(27 days)
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.
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.
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.
§ 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).