FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

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).