(86 days)
The Fort Defiance Industries FRONT-LINE Field Sterilizer (FL135) is an autoclave designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities.
The Fort Defiance Industries FRONT-LINE Field Sterilizer, model FL135, is an autoclave designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped and unwrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities. The device uses electrical resistive heaters to produce steam as the sterilizing agent. The device adheres to sterilization processes and requirements that are universally accepted sterilization standards for Tabletop Steam Sterilizers. A touchscreen controller is used for monitoring and control of the device.
The provided text describes the 510(k) summary for the Fort Defiance Industries FRONT-LINE Field Sterilizer (FL135) and its modifications. The key changes involve reducing the dry times for wrapped instruments, textiles, and handpieces cycles. The study provided focuses on the sterilizer's performance and safety and is not an AI/ML-driven device. Therefore, many of the requested criteria related to AI/ML studies (such as MRMC studies, number of experts for ground truth, sample sizes for training sets, etc.) are not applicable to this submission.
The acceptance criteria and performance data are primarily based on the sterilizer's ability to achieve and maintain sterility, as well as its moisture retention characteristics, according to the AAMI ST55:2016 standard.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are derived from ANSI/AAMI ST55:2016. The reported device performance is indicated by "PASS" for each test.
| Acceptance Criteria (from AAMI ST55:2016 Requirements) | Reported Device Performance |
|---|---|
| Sterilizer Temperature Control & Pressure Measurement | |
| 4.4.3 -0/+6°F temp control | PASS (5.4.3 - Temperature instrumented chamber tests to confirm steady state temperature control range and documentation of cold point) |
| Software Verification and Validation | |
| 4.4.7 Sterilizer fault conditions | PASS (5.4.7 - Verified by inspection, TP-5110: Sterilizer Fault Conditions, TP-5120: General Functions, TP-5130: Full Cycle Verification) |
| Biological Performance - Wrapped Instrument | |
| 4.5 Biological performance of sterilizers | PASS (5.5.4 Biological performance with wrapped instruments) |
| Moisture Retention - Textiles | |
| 4.7 Moisture Retention | PASS (5.7.1 Textile test packs) |
| Moisture Retention - Wrapped Instrument | |
| 4.7 Moisture Retention | PASS (5.7.2 Wrapped Instr. Test trays) |
| Moisture Retention - Pouches | |
| 4.7 Moisture Retention | PASS (5.7.3 Paper-plastic peel pouches) |
| Safety - Electrical Safety | PASS (3rd Party test protocol per IEC 61010-1 Edition 3.1 2017-01) |
| Safety - EMC/EMI | PASS (3rd Party test protocol per IEC 61326-1:2020) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions "3 successive cycles at half the programmed exposure time" for the overkill method to guarantee a sterility assurance level (SAL) of at least 10^-6. It also mentions validation studies were conducted. However, the exact sample sizes for each specific test (e.g., number of textile packs, wrapped instruments, or handpieces tested) are not explicitly stated in the provided summary.
- Data Provenance: The studies were conducted by Fort Defiance Industries LLC which is based in Loudon, Tennessee, USA. The studies appear to be prospective validation studies performed to support the 510(k) submission for the device modifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a hardware medical device (steam sterilizer) and the ground truth is established through physical and biological indicators, not human expert consensus on interpretations of images or data. The validation is against established engineering and sterilization standards (ANSI/AAMI ST55:2016).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is not an AI/ML or diagnostic study requiring human expert adjudication. The performance is objectively measured against physical and biological parameters.
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 not an AI/ML device, and no human reader comparative effectiveness studies were performed or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML algorithm. The performance is the standalone performance of the sterilizer itself. The summary evaluates the device's ability to sterilize and dry items on its own, based on programmed cycles.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for sterilizer performance is based on established industry standards and scientific principles of sterilization. This includes:
- Biological Indicators: Used in the "overkill method" to demonstrate a Sterility Assurance Level (SAL) of at least 10^-6. This typically involves challenging the sterilizer with a high concentration of resistant microorganisms, and "ground truth" is established by their survival or inactivation.
- Physical Parameters: Temperature and pressure measurements throughout the cycle, as defined by ANSI/AAMI ST55:2016 (e.g., -0/+6°F temp control).
- Moisture Retention: Empirical measurements of water remaining on processed items, compared against defined limits in the AAMI standard.
8. The sample size for the training set
- Not Applicable. This device uses pre-programmed cycles based on engineering design and validation against recognized standards, not machine learning models that require a training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set for an AI/ML model.
§ 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).