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510(k) Data Aggregation
(51 days)
Sterilization Wraps is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
• Pre-vacuum steam at 270°F/132°C for 4 minutes
Types of medical devices to be sterilized in the pre-vacuum cycle:
General purpose reusable metal and nonmetal devices(No lumen) including devices with stainless steel diffusionrestricted spaces such as forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
The size of the Devices to be sterilization Wraps pack and form a closed space. Validated for dry time is 30 minutes for Sterilization Wraps.
Color of wrap: Blue Size of wrap: 48 in x 48 in
The maximum validated weight of load for Sterilization Wraps is 12kg.
The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.
Sterilization Wraps is a 63gsm, latex-free, 3-layer (SMS) non-woven sterile wrap, manufactured with spun-bonded / meltblown polypropylenem. Sterilization Wraps provides a strong barrier which protects against cuts, tears with particularly heavy orthopedic sets. Sterilization Wraps is designed to be implemented as an outer sterilization wrap which can be used in combination with Clinipak choice. Sterilization Wraps is made of polypropylene and blue pigment by non-woven process.
The provided document describes the acceptance criteria and the results of the study for the Sterilization Wraps device (K220133). This is a non-clinical study focused on the physical and biological characteristics of the wrap, rather than a clinical study involving human or AI performance.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by meeting the requirements of recognized industry standards. The study demonstrates that the proposed device complies with these standards.
| Study/Test | Standard(s) Used | Description/Criteria (Acceptance Criteria) | Reported Device Performance (Results) |
|---|---|---|---|
| Sterilization Validation - Steam PREVACUUM | ANSI AAMI ISO 17665-1:2006/(R)2013 | A method of steam sterilization was validated to a sterility assurance level (SAL) of 10^-6 | Pass |
| Sterilant Penetration - Steam PREVACUUM | ANSI AAMI ISO 17665-1:2006/(R)2013 | The testing details the methods used in determining the internal temperature profile for wrapped sterilization packs when processed in a steam sterilization pre-vacuum cycle at 132°C (270°F) for four (4) minutes exposure. | Testing has demonstrated adequate sterilant penetration |
| Validation - Dry Time | ANSI AAMI ISO 17665-1:2006/(R)2013 | Determining the proper drying time required | Test samples meet or exceed the minimum criteria for dry time. |
| 90 Day Real Time Maintenance of Sterility Validation -Steam PREVACUUM | AATCC 127-18, ISO 11607:2019, ASTM D3776/D3776M, ASTM D3786/D3786M-18 | The study details the methods used in verifying the test samples can maintain the integrity of its contents for an extended period of time following exposure to a steam sterilization process. | No growth |
| Package Integrity Test - Steam PREVACUUM | ASTM D5587-15, ASTM D5034-2009, ASTM D737-18, ASTM F2101-14, AATCC 127-18, ISO 11607:2019, ASTM D5587-15, ASTM D5034-2009 | The testing details the methods of the test sample in maintaining package integrity. The purpose of the physical properties testing was to demonstrate passing results for the physical properties (contain Hydrostatic pressure, Weight, Bursting Strength, Tear Resistance, Tensile Strength ) for the wrap. | The subject wrap, were found to be effective barriers when processed in a Steam Pre-Vacuum cycle. The physical properties testing met the acceptance criteria and demonstrated passing results. |
| Bacterial Filtration Efficiency (BFE) of Non-Woven Sterilization Wrap When Processed In a Steam Sterilization Cycle | ISO 11607:2019, ASTM F2101-14 | BFE testing is a type of test used to determine the efficiency of filter materials to provide protection against microbial organisms. | Pass |
| Dimension testing | ISO 11607:2019 | 48 in X 48 in (This is the specified dimension, implying it's the acceptance criterion) | Pass |
| Weight testing | ASTM D3776/D3776M | According to the standard test, the weight should meet the requirements | Pass |
| Air Permeability Test | ASTM D737 | Air permeability should meet the requirements of ASTM D737. | Pass |
| Shelf Life Testing | AATCC 127-18, ISO 11607:2019, ASTM D3786/D3786M-18, ASTM D5587-15, ASTM D5034-2009, ASTM D737-18, ASTM F2101-14 | Whole package integrity test of real time shelf life samples (The acceptance criterion is implied to be capable of maintaining sterility and package integrity) | Sterilization Wraps was capable of maintaining sterility and package sterilization wrapper) following an approximate 18 month period of real time shelf life prior to being sterilized in the steam sterilization cycles. |
| Cytotoxicity testing | ISO 10993-5: 2009 | No cytotoxic potential | Pass |
| Irritation testing | ISO 10993-10: 2010 | No irritation on the skin | Pass |
| Sensitization testing | ISO 10993-10: 2010 | No skin sensitization | Pass |
Additional Information
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state numerical sample sizes for each test. Instead, it refers to "test samples" or "subject wrap."
- Data Provenance: Not specified, but generally, these types of non-clinical tests are performed in a laboratory setting. There is no information regarding country of origin for the test data, nor if it's retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a non-clinical study involving material and biological performance testing (e.g., sterilization effectiveness, physical properties, biocompatibility). It does not involve "experts" establishing a ground truth in the way a clinical diagnostic study would (e.g., radiologists interpreting images). The "ground truth" is established by the technical specifications and performance requirements outlined in the referenced international standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is a non-clinical performance study against predetermined technical standards, not a diagnostic accuracy study requiring adjudication of interpretations.
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 not a study involving human readers, AI assistance, or diagnostic effectiveness.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical sterilization wrap, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is based on the requirements and methodologies defined by internationally recognized standards (e.g., ISO, ASTM, AAMI, AATCC, USP) for sterilization wraps and medical device packaging. Compliance with these standards serves as the "ground truth" for acceptable performance.
8. The sample size for the training set:
- Not applicable. This is a physical product, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
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