(454 days)
Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized for Immediate Use and/or Pre Vacuum Sterilization. Pre Vacuum sterilized devices may be stored in protective storage (temperature, humidity, air filtration etc. controlled hospital storage room conditions) for up to 6 months provided integrity of container is not compromised. Bahadir Pre Vacuum sterilization containers may be stacked during storage, one on top of one another, the heavier container being on the bottom. Pre Vacuum sterilization containers may be stacked up to 18 inches during the sterilization process with no more than THREE containers as part of the 18" maximum configuration. Containers are marked as to their height to facilitate this process.
- 3 containers MAXIMUM can be stacked.
- Stacked containers may not exceed a maximum of 18 inches
Immediate Use only intended for non-stacked configurations during the sterilization process. Immediate Use sterilized devices cannot be stored.
The devices included in this submission are to be used with a pre-vacuum, three pulse of 4 minutes at 270 degrees F with a dry time of 20 minutes or Immediate Use sterilization.
The devices (natural aluminum color containers with colored lids as follows: green, yellow/golden orange, red, deep black and natural aluminum) subject to this submission are as follows:
| Flat Size Y310.05A | Mini Size Y410.04A | Dental Size Y510.04A |
|---|---|---|
| Flat Size Y310.08A | Mini Size Y410.07A | Dental Size Y510.06A |
| Flat Size Y311.08A | Mini Size Y410.10A | Dental Size Y510.08A |
| Mini Size Y411.04A | Dental Size Y510.10A | |
| Mini Size Y411.07A | Dental Size Y510.13A | |
| Mini Size Y411.10A | Dental Size Y511.04A | |
| Dental Size Y511.06A | ||
| Dental Size Y511.08A | ||
| Dental Size Y511.10A | ||
| Full size Y110.10W | 3/4 size Y210.10W | 1/2 size Y310.10W |
| Full size Y111.10W | 3/4 size Y210.13W | 1/2 size Y310.13W |
| Full size Y110.13W | 3/4 size Y210.15W | 1/2 size Y310.15W |
| Full size Y111.13W | 3/4 size Y211.10W | 1/2 size Y310.20W |
| Full size Y110.15W | 3/4 size Y211.13W | 1/2 size Y310.26W |
| Full size Y111.15W | 3/4 size Y211.15W | 1/2 size Y311.10W |
| Full size Y110.20W | 1/2 size Y311.13W | |
| Full size Y111.20W | 1/2 size Y311.15W | |
| Full size Y111.26W | 1/2 size Y311.20W | |
| Wide size Y110.62W | 1/2 size Y311.26W | |
| Wide size Y110.68W | ||
| Wide Size Y111.62W | ||
| Wide Size Y111.68W |
The devices are composed of anodized aluminum alloy with lid colors as follows: green, yellow/ qolden orange, red, black and natural aluminum.
The provided document describes the acceptance criteria and the studies performed for the Bahadir Sterilization Containers. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly list "acceptance criteria" in a formal table with corresponding performance metrics in a way that typically applies to AI/software performance (e.g., sensitivity, specificity, AUC). Instead, it describes various validation tests for the physical sterilization containers. The "acceptance criterion" for each test is implicitly that the "Test Passed."
| Acceptance Criteria (Implicit: Test Passed) | Reported Device Performance |
|---|---|
| Device maintains sterility after 6-month real-time aging | Test Passed for Dental Containers |
| Device maintains sterility after 6-month real-time aging | Test Passed for Aluminum Sterilization Containers |
| Device maintains microbial barrier integrity after 6-month accelerated aging | Test Passed for Half, Three Quarter & Full Size Containers; Full and Wide Body Size Containers; Mini, Flat & Dental Size Containers |
| Device effectively sterilizes instruments in pre-vac cycles | Test Passed for Mini, Dental & Flat Containers; Half, Three-Quarter & Full Size Containers; Wide Body Containers |
| Device maintains air impermeability after 500 sterilization cycles | Test Passed |
| Device demonstrates microbial barrier properties | Test Passed |
| Device effectively sterilizes instruments for immediate use | Test Passed for Mini, Dental & Flat Containers; Half, Three Quarter, Full & Wide Body Size Containers |
| Stacking of containers during sterilization is validated | Test Passed for Full, Wide, Three Quarter & Half Size Containers; Dental Sterilization; ¾ Size Containers; Mini Dental Size Containers |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document is a 510(k) summary for a physical medical device (sterilization containers), not an AI/software device. Therefore, the concepts of "test set sample size" and "data provenance" (like country of origin of data, retrospective/prospective) as they apply to clinical studies for AI are not directly relevant or reported. The "samples" in this context refer to the physical containers themselves and the items sterilized within them. The specific number of containers tested for each validation is not provided in this summary but is implied to be sufficient for a "Test Passed" conclusion. The provenance of the testing (where the tests were conducted) is not explicitly stated, but it would typically be in a certified testing laboratory.
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 information is not applicable to this document. The "ground truth" for a sterilization container is assessed through validated physical and microbiological testing methods, not through expert consensus or interpretation in the way it would be for an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies where human interpretation of medical data (e.g., radiology images) is being compared or refined.
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 information is not applicable. MRMC studies are relevant for AI/software devices that assist human readers (e.g., radiologists, pathologists). This document concerns a physical sterilization container.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. A standalone algorithm performance study applies to AI/software, not physical sterilization containers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of the sterilization containers is established through physical and microbiological validation testing. This includes:
- Sterility testing: Ensuring no microbial growth after sterilization and storage.
- Aging studies: Demonstrating maintained integrity over time.
- Microbial barrier integrity studies: Confirming the container prevents microbial ingress.
- Air impermeability testing: Verifying the container's seals and filters function correctly.
- Stacking validation: Confirming structural integrity and sterilization effectiveness when stacked.
8. The sample size for the training set
This information is not applicable. The device is a physical product and does not involve AI or machine learning models that require a "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of 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).