MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER

• K Number: K020590
• Device Name: MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER
• Manufacturer: GETINGE/CASTLE, INC.
• Date Cleared: 2002-03-20 ( 26 days)
• Product Code: FLE
• Regulation Number: 880.6880

Intended Use

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.

Predicate Devices

K012573

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a steam sterilizer with standard control system features and does not mention any AI or ML capabilities.

Therapeutic

No
This device is a sterilizer for surgical instruments and other materials, not a device used to treat patients or address health conditions directly.

Diagnostic

No

The device is a sterilizer, used to clean medical instruments, linens, and liquids, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "Vacuum/Gravity Steam Sterilizer" with a "medium sized chamber," indicating it is a physical hardware device used for sterilization.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is used to sterilize surgical instruments, linens, and liquids. This is a sterilization process for medical devices and materials, not a diagnostic test performed on biological samples in vitro (outside the body).
• Device Description: The description focuses on the physical characteristics and control system of a steam sterilizer. 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 information about a patient's health
  • Using reagents or assays
  • Measuring biomarkers or analytes

The device is a medical device used for sterilization, which is a crucial process in healthcare but is distinct from in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

FLE

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.

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.

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 and 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 device classification 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.

K012573

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

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).

Summary

0

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 [phone] Phone: [phone] 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:

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. .

1

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 Leak
Test 5
(lkt)	P20	268°F
(131°C)	3 min.	15 min. dry
5 min. dwell
15 min. test	Empty chamber

Notes for Table 1:

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

1. Factory set drying time is the recommended minimum drying time may be required depending on local conditions.

2. 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.

3. Items may NOT be dry. Dry time may be added if required.

4. Cooldown rate

5. Vacuum leak test cycle parameters are not adjustable.

14/15

March 15, 2002

2

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.

3

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.

4

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

5

MAR 2 0 2002

INDICATIONS FOR USE STATEMENT

K020590 510(k) Number:

733HC Vacuum/Gravity Steam Sterilizer

Indications for Use:

Device Name:

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.

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

| 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. |
| 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 Leak
Test5
(lkt) | P20 | 268°F
(131°C) | 3 min. | 15 min. dry
5 min. dwell
15 min. test | Empty chamber |

6

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.
• 3. Items may NOT be dry. Dry time may be added if required.
• 4. Cooldown rate
• 5. 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 _