(212 days)
The PAL Sterilization Case is a reusable sterilization case intended to provide storage for the PAL handpiece, the PAL cable, and 4 PAL cannulas during sterilization, storage, and transportation within the hospital environment. The PAL Sterilization Case is only intended to maintain sterility of the enclosed components during autoclave sterilization when used in conjunction with FDA-cleared sterilization wraps. The PAL Sterilization Case has only been evaluated for a non-stacked configuration. The validated steam sterilization parameters are listed below:
| Cycle Type | Exposure Temperature | Exposure Time (minutes) | Minimum Dry Time (minutes) | Compatible Sterile Barriers |
|---|---|---|---|---|
| Pre-Vacuum | 132 °C (270 °F) | 4 minutes | 20 minutes | Wrap(s) |
| Gravity | 121 °C (250 °F) | 30 minutes | 20 minutes | Wrap(s) |
The MicroAire PAL Sterilization Case is a non-surgical, non-patient contacting, accessory to the already existing PAL (Power-Assisted Liposuction) System (cleared for market under K212024, K171286 and K220318), designed to contain reusable surgical instruments during steam sterilization. The case is designed to contain four (4) PAL Multi-Use Cannulas, one (1) PAL Electric Handpiece, and one (1) PAL Handpiece Cable. The subject product scope only includes the sterilization case, constructed of a separable base and lid, as illustrated in Figure 11-A.
The PAL Sterilization Case (subject device) is a stainless-steel case comprised of a separable lid and base. These two components latch together via the latch mechanisms on either side of the base which mate with the flanges on either side of the lid. Inside the case there are silicone mounts for a PAL handpiece, cable, and 4 cannulas (30 cm or less in length). The sterilization case is used to steam sterilize its contents via standard gravity or dynamic air removal autoclave processes. The subject device is a non-surgical, non-patient contacting, accessory device to the MicroAire PAL System. The subject device allows a user to organize and transport PAL reusable surgical instruments before, during, and after steam sterilization. The case is provided non-sterile and contains silicon mounting brackets to keep the devices in place, and a perforated stainless-steel enclosure to allow penetration of steam. The case has an overall footprint of approximately 16" x 6" x 2". Its construction of 1mm thick stainless steel and silicone make it lightweight and easy to transport when fully loaded with instruments. The lid also has two carrying handles on its lid for easy transport.
The provided FDA 510(k) clearance letter and summary describe a "PAL Sterilization Case," which is a reusable case for sterilizing surgical instruments. This is a medical device, but it is not an AI/ML powered medical device. Therefore, the questions about acceptance criteria for AI algorithms, such as sample size for test sets, data provenance, expert adjudication, MRMC studies, and standalone algorithm performance, do not apply to this submission.
The document focuses on the performance validation of a physical sterilization case and its ability to maintain sterility under specific sterilization parameters.
Here's an analysis of the available information regarding its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Description | Applicable Standards | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| PAL Sterilization Case Gravity Steam Sterilization Validation | ANSI/AAMI ST77:2013/(R)2018, AAMI TIR12:2020, ISO 17665:2024, FDA Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling | A full cycle of 30 minutes at 121°C using gravity air displacement for the PAL Sterilization Case in a double-wrapped configuration. | Passed. The study found that a 121°C, 30-minute gravity sterilization and dry time of 20 minutes is sufficient to sterilize (and dry) the PAL product family (not including cannulas over 30 cm in length) to a Sterility Assurance Level (SAL) of 10⁻⁶ in the PAL Sterilization Case (PAL-CASE) in a double wrapped configuration. |
| PAL Sterilization Case Pre-Vacuum Steam Sterilization Validation | ANSI/AAMI ST77:2013/(R)2018, AAMI TIR12:2020, ISO 17665:2024, FDA Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling | A full cycle of four (4) minutes at 132°C using pre-vacuum air removal for the PAL Sterilization Case in a double wrapped configuration. | Passed. The study found that a 132°C, 4-minute pre-vacuum sterilization and dry time of 20 minutes is sufficient to sterilize (and dry) the PAL product family (not including cannulas over 30 cm in length) to a Sterility Assurance Level (SAL) of 10⁻⁶ in the PAL Sterilization Case (PAL-CASE) in a double wrapped configuration. |
| Validation of Automated and Manual Cleaning Methods for PAL Sterilization Case | AAMI ST98:2022, FDA Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling | In accordance with ST98 requirements. There shall be no visible evidence of test soil remaining on any surface of the device post cleaning from a distance of 18 inches with 20/20 vision. | Passed. The results confirm that MicroAire's draft automated and manual cleaning instructions for the PAL Sterilization Case (PAL-CASE) are effective in removing soil from the devices to the point that they are considered cleaned. |
| Design Verification - PAL Sterilization Case Weight | ANSI/AAMI ST77:2013/(R)2018 (for sample size) | There shall be 90% confidence that the mean weight of the PAL Sterilization Case population is less than 25lb while containing the following: one PAL Electric Handpiece, one PAL Instrument Cable, and four PAL Cannula. | Passed. There is a 90% confidence that the fully loaded PAL Sterilization case population has a mean weight of 5.582 lb ± 0.026 lb, which is within the required upper bound of 25 lb. |
2. Sample size used for the test set and the data provenance:
- Sterilization Validation: The document does not explicitly state the specific sample size (e.g., number of test runs or sterilization cycles) for the gravity and pre-vacuum steam sterilization validations. However, it indicates that the tests were conducted according to recognized standards (ANSI/AAMI ST77, AAMI TIR12, ISO 17665, and FDA guidance), which would prescribe appropriate sample sizes and methodologies for achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
- Cleaning Validation: The sample size for cleaning validation is not explicitly stated. It adheres to AAMI ST98 requirements.
- Weight Verification: The document states "ANSI/AAMI ST77:2013/(R)2018 (for sample size)," implying that the sample size for weight verification was derived from this standard. The outcome states a mean weight of 5.582 lb ± 0.026 lb, which suggests multiple measurements were taken to achieve 90% confidence, but the exact number of cases or measurements isn't provided.
Data Provenance: The data is from "non-clinical testing" performed by MicroAire Surgical Instruments, LLC, the device manufacturer. The tests are laboratory-based validations rather than observational studies, so concepts like "country of origin of the data" or "retrospective/prospective" are not directly applicable in the same way they would be for patient data.
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):
- This question is not applicable. For physical sterilization validation, "ground truth" is established through standardized microbiological testing (such as biological indicators and physicochemical parameters) and subsequent lab analysis to confirm the absence of viable microorganisms or the attainment of a specified Sterility Assurance Level (SAL), not by human expert interpretation in the medical imaging sense.
- For cleaning validation, "visible evidence of test soil" is typically assessed by trained personnel using visual inspection criteria.
- For weight verification, it's a direct measurement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable to the non-clinical performance data presented for this physical sterilization case. Adjudication methods are typically used in clinical studies or AI/ML performance evaluations where there is subjective interpretation of findings by multiple experts.
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:
- This question is not applicable. The PAL Sterilization Case is a physical device, not an AI/ML system, and therefore, an MRMC study related to AI assistance for human readers was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The PAL Sterilization Case is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Sterilization Validation: The ground truth for sterilization effectiveness is based on microbiological assay results (confirming a Sterility Assurance Level (SAL) of 10⁻⁶) and physicochemical parameters (temperature, time, pressure, and dryness) as defined by established sterilization standards (e.g., ANSI/AAMI ST77, ISO 17665). This is an objective, laboratory-derived ground truth.
- Cleaning Validation: The ground truth for cleaning effectiveness is the absence of visible test soil after cleaning, as assessed by visual inspection from a specified distance according to AAMI ST98, and potentially measured levels of residual soil.
- Weight Verification: The ground truth for weight is direct measurement using calibrated scales.
8. The sample size for the training set:
- This question is not applicable. The PAL Sterilization Case is a physical device and does not involve AI/ML algorithms that require a "training set."
9. How the ground truth for the training set was established:
- This question is not applicable, as there is no "training set" for this physical device.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).