(26 days)
The Model 733HC 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 (liquids not intended for direct patient contact) by means of pressurized steam.
The 733HC Vacuum/Gravity Steam Sterilizer is intended for use in hospital and health care facilities. The product incorporates a medium sized chamber and has the same control system and offers similar overall features as those on the 400HC/500HC Series 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.
Here's a breakdown of the acceptance criteria and study information for the Model 733HC Vacuum/Gravity Steam Sterilizer based on the provided text:
Acceptance Criteria and Device Performance Table:
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It doesn't present "acceptance criteria" in the sense of a numerical performance metric (e.g., accuracy, sensitivity, specificity) for a diagnostic AI device. Instead, the "acceptance criteria" for a steam sterilizer are its ability to effectively sterilize the specified loads under the given cycle parameters, as demonstrated by compliance with recognized standards. The "reported device performance" is essentially the listed cycle parameters and load configurations that the device claims to achieve.
| Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance (Cycle Parameters & Load Configurations) |
|---|---|
| Sterilization Efficacy for PREVAC1 (vacuum): Sterilization of wrapped instrument trays (up to 16 lbs.) and fabric packs within specified load limits and cycle conditions (AAMI ST8 compliance). | Factory Settings: 275°F (135°C), 3 min. Dry Time: 16 min. Load Configuration: Wrapped instrument trays, up to 16 lbs., per tray (39" length - 10 max., 53" length - 15 max., 61" length - 20 max.); Fabric packs (39" length - 24 max., 53" length - 32 max., 61" length - 48 max.). |
| Sterilization Efficacy for PREVAC2 (vacuum): Sterilization of fabric packs within specified load limits and cycle conditions (AAMI ST8 compliance). | Factory Settings: 275°F (135°C), 3 min. Dry Time: 3 min. Load Configuration: Fabric packs (39" length - 24 max., 53" length - 32 max., 61" length - 48 max.). |
| Bowie-Dick Test Performance (vacuum): Ability to pass the Bowie-Dick test to detect air removal (AAMI ST8 compliance). | Factory Settings: 273°F (134°C), 3.5 min. Dry Time: 0 min. Load Configuration: S.M.A.R.T. Pack or equivalent (1 max.). |
| Sterilization Efficacy for GRAVITY1 (gravity): Sterilization of wrapped instrument trays (up to 16 lbs.) and fabric packs within specified load limits and cycle conditions (AAMI ST8 compliance). | Factory Settings: 250°F (121°C), 30 min. Dry Time: 30 min. Load Configuration: Wrapped instrument trays, up to 16 lbs., per tray (39" length - 10 max., 53" length - 15 max., 61" length - 20 max.); Fabric packs (39" length - 24 max., 53" length - 32 max., 61" length - 48 max.). |
| Sterilization Efficacy for GRAVITY2 (gravity): Sterilization of wrapped instrument trays (up to 16 lbs.) and fabric packs within specified load limits and cycle conditions (AAMI ST8 compliance). | Factory Settings: 275°F (135°C), 10 min. Dry Time: 30 min. Load Configuration: Wrapped instrument trays, up to 16 lbs., per tray (39" length - 10 max., 53" length - 15 max., 61" length - 20 max.); Fabric packs (39" length - 24 max., 53" length - 32 max., 61" length - 48 max.). |
| Sterilization Efficacy for Flash 3+2: Sterilization of unwrapped non-porous instrument trays within specified load limits and cycle conditions (AAMI ST37 compliance). | Factory Settings: 275°F (135°C), 3 min. Dry Time: 10 sec. (Note: Items may not be dry, extended dry time may be added). Load Configuration: Unwrapped non-porous instrument trays (3 trays maximum; up to 16 lbs., per each tray). |
| Sterilization Efficacy for Liquids1: Sterilization of up to 250 mL containers within specified load limits and cycle conditions. | Factory Settings: 250°F (121°C), 30 min. Cooldown Rate: 0.75 psi/min. Load Configuration: Up to 250 mL containers (39" length 384 max., 53" length 544 max., 61" length 672 max.). |
| Sterilization Efficacy for Liquids2: Sterilization of up to 1000 mL containers within specified load limits and cycle conditions. | Factory Settings: 250°F (121°C), 45 min. Cooldown Rate: 0.75 psi/min. Load Configuration: Up to 1000 mL containers (39" length 112 max., 53" length 154 max., 61" length 196 max.). |
| Vacuum Leak Test: Ability to detect vacuum leaks within specified cycle parameters. | Factory Settings: 268°F (131°C), 3 min. Dry Time: 15 min. dry, 5 min. dwell, 15 min. test. Load Configuration: Empty chamber. (Note: Cycle parameters are not adjustable). |
| Overall Device Performance: The device functions as a steam sterilizer for its intended use, is safe and effective, and is substantially equivalent to the predicate device. | The 733HC model incorporates an updated control system and larger chamber sizes compared to the predicate device, but maintains the same fundamental sterilization technology. The changes are minor enough to claim substantial equivalence without requiring new clinical data. The device "meets the applicable requirements of AAMI ST8, CSA-Z314.7, GGS-1340A and GGS-1343A Standards." |
Study Information:
This 510(k) summary does not describe a study that "proves the device meets acceptance criteria" in the way one might expect for a diagnostic or AI-driven device. Instead, it demonstrates substantial equivalence to a legally marketed predicate device (Castle® 400HC/500HC Series Steam Sterilizer [K012573]). For devices like sterilizers, substantial equivalence is typically shown through engineering testing, comparison of technical specifications, and compliance with recognized industry standards. No clinical data was required or submitted.
Therefore, most of the specific questions about sample sizes, experts, adjudication, MRMC studies, standalone performance, and training sets are not applicable to this type of submission.
Here's a breakdown of what is available based on the provided text:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not explicitly stated. This summary doesn't detail specific testing data like a clinical trial. The device's performance is asserted to comply with AAMI, CSA, and GGS standards, which implies various engineering and microbiological tests would have been performed during design validation, but the details of these tests (sample sizes, specific data provenance) are not provided in this 510(k) summary. These would typically be found in the full 510(k) submission, not the summary.
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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 in the context of a clinical test set in this submission. Compliance with sterilization standards (AAMI, CSA) serves as the "truth" or benchmark for non-clinical performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or human adjudication process is described.
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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:
- No. This is a steam sterilizer, not an AI or diagnostic device. MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for a sterilizer is confirmed sterility. This is achieved through adherence to validated cycle parameters derived from physical and biological indicator testing against industry standards (AAMI ST8, CSA-Z314.7, GGS-1340A, GGS-1343A). This is more akin to engineering validation and microbiological testing against defined performance specifications rather than a "clinical ground truth" established by expert review of patient data.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. As above, no training set.
§ 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).