(27 days)
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.
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).
Here's an analysis of the provided text regarding the Castle® 400HC/500HC Series Steam Sterilizer, focusing on acceptance criteria and the study proving its performance.
Please note: This document is a 510(k) summary for a medical device (steam sterilizer), not a study report for a human-AI effectiveness study. Therefore, many of the requested fields related to AI, human readers, and ground truth in a clinical context are not applicable. The information provided heavily focuses on the device's functional specifications and equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly defined by its functional specifications, regulatory standards, and claimed equivalence to a predicate device. The performance is reported in terms of its ability to achieve sterilization under specific cycle parameters and load configurations.
| Acceptance Criteria Category | Specific Acceptance Criteria (from text) | Reported Device Performance (from Tables 1 & 2) |
|---|---|---|
| Intended Use | Sterilize wrapped and unwrapped surgical instruments, linens, and liquids (liquids not for direct patient contact) by means of pressurized steam. | The device provides specific cycles and load configurations for these items (e.g., "Double-wrapped Instrument trays," "Fabric packs," "Unwrapped non-porous single instrument," "Up to 250 mL containers," "Up to 1000 mL containers") across various temperatures and times, indicating its capability to perform the intended function for these items. |
| Sterilization Efficacy (Cycle Parameters) | Achieve sterilization at specified temperatures and times for various load types. | The tables provide detailed "Exp. Temp." (Exposure Temperature) and "Exp. Time" (Exposure Time) for each cycle type (e.g., GRAVITY 1: 250°F/121°C for 30 min; PREVAC 1: 275°F/135°C for 3 min). These are the operational parameters designed to achieve sterilization. |
| Drying Efficacy | Ensure items are dry after sterilization, with provisions for extended drying. | "Dry Time" is specified for each cycle type (e.g., GRAVITY 1: 30 min; Flash cycles: 10 sec, with a note that items may not be dry). The notes indicate that "Factory set drying time is the recommended minimum drying time. Extended drying time may be required depending on local conditions." and "Gravity cycle drying time may be reduced by selecting vacuum drying phase." |
| Load Capacity | Handle specific maximum quantities and types of items per chamber size. | "Maximum Items per Chamber Size" is specified for both 433HC/422HC and 533HC/522HC models across all cycle types (e.g., GRAVITY 1 (433HC): 2 double-wrapped trays, 4 fabric packs; LIQUIDS 2 (533HC): 32 x 1000 mL containers). |
| Compliance with Standards | Adherence to applicable requirements of AAMI ST8, AAMI ST46, AAMI ST37, CSA-Z314.7, GGS-1340A, and GGS-1343A Standards. | The document explicitly states: "Load configurations follow AAMI Standards ST8 Hospital Steam Sterilizers where applicable." and "Refer to AAMI Standards ST46 Good Hospital Practice: Steam Sterility Assurance and ST37 Good Hospital Practice: Flash Sterilization - Steam Sterilization of Patient Care Items for Immediate Use." The conclusion also states the device "meets the applicable requirements of AAMI ST8, CSA-Z314.7, GGS-1340A and GGS-1343A Standards." This implies that the device's performance aligns with these established sterilization standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" in the context of clinical data for AI systems. For a physical device like a sterilizer, testing would involve multiple runs under various conditions. The exact number of test runs or items processed during validation is not provided in this 510(k) summary.
- Data Provenance: Not applicable in the context of clinical data. The validation of a sterilizer typically involves engineering and microbiological challenge tests performed in a laboratory or factory setting. The specific country of origin for these tests is not mentioned, but the submitting company is "Getinge/Castle Inc." located in Rochester, NY, USA. The testing would be considered prospective as it validates the device's performance against its specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. For a sterilizer, the "ground truth" for sterilization efficacy is typically established through standardized microbiological challenge tests (e.g., using biological indicators or thermocouples to verify physical parameters) rather than expert consensus on images or clinical outcomes.
- Qualifications of Experts: If experts (e.g., microbiologists, sterilization specialists) were involved in validating the test methodologies or interpreting results for sterilization, their qualifications are not provided in this summary.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are used in clinical studies, often for image interpretation tasks, to resolve discrepancies between readers. For a sterilizer, validation relies on objective physical and biological measurements.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive tools, not for a physical device like a steam sterilizer.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The "device" is a physical sterilizer, not an algorithm. Its performance is inherent to its design and function. While it has an updated control system and software, these are integral to the sterilizer's operation, not a separate standalone AI algorithm.
7. The Type of Ground Truth Used
-
Type of Ground Truth: For a steam sterilizer, the ground truth for sterilization efficacy is established through:
- Microbiological challenge tests: Using biological indicators (BIs) containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) to demonstrate a sterility assurance level (SAL).
- Physical parameter monitoring: Measuring and confirming that critical parameters (temperature, pressure, time, steam penetration) are met throughout the sterilization cycle using calibrated sensors (e.g., thermocouples).
- Chemical indicators: Used as process indicators but not primary ground truth for sterility.
- Industry Standards: Compliance with recognized national and international sterilization standards (e.g., AAMI, ISO).
The document explicitly mentions adherence to AAMI standards (ST8, ST46, ST37) and CSA-Z314.7, GGS-1340A, and GGS-1343A Standards, implying these are the basis for validating "ground truth" performance.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This summary is for a physical steam sterilizer, not an AI or machine learning model that requires a training set of data. The device's "training" refers to its design, engineering, and manufacturing process.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As mentioned, this is not an AI/ML device. For a physical device, its "ground truth" (i.e., its intended design specifications and performance parameters) is established through design controls, engineering principles, and adherence to relevant industry standards and regulatory requirements. These designs are then validated through testing.
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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 RoadRochester, NY 14623-3133 |
|---|---|
| Contact Person: | Frederick R. CattSenior, Regulatory Compliance EngineerPhone: (716) 272-5013Fax: (716) 272-5299 |
| Date prepared: | August 31, 2001 |
| Proprietary Name: | Castle® 400HC/500HC Series Steam SterilizerModels: 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 ... )
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Model 433HC and 533HC Vacuum Steam Sterilizer Cycles and Load Chart Table 1.
| Cycle Type | No. ofAvailableCycles | Factory Settings | Load Configuration2 | Maximum Items perChamber 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 singleinstrument | 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-poroussingle instrument | 1 | 1 |
| • Unwrapped porous and non-porous instrument trays, up to 16 lbs. pertray. | 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-poroussingle instrument | 1 | 1 |
| • Unwrapped porous and non-porous instrument trays, up to 16 lbs. pertray. | 2 | 2 | |||||
| Bowie-DickTest (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 TestPack | 1 TestPack |
| VacuumLeak Test(Ikt) | 1 | 268°F(131°C) | 3 min. | 15 min. dry5 min. dwell15 min. test | Empty chamber | -- | -- |
| LIQUIDS 1(liq) | 1 | 250°F(121°C) | 30 min. | 0.75psi/min.4 | Up to 250 mL containers | 80 | 168 |
| LIQUIDS2(liq) | 1 | 250°F(121°C) | 45 min. | 0.75psi/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.
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| Table 2. Model 422HC and 522HC Gravity Steam Sterilizer Cycles an Load Chan | ||
|---|---|---|
| -- | -- | ------------------------------------------------------------------------------- |
| Cycle Type | No. ofAvailableCycles | Factory Settings | Load Configuration2 | Maximum Items perChamber 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. | 0.75psi/min.3 | Up to 250 mL containers | 80 | 168 |
| LIQUIDS2(liq) | 1 | 250°F(121°C) | 45 min. | 0.75psi/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].
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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.
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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.
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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
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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. ofAvailableCycles | Factory Settings | Load Configuration2 | Maximum Items perChamber 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 singleinstrument• Unwrapped non-porous instrument 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-poroussingle instrument• Unwrapped porous & non-porousInstrument trays, up to 16 lbs. pertray. | 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-poroussingle Instrument• Unwrapped porous & non-porousinstrument trays, up to 16 lbs. pertray. | 1 | 1 |
| Bowie-DickTest (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 TestPack | 1 TestPack |
| VacuumLeak Test(lkt) | 1 | 268°F(131°C) | 3 min. | 15 min. dry5 min. dwell15 min. test | Empty chamber | -- | -- |
| LIQUIDS 1(liq) | 1 | 250°F(121°C) | 30 min. | 0.75psi/min.4 | Up to 250 mL containers | 80 | 168 |
| LIQUIDS2(liq) | 1 | 250°F(121°C) | 45 min. | 0.75psi/min.4 | Up to 1000 mL containers | 15 | 32 |
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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. ofAvailableCycles | Factory Settings | Load Configuration2 | Maximum Items perChamber 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 singleinstrument Unwrapped non-porous instrument 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-poroussingle instrument Unwrapped porous & non-porousinstrument trays, up to 16 lbs. pertray. | 1 | 1 |
| 2 | 2 | ||||||
| LIQUIDS 1(llq) | 1 | 250°F(121°C) | 30 min. | 0.75psi/min.3 | Up to 250 mL containers | 80 | 168 |
| LIQUIDS2(llq) | 1 | 250°F(121°C) | 45 min. | 0.75psi/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.
§ 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).