The Model 833HC Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments and linens, by means of pressurized steam.

Device Description

The 833HC Vacuum/Gravity Steam Sterilizer is intended for use in hospital and health care facilities. The product incorporates a large sized chamber and has the same control system and offers similar overall features as those on the 733HC Vacuum/Gravity 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

The provided document is a 510(k) summary for a steam sterilizer, not an AI/ML device, and thus does not contain information typically associated with studies proving device performance against acceptance criteria for AI algorithms. Therefore, most of the requested information (sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set information) is not applicable or present in this document.

However, I can extract the acceptance criteria and the statement regarding how the device meets them from the provided text.

Acceptance Criteria and Device Performance for Getinge Sourcing LLC Model 833HC Vacuum/Gravity Steam Sterilizer

This device is a steam sterilizer, and its performance is assessed against established industry standards for sterilization efficacy and safety, rather than through AI/ML model performance metrics. The core acceptance criterion for such a device is its ability to sterilize medical instruments effectively and safely according to recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Standard	Reported Device Performance (Statement of Conformance)
AAMI ST8:2001 (Hospital Steam Sterilizers)	"This steam sterilizer meets the applicable requirements of AAMI ST8:2001..."
CSA-Z314.7 (Performance Standards)	"...and CSA-Z314.7 performance standards."
Substantial Equivalence to Predicate Device (Model 733HC)	"The 833HC Vacuum/Gravity Steam Sterilizer is a substantially equivalent device to that of the predicate device." "Based on the provided information in this premarket notification, it can be concluded that the subject device is substantial equivalent to the predicate device and is safe and effective when used as intended."
Intended Use	"The Model 833HC Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments and linens, by means of pressurized steam." (The device is presented as capable of fulfilling this intended use through its design and adherence to standards).

2. Sample size used for the test set and the data provenance:

Not Applicable. This is a physical medical device (steam sterilizer), not an AI algorithm. Its performance is demonstrated through adherence to engineering and sterilization standards, not data analysis on a test set. There is no mention of "test set" in the context of data for this device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. As a physical device, the "ground truth" for its efficacy is established by widely accepted microbiological principles and validated industry standards for sterilization, rather than expert consensus on a dataset.

4. Adjudication method for the test set:

Not Applicable. No test set or adjudication process as defined for AI/ML algorithms is mentioned or relevant for this device.

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:

Not Applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a standalone physical device, but not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Established Sterilization Standards and Physical Testing: The "ground truth" for a sterilizer's performance is biological inactivation (killing microorganisms) as demonstrated through validation studies that adhere to standards like AAMI ST8. While direct biological indicator testing results are not provided in this summary, the claim of meeting the standards implies such validation was performed.

8. The sample size for the training set:

Not Applicable. This device does not use a "training set" in the AI/ML sense.

9. How the ground truth for the training set was established:

Not Applicable. This device does not have a "training set."

Summary

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510(k) SUMMARY

HO31259

Model 833HC Vacuum/Gravity Steam Sterilizer

Submitted by:	Getinge Sourcing LLC1777 E Henrietta RoadRochester, NY 14623-3133
Contact Person:	Frederick R. CattSenior, Regulatory EngineerPhone: (585) 272-5013Fax: (585) 272-5299
Date prepared:	April 18, 2003
Proprietary Name:	Model 833HC Vacuum/Gravity Steam Sterilizer
Common Name:	Steam Sterilizer
Device Classification:	Steam Sterilizer (80 FLE)Class II, as listed per 21 CFR 880.6880
Predicate Device:	Model 833HC Vacuum/Gravity Steam Sterilizer [K020590]

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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K03i259

April 18, 2003

The full list of available cycles is as follows in Table 1:

Model 833HC Vacuum/Gravity Steam Sterilizer Cycle and Load Chart Table 1.

	FactorySet CycleP#	Factory Settings			Load Configuration2
Cycle Type		ExposureTemp.	ExposureTime	Dry Time1
PREVAC1(vac)	P1-P6	275°F(135°C)	3 min.	16 min.	Wrapped instrumenttrays, up to 16 lbs., pertray 42" length - 12 max. 76" length - 24 max.	Fabric packs 42" length - 36 max. 76" length - 72 max.
Bowie-Dick Test(vac)	P7	273°F(134°C)	3.5 min	0 min.	S.M.A.R.T. Pack or equivalent (1 max.)
GRAVITY1(grv)	P8-P10	250°F(121°C)	30 min.	30 min.	Wrapped instrumenttrays, up to 16 lbs., pertray 42" length 12 max. 76" length 24 max.	Fabric packs 42" length 36 max. 76" length 72 max.
GRAVITY2(grv)	P11-P13	275°F(135°C)	10 min.	30 min.	Wrapped instrumenttrays, up to 16 lbs., pertray 42" length 12 max. 76" length 24 max.	Fabric packs 42" length 36 max. 76" length 72 max.
Vacuum LeakTest3(lkt)	P14	268°F(131°C)	3 min.	15 dry +5dwell +15test	Empty chamber

Notes for Table 1:

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

t. Factory set drying time is the recommended minimum drying time. Extended drying time may be required depending on local conditions.
1. Refer to AAMI standards ST46 Good Hospital Practice: Steam Sterilization and Sterility Assurance.
టు Vacuum leak test cycle parameters are not adjustable.

Intended Use:

Model 833HC Vacuum/Gravity Steam Sterilizers are intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments and linens by means of pressurized steam.

Predicate Device

Model 733HC Vacuum/Gravity Steam Sterilizers [K020590].

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K031259

Getinge Sourcing LLC FDA 510(k) Summary Device: 833HC Vacuum/Gravity Steam Sterilizer

April 18, 2003

Nonclinical Comparisons to Predicate Device

The 833HC Vacuum/Gravity Steam Sterilizer is a new model number designation to identify incorporation of our updated sterilizer control system (PACS 3000) with large sterilizer chamber sizes and loads. The chamber cross-section dimensions are 672mm x 920mm (26.5" x 36"). Two lengths are available - 1067mm (42"), and 1930mm (76"). The 833HC sterilizer is similar to the 733HC Steam Sterilizer (predicate device), but with a larger chamber size and volume. Modifications made from the predicate device include:

The sterilizer chamber height and volumes are increased. .
The 833HC steam sterilizers can be either pit mounted (with the chamber floor . level to the room floor) or floor mounted.
Door movements were modified to include a door lift phase that accommodates ● for the increased door height and the need to lift the door from being below floor level, especially for pit mounted sterilizers.
. Flash and Liquids Cycles are not offered for this larger capacity sterilizer.
Pipe routing changes were done to integrate with the larger pressure vessel . design where some of the piping is routed to either the left or right side of the vessel, due to limited space beneath the vessel.

Clinical Data:

No clinical data is required for this device classification submission.

Conclusion:

The 833HC 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 steam sterilizer meets the applicable requirements of AAMI ST8:2001, and CSA-Z314.7 performance standards.

Based on the provided information in this premarket notification, it can be concluded that the subject device is substantial equivalent to the predicate device and is safe and effective when used as intended.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 2003

Mr. Frederick R. Catt Senior, Regulatory Engineer Getinge Sourcing LLC 1777 E Henrietta Road Rochester, New York 14623-3133

Re: K031259

Trade/Device Name: Model 833HC Vaccuum/Gravity Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: April 18, 2003 Received: April 22, 2003

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.

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Page 2 - Mr. Catt

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. 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.

Susan Ruane

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number:

K03 1259

833HC Vacuum/Gravity Steam Sterilizer Device Name:

Indications for Use:

Cycle Type	Factory SetCycle P#	ExposureTemp.	ExposureTime	Dry Time¹	Load Configuration²
PREVAC1(vac)	P1-P6	275°F(135°C)	3 min.	16 min.	Wrapped instrument trays, up to 16 lbs., per tray 42" length – 12 max. 76" length – 24 max.	Fabric packs 42" length – 36 max. 76" length – 72 max.
Bowie-Dick Test(vac)	P7	273°F(134°C)	3.5 min	0 min.	S.M.A.R.T. Pack or equivalent (1 max.)
GRAVITY1(grv)	P8-P10	250°F(121°C)	30 min.	30 min.	Wrapped instrument trays, up to 16 lbs., per tray 42" length 12 max. 76" length 24 max.	Fabric packs 42" length 36 max. 76" length 72 max.
GRAVITY2(grv)	P11-P13	275°F(135°C)	10 min.	30 min.	Wrapped instrument trays, up to 16 lbs., per tray 42" length 12 max. 76" length 24 max.	Fabric packs 42" length 36 max. 76" length 72 max.
Vacuum LeakTest³(lkt)	P14	268°F(131°C)	3 min.	15 dry +5 dwell+15 test	Empty chamber

Model 833HC Vacuum/Gravity Steam Sterilizer Cycle and Load Chart Table 1.

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. Extended drying time may be required depending on local conditions.
1. Refer to AAMI standards ST46 Good Hospital Practice: Steam Sterilization and Sterility Assurance.
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)

4 3 '7

Prescription Use(Per 21 CFR 801.109)
	OR Over-The-Counter Use
(Division Sign-Off)Division of Anesthesiology, General Hospital,Infection Control, Dental Devices
510(k) Number	K031259

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).