(304 days)
The perforated base containers are part of a line of the SteriTite® Reusable Rigid Sterilization Container system. The SteriTite® perforated base containers have been validated for use in STERRAD 100 Sterilization under the following conditions. They are intended to be used for the sterilization of surgical instruments and devices in STERRAD 100 Sterilization for a hospital or other health care facilities.
The SteriTite® perforated base containers using polypropylene nonwoven Disposable Filter # SCF02 may be used for the sterilization of surgical instruments in STERRAD 100 Sterilization for a hospital or other health care facilities.
The SteriTite® Rigid Container System consists of a family of rigid containers that provide an effective sterilization packaging method for operating room instruments. The SteriTite® perforated base containers include a vented base and a vented lid with filter retention plates. The SteriTite® unit consists of an anodized aluminum sealed case with a microbial barrier filtration system that allows effective penetration by the sterilant steam previously cleared K960738. In addition the SteriTite® perforated base containers have been validated for blades and lumens in STERRAD 100 Sterilization. For STERRAD 100 Sterilization each stainless steel filter retention plate secures a disposable round non-woven polypropylene disposable bacterial filter. Silicone gaskets are permanently attached to the filter retention plates and lid with silicone adhesive. A stainless steel latching mechanism with handles on both ends secures the lid to the base and provides a method to incorporate tamperproof disposable locks.
The polypropylene non-woven disposable filter # SCF02 is cut from Kimguard ® wrap. Kimguard ® wrap is manufactured from a hydrophobic nonwoven polypropylene material as is Spunguard wrap, the previously cleared device.
The provided document is a 510(k) summary for the SteriTite® perforated base rigid reusable sterilization container system with SCF02- polypropylene non-woven Disposable Filter. It describes the device, its intended use, and performance testing to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a formal "acceptance criteria" table with pass/fail thresholds. Instead, it compares the performance of the SteriTite® container with its polypropylene filter to the predicate device (Spunguard wrap/SteriTite® Container System) and established standards. The acceptance criteria are implicitly defined by demonstrating equivalence or superior performance to the predicate and compliance with relevant standards.
Here's a table summarizing the comparison, effectively acting as an implicit acceptance criteria fulfillment:
| Acceptance Criteria (Implicit from Predicate & Standards) | SteriTite Perforated Container with Polypropylene Filter Performance | Predicate (Spunguard wrap) Performance | Notes / Confirmation |
|---|---|---|---|
| Intended Use | |||
| Holding instruments for sterilization & storage | YES | YES | Confirmed |
| Reusability | YES | NO | SteriTite is reusable, predicate is not |
| Methods of Sterilization | |||
| Prevacuum steam | YES | YES | Confirmed |
| Gravity steam | YES | YES | Confirmed |
| STERRAD 100 Sterilization (Blades) | YES | YES | Confirmed |
| STERRAD 100 Sterilization (Lumens) | YES FOR LUMENS | YES FOR LUMENS | Confirmed for lumens ≥3mm x 400mm |
| Design | |||
| Filter/wrap system for sterilant entry & microbial barrier | YES | YES | Confirmed |
| Materials (Container/Basket) | Aluminum, SS, silicone | Aluminum, SS, silicone | Confirmed as equivalent |
| Materials (Filter/Wrap) | Polypropylene (Kimguard) | Polypropylene (Spunguard) | Confirmed as equivalent |
| Performance Standards/Specifications (AAMI ST33) | |||
| Permits transfer of contaminated materials | YES | YES | Confirmed |
| Removable filter assembly disassembles | YES | NO | SteriTite has this feature, predicate does not |
| Labeling | YES | YES | Confirmed |
| Decontamination instructions | YES | YES | Confirmed |
| Instructions for inspections | YES | YES | Confirmed |
| Sterility maintenance - discussed in labeling | YES | YES | Confirmed |
| User responsibilities listed in labeling | YES | YES | Confirmed |
| Routine inspection in labeling | YES | YES | Confirmed |
| Validation Testing | |||
| Overkill approach | YES | YES | Confirmed |
| STERRAD® half-cycle parameters | YES | YES | Confirmed |
| STERRAD® increments below half-cycle parameters | YES | YES | Confirmed |
| Incremental Testing - diffusion time | 10 minute kill | 10 minute kill | Confirmed as equivalent |
| Incremental Testing - diffusion H2O2 | 720 μl | 360 μl | SteriTite used a higher concentration, implying robustness |
| Load | STU load + basket | STU load + basket | Confirmed as equivalent |
| Testing Organism | |||
| Bacillus stearothermophilus | YES | YES | Confirmed |
| Inoculated spore carriers with 1 x 10^6^ B. Stearothermophilus | YES | YES | Confirmed |
| Inoculated blades under half-cycle conditions | YES | YES | Confirmed |
| Inoculated lumens (3mm DIA x 400mm) under half-cycle conditions | YES | YES | Confirmed |
| Filter Performance (Kimguard vs. Spunguard) | |||
| Filtration Efficiency / Bacteria (3-regular) | 3 (equal to heavy-duty Spunguard) | 3-heavy duty | Confirmed as equivalent or superior for regular Kimguard |
| Water Resistance (55cms-regular) | 55cms (better than heavy-duty Spunguard) | 44cms.-heavy duty | Kimguard is better. |
| Strength (Tensile load / lbs.) | 14.5-regular | 18-heavy duty | Spunguard is stronger, but "Not important due to the offset hole design of the SteriTite container." |
| Peak energy absorption / in-lbs. | 14.5-regular | 20-heavy duty | Spunguard is better, but "Not important due to the offset hole design of the SteriTite container." |
| Resistance to Linting / no. of lint particles >10μ | 21-regular (better than heavy-duty Spunguard) | 28-heavy duty | Kimguard is better. |
| Bio-compatibility | Kimguard: Negative (USP Acute Systemic Toxicity, Human Patch, Guinea Pig Sensitization) SteriTite components: Non-cytotoxic, compatible with STERRAD System. | Not explicitly detailed for Spunguard here, but generally accepted for predicate. | Confirmed as safe. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The "test set" primarily refers to the biological indicator (BI) challenge performed during sterilization efficacy validation.
- Sample Size: The efficacy testing was conducted "in triplicate" for both the SteriTite® Container and for comparison against the wrapped tray. This means 3 runs were performed for each test condition.
- Data Provenance: The studies were conducted by ASP (a company, likely supporting the STERRAD system) and were independent. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, implying compliance with U.S. regulatory standards and likely conducted within the U.S. or by organizations adhering to U.S./international best practices. The data is prospective as it involves controlled experiments to validate the device's performance.
- Reuse Testing: The container and inserts were subjected to "100 cycles" of reuse testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The document does not mention the use of human experts to establish "ground truth" for the sterilization efficacy tests in the way one might for diagnostic imaging.
- Instead, the "ground truth" for sterilization efficacy is established by biological indicators (BIs), specifically Bacillus stearothermophilus spores. The absence of microbial growth after sterilization is the definitive indicator of successful sterilization (a "kill").
- The tests were conducted by ASP, an entity specializing in sterilization and likely possessing qualified microbiologists and technicians to perform and interpret these tests accurately. The standards cited (AAMI ST 34, ANSI/AAMI ST33-1996, ANSI/AAMI/ISO 11134-1994, pr EN 868-8) imply that the methodologies and interpretations follow established scientific and industry best practices.
4. Adjudication Method for the Test Set
- Not applicable in the human expert sense. The "adjudication" for the sterilization efficacy test results (i.e., whether sterilization was achieved) is based on the objective outcome of the biological indicator (BI) tests: growth or no growth of Bacillus stearothermophilus.
- The "triplicate" testing provides a form of internal verification, where consistent results across the three runs confirm efficacy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No MRMC study was done. This device is a medical device (sterilization container) and not a diagnostic AI system. Therefore, the concept of "human readers" or "AI assistance" does not apply to this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm. The performance tested is the device's ability to achieve sterilization, which is inherently a "standalone" performance of the container system under specific sterilization conditions. The sterilizer itself is the "algorithm," and the container facilitates its function.
7. The Type of Ground Truth Used
- Biological Ground Truth: For the sterilization efficacy studies, the ground truth was the viability of microorganisms. Specifically, the ground truth for successful sterilization was the complete inactivation of a high concentration of Bacillus stearothermophilus spores as indicated by the absence of growth of the biological indicators after exposure to the sterilization process within the device.
- Benchmarking/Standards Conformity: Other aspects of "ground truth" relate to compliance with established industry standards (AAMI ST33) and comparison to the physical and barrier properties of the legally marketed predicate device (Spunguard wrap).
8. The Sample Size for the Training Set
- Not applicable in the context of an AI/ML training set. This is a physical device. "Training" for this device would refer to its manufacturing process and quality control, not an AI model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As this is not an AI/ML device, there is no "training set" in that sense. The "ground truth" for the performance of the materials and design are established through established engineering principles, material science, and prior regulatory clearances for similar components (e.g., Kimguard being approved for other container systems).
§ 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).