(283 days)
Steriking® Pouch for Robotic Instruments serve as an enclosure for Intuitive Endowrist Robotic Instruments during steam sterilization that maintains the sterility of the enclosed medical devices until they are used.
Pouches are intended for use as packaging material of Intuitive Endowrist Robotic Instruments for steam sterilization in health care establishments. The products are for single use only. The pouches allow sterilization, mamtain sterility and enable aseptic presentation of packed medical device.
The recommended sterilization cycles are as follows: Pre-vacuum steam at 132ºC for 4 minutes; Drying time of 20 minutes Pre-vacuum steam at 135℃ for 3 minutes: Drying time of 16 minutes
The maximum load for the Steriking® Pouch for Robotic Intuitive Endowrist Robotic Instrument or other medical devices with a combined weight of metal and plastics of 2.6 pounds or less.
Steriking® Pouch for Robotic Instruments consist 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.
Steriking® Pouch for Robotic Instruments consists of pouch sizes that can be heat sealed, and pouch sizes that are selfsealed.
For heat-sealed sizes: 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).
Steriking® Pouch for Robotic Instruments have Dimensional heat-seal configurations (2 sizes 200mm x 800mm, 250mm x 900mm).
Steriking® Pouch for Robotic Instruments with heat-seal maintains the sterility of the enclosed devices for up to 1 year post Steam sterilization and before sterilization has a maximum shelf life of 5 years from the date of manufacture.
For self-sealed sizes: 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 flap is pre-folded to facilitate the closure. When closing the self-seal pouch the paper flap shall be folded line. Flap should be pressed firmly against the laminate from the center working outwards to ensure a good, even seal.
Steriking® Pouch for Robotic Instruments have Dimensions (2 sizes 200mm x 800mm x 800mm x 875mm).
Steriking® Pouch for Robotic Instruments with self-seal maintains the sterility of the enclosed devices for up to 1 year post Steam sterilization and before sterilization has a maximum shelf life of 3 years from the date of manufacture.
The provided text describes the acceptance criteria and the results of performance tests for the "Steriking® Pouch for Robotic Instruments". However, it does not include information about any AI-powered function, a "study that proves the device meets the acceptance criteria" in the context of an algorithm's performance, or details regarding ground truth establishment, expert involvement, or sample sizes related to AI/algorithm development.
The document is a 510(k) Premarket Notification from the FDA for a medical device (sterilization pouch), which is a physical product, not a software or AI device. Therefore, the questions about AI, algorithms, ground truth, expert consensus, and training/test set sizes are not applicable to this document.
Here's a summary of the available information regarding acceptance criteria and performance, as it relates to a physical medical device.
1. Table of acceptance criteria and the reported device performance:
| Element | Standard Reference | Acceptance Criteria | Results |
|---|---|---|---|
| Sterilant Penetration | AAMI TIR 12:2020 | Demonstrates that a minimum of 1.0x10^6 Geobacilus stearothermophilus spores were killed in a half-cycle (6-log reduction) | Pass |
| Drying Time | ISO 17665-1: 2006/2016 | Test samples do not exceed a 3% weight gain | Pass |
| Material Compatibility | EN 868-5: 2009 4.2.2.1, Annex B | no objections | Pass |
| EN 868-5: 2009 4.2.2.1, Annex C | no pinholes | No result listed, but "Pass" can be inferred from conclusion. | |
| ASTM D 882:2012, procedure A | >= 20 N/15 mm | No result listed, but "Pass" can be inferred from conclusion. | |
| ISO 1924-3 | > 66 N/15 mm | No result listed, but "Pass" can be inferred from conclusion. | |
| > 33 N/15 mm | No result listed, but "Pass" can be inferred from conclusion. | ||
| Internal Method | 152 μm +/- 10% | No result listed, but "Pass" can be inferred from conclusion. | |
| ISO 1974 | > 550 N | No result listed, but "Pass" can be inferred from conclusion. | |
| DIN 53363 | > 10 N | No result listed, but "Pass" can be inferred from conclusion. | |
| ISO 2758 | > 230 kPa | No result listed, but "Pass" can be inferred from conclusion. | |
| ISO 5636-3 | >=3.9 - 5.7 μm/Pa•s | No result listed, but "Pass" can be inferred from conclusion. | |
| Puncture Resistance | ISO 14477 | Internal protocol, Accepted by Sponsor | Pass |
| Package Integrity | ASTM F1929 - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | No leaks detected after dye migration | Pass |
| Microbial Barrier Properties | DIN EN ISO -11607-1:2017-10 Section 5.1.6. a) microbial barrier; DIN 953-6, section 4.8.6. | Evaluated as "sufficiently germ-proof" | Pass |
| Shelf Life Prior to Sterilization | ASTM F1929-15 | No leaks detected after dye migration | No result listed, but "Pass" can be inferred from conclusion. |
| EN 868-5 Packaging for terminally sterilized medical devices — Part 5 | >= 1.5 N/15 mm | Pass | |
| ISO 5636-3 Paper and board — Determination of air permeance | >=3.4 μm/Pa •s | No result listed, but "Pass" can be inferred from conclusion. | |
| ASTM F1980 - 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | Executed as per standard, No Acceptance Criteria | No result listed, likely because it's a guide, not a pass/fail test. | |
| Shelf Life Post sterilization | ASTM F1929-15 | No leaks detected after dye migration | Pass |
| ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials | >= 1.5 N/15 mm | No result listed, but "Pass" can be inferred from conclusion. | |
| Biocompatibility | ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | Not greater than Grade 2 reactivity (mildly reactive) | Pass |
| Evidence that printing ink on paper material does not leach into the interior of the pouch | DIN EN 646 | 5 Evaluation grades | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes used for each test. The data provenance is not explicitly stated, but the submission is from Wipak Oy, Nastola, Finland, suggesting the testing was conducted or overseen by this company. The tests are for device performance, not a dataset in the context of an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is a physical medical device; the performance tests are based on established international and national standards for sterilization packaging, not on expert interpretation or ground truth derived from clinical data in the way an AI algorithm would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is for a physical medical device, not an algorithm where adjudication of results would be relevant.
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:
Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device's performance is objective measurement against established industry standards and regulations for sterilization, package integrity, microbial barriers, and biocompatibility.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device, not an AI algorithm.
§ 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).