(238 days)
Safe Secure Paper Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:
- Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time .
- Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time .
- . Pre-vacuum steam at 134°C (273°F) for 3 minutes; 20 minutes dry time
- . Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
- . Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃ (140°F).
The device is not intended and has not been validated for sterilization of devices that contain lumens.
The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed devices. The chemical indicators change from green to purple after exposure to steam and from yellow to brown after exposure to ethylene oxide.
The Tyvek version of the pouch is for EO sterilization only.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10 4). The subject device is intended and has been validated to maintain sterlity of the enclosed devices for 6 months after steam sterilization and 24 months after EO sterilization.
The maximum validated pouch load is 2.64 pounds (1.2kg).
The Safe Secure Sterilization Pouches are made from either a medical grade porous paper or Tyvek thermally sealed to a plastic film on the left, right, and bottom of the pouch. The top side is open in order to receive the medical device to be sterilized and to seal the pouch. They are available either pre-manufactured self-seal or heat-seal sizes or in a roll of heat-seal tubing for the customer to cut the pouches to their required size.
The base model numbers for the subject device are described as follows, where the last three letters corresponds to the type of material:
- ABSST - Self seal Tyvek
- ABHST Heat seal Tyvek .
- ABHSP Heat seal paper ●
- ABSSP Self seal paper .
The pouches also contain external chemical indicators used to indicate that the pouches have been processed by either a steam or ethylene oxide sterilization process.
The medical grade paper versions can be used in either gravity steam, pre-vacuum steam, or ethylene oxide (EO) sterilization cycles. The Tyvek version is only for EO sterilization.
The document describes the Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators, and its substantial equivalence to a predicate device (K112591). It details the device's indications for use, material composition, and performance testing.
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria and reported device performance" as a distinct section. However, it provides a "Substantial Equivalence Table" (starting on page 9) that compares various characteristics of the subject device to its predicate. This table implicitly highlights the acceptance criteria by stating how the subject device performs compared to the predicate, often indicating "Same" or "Substantially Equivalent."
Below is a consolidated table based on the information provided in the "Substantial Equivalence Table" and the "Functional Testing" section. The "Acceptance Criteria" column is inferred from the values or descriptions given for the predicate and often directly matched by the subject device. The "Reported Device Performance" column reflects the subject device's characteristics.
| Item No. | Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|---|---|
| 1 | 510(k) Number | K1125591 | TBD (Assigned K153540 later) |
| 2 | Manufacturer | Safe Secure Packaging (Shenzhen) Co., Ltd | Safe Secure Packaging (Shenzhen) Co., Ltd |
| 3 | Model Numbers | ABHSP, ABSSP | ABHSP, ABSSP, ABHST, ABSST |
| 4 | Classification | Class II | Class II |
| 5 | Product Code | FRG | FRG |
| 6 | Regulation | 21 CFR 880.6850 | 21 CFR 880.6850 |
| 7 | Indications for Use | Sterilization by gravity steam (121°C/30 min) and EO (735mg/L at 55°C/60 min). External chemical indicators change color; maintains sterility (SAL=10^-6). | Sterilization by gravity steam (121°C/30 min), pre-vacuum steam (132°C/4 min, 134°C/3 min, 135°C/3 min), and EO (735mg/L at 55°C/60 min). External chemical indicators change color; maintains sterility (SAL=10^-6), Tyvek for EO only. Max validated pouch load 2.64 lbs (1.2kg). For products without lumens. |
| 8 | Material Composition | Porous paper or Tyvek, PET/CPP high-temperature blue compound film, High temperature adhesive paper, Medical Double Side Tape, EO gas indicator ink, Steam indicator ink. | Porous paper or Tyvek, PET/CPP high-temperature blue compound film, High temperature adhesive paper, Medical Double Side Tape, EO gas indicator ink, Steam indicator ink. |
| 9 | Pouch Dimensions (Nominal) | Length: 2 to 20 inches; Width: 8 to 30 inches | Length: 2 to 20 inches; Width: 8 to 30 inches |
| 10 | Roll Dimensions | Width: 8 to 30 inches | Width: 8 to 30 inches |
| 11 | Air Permeance | Maximum equivalent pore size diameter shall not exceed 50µm. | Maximum equivalent pore size diameter shall not exceed 50µm. |
| 12 | Shelf Life | 5 years before sterilization; 6 months after gravity steam sterilization or 24 months after EO sterilization. | 5 years before sterilization; 6 months after steam sterilization (gravity or pre-vacuum) or 24 months after EO sterilization. |
| 13 | Paper and Film Thickness & Density | Paper: ±2 gm/m²; Film: +0.002 mm; Tyvek: ±2 gm/m² | Paper: ±2 gm/m²; Film: +0.002 mm; Tyvek: ±2 gm/m² |
| 14 | Seal Strength before sterilization | 2.5 to 5.5 N/15mm | 2.5 to 5.5 N/15mm |
| 15 | Seal Strength after steam sterilization | 2.5 to 5.5 N/15mm | > 1.5 N / 15mm |
| 16 | Seal Strength after EO sterilization | 2.5 to 5.5 N/15mm | > 1.5 N / 15mm |
| 17 | Burst Strength | 2.5 to 5.5 N/15mm | 2.5 to 5.5 N/15mm |
| 18 | Peel-Open | No splitting of paper more than 10mm from heat seal lines. | No splitting of paper more than 10mm from heat seal lines. |
| 19 | Tensile Strength | Paper: > 220 N/50mm; Film: > 550 N/50mm; Tyvek: > 250 N/50mm. | Paper: > 220 N/50mm; Film: > 550 N/50mm; Tyvek: > 250 N/50mm. |
| 20 | Seal Integrity | Visual examination of the seal area through the transparent side of the package shows no channels present. | Visual examination of the seal area through the transparent side of the package shows no channels present. |
| 21 | Seal Width | More than 8mm | More than 8mm |
| 22 | Limits for acidity or alkalinity | The PH value of an extract prepared shall be within one PH unit of that of the control fluid. | The PH value of an extract prepared shall be within one PH unit of that of the control fluid. |
| 23 | Limits for extractable metals | Shall not contain greater than a combined total of 5 mg/ml of lead, zinc, or iron. | Shall not contain greater than a combined total of 5 mg/ml of lead, zinc, or iron. |
| 24 | EO Residual Limits | Less than 1 mg/pouch/day | Less than 1 mg/pouch/day |
| 25 | Chemical Process Indicators | For Steam: Green to Purple. For EO: Yellow to Brown. | For Steam: Green to Purple. For EO: Yellow to Brown. |
Summary of Device Performance: The "Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators" generally meets the same criteria as its predicate device. The primary changes in the subject device are the expansion of available model numbers to include Tyvek versions (specifically for EO sterilization) and additional pre-vacuum steam sterilization cycles. For most physical and chemical properties, the acceptance criteria are met by matching the predicate's performance. For "Seal strength after steam sterilization" and "Seal strength after EO sterilization," the acceptance criteria shifted from "2.5 to 5.5 N/15mm" to "> 1.5 N / 15mm", still indicating a performance deemed "Substantially Equivalent."
2. Sample Size Used for the Test Set and Data Provenance
The document states that "testing was conducted in accordance with ASTM and ISO standards relating to sterile packaging of medical devices" and "bench performance tests were performed." However, specific sample sizes for these tests (test sets) are not provided in this summary.
Regarding data provenance:
- Country of Origin of the Data: Not explicitly stated, but the submission sponsor and manufacturer are "Safe Secure Packaging (Shenzhen) Co., Ltd" in China. It is reasonable to infer that the testing data originated from or was managed by this entity, potentially through a testing lab.
- Retrospective or Prospective: The testing described (functional testing, biocompatibility, accelerated aging, validation of sterilization cycles) is typically prospective as it's conducted to demonstrate the performance of the device for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The tests described are largely objective physical, chemical, and biological tests (e.g., seal strength, air permeance, sterilization indicator function, biological indicator tests) performed against established industry standards (ASTM, ISO). These types of tests typically do not involve human experts establishing a "ground truth" in the same way clinical image analysis would. Instead, their results are measured against predefined specifications or pass/fail criteria derived from these standards.
4. Adjudication Method for the Test Set
Given the nature of the tests (bench performance, physical, chemical, biological tests), an "adjudication method" as typically understood in studies involving human interpretation (e.g., 2+1, 3+1 for clinical reads) is not applicable or mentioned. The results of the tests would be objectively measured and compared against specified acceptance 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 relevant for diagnostic devices where human readers interpret data, often with and without AI assistance, to measure changes in reader performance. The "Safe Secure Sterilization Pouch" is a sterilization packaging device, not a diagnostic device involving human interpretation of medical images or data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical sterilization pouch and not an AI algorithm. The performance evaluation focuses on the pouch's physical, chemical, and functional attributes, not on an algorithm's standalone performance.
7. The Type of Ground Truth Used
For the various tests conducted:
- Physical and Chemical Tests (e.g., Seal Strength, Air Permeance, Dimensions, Acidity, Metals, EO Residual): The "ground truth" is established by the specified ISO/ASTM standards and internal specifications derived from these standards. These are objective measurements compared against quantitative limits.
- Sterilization Indicator Test: The "ground truth" is the visually observable color change (Green to Purple for Steam, Yellow to Brown for EO) as specified, which indicates exposure to the sterilization process.
- Biological Indicator Test: The "ground truth" for sterilization effectiveness is typically the absence of microbial growth after exposure to the sterilization process, demonstrating a Sterility Assurance Level (SAL) of 10^-6.
- Shelf-life Tests: The "ground truth" is the maintenance of specified physical, chemical, and sterility properties over the stated shelf-life durations (6 months after steam, 24 months after EO, 5 years before sterilization) as determined by various challenge tests and aging studies.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical sterilization pouch and does not involve machine learning or a "training set" in the context of AI/algorithms.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
§ 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).