The Model 633HC Series 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 not intended for direct patient contact) by means of pressurized steam.

Device Description

The 633HC Series Vacuum/Gravity Steam Sterilizer is intended for use in hospital and health care facilities. The device is an intermediate sized sterilizer within our product offering, it has a vertical sliding power door, upgraded control system and offers similar overall features as those on the Getinge 400HC/500HC Steam Sterilizers including a control panel (user interface) that incorporates a color display with soft key menu navigation, has the same cycle types with similar number of preset cycle types offered.

AI/ML Overview

The provided documentation describes the 510(k) Pre-Market Notification for the Getinge 633HC Series Vacuum/Gravity Steam Sterilizer (K070657), which is a device for sterilizing medical instruments, linens, and liquids in healthcare facilities.

This document is a marketing submission seeking substantial equivalence to a predicate device, not a study report demonstrating the device meets performance criteria through specific, detailed testing. As such, information regarding acceptance criteria and a study proving performance, as typically found in clinical validation studies for AI/ML devices or novel medical devices, is largely not applicable or not present in the context of this 510(k) submission for a steam sterilizer.

However, I can extract information related to the device's functionality and regulatory compliance as presented.

Here's a breakdown based on the provided text, addressing your points where possible and noting where information is not available:

Description of Acceptance Criteria and Device Performance (Steam Sterilizer)

For a steam sterilizer, "acceptance criteria" and "device performance" are typically defined by its ability to reliably achieve sterilization under specified conditions (temperature, pressure, time) for various loads. The documentation confirms that the device meets applicable performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from Standards & Intended Use)	Reported Device Performance (from "List of available cycles" and "Load Chart")
Sterilization Efficacy: Achieve sterility for various loads (wrapped instruments, fabrics, liquids)	The device offers various cycles for different load types and sizes, specifying exposure temperature, time, and dry time to achieve sterilization. (See load chart below for details).
- Specific Temperature/Time for PREVAC cycles (e.g., 275°F for 3 min)	Achieved (device is designed to maintain these parameters).
- Specific Temperature/Time for GRAVITY cycles (e.g., 250°F for 30 min)	Achieved (device is designed to maintain these parameters).
- Specific Temperature/Time for Flash cycles	Achieved (device is designed to maintain these parameters).
- Specific Temperature/Time for LIQUID cycles	Achieved (device is designed to maintain these parameters).
- Ability to perform Bowie-Dick Test	Dedicated cycle parameters for Bowie-Dick Test are provided.
- Ability to perform Vacuum Leak Test	Dedicated cycle parameters for Vacuum Leak Test are provided.
Load Capacity: Accommodate specified maximum item configurations per chamber length	Detailed in the "Load Chart" for 26", 39", and 51" sterilizer models (e.g., 4 double-wrapped instrument trays for 26" PREVAC 1).
Compliance with Standards: Meet relevant industry standards (AAMI, CSA)	Explicitly stated: "This steam sterilizer meets the applicable requirements of AAMI ST8:2001 and CSA-Z314.7 performance standards."

Detailed Load Chart (Excerpt from the document provided as "device performance"):

Cycle Type	Exp. Temp.	Exp. Time	Dry Time	Load Configuration	Max Items (26" Model)	Max Items (39" Model)	Max Items (51" Model)
PREVAC 1 (vac)	275°F (135°C)	3 min.	16 min.	Double-wrapped instrument trays, up to 16 lbs (per tray); Fabric packs	Trays: 4; Packs: 8	Trays: 8; Packs: 18	Trays: 12; Packs: 24
PREVAC 2 (vac)	275°F (135°C)	3 min.	3 min.	Fabric packs	8	18	24
Bowie-Dick Test (vac)	273°F (134°C)	3 min. 30 sec.	0 min.	S.M.A.R.T. Pack or equivalent (1 max.)	1 Test Pack	1 Test Pack	1 Test Pack
GRAVITY 1 (grv)	250°F (121°C)	30 min.	30 min.	Double-wrapped instrument trays, up to 16 lbs (per tray); Fabric packs	Trays: 4; Packs: 8	Trays: 8; Packs: 18	Trays: 12; Packs: 24
GRAVITY 2 (grv)	275°F (135°C)	10 min.	30 min.	Double-wrapped instrument trays, up to 16 lbs (per tray); Fabric packs	Trays: 4; Packs: 8	Trays: 8; Packs: 18	Trays: 12; Packs: 24
Flash 3+ (f 3)	275°F (135°C)	3 min.	30 sec.	Unwrapped non-porous single instrument; trays	Singles: 1; Trays: 2	Singles: 1; Trays: 2	Singles: 1; Trays: 2
Flash 10+ (f10)	275°F (135°C)	10 min.	30 sec.	Unwrapped porous or non-porous single instrument; trays	Singles: 1; Trays: 2	Singles: 1; Trays: 2	Singles: 1; Trays: 2
LIQUIDS (liq)	250°F (121°C)	45 min.	0.75 psi/min. (Cooldown rate)	Up to 1000 mL containers	60	80	100
Vacuum Leak Test (lkt)	268°F (131°C)	3 min.	15 min. dry, 5 min. dwell	Empty chamber	---	---	---

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

Not Applicable / Not Provided. This document is a 510(k) summary for a steam sterilizer, which typically relies on established engineering principles, adherence to recognized performance standards (like AAMI ST8, CSA-Z314.7), and comparison to a predicate device. It does not involve a "test set" in the sense of a data set for AI/ML validation or a clinical trial with human subjects. The performance testing would involve physical validation of the sterilizer's cycles using biological indicators and thermometric probes, typically conducted by the manufacturer in a controlled environment. Details of such specific test runs (e.g., number of cycles performed) are not included in this summary.

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

Not Applicable. As noted above, there isn't a "test set" with "ground truth" established by experts in the context of this 510(k) submission for a steam sterilizer. Sterilizer efficacy is validated by standard microbiological and physical testing methods, not expert human interpretation.

4. Adjudication method for the test set

Not Applicable. No expert adjudication method is relevant for this type of device and submission.

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 a hardware medical device (steam sterilizer), not an AI/ML diagnostic or assistive tool. No such study would be performed for this device.

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

Not Applicable. This is a hardware medical device. There is no algorithm in the sense of an AI/ML system to evaluate in standalone mode. The sterilizer operates automatically based on programmed cycles, and its "performance" is its ability to meet those physical parameters.

7. The type of ground truth used

Engineering and Performance Standards/Physical Measurements: The "ground truth" for a steam sterilizer's effectiveness is based on scientific principles of sterilization (e.g., lethality achieved by sustained temperature and pressure), microbiological validation (e.g., biological indicators showing kill of highly resistant spores), and adherence to recognized industry standards (AAMI ST8, CSA-Z314.7). The device's ability to maintain specified temperature, pressure, and time, and thus render items sterile, is the core of its performance. This is typically verified through physical measurements and biological indicator tests.

8. The sample size for the training set

Not Applicable / Not Provided. This is a hardware device. There is no "training set" in the context of machine learning. The device design and validation relies on engineering principles and performance testing.

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

Not Applicable. There is no "training set" for establishing ground truth in this submission. The "ground truth" for acceptable sterilizer parameters is established by scientific consensus in microbiology and healthcare standards organizations (e.g., AAMI, ISO) over many years of research and practice in infection control.

Summary

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K070657

'APR 5 - 2007

510(k) SUMMARY

Model 633HC Series Vacuum/Gravity Steam Sterilizer (Sterilizer Models with 26", 39" and 51" lengths)

Submitted by:	Getinge Sourcing LLC1777 E Henrietta RoadRochester, NY 14623-3133
Contact Person:	Ann G. WheelerSr. Quality Assurance EngineerPhone: (585) 272-5036Fax: (585) 272-5299
Date prepared:	April 5, 2007
Proprietary Name:	Model 633HC Series Vacuum/Gravity Steam Sterilizer (SterilizeModel with lengths 26", 39" and 51")
Common Name:	Steam Sterilizer
Device Classification:	Steam Sterilizer (80 FLE)Class II, as listed per 21 CFR 880.6880
Predicate Device:	Model 400HC/500HC Series Steam Sterilizer [K012573]

Description of Device:

The state

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Getinge Sourcing LLC FDA 510(k) Summary Device: 633HC Series Vacuum/Gravity Steam Sterillizer

List of available cycles

Cycle Type	No. ofAvailableCycles	Factory Settings			Load Configuration2	Maximum Items per ChamberSterilzer Model Length
		Exp. Temp.	Exp. Time	Dry Time1		26"	39"	51"
PREVAC 1 (vac)	6	275°F (135°C)	3 min.	16 min.	Double-wrapped instrument trays, up to16 lbs (per tray).	4	8	12
					Fabric packs	8	18	24
PREVAC 2 (vac)	2	275°F (135°C)	3 min.	3 min.	Fabric packs	8	18	24
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 cham ber	1 Test Pack	1 Test Pack	1 Test Pack
GRAVITY 1 (grv)	3	250°F (121°C)	30 min.	30 min.	Double-wrapped instrument trays, up to16 lbs (per tray).	4	8	12
					Fabric packs	8	18	24
GRAVITY 2 (grv)	3	275°F (135°C)	10 min.	30 min.	Double-wrapped instrument trays, up to16 lbs (per tray).	4	8	12
					Fabric packs	8	18	24
Flash 3+(f 3)	2	275°F (135°C)	3 min.	30 sec.5	Unwrapped non-porous singleinstrument	1	1	1
					Unwrapped non-porous instrumenttrays, up to 16 lbs (per tray).	2	2	2
Flash 10+ (f10)	2	275°F (135°C)	10 min.	30 sec.5	Unwrapped porous or non-poroussingle instrument	1	1	1
					Unwrapped porous & non-porousinstrument trays, up to 16 lbs (per tray).	2	2	2
LIQUIDS (liq)	1	250°F (121°C)	45 min.	0.75psi/min.4	Up to 1000 mL containers	60	80	100
Vacuum LeakTest (lkt)3	1	268°F (131°C)	3 min.	15 min. dry5 min. dwell	Empty chamber	---	---	---

Model 633HC Series Vacuum/GravitySteam Sterilizer Load Chart

Notes for Table

Load configurations follow AAM 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. Gravity cycle drying time may be reduced by selecting vacuum drying phase.

2 Refer to AAM Standards ST79 Comprehensive guide to steam sterility assurance in health care facilities.

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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Intended Use:

The Model 633HC Series Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped surgical instruments. linens and liquids (liquids not intended for direct patient contact) by means of pressurized steam.

Predicate Device

Getinge 400HC/500HC Series Steam Sterilizers (K012573).

Nonclinical Comparisons to Predicate Device

In summary, the differences between the 633HC Series and the predicate 400HC/500HC Series are:

1. The 633HC door drive mechanism is designed to accommodate a slightly larger and heavier door. The predicate 400HC/500HC Series power door utilizes a counter weight and pulley that engages with a small motor to drive the doors vertical movement. The 633HC uses a motorized lead screw to accomplish the same vertical door movement.
1. The frame material for the predicate is carbon steel welded construction, the 633HC is an aluminum extrusion framing that is secured with together with joining plates and hardware.
1. The operating system has been upgraded to allow more inputs and outputs but the same fundamental micro processor technology is used.
1. Vessel material has changed both materials meet ASME BPVC Section II Part A -Materials - Ferrous Material Specifications.
1. The 633HC series has a larger vessel size range than the 400HC/500HC. It is an intermediate size within he steam sterilizer offered by Getinge Sourcing LLC.

Clinical Data:

No clinical data is required for this device classification submission.

Conclusion:

The 633HC Series Vacuum/Gravity Steam Sterilizer is a substantially equivalent device to that of the predicate device. There have been no substantial changes in technology and no changes to the 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three abstract human figures, represented by flowing lines, symbolizing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 6 = 2007

Ms. Ann G. Wheeler Senior Quality Assurance Engineer Getinge Sourcing, LLC 1777 East Henrietta Road Rochester, New York 14623-3133

Re: K070657

Trade/Device Name: 633HC Series Vacuum/Gravity Steam Sterilizers Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: March 8, 2007 Received: March 9, 2007

Dear Ms. Wheeler:

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 - Ms. Wheeler

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 your 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

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

510(k) Number (if known): K070657

Device Name: 633HC Series Vacuum/Gravity Steam Sterilizer (Sterilizer Model with lengths 26", 39" and 51")

Indications For Use: The Model 633HC Series 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 not intended for direct patient contact) by means of pressurized steam.

Cycle Type	No. ofAvailableCycles	Factory Settings			Load Configuration²	Maximum Items per ChamberSterilizer Model Length
		Exp. Temp.	Exp. Time	Dry Time¹		26"	39"	51"
PREVAC 1 (vac)	6	275°F (135°C)	3 min.	16 min.	Double-wrapped instrument trays, up to16 lbs (per tray).- Fabric packs	4	8	12
					- Fabric packs	8	18	24
PREVAC 2 (vac)	2	275°F (135°C)	3 min.	3 min.	- Fabric packs	8	18	24
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 cham ber	1 Test Pack	1 Test Pack	1 Test Pack
GRAVITY 1 (grv)	3	250°F (121°C)	30 min.	30 min.	Double-wrapped instrument trays, up to16 lbs (per tray).- Fabric packs	4	8	12
					- Fabric packs	8	18	24
GRAVITY 2 (grv)	3	275°F (135°C)	10 min.	30 min.	Double-wrapped instrument trays, up to16 lbs (per tray).- Fabric packs	4	8	12
					- Fabric packs	8	18	24
Flash 3+(f 3)	2	275°F (135°C)	3 min.	30 sec.⁵	Unwrapped non-porous singleinstrument- Unwrapped non-porous instrumenttrays, up to 16 lbs (per tray).	1	1	1
					- Unwrapped non-porous instrumenttrays, up to 16 lbs (per tray).	2	2	2
Flash 10+ (f10)	2	275°F (135°C)	10 min.	30 sec.⁵	Unwrapped porous or non-poroussingle instrument- Unwrapped porous & non-porousinstrument trays, up to 16 lbs (per tray).	1	1	1
					- Unwrapped porous & non-porousinstrument trays, up to 16 lbs (per tray).	2	2	2
LIQUIDS (liq)	1	250°F (121°C)	45 min.	0.75psi/min.⁴	Up to 1000 mL containers	60	80	100
Vacuum LeakTest (lkt)³	1	268°F (131°C)	3 min.	15 min. dry5 min. dwell15 min. test	Empty chamber	-----	-----	-----

Table 1: Model 633HC Series Vacuum/GravitySteam Sterilizer Load Chart

Notes for Table

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

Factory set drying time is the recommended minimum drying time. Extended drying time may be required

depending on local conditions. Gravity cycle drying time may be reduced by selecting vacuum drying phase.

Reler to AAM Standards ST79 Comprehensive guide to steam sterility assurance in health care facilities

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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Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 1. 1. 1.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of ____________________________________________________________________________________________________________________________________________________________________

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http://www.fda.gov/cdrh/ode/INDICUSE.HTML

Shula H. Murphy, R

rion of Anestherineey, General Hospital, Juon Control, Dentral Devices

:(k) Number: K070457

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).