(30 days)
Steriking Packaging for Medical Devices serve as an enclosure for medical devices during steam sterilization that maintains the sterility of the enclosed medical devices until use of the medical devices with a combined weight of metal and plastics of 2.6 pounds or less. The recommended sterilization cycles are as follows: Pre-vacuum steam at 132oC for 4 minutes; Drying time of 20 minutes Pre-vacuum steam at 1350C for 3 minutes; Drying time of 16 minutes
The Steriking Packaging for Medical Devices consists of a paper backing (Bleached wood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2 sheets of laminated plastic with a total grammage of 55 g/m2, 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper. The open end of the pouch is to be self sealed once a device is inserted. Self-sealable pouches are featured with adhesive strip allowing tight, impermeable closing of a pack. The closing flap is pre-folded to facilitate the closure. When closing the self-seal pouch the paper flap shall be folded along the pre-folded line. Flap should be pressed firmly against the laminate from the centre working outwards to ensure a good, even seal. Dimensional configurations as follows (2 sizes 200mm x 800mm, 250mm x 875mm).
This document is a 510(k) premarket notification for a medical device, which means it's a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission relies on showing equivalence to an existing device rather than presenting new clinical study data with acceptance criteria for a novel AI device.
Therefore, the requested information about acceptance criteria, specific study details (sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details), and ground truth establishment methods is not applicable to this document. This document details the technical characteristics of a sterilization packaging material and its comparison to a predicate device, not the performance of an AI/ML algorithm.
The table for acceptance criteria and reported device performance is presented in the original document as a comparison between the submitted device and its predicate, rather than against specific pre-defined acceptance criteria for an AI model.
Here's a summary of the information provided in the document, framed in the context of device equivalence rather than AI performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comparison table (pages 4-6) showing the technical characteristics of the new device ("Submission Device – Steriking Packaging for Medical Devices") against its predicate device ("Predicate Device – Steriking Packaging for Medical Devices K210810"). This comparison serves as the "acceptance criteria" in the context of a 510(k) submission, where the new device must be substantially equivalent to the predicate. "Reported device performance" here refers to the measured physical and functional properties of the submitted device.
| Comparison Element | Submission Device – Steriking Packaging for Medical Devices | Comparison | Predicate Device – Steriking Packaging for Medical Devices K210810 |
|---|---|---|---|
| Intended Use | To serve as an enclosure for medical devices during steam sterilization that maintains the sterility of the enclosed devices until used. | No Change | To serve as an enclosure for medical devices during steam or gas sterilization that maintains sterility of the enclosed device until used. |
| Design | Pouches plastic film triple heat sealed to paper backing thumb notches chevron-type seal at end for opening Adhesive strip for self seal | Different | Pouches plastic film triple heat sealed to paper backing thumb notches chevron-type seal at end for opening |
| Principle of Operation | Medical device to be sterilized is put into pouch and the open parts of the pouches are closed by self-sealing. Sterilization packages then are subjected to validated sterilization operation of steam. Sterilant penetration is carried out through the medical grade paper into the package and microorganisms on the surface of the medical device are destroyed with the effect of the sterilant process. Other parameters of the sterilization process are temperature, pressure, humidity, time and are determined according to the sterilization type. After the sterilization is completed, the sterility of the enclosed medical device is maintained for 12 months. | Different | Medical device to be sterilized is put into pouch and the open parts of the pouches are closed by heat sealing. Sterilization packages then are subjected to validated sterilization operation of steam. Sterilant penetration is carried out through the medical grade paper into the package and microorganisms on the surface of the medical device are destroyed with the effect of the sterilant process. Other parameters of the sterilization process are temperature, pressure, humidity, time and are determined according to the sterilization type. After the sterilization is completed, the sterility of the enclosed medical device is maintained for 12 months. |
| Dimensions | 200mm x 800mm, 250mm x 875 mm | Different | 200mm x 800mm, 250mm x 900 mm |
| Backing Paper | Bleached wood pulp, grammage: 100g/m2 | No Change | Bleached wood pulp, grammage: 100 g/m2 |
| Tensile Strength MD-kNm | >66 N/15mm | No Change | >66 N/15mm |
| Tensile Strength CD-kNm | >33 N/15mm | No Change | >33 N/15mm |
| Tear Strength MD-mN | >550 Nm | No Change | >550 Nm |
| Tear Strength CD-mN | >550 Nm | No Change | >550 Nm |
| Burst Strength-kPa | >230 kpa | No Change | >230 kpa |
| Porosity ISO 5636-3 ISO 5636-5 | 3.9 – 5.7 µm/Pa·s 24-34 s | No Change | 3.9 – 5.7 µm/Pa·s 24-34 s |
| Seal Strength – N/mm | Peel ≥ 1.5 N/15mm | No Change | Peel ≥ 1.5 N/15mm |
| Transparent Film | Two sheets of laminated plastic with a total grammage of 55 g/m2. One sheet of oriented polyester 12 microns thick. One sheet of coextruded polypropylene 40 microns Thick. | No Change | Two sheets of laminated plastic with a total grammage of 55 g/m2. One sheet of oriented polyester 12 microns thick. One sheet of coextruded polypropylene 40 microns Thick. |
| Sterilization Properties | Steam sterilization conditions are 4 minutes at 132° C or 3 minutes at 135° C | No Change | Steam sterilization conditions are 4 minutes at 132° C or 3 minutes at 135° C |
| Sterilant Penetration | Full-cycle steam sterilization process will produce sufficient lethality to achieve a 12-log reduction, thus providing a 10-6 Sterility Assurance Level (SAL) | No Change | Full-cycle steam sterilization process will produce sufficient lethality to achieve a 12- log reduction, thus providing a 10-6 Sterility Assurance Level (SAL). |
| Material Compatibility | Compatible with Steam Sterilization | No Change | Compatible with Steam Sterilization |
| Package Integrity Test | Closure integrity maintained before and after steam sterilization | No Change | Closure integrity maintained before and after steam sterilization |
| Maintenance of Sterility — Shelf life post sterilization | 12 months | No Change | 12 months |
| Shelf Life - Pre-sterilization | 5 years | No Change | 5 years |
| Drying Time | 20 minutes | No Change | 20 minutes |
| Microbial Barrier Properties | The paper of the sterile barrier system was examined on the packaging outer side for its germ proofness with air permeance after steam sterilization and is evaluated as "sufficiently germ-proof" | No Change | The paper of the sterile barrier system was examined on the packaging outer side for its germ proofness with air permeance after steam sterilization and is evaluated as "sufficiently germ-proof" |
| Biocompatibility | Non-Cytotoxic | No Change | Non-Cytotoxic |
The following points are N/A (Not Applicable) as the document describes a traditional medical device (sterilization packaging) and not an AI/ML powered device.
- Sample sizes used for the test set and the data provenance: N/A
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: N/A
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A
- The sample size for the training set: N/A
- How the ground truth for the training set was established: N/A
§ 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).