(111 days)
Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices using steam sterilizers. Sterilized devices may be stored and transferred in the container.
The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.
The devices (natural aluminum color containers and lids) subject to this submission are as follows:
Full Size 1/1 Y110.20 Full Size 1/1 Y110.15 Full Size 1/1 Y110.13 Full Size 1/1 Y110.10 3/4 Size Y210.10 34 Size Y210.15 3/4 Size Y210.13 1/2 Size Y310.20 1/2 Size Y310.15 1/2 Size Y310.13 1/2 Size Y310.10
The maximum load weight is 24.75 lbs for full size, 12.5 lbs for 34 size, and 9.25 Ibs for 1/2 size. The sterilization validation included three types of loads, empty, full load of textiles, and full load of surgical instruments.
The subject trays are not validated for use with lumened devices, air driven instruments, power systems, or cannulized instruments.
The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes. Stacking during sterilization is not recommended.
The devices subject to this submission are as follows:
Full Size 1/1 Y110.20 (580 x 280 x 200mm) Full Size 1/1 Y110.15 (580 x 280 x 150mm) Full Size 1/1 Y110.13 (580 x 280 x 135mm) Full Size 1/1 Y110.10 (580 x 280 x 100mm) 3/4 Size Y210.15 (465 x 280 x 150mm) 3/4 Size Y210.13 (465 x 280 x 135mm) 3/4 Size Y210.10 (465 x 280 x 100mm) 1/2 Size Y310.20 (285 x 280 x 200mm) 1/2 Size Y310.15 (285 x 280 x 150mm) 1/2 Size Y310.13 (285 x 280 x 135mm) 1/2 Size Y310.10 (285 x 280 x 100mm)
The maximum load weight is 24.75 lbs for full size, 12.5 lbs for ¾ size, and 9.25 lbs for 1/2 size.
The devices are composed of anodized aluminum (this does not include colored anodized lids).
Here's a breakdown of the acceptance criteria and study information for the Bahadir USA STERILIZATION TRAYS, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details non-clinical tests performed rather than specific quantitative acceptance criteria or their corresponding performance results in a structured format. However, based on the types of tests performed and the ultimate goal of substantial equivalence for sterilization trays, we can infer the implied acceptance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilization Effectiveness: |
- Pass steam sterilization (pre-vacuum cycle: 4 min at 270°F, 20 min dry time).
- Effective sterilization of various loads (empty, full textile, full surgical instruments).
- Prevention of microbial migration during storage. | The devices were subjected to "sterility testing" and "half cycle" tests.
Validation included three types of loads: empty, full load of textiles, and full load of surgical instruments.
The trays "Permits entry of sterilization agent and prevents microbial migration during storage." |
| Cleaning Effectiveness: - Device can be effectively cleaned. | The devices were subjected to "cleaning validation." |
| Material Durability/Aging: - Device maintains integrity and function over time/usage. | The devices were subjected to "aging studies." |
| Product Performance/Integrity: - Device physically holds contents.
- Maintains seal integrity.
- Withstands sterilization cycle conditions. | The devices were subjected to "performance testing."
Features like "Sealed: Yes" and "Gasket: Silicone Based" indicate an expectation of seal integrity. |
| Biocompatibility/Safety (Implied): - Materials are safe for medical device contact. | The main material is anodized aluminum (with stainless steel handles, silicone seal, paper filter). Substantial equivalence to predicate devices (also aluminum alloy with similar components) implies material safety. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "The devices were subjected to cleaning validation, aging studies, half cycle, sterility testing and performance testing." It refers to "the devices included in this submission" as a set of specific models (11 different sizes). It does not specify how many units of each model, or total units, were tested for each type of study.
- Data Provenance: Not explicitly stated. It's unclear if the testing was done by the manufacturer, an independent lab, or in a specific country. Given the manufacturer's address in New York, USA, it is likely the testing was conducted in the USA or supervised from there. The study appears to be prospective in nature, as it describes tests performed on the physical devices to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical sterilization tray, and the "ground truth" for its performance is established through objective physical, biological, and chemical tests (e.g., sterility indicators, microbial challenge tests, physical integrity checks, material degradation analysis). There were no human experts establishing a "ground truth" through interpretation or consensus, unlike in studies involving diagnostic imaging or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" for this type of device is based on objective scientific testing, not expert consensus or adjudication. Test results would be interpreted against predefined pass/fail criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers (e.g., radiologists) interpret cases, and the AI's impact on their performance is evaluated. Sterilization trays do not involve human interpretation in this manner.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, the studies performed (cleaning validation, aging studies, half cycle, sterility testing, performance testing) represent a "standalone" evaluation of the device's physical and functional properties, without human interaction as an integral part of its direct performance (beyond setup and monitoring). The device itself, independent of human interpretive input during use, was tested for its intended function.
7. The Type of Ground Truth Used
The ground truth used for these studies would be based on:
- Biological Indicators/Chemical Indicators: For sterility testing, the absence of viable microorganisms after sterilization, often confirmed by biological indicator sterility (e.g., spore strips showing no growth) and chemical indicator changes.
- Physical Measurements/Observation: For cleaning validation (absence of residual soil), aging studies (material integrity, absence of cracks/corrosion), and performance testing (device remaining intact, seals functional, filters allowing air passage while trapping microbes).
- Adherence to Standards: Compliance with relevant industry standards (e.g., AAMI ST77, as mentioned).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI algorithm or training set, this question is not relevant.
§ 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).