The Model 733HC Vacuum/Gravity 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 not intended for direct patient contact) by means of pressurized steam.

Device Description

The 733HC Vacuum/Gravity Steam Sterilizer is intended for use in hospital and health care facilities. The product incorporates a medium sized chamber and has the same control system and offers similar overall features as those on the 400HC/500HC Series Steam Sterilizers. These include: additional functionality, ease of use to the end user, large color display that will allow the user to choose from the entire list of available cycles, allows renaming and re-sequencing of sterilization cycles.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Model 733HC Vacuum/Gravity Steam Sterilizer based on the provided text:

Acceptance Criteria and Device Performance Table:

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It doesn't present "acceptance criteria" in the sense of a numerical performance metric (e.g., accuracy, sensitivity, specificity) for a diagnostic AI device. Instead, the "acceptance criteria" for a steam sterilizer are its ability to effectively sterilize the specified loads under the given cycle parameters, as demonstrated by compliance with recognized standards. The "reported device performance" is essentially the listed cycle parameters and load configurations that the device claims to achieve.

Acceptance Criteria (Implied by Standards Compliance)	Reported Device Performance (Cycle Parameters & Load Configurations)
Sterilization Efficacy for PREVAC1 (vacuum): Sterilization of wrapped instrument trays (up to 16 lbs.) and fabric packs within specified load limits and cycle conditions (AAMI ST8 compliance).	Factory Settings: 275°F (135°C), 3 min. Dry Time: 16 min. Load Configuration: Wrapped instrument trays, up to 16 lbs., per tray (39" length - 10 max., 53" length - 15 max., 61" length - 20 max.); Fabric packs (39" length - 24 max., 53" length - 32 max., 61" length - 48 max.).
Sterilization Efficacy for PREVAC2 (vacuum): Sterilization of fabric packs within specified load limits and cycle conditions (AAMI ST8 compliance).	Factory Settings: 275°F (135°C), 3 min. Dry Time: 3 min. Load Configuration: Fabric packs (39" length - 24 max., 53" length - 32 max., 61" length - 48 max.).
Bowie-Dick Test Performance (vacuum): Ability to pass the Bowie-Dick test to detect air removal (AAMI ST8 compliance).	Factory Settings: 273°F (134°C), 3.5 min. Dry Time: 0 min. Load Configuration: S.M.A.R.T. Pack or equivalent (1 max.).
Sterilization Efficacy for GRAVITY1 (gravity): Sterilization of wrapped instrument trays (up to 16 lbs.) and fabric packs within specified load limits and cycle conditions (AAMI ST8 compliance).	Factory Settings: 250°F (121°C), 30 min. Dry Time: 30 min. Load Configuration: Wrapped instrument trays, up to 16 lbs., per tray (39" length - 10 max., 53" length - 15 max., 61" length - 20 max.); Fabric packs (39" length - 24 max., 53" length - 32 max., 61" length - 48 max.).
Sterilization Efficacy for GRAVITY2 (gravity): Sterilization of wrapped instrument trays (up to 16 lbs.) and fabric packs within specified load limits and cycle conditions (AAMI ST8 compliance).	Factory Settings: 275°F (135°C), 10 min. Dry Time: 30 min. Load Configuration: Wrapped instrument trays, up to 16 lbs., per tray (39" length - 10 max., 53" length - 15 max., 61" length - 20 max.); Fabric packs (39" length - 24 max., 53" length - 32 max., 61" length - 48 max.).
Sterilization Efficacy for Flash 3+2: Sterilization of unwrapped non-porous instrument trays within specified load limits and cycle conditions (AAMI ST37 compliance).	Factory Settings: 275°F (135°C), 3 min. Dry Time: 10 sec. (Note: Items may not be dry, extended dry time may be added). Load Configuration: Unwrapped non-porous instrument trays (3 trays maximum; up to 16 lbs., per each tray).
Sterilization Efficacy for Liquids1: Sterilization of up to 250 mL containers within specified load limits and cycle conditions.	Factory Settings: 250°F (121°C), 30 min. Cooldown Rate: 0.75 psi/min. Load Configuration: Up to 250 mL containers (39" length 384 max., 53" length 544 max., 61" length 672 max.).
Sterilization Efficacy for Liquids2: Sterilization of up to 1000 mL containers within specified load limits and cycle conditions.	Factory Settings: 250°F (121°C), 45 min. Cooldown Rate: 0.75 psi/min. Load Configuration: Up to 1000 mL containers (39" length 112 max., 53" length 154 max., 61" length 196 max.).
Vacuum Leak Test: Ability to detect vacuum leaks within specified cycle parameters.	Factory Settings: 268°F (131°C), 3 min. Dry Time: 15 min. dry, 5 min. dwell, 15 min. test. Load Configuration: Empty chamber. (Note: Cycle parameters are not adjustable).
Overall Device Performance: The device functions as a steam sterilizer for its intended use, is safe and effective, and is substantially equivalent to the predicate device.	The 733HC model incorporates an updated control system and larger chamber sizes compared to the predicate device, but maintains the same fundamental sterilization technology. The changes are minor enough to claim substantial equivalence without requiring new clinical data. The device "meets the applicable requirements of AAMI ST8, CSA-Z314.7, GGS-1340A and GGS-1343A Standards."

Study Information:

This 510(k) summary does not describe a study that "proves the device meets acceptance criteria" in the way one might expect for a diagnostic or AI-driven device. Instead, it demonstrates substantial equivalence to a legally marketed predicate device (Castle® 400HC/500HC Series Steam Sterilizer [K012573]). For devices like sterilizers, substantial equivalence is typically shown through engineering testing, comparison of technical specifications, and compliance with recognized industry standards. No clinical data was required or submitted.

Therefore, most of the specific questions about sample sizes, experts, adjudication, MRMC studies, standalone performance, and training sets are not applicable to this type of submission.

Here's a breakdown of what is available based on the provided text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not explicitly stated. This summary doesn't detail specific testing data like a clinical trial. The device's performance is asserted to comply with AAMI, CSA, and GGS standards, which implies various engineering and microbiological tests would have been performed during design validation, but the details of these tests (sample sizes, specific data provenance) are not provided in this 510(k) summary. These would typically be found in the full 510(k) submission, not the summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. There is no "ground truth" established by experts in the context of a clinical test set in this submission. Compliance with sterilization standards (AAMI, CSA) serves as the "truth" or benchmark for non-clinical performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or human adjudication process is described.
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:
- No. This is a steam sterilizer, not an AI or diagnostic device. MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for a sterilizer is confirmed sterility. This is achieved through adherence to validated cycle parameters derived from physical and biological indicator testing against industry standards (AAMI ST8, CSA-Z314.7, GGS-1340A, GGS-1343A). This is more akin to engineering validation and microbiological testing against defined performance specifications rather than a "clinical ground truth" established by expert review of patient data.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; there is no "training set."
How the ground truth for the training set was established:
- Not applicable. As above, no training set.

Summary

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510(k) SUMMARY

K02 0590

Model 733HC Vacuum/Gravity Steam Sterilizer

Submitted by:

Getinge/Castle Inc. 1777 E Henrietta Road Rochester, NY 14623-3133

Contact Person:

Frederick R. Catt Senior, Regulatory Compliance Engineer (585) 272-5013 Phone: (585) 272-5299 Fax:

March 15, 2002 Date prepared:

Model 733HC Vacuum/Gravity Steam Sterilizer Proprietary Name:

Common Name: Steam Sterilizer

Steam Sterilizer (80 FLE) Device Classification:

Class II, as listed per 21 CFR 880.6880

Castle® 400HC/500HC Series Steam Sterilizer [K012573] Predicate Device:

Description of Device:

additional functionality .
ease of use to the end user .
large color display that will allow the user to choose from the entire list of available . cycles
allows renaming and re-sequencing of sterilization cycles. .

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K020590

Getinge/Castle, Inc. FDA 510(k) Summary Device: 733HC Vacuum/Gravity Steam Sterilizer

The full list of available cycles is as follows:

		Table 1. Model 733HC Vacuum/Gravity Steam Sterilizer Cycle and Load Chan
Cycle Type	Factory Set Cycle P#	Factory Settings		Dry Time¹	Load Configuration²
PREVAC1(vac)	P1-P5	275°F(135°C)	3 min.	16 min.	Wrapped instrument trays, up to 16 lbs., per tray• 39" length - 10 max.• 53" length - 15 max.• 61" length - 20 max.	Fabric packs• 39" length - 24 max.• 53" length - 32 max.• 61" length - 48 max.
PREVAC2(vac)	P6-P8	275°F(135°C)	3 min.	3 min.		Fabric packs• 39" length 24 max.• 53" length 32 max.• 61" length 48 max.
Bowle-Dick Test(vac)	P9	273°F(134°C)	3.5 min	0 min.	S.M.A.R.T. Pack or equivalent (1 max.)
GRAVITY1(grv)	P10-P13	250°F(121°C)	30 min.	30 min.	Wrapped instrument trays, up to 16 lbs., per tray• 39" length 10 max.• 53" length 15 max.• 61" length 20 max.	Fabric packs• 39" length 24 max.• 53" length 32 max.• 61" length 48 max.
GRAVITY2(grv)	P14-P16	275°F(135°C)	10 min.	30 min.	Wrapped instrument trays, up to 16 lbs., per tray• 39" length 10 max.• 53" length 15 max.• 61" length 20 max.	Fabric packs• 39" length 24 max.• 53" length 32 max.• 61" length 48 max.
Flash 3+2(f 3)	P17	275°F(135°C)	3 min.	10 sec, 3	• Unwrapped non-porous instrument trays(3 trays maximum; up to 16 lbs., per each tray.)
Liquids1(liq)	P18	250°F(121°C)	30 min.	0.75 psi/min. 4	Up to 250 mL containers• 39" length 384 max.• 53" length 544 max.• 61" length 672 max.
Liquids2(liq)	P19	250°F(121°C)	45 min.	0.75 psi/min. 4	Up to 1000 mL containers• 39" length 112 max.• 53" length 154 max.• 61" length 196 max.
Vacuum LeakTest 5(lkt)	P20	268°F(131°C)	3 min.	15 min. dry5 min. dwell15 min. test	Empty chamber

Notes for Table 1:

Load configurations follow AAMI Standards ST8 Hospital Steam Sterilizers where applicable.

Factory set drying time is the recommended minimum drying time may be required depending on local conditions.
Refer to AAM standards ST46 Good Hospital Practice: Steam Sterility Assurance and ST37 Good Hospital Practice: Flash Sterilization - Steam Sterilization of Patient Care Items for Immediate Use.
Items may NOT be dry. Dry time may be added if required.
Cooldown rate
Vacuum leak test cycle parameters are not adjustable.

14/15

March 15, 2002

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K020590

Getinge/Castle, Inc. FDA 510(k) Summary Device: 733HC Vacuum/Gravity Steam Sterilizer 15/15

Intended Use:

Model 733HC Vacuum/Gravity 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.

Prodicato Device

Castle® 400HC/500HC Series Steam Sterilizer [K012573].

Nonclinical Comparisons to Predicate Device

The 733HC Vacuum/Gravity Steam Sterilizer is a new model number designation to identify incorporation of our updated sterilizer control system (PACS 3000) with medium sterilizer chamber sizes and loads. The chamber cross-section dimensions are 672mm x 920mm (26.5" x 36"). Three lengths are available - 1000mm (39"), 1350mm (53") and 1550mm (61"). The 733HC sterilizer is similar to the 400HC/500HC Series Steam Sterilizer (predicate device), but with a larger chamber size and volume. Modifications made from the predicate device include:

The sterilizer chamber sizes are larger. New slide/swing door closure . designs are used, that accommodates the larger vessel opening.
Added door key lockout type feature to prevent door movement when there is a . need to enter the sterilizer chamber of the Model 733HC.
Two cycles, Flash 10+ and PreVac 3, are not offered since they are not used with . larger capacity sterilizers.
Piping changes for incorporation with the larger pressure vessel design. .
Parameter Check feature has been added to the control system to warn an operator ◆ if changes made to a preset cycle time or temperature settings fall outside an allowable range.

Clinical Data:

No clinical data is required for this device classification submission.

Conclusion:

The 733HC Vacuum/Gravity Steam Sterilizer is a substantially equivalent device to that of the predicate device. There have been no substantial changes in technology, intended use of this device. This sterilizer meets the applicable requirements of AAMI ST8, CSA-Z314.7, GGS-1340A and GGS-1343A Standards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, with three figures in profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

MAR 2 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frederick R. Catt Senior Regulatory Compliance Engineer Getinge Castle, Incorporated 1777 East Henrietta Road Rochester, New York 14623-3133

Re: K020590

Trade/Device Name: Model 733HC Vacuum/Gravity Steam Sterilizer Regulation Number: 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: February 20, 2002 Received: February 22, 2002

Dear Mr. Catt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 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 (PMA), 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Mr. Catt

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

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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MAR 2 0 2002

INDICATIONS FOR USE STATEMENT

K020590 510(k) Number:

733HC Vacuum/Gravity Steam Sterilizer

Indications for Use:

Device Name:

Model 733HC Vacuum/Gravity Steam Sterilizer Cycle and Load Chart Table 1.

Cycle Type	Factory SetCycle P#	Factory Settings		Dry Time1	Load Configuration2
PREVAC1(vac)	P1-P5	275°F(135°C)	3 min.	16 min.	Wrapped instrument trays,up to 16 lbs., per tray• 39" length - 10 max.• 53" length - 15 max.• 61" length - 20 max.Fabric packs• 39" length - 24 max.• 53" length - 32 max.• 61" length - 48 max.
PREVAC2(vac)	P6-P8	275°F(135°C)	3 min.	3 min.	Fabric packs• 39" length 24 max.• 53" length 32 max.• 61" length 48 max.
Bowie-Dick Test(vac)	P9	273°F(134°C)	3.5 min	0 min.	S.M.A.R.T. Pack or equivalent (1 max.)
GRAVITY1(grv)	P10-P13	250°F(121°C)	30 min.	30 min.	Wrapped instrument trays,up to 16 lbs., per tray• 39" length 10 max.• 53" length 15 max.• 61" length 20 max.Fabric packs• 39" length 24 max.• 53" length 32 max.• 61" length 48 max.
GRAVITY2(grv)	P14-P16	275°F(135°C)	10 min.	30 min.	Wrapped instrument trays,up to 16 lbs., per tray• 39" length 10 max.• 53" length 15 max.• 61" length 20 max.Fabric packs• 39" length 24 max.• 53" length 32 max.• 61" length 48 max.
Flash 3+2(f 3)	P17	275°F(135°C)	3 min.	10 sec.3	Unwrapped non-porous instrument trays(3 trays maximum; up to 16 lbs., per each tray.)
Liquids1(liq)	P18	250°F(121°C)	30 min.	0.75 psi/min.4	Up to 250 mL containers• 39" length 384 max.• 53" length 544 max.• 61" length 672 max.
Liquids2(liq)	P19	250°F(121°C)	45 min.	0.75 psi/min.4	Up to 1000 mL containers• 39" length 112 max.• 53" length 154 max.• 61" length 196 max.
Vacuum LeakTest5(lkt)	P20	268°F(131°C)	3 min.	15 min. dry5 min. dwell15 min. test	Empty chamber

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Indications for Use - Model 733HC Vacuum/Gravity Steam Sterilizer K020590

Notes for Table 1:

Load configurations follow AAM! Standards ST8 Hospital Steam Sterilizers where applicable.

1 Factory set drying time is the recommended minimum drying time. Extended drying time may be required depending on local conditions.
2 Refer to AAMI standards ST46 Good Hospital Practice: Steam Sterilization and Sterility Assurance Nelle to Annifal Practice: Flash Sterilization - Steam Sterliization of Patient Care Items for Immediate Use.
1. Items may NOT be dry. Dry time may be added if required.
1. Cooldown rate
1. Vacuum leak test cycle parameters are not adjustable.

(Please Do NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _ OR

Qum Si Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

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).