(312 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 heat sealed once a device is inserted. Heat sealing parameters to provide a sterile barrier are 165oC-200oC (329oF-392oF).
Steriking Packaging for Medical Devices maintains the sterility of the enclosed devices for up to 12 months post Steam sterilization and before sterilization has a maximum shelf life of 5 years from the date of manufacture. Steriking Packaging for Medical Devices Dimensional configurations (2 sizes 200mm x 800mm)
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 heat sealed once a device is inserted. Heat sealing parameters to provide a sterile barrier are 165°C – 200°C (329°F - 392°F) Dimensional configurations as follows (2 sizes 200mm x 800mm, 250mm x 900mm).
The provided document is a 510(k) Premarket Notification summary for "Steriking Packaging for Medical Devices." It details the device's characteristics, indications for use, comparison to a predicate device, and the results of non-clinical testing to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided text, formatted to address your specific points.
The document describes pre-market testing of a medical device packaging system, not an AI/ML-driven device. Therefore, many of the questions related to AI/MRMC studies, training sets, and expert consensus for ground truth are not applicable to this kind of submission. I will address the applicable parts of your request.
Acceptance Criteria and Device Performance for Steriking Packaging for Medical Devices
The study proves that the device meets its acceptance criteria through a series of non-clinical performance tests, designed to demonstrate the safety and effectiveness of the packaging for maintaining sterility of medical devices after steam sterilization.
1. A table of acceptance criteria and the reported device performance
The document provides a detailed table within the "Summary of Non-Clinical Testing" section. This table lists the test methodology, purpose, acceptance criteria, and the results (which are uniformly "Pass" or specific measurements that meet the criteria).
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 14477 - Packaging. Flexible packaging material. Determination of puncture resistance. | Puncture Resistance | No pass/fail criteria (Note: This is unusual for an acceptance criterion, but listed as such in the document) | Acceptable => 13.1N |
| ASTM F1929-15 "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration" | |||
| EN 868-5 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods | |||
| ISO 5636-3 Paper and board — Determination of air permeance | SHELF LIFE Prior to Sterilization | Seal Strength: =>1.5N/15mm | |
| Seal Integrity: No dye leaks | |||
| Air Permeability: =>3.4um/Pa | |||
| Peel Properties: free of fibers after peeling | Pass | ||
| AAMI TIR 12:2010, Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Medical Device Manufacturers | Sterilant Penetration & Drying Time | Biological indicator 6-log reduction in half cycle providing 10-6 SAL | |
| Drying time post sterilization moisture content weight gain 20N/15mm |
- =>66N/15mm
- =>33N/15mm
- =152 +/- 10% μm
-
550mN (MD & CD)
-
10N
-
230kPa
- 3.9 – 5.7 µm/PAS
- Corresponds
- 1.5N/15mm
- No irregularities or splitting >10mm
- evaluation grade = 5
- No objections
- No pinholes | Pass |
| ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Biocompatibility | If viability is reduced to 1.5N/15mm | Pass |
| ASTM F1929 - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | Package Integrity | No dye penetration/channeling travelling full width of seal in ~5 seconds | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. This type of information is typically found in the full test reports referenced by the standards, not in the summary.
Data Provenance: The manufacturing entity is Wipak Oy in Nastola, Finland, indicating the origin of the device. The testing was non-clinical (laboratory/material testing) rather than clinical data from human subjects. Therefore, terms like "retrospective" or "prospective" and "country of origin of the data" in the sense of patient data are not applicable. The testing was performed according to international standards (e.g., ISO, ASTM, EN, DIN), which are universally recognized.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a medical packaging product, and its "ground truth" is established through physical and material science testing against recognized international engineering and materials standards (e.g., ISO, ASTM). These tests do not involve expert human interpretation in the way, for example, a diagnostic imaging AI would. The "ground truth" is determined by the objective measurements and criteria defined in the specific test methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used in studies involving human readers or subjective interpretations, such as clinical trials or diagnostic accuracy studies. For material and physical properties testing, the results are objectively measured against predefined scientific criteria, not adjudicated.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. The submission is for a medical device packaging material, not an AI or imaging device that would involve human readers or comparative effectiveness studies of diagnostic performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is physical packaging, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established by objective measurements of physical, chemical, and biological properties against established industry and international standards (e.g., seal strength, microbial barrier, puncture resistance, sterility assurance level, material compatibility, cytotoxicity). This is based on scientific and engineering principles, not expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
This question is not applicable. "Training set" refers to data used to train machine learning models. This submission is for a physical medical device packaging product, not an AI/ML device.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set mentioned or relevant to this type of device submission.
§ 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).