(266 days)
Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:
A) Pre-vacuum Steam: 134℃ for 4 minutes, 30 minutes dry time.
B) Ethylene Oxide Sterilization: 100% Ethylene Oxide (EO) with a concentration of 360-363 mg/L @ 54°C and 40% relative humidity for 480 minutes, 24 hours aeration time at 42 ℃
Model: ZSW1610, ZSW 1611. Material: 45gms SMS, 54gms SMS. Color of wrap: Pink/Blue (double layers). Size (inches): 1212, 1515, 1818, 2020, 2424, 3030, 3636, 4040, 4545, 4848, 5454, 7254.
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post sterilization.
Types of medical devices to be sterilized in the Pre-Vacuum Steam Sterilization and Ethylene Oxide Sterilization: General purpose non-lumened reusable metal and nonmetal devices with stainless steel diffusion restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments etc. Models validated for both sterilization methods with stainless steel as part of the load, which with a maximum weight of each types, range from 21bs to 9lbs, which dependent on each model's size.
For size212, 1515, 1818, maximum weight is 216, for 2020, 3636, 4040, 4545, 4848, maximum weight is 6lb, and for 5454, 7254, maximum weight is 9lb.
Sterilization Wrap is square or rectangular three-layer (SMS) non-woven sheet which manufactured with Polypropylene spunbond-meltblown-spunbond (SMS) fabric. Sterilization wrap provides a strong barrier which protects against cuts, tears with particularly device sets. The device is designed to be implemented as an outer sterilization wrap which allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post Pre-Vacuum Steam Sterilization or Ethylene Oxide Sterilization.
Sterilization Wrap is two-layer sheet which ultrasonically bonded blue and pink nonwoven sheet together along two edges, thus for convenient simultaneous wrapping.
Sterilization Wrap separated into two distinct types depending on different grams of weight of material, for ZSW 1610, it is two 45gsm SMS non-woven sheet ultrasonically bonded together, and for model ZSW 1611, it is two 54gsm SMS sheet. Each model contains series specification, including 12 Sizes (inches): 1212, 1515, 1818, 2020, 2424, 3030, 3636, 4040, 4545, 4848, 5454, 7254. With non-lumened reusable metal and nonmetal devices as part of the load, which with a maximum weight of each type, range from 21bs to 9lbs, which dependent on each model's size.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a Sterilization Wrap (K223600).
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
The document presents the acceptance criteria and device performance as "Test Items" and "Test Result" (always "Pass"). The specific numerical/quantitative acceptance criteria are listed under "Standard and Acceptance Criteria".
| Test Items | Standard and Acceptance Criteria | Reported Device Performance (Test Result) |
|---|---|---|
| Size and Gram weight | ASTM D3776M-20: Standard Test Methods for Mass Per Unit Area (Weight) of Fabric | |
| Size: Marking dimension tolerance ±10%; Weight: Marking gram tolerance ±2g/m² | Pass | |
| Bacterial Filtration Efficiency (BFE) | ASTM F 2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus | |
| BFE ≥ 90% | Pass | |
| Hydrostatic Pressure | AATCC 127-03 Test Method for Water Resistance: Hydrostatic Pressure | |
| Hydrostatic Pressure ≥ 50 cm H2O | Pass | |
| Tensile Strength | ASTM D5034-09 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) | |
| MD≥ 90N; CD≥ 63N | Pass | |
| Air Permeability | ASTM D737-18 Standard Test Method for Air Permeability of Textile Fabrics | |
| Air Permeability ≥ 30 cfm | Pass | |
| Bursting Strength | ASTM D3786-18 Standard Test Method for Bursting Strength of Textile Fabrics—Diaphragm Bursting Strength Tester Method | |
| Bursting Strength ≥ 130 kpa (18.86psi) | Pass | |
| Tearing Strength | ASTM D5587-15 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure | |
| MD≥ 50N; CD≥ 30N | Pass | |
| Lint Generation | ISO9073-10: 2019 Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state | |
| Coefficient of linting ≤4.0 | Pass | |
| Skin Irritation AND Skin Sensitization | ISO 10993-1, ISO 10993-5, ISO 10993-10:2010. | |
| "Under the conditions of the study, the test article (pouches and chemical indicator) extract did not show no significant evidence of causing skin sensitization in the guinea pig before and after sterilized." | Pass | |
| Shelf-Life Validation | Shelf Life Validation Test: Real time aging method. | |
| Shelf Life: 2 Years; Shelf Life after Sterilized: 90 days. | ||
| The device performance shall be meet the requirements of the device. SAL=10-6. | Pass | |
| Sterilization Process Validation for EO | ISO11135: 2014 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process. | |
| Ethylene Oxide Sterilization: 100% Ethylene Oxide (EO) with a concentration of 360-363 mg/L @ 54°C and 40% relative humidity for 480 minutes, 24 hours aeration time at 42 °C. | ||
| The device performance shall be meet the requirements of the device with the worst loading, SAL=10-6. | Pass | |
| Sterilization Process Validation for Steam | AAMI / ANSI ST79: 2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities and ISO 17665-1:2006. | |
| Pre-vacuum Steam: 134°C for 4 minutes, 30 minutes dry time. | ||
| The device performance shall be meet the requirements of the device with the worst loading, SAL=10-6. | Pass | |
| Material compatibility | After Pre-vacuum Steam or 100% Ethylene Oxide (EO) sterilization, the materials were not degraded. Performance test including: Size and Gram weight, Bacterial Filtration Efficiency (BFE), Hydrostatic Pressure, Tensile Strength, Air Permeability, Bursting Strength, Tearing Strength, Lint Generation should meet requirements. | Pass |
| EO/ECH residue | ISO 10993-7: 2008 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals | |
| EO≤4mg/d, ECH ≤9mg/d | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each of the non-clinical tests. It only states that the tests were conducted and "all results can meet standards requirements" or "Passed".
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective for each specific test. However, the submitter is "Wuhan Zonsen Medical Products Co., Ltd." located in Wuhan, Hubei, China, which implies the testing likely occurred in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device is a medical accessory (sterilization wrap) and the validation involves non-clinical laboratory and performance testing, not expert interpretation of medical images or data requiring ground truth establishment by medical experts. The "ground truth" for this device's performance is established by meeting the specified international and national standards for physical properties, sterilization efficacy, and biocompatibility.
4. Adjudication method for the test set
This information is not applicable for the type of testing performed for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple readers for diagnostic accuracy, which is not relevant here.
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 information is not applicable. The device is a sterilization wrap, not an AI-powered diagnostic tool. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. As stated above, this is a physical medical accessory, not an algorithm or software device.
7. The type of ground truth used
The "ground truth" for this device's performance is based on established international and national standards for medical device physical properties, biocompatibility, and sterilization process validation (e.g., ASTM, AATCC, ISO standards). The "truth" is whether the device's measured properties and performance meet the predefined thresholds set by these standards.
8. The sample size for the training set
This information is not applicable. This is a physical medical device that undergoes manufacturing and quality control testing, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information 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).