无菌器械FDA注册运输验证审核官提问

xieke2008

FDA S001 Review Questions:
Issued: 2020-05-08
FDA答复截止日期: 2020-11-05
IRC要求答复日期: 2020-10-01前

K200557
Enteral Feeding Syringes with ENFit connector
Model: 10ml, 60ml control ring

Sterility/Shelf Life灭菌和货架周期

1. You have provided Package Integrity tests and accelerated aging test report summaries. However, the information was unclear, and we were not able to verify that you performed Simulated Distribution testing. As noted in the 2016 FDA sterility guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff, FDA recommends that package test methods include simulated distribution as well as simulated (and/or real-time) aging followed each by associated packaging testing, to validate package integrity and shelf life claims. FDA needs this information to ensure that your device can withstand the rigors of shipping distribution. Please address the items below.
您提供了包装完整性测试和加速老化测试报告摘要。但是，这些信息并不清楚，FDA无法验证您是否执行了模拟分布测试。如2016年FDA无菌指南提交和上市前通知（510（k））无菌信息审查中所述，FDA建议包装测试方法包括模拟分布和模拟（和/或实时）老化随后进行相关包装测试，以验证包装完整性和保质期要求。FDA需要这些信息来确保你的设备能够经受住运输配送的严格考验。请答复以下提问：

a. FDA requires packaging integrity testing to confirm the ability of the packages to maintain the sterile barrier through the rigors of shipping distribution. Please provide a description of the method used to validate the ability of the packages to withstand the rigors of shipping distribution. You should include a description of the conditions used for environmental conditioning and methods used to determine package integrity. For packaging integrity testing, FDA recommends at least the following tests; visual inspection, bubble leak or dye penetration testing, and seal (peel) strength testing.
FDA要求进行包装完整性测试，以确认包装在严格的运输配送过程中保持无菌屏障的能力。请提供用来验证包装承受运输分配的严酷性的方法描述。并包括环境条件的描述和用于确定包装完整性的方法/原理。对于包装完整性测试，FDA建议至少进行以下测试：目视检查、气泡泄漏或染料渗透测试和密封（剥离）强度测试。

b. You indicated that 12 samples were tested (Test Reports SL-SBGYR-22-03 and SL-SBGYR-22-06).Please be aware that the number of samples used in package integrity testing should be large enough to provide for statistically significant analysis with a high degree of reliability; for example, 95% confidence at 95% reliability or greater. Please provide scientific justification for the chosen sample size or conduct package integrity testing on a large enough sample size to provide high confidence and reliability that the packaging will maintain the sterile barrier.
您指出已测试了12个样品（测试报告SL-SBGYR-22-03和SL-SBGYR-22-06）(见<Package Verification Test_60ml control ring_updated>)。请注意，包装完整性测试中使用的样品数量应足够大以提供具有统计意义的分析具有高度的可靠性； 例如，在95％或更高的可靠性下具有95％的置信度。 请为选定的样本量提供科学依据，或对足够大的样本量进行包装完整性测试，以提供使包装保持无菌屏障的高置信度和可靠性。

c. If you have not conducted simulated shipping distribution testing followed by appropriate packaging integrity testing, we have the following general recommendations.
如果您还没有进行模拟运输测试，然后再进行适当的包装完整性测试，则我们有以下一般建议。
i. Please be aware that the testing should be conducted on final, finished devices.
测试样品为终灭菌后的样品
ii. For environmental conditioning prior to simulated shipping distribution, test samples should be exposed to different anticipated environmental conditions of cold, hot, and humidity that your device might be exposed to.
为了在模拟运输试验前设置环境条件，应将测试样品暴露于该产品可能暴露的不同预期冷，热和潮湿环境条件下。
iii. Please be aware that the number of samples used in package integrity testing should be large enough to provide for statistically significant analysis with a high degree of reliability; for example, 95% confidence at 95% reliability or greater.
请注意，包装完整性测试中使用的样品数量应足够大，以提供具有高度可靠性的统计显着性分析； 例如，在95％或更高的可靠性下具有95％的置信度。
iv. In addition, device specific performance testing as appropriate should be conducted to determine whether the rigors of shipping and distribution may affect the performance of your device.
此外，应进行特定的性能测试，以确定严酷的运输和发运方式是否会影响产品性能。
1. ISO 11607-1:2006/(R)2010, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems, and packaging systems.
2. ISO 11607-2:2006/(R)2010, Packaging for terminally sterilized medical device – Part 2: Validation requirements for forming, sealing, and assembly processes.
3. ASTM D4332-14, Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
4. ASTM D4169-14, Standard Practice for Performance Testing of Shipping Containers and Systems
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