The Getinge 633HC Steam Sterilizer Air Glide System is intended to provide automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The Air Glide System is used with multiple Getinge Model 633HC 51" steam sterilizers with double-door, pass-through configurations. The system consists of a single point user interface station, loading conveyor, load transport shuttles, unloading conveyor and 2 to 7 Getinge Model 633HC Steam Sterilizers.

Device Description

The 633HC AGS is designed to minimize the manual handling of sterilizer loads during transfer, chamber loading and chamber unloading of 633HC steam sterilizers. Users place the load car on the AGS conveyor, scan the load car with a barcode reader, scan the required cycle from the cycle list and click OK to enter the requirements into the AGS system. The AGS now automatically moves the load car to an available sterilizer and automatically loads the sterilizer, signals the sterilizer to run the required cycle and following a successful cycle will automatically unload the sterilizer on the unload end and move the load to the unload conveyor for pick up. Users do not need to load and unload individual sterilizers. The 633HC sterilizer controls the sterilization cycle as it normally would and does not open the unload door unless the cycle completed without error.

AI/ML Overview

The provided document is a 510(k) summary for the Getinge 633HC Steam Sterilizer Air Glide System. It does not include information about acceptance criteria or a study that proves the device meets specific performance metrics in the way a diagnostic software or AI model document would.

Here's why and what information is present:

This device is a hardware system for automated loading/unloading of sterilizers, not a diagnostic or AI software. Therefore, the typical "acceptance criteria" and "study" questions regarding performance metrics (like sensitivity, specificity, etc.), ground truth, expert adjudication, or MRMC studies are not applicable.

Instead, the FDA 510(k) summary focuses on demonstrating substantial equivalence to an existing predicate device (Getinge 633HC Series Vacuum/Gravity Steam Sterilizer, K070657).

Here's a breakdown of the relevant information from the document in relation to your request:

1. A table of acceptance criteria and the reported device performance

Not applicable in the typical sense for this hardware device.
The document states that "No clinical data is required for this device classification submission." This indicates that the performance criteria are assessed through other means, likely focusing on engineering specifications, safety, and functionality, rather than clinical performance metrics.
Implied "Acceptance Criteria" (Substantial Equivalence): The primary "acceptance criteria" for the FDA 510(k) process for this device are demonstrating that it is substantially equivalent to a legally marketed predicate device in terms of intended use, operating principles, safety, and effectiveness.
Reported Device Performance (as per Substantial Equivalence Comparison):
- Similarities to Predicate:
  - Intended use of the 633HC Steam Sterilizer is the same (sterilization of wrapped/unwrapped, porous/nonporous items by pressurized steam).
  - Operating Principle of the 633HC Steam Sterilizer is the same (saturated steam as sterilizing agent).
  - No direct patient contact.
  - Cycle Types are the same.
  - Interior of the 633HC Steam Sterilizer and loading car are the same.
- Differences from Predicate:
  - Software change to the 633HC sterilizer to allow automatic door operation, cycle start, and unload door opening upon successful cycle completion.
  - Addition of a NetCOM card for communication with the Air Glide System.
  - Allows for automated loading and unloading of a bank of multiple 633HC sterilizers, reducing manual handling.
  - Main application is in high-volume, large sterile reprocessing centers.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. There is no "test set" in the context of clinical performance data for this device as no clinical data was required. The evaluation is based on engineering and functional equivalence.

3. 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 for a test set, as this is a hardware system for automation, not a diagnostic or AI algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or adjudication method is described.

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 automation system, not an AI or diagnostic tool requiring MRMC studies or human reader improvement analysis.

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

Not applicable. This device integrates an "Air Glide System" with existing sterilizers. While it automates tasks, it's not an algorithm being tested in a standalone diagnostic capacity. The core sterilization function remains within the previously cleared 633HC sterilizer.

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

Not applicable. No clinical ground truth data is used or discussed. The evaluation focuses on the safety and functional equivalence of the new automated loading/unloading mechanism and its integration with the sterilizer.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm that requires a training set.

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

Not applicable. No training set or ground truth for a training set is relevant here.

In summary: The provided document is a 510(k) summary for a Steam Sterilizer Air Glide System (hardware automation), not a diagnostic or AI software. Therefore, the questions related to clinical performance, ground truth, expert opinions, and AI/ML study methodologies are not addressed because they are not relevant to the substantial equivalence determination for this type of device. The focus is on demonstrating that the modifications (automated loading/unloading, software changes) do not raise new questions of safety or effectiveness compared to the predicate device.

Summary

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KIZOS32

510(k) SUMMARY

MAY 2 2013

Getinge 633HC Steam Sterilizer Air Glide System

Submitted by:	Getinge Sourcing LLC1777 E Henrietta RoadRochester, NY 14623-3133
Contact Person:	Barb Smith, RACSr. Manager, Regulatory AffairsPhone:(585) 214-6049Fax:(585) 272-5299
Date prepared:	February 17, 2012
Proprietary Name:	Getinge 633HC Steam Sterilizer Air Glide System
Common Name:	Steam Sterilizer
Device Classification:	PEC
	Class II, as listed per 21 CFR 880.6880
Predicate Device:	K070657, Getinge 633HC Series Vacuum/Gravity SteamSterilizer. S.E. Date 4/6/07

Description of Device:

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Getinge Sourcing LLC FDA 510(k) Summary Device: 633HC Steam Sterilizer Air Glide System

Intended Use:

The Getinge 633HC Steam Sterilizer Air Glide System is intended to provide automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The Air Glide System is used with multiple Getinge Model 633HC 51" steam sterilizers with double-door, pass-through configurations. The system consists of a single point user interface station, loading conveyor, load transport shuttles; unloading conveyor and 2 to 7 Getinge Model 633HC Steam Sterilizers.

The intended use of the 633HC Steam Sterilizer has not changed; Intended for use by health care facilities to sterilize wrapped and unwrapped, porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.

Comparisons to Predicate Device:

Similarities between the Getinge 633HC Steam Sterilizer Air Glide System and the identified predicate are:

Intended use of the 633HC Steam Sterilizer is the same: Intended for use by . health care facilities to sterilize wrapped and unwrapped, porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
Operating Principle of the 633HC Steam Sterilizer is the same: Saturated steam . is the sterilizing agent.
. There is no direct patient contact associated with this device.
Cycle Types: The cycle types offered on the 633HC Steam Sterilizer are the . same.
The interior of the 633HC Steam Sterilizer and the loading car that goes into the . sterilizer are the same.

The differences between the Getinge 633HC Steam Sterilizer Air Glide System and the predicate device (Getinge 633HC Series Vacuum/Gravity Steam Sterilizer) are:

. The only change made to the 633HC sterilizer to accommodate the AGS is a software change to allow the AGS to automatically open the door, close door, start a cycle and automatically open the unload door when the cycle is properly completed and the addition of a NetCOM card to allow communication with the AGS.
The 633HC AGS allows for automated loading and unloading of a bank of . double-door pass-through Getinge Model 633HC 51" steam sterilizers. Users do not need to load and unload individual sterilizers.

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Getinge Sourcing LLC FDA 510(k) Summary

Device: 633HC Steam Sterilizer Air Glide System

The main application of the 633HC AGS is in the high volume, large sterile . reprocessing centers of large hospitals or offsite reprocessing centers supplying sterile goods to multiple hospitals.

Clinical Data:

No clinical data is required for this device classification submission.

Conclusion:

The Getinge 633HC Steam Sterilizer Air Glide System is a substantially equivalent device to that of the predicate device. There have been no substantial changes in the sterilization technology and no changes to the intended use of this device (sterilization of hospital goods). Based on the information provided, it is our opinion that the Getinge 633HC Steam Sterilizer Air Glide System is substantially equivalent to the predicate device and is safe and effective when used as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 2, 2013

Ms. Barb Smith Senior Manager, Regulatory Affairs Getinge Sourcing LLC 1777 East Henrietta Road ROCHESTER New York 14623-3133

Re: K120532

Trade/Device Name: Getinge 633HC Steam Sterilization Air Glide System Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: PEC Dated: February 17, 2012 Received: April 30, 2013

Dear Ms. Smith:

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. Please note: . CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Anthony D. Anthony D. watsony -2013.05.02 Watson -S 16:00:49 -04'00'

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, 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):

Device Name: Getinge 633HC Steam Sterilizer Air Glide System

Indications for Use:

The Getinge 633HC Steam Sterilizer Air Glide System is intended to provide automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The Air Glide System is used with multiple Getinge Model 633HC 51" steam sterilizers with double-door, pass-through configurations. The system consists of a single scent user interface station, loading conveyor, load transport shuttles, unloading conveyor and 2 to 7 Getinge Model 633HC Steam Sterilizers.

Prescription Use (Part 21 CFR 801 Subpart D) · AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Elizabeth F. Claverie

Digitally signed by Elizabeth F. Clayerie DN c=US o=l $ Government ou=HHS. ou=FDA. ou=People. 0.9.2342.19200300.100.1.1=130005586 4, cn=Elizabeth F. Claverie Date: 2013.05.02 15:13:38 -04'00'

Division Sign-Off) Ulvision Sign-Oh)
ifection Control, Dental 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).