min. | Double-wrapped instrument trays,
up to 16 lbs. per tray. Fabric packs | 2 | 3 |
| | | | | | | 4 | 12 |
| GRAVITY 2
(grv) | 3 | 275°F
(135°C) | 10 min. | 30 min. | Double-wrapped instrument trays,
up to 18 lbs. per tray. Fabric packs | 2 | 3 |
| | | | | | | 4 | 12 |
| Flash 3+
(f 3) | 4 | 275°F
(135°C) | 3 min. | 10 sec.4 | Unwrapped non-porous single
instrument Unwrapped non-porous instru
ment trays, up to 18 lbs. per tray. | 1 | 1 |
| | | | | | | 2 | 2 |
| Flash 10+
(f10) | 2 | 275°F
(135°C) | 10 min. | 10 sec.4 | Unwrapped porous or non-porous
single instrument Unwrapped porous & non-porous
instrument trays, up to 16 lbs. per
tray. | 1 | 1 |
| | | | | | | 2 | 2 |
| LIQUIDS 1
(llq) | 1 | 250°F
(121°C) | 30 min. | 0.75
psi/min.3 | Up to 250 mL containers | 80 | 168 |
| LIQUIDS2
(llq) | 1 | 250°F
(121°C) | 45 min. | 0.75
psi/min.3 | Up to 1000 mL containers | 15 | 32 |
Load configurations follow AAMI Standards ST8 Hospital Steem Sterilizers where applicable.
1Factory set drying time is the recommended minimum drying time. Extended drying time may be Factory set drying time is the recommendou mininem arying time may be reduced by selecting vacuum drying phase.
2 Refer to AAMI Standards ST46 Good Hospital Practice: Steam Sterilly Assurance and Reler (098)Mi Clandards Of To Coose Herlization Steam Sterliization of Patient Care Items for Immediate Use.
Cooldown rate
4Items may NOT be dry. Dry time may be added if required.
510/k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ OR Over-The-Counter Use _
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
1 Factory set drying time is the recommended minimum drying time may be required depending on local conditions. Gravity cycle drying time may be reduced by selecting vacuum drying phase.