醫療器械FDA注冊審核官提問

FDA S001 Review Questions:

Issued: 2020-05-08

FDA答復截止日期: 2020-11-05

IRC要求答復日期: 2020-10-01前

K200557

Enteral Feeding Syringes with ENFit connector

Model: 10ml, 60ml control ring

Sterility/Shelf Life滅菌和貨架周期

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.

您提供了包裝完整性測試和加速老化測試報告摘要。但是，這些信息并不清楚，FDA無法驗證您是否執行了模擬分布測試。如2016年FDA無菌指南提交和上市前通知（510（k））無菌信息審查中所述，FDA建議包裝測試方法包括模擬分布和模擬（和/或實時）老化隨后進行相關包裝測試，以驗證包裝完整性和保質期要求。FDA需要這些信息來確保你的設備能夠經受住運輸配送的嚴格考驗。請答復以下提問：

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要求進行包裝完整性測試，以確認包裝在嚴格的運輸配送過程中保持無菌屏障的能力。請提供用來驗證包裝承受運輸分配的嚴酷性的方法描述。并包括環境條件的描述和用于確定包裝完整性的方法/原理。對于包裝完整性測試，FDA建議至少進行以下測試：目視檢查、氣泡泄漏或染料滲透測試和密封（剝離）強度測試。

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.

您指出已測試了12個樣品（測試報告SL-SBGYR-22-03和SL-SBGYR-22-06）(見<Package Verification Test_60ml control ring_updated>)。請注意，包裝完整性測試中使用的樣品數量應足夠大以提供具有統計意義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。 請為選定的樣本量提供科學依據，或對足夠大的樣本量進行包裝完整性測試，以提供使包裝保持無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.

如果您還沒有進行模擬運輸測試，然后再進行適當的包裝完整性測試，則我們有以下一般建議。

                          i.          Please be aware that the testing should be conducted on final, finished devices.

測試樣品為Zui終滅菌后的樣品

                         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.

為了在模擬運輸試驗前設置環境條件，應將測試樣品暴露于該產品可能暴露的不同預期冷，熱和潮濕環境條件下。

                        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.

請注意，包裝完整性測試中使用的樣品數量應足夠大，以提供具有高度可靠性的統計顯著性分析； 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，應進行特定的性能測試，以確定嚴酷的運輸和發運方式是否會影響產品性能。

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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