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510(k) Data Aggregation
(158 days)
The Sterilization Trays are designed to hold various dental surgical and prosthetic instruments to organize, steam sterilize and transport the instruments between uses. The kit is to be enclosed in an FDA cleared steam sterilizable pouch large enough to fit a tray, and sterilized in an FDA cleared sterilizer for the following cycles:
- Gravity Steam Cycle – At 132°C for 15 minutes with a 30-minute dry time
- Pre-vacuum Steam Cycle – At 132°C for 4 minutes with a 20-minute dry time
- The kits are intended for sterilization of non-porous loads
- The tested kit represents the worst-case validated load of 497.1 grams
Paragon sterilization trays are divided into the following types:
- Complete Surgical Kit
- Standard Surgical Kit
- Drill Stop Kit
- Prosthetic Kit
The Surgical, Drill Stop, and Prosthetic Kits are reusable perforated instrument cassette systems, composed of an outer case (base), cover (lid), and insert, that is designed to hold dental instruments in place during transport, steam sterilization, and storage. The Surgical Kits are designed to support Paragon implant/prosthetic placement protocols, as well as hold various dental instruments such as: Surgical Drills, Drill Stops, Paralleling Tools, Implant Drivers, Drill Extender, Prosthetic Drivers and Torque Wrenches. The insert contains markings and colors to indicate either the surgical workflow or the position of the instruments within the cassette.
The Standard Surgical Kit includes a removable stainless-steel pan, which functions as a storage receptacle for used surgical instruments.
N/A
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(269 days)
The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for steam sterilization. The recommended sterilization cycle is as follows:
• Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.
The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintain the sterility of the enclosed devices for up to 6 months post steam sterilization. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The steam sterilization indicator color will change from blue before sterilization to dark grey after sterilization.
The subject Sterilization Pouch and Roll device has five types:
(1) Self-sealing sterilization pouches:
These pouches are made from a medical grade plastic film that is heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.
(2) Sterilization pouches, Flat:
These pouches have the same components with the Self-sealing sterilization pouches, except the fourth side is left opened instead of an adhesive strip and will be heat-sealed when using.
(3) Sterilization pouches, Gusseted:
These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
(4) Sterilization rolls, Flat:
These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.
(5) Sterilization rolls, Gusseted:
These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
The Sterilization pouch and roll is composed of medical grade paper (60g/m2) and medical compound film (52μm), it is intended to be used to contain medical devices to be terminally sterilized by the Steam sterilization process. The recommended sterilization cycle parameters are:
Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.
The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.
The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 6 months post sterilization. The shelf life of the device is 3 months.
The Pouch/Roll is printed with a chemical indicator bar that changes from Blue to Dark grey when exposed to steam during the sterilization process. The steam chemical Indicator offers an addition way to verity processing in the sterilization cycle. The endpoint stability of the chemical indicator color change to dark grey is 3 months. The chemical Indicator should be used in addition to, not in place of, the biological indicator. The steam chemical indicator does not signify sterilization; it only indicates that the indicator has been exposed to steam.
The provided FDA 510(k) clearance letter and summary describe a Sterilization Pouch and Roll device, which is a Class II medical device. This is NOT an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, such as effect size of human readers improving with AI, standalone algorithm performance, number of experts for ground truth, and training set information, are not applicable.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (Endpoint) | Reported Device Performance (Results) |
|---|---|---|
| Sterilant Penetration/Drying Time | - Meets the requirement of SAL 10-6- The weight difference before sterilization and after drying shall not exceed 3% | Pass |
| Biocompatibility - Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. Pass |
| Biocompatibility - Irritation | Non-irritating | Under the conditions of the study, not an irritant. Pass |
| Biocompatibility - Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. Pass |
| Package Appearance | The appearance of the sterilization pouch is clean, intact, and sealed on all four sides. | Pass |
| Thickness | 52 ± 12% μm | Pass |
| Tensile Strength of Paper | MD ≥ 4.4 KN/mCD ≥ 2.2 KN/m | Pass |
| Bursting Test | Burst value > 3 Kpa or No Burst | Pass |
| Dye Penetration Test | The dye solution is no any leakage across the seal width of sterile barrier system. (No Infiltration) | Pass |
| Seal Strength Test | ≥ 2.5 N/15mm | Pass |
| Vacuum Leakage Test | No water can penetrate the sterilization pouch. | Pass |
| Microbial Barrier | 0 CFU No growth | Pass |
| Chemical Indicator Functionality | Color of indicator changes from blue to dark grey after Steam sterilization | Pass |
| Chemical Indicator Shelf Life & Endpoint Stability | Shelf life: 3 monthsEndpoint stability: 3 months | Pass |
| Shelf Life (Product) | Shelf life: 3 months | Pass |
| Maintenance of Sterility | Maintains sterility of enclosed devices for up to 6 months post steam sterilization. (This is an indication from the "Indications for Use" and is generally supported by the package integrity and microbial barrier tests over time, often through accelerated aging studies). | The document states "The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 6 months post sterilization." The "Maintenance of Sterility" is listed as a "Different" characteristic compared to the predicate (6 months vs. 3 years for EO and 6 months for Steam). The microbial barrier test is passed, supporting the general concept of sterility maintenance, but the specific validation for the 6-month claim is not detailed in the summary table. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document details various performance tests such as sterilant penetration, biocompatibility, package integrity, and chemical indicator testing. However, it does not explicitly state the sample sizes used for each of these test sets. The tests are "bench testing" (non-clinical) and do not involve human subjects.
The data provenance is from non-clinical bench testing. The tests were performed to evaluate the performance and functionality of the device against a requirement specification. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms are typically relevant for clinical studies or data collection in human populations.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a physical sterilization pouch and roll, and its performance is evaluated through standardized laboratory and bench testing against established physical, chemical, and biological criteria, not by human expert interpretation of data or images. Ground truth is established by objective measurements and standardized test methods.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation relies on objective measurements and established standards rather than expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where human performance with and without AI assistance is being compared. This document is for a physical sterilization product.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. This device is a physical product, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.
7. The Type of Ground Truth Used
The ground truth for this device's testing is based on:
- Standardized Test Methodologies and Acceptance Criteria: As outlined in the "Test Methodology" and "Acceptance Criteria or End Point" columns in Table 3 of the 510(k) summary. These include standards like ISO 17665-1, ISO 10993 series, ASTM F1886, ASTM F2251, ISO 1924-2, ASTM F1140, ASTM F1929, ASTM F88, ASTM D3078, DIN 58953-6, ISO 11140-1, and ASTM F1980.
- Physical and Chemical Measurement: For properties like thickness, tensile strength, burst strength, seal strength, and the color change of the chemical indicator.
- Microbiological Evaluation: For the microbial barrier test (e.g., 0 CFU No growth).
- Biocompatibility Testing: Evaluating potential toxicity, irritation, and sensitization in laboratory settings (e.g., L-929 cells).
- Sterilization Effectiveness: Meeting a specified Sterility Assurance Level (SAL 10-6).
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML component described for this device, so there is no training set in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
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(269 days)
The Sterilization Package/Reel is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: · Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 30 minutes. · Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃(140°F). Furthermore, the Sterilization Package/Reel maintains the enclosed devices up until 6 months post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the Sterilization Package/Reel has undergone either a steam or EO sterilization process. The Sterilization Package/Reel is offered 3 types in the following: Self -Seal Sterilization Pouch; Flat Sterilization Reel; Gusseted Sterilization Reel.
The medical devices are inserted into the Sterilization Package/Reel,sealed, and then sterilized. After completion of the sterilization process, the Pouch/Roll main- tains the sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 6 months post Steam or EO gas sterilization. The Self-seal Sterilization Package permits the sealing of the pouch without the need of heat-sealing equipment, while the Heat-Seal Sterilization Reel are heat-sealed prior to processing in the steam/or EO Sterilization. The chemical indicators ink printed on the "medical dialysis paper" will exhibit a color change after the Package/Reel is exposed to steam or ethylene oxide gas. The color of the Chemical Indicator changes from blue to black when exposed to Steam. And the color changes from pink to yellow, when exposed to EO gas. The Chemical Indicator which is Type 1 Process Indicator as categorized by ISO 11140-1:2014 offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.
I am sorry, but the provided text describes a 510(k) premarket notification for a medical device called "Sterilization Package/Reel." This document focuses on the substantial equivalence of the device to existing predicate devices, primarily through non-clinical bench testing and comparisons of technological characteristics.
The information you requested, relating to acceptance criteria and studies proving an AI/Software as a Medical Device (SaMD)'s performance (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment), is not present in the provided text.
The document discusses validation of sterilization processes (ISO 11135, ISO 17665-1), material compatibility, package integrity, and biocompatibility, which are standard tests for physical sterilization packaging, not for AI device performance.
Therefore, I cannot fulfill your request for this specific information based on the text provided.
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(151 days)
The Sterilization Pouches and Reels is intended to provide health care workers with an effective method to enclosed devices in a single or double pouch configuration by steam or ethylene oxide sterilization. The recommended sterilization cycle parameters are as follows:
a) Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 ℃ (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).
The Sterilization Pouches and Reels is composed of medical compound film, maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture. The pouch's external chemical indicators are designed to indicate to the user that the pouch has undergone either a steam or EO Sterilization indicators will change color according to the sterilization method (Steam, Ethylene oxide). The color of steam sterilization indicator changes from Pink before sterilization to Cocoa after sterilization. The color of Ethylene oxide sterilization indicator changes from Blue before sterilization to Golden Brown after sterilization. The maximum validated pouch load is 1.87 lbs. (850g); The maximum validated reel load is 1.87 lbs. (850 g)
The Sterilization Pouches and Reels is composed of medical compound film. It is intended to be used to contain medical devices to be terminally sterilized by Steam or EO sterilization process. The recommended sterilization cycle parameters are as follows:
- Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. a)
- b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 °C (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).
The medical devices are inserted into the Pouches/Reels, and then sterilized for the EO or Steam Sterilization Process. The heat-sealed Pouches/Reels are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouches/Reels maintain sterility of the enclosed medical devices until the seal is opened. The Sterilization Pouches and Reels maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture.
The Sterilization Pouches and Reels is printed with chemical indicator bars that changed from Pink to Cocoa(Steam) or Blue to Golden Brown (EO) when exposed to steam vapor or EO gas during process. The steam and EO chemical indicator offer an addition way to verify processing in the sterilization cycle. The chemical indicator should be used in addition to, not in place of, the biological indicator. The steam and EO chemical indicators do not signify sterilization; they only indicate that the indicators have been exposed to the Steam or EO.
Based on the provided text, the device in question is "Sterilization Pouches and Reels" (K242898), which is a medical device intended for enclosing other medical devices for sterilization. There is no mention of "AI" or "human readers" in the context of this device. The document describes a traditional 510(k) submission, primarily focusing on non-clinical performance testing and comparison to a predicate device.
Therefore, many of the requested points in your prompt that relate to AI/algorithm performance, human readers, ground truth establishment for complex data, and MRMC studies are not applicable to the information provided.
However, I can extract information related to the acceptance criteria and the study that proves the device meets them, based on the non-clinical performance testing described.
Table of Acceptance Criteria and Reported Device Performance
The document details various performance tests conducted to demonstrate the safety and effectiveness of the Sterilization Pouches and Reels. The acceptance criteria are implicitly met if the "Pass" status is achieved for each test, indicating conformity to the referenced ISO or ASTM standards.
| Acceptance Criteria (Measured Performance Aspect) | Standard (Acceptance Threshold/Method) | Reported Device Performance |
|---|---|---|
| Sterilant Penetration Efficiency | SAL10-6 (Specific threshold for sterility assurance level - not explicitly defined in text but implied by standard) | Meets the requirement of SAL10-6 |
| EO, ECH (Ethylene Oxide, Ethylene Chlorohydrin) Residue | ISO 10993-7:2008 (EO < 4mg, ECH < 9mg) | EO < 4mg, ECH < 9mg (Pass) |
| Chemical Indicator (CI) Functionality and Endpoint | Sterilant penetrated through pouch, CI color changed to endpoint color (Steam: Pink to Cocoa; EO: Blue to Golden Brown) | Sterilant penetrated, CI color changed (Pass) |
| Thickness Variations | ASTM F 2251-13 (Acceptance threshold not explicitly defined, but implies compliance with standard specifications) | Pass |
| Tensile Strength | ISO 1924-2:2008 (Acceptance threshold not explicitly defined, but implies compliance with standard specifications) | Pass |
| Burst Strength | ASTM F1140 (≥ 0.45 Psig (3.1Kpa)) | ≥ 0.45 Psig (3.1Kpa) (Pass) |
| Bubble Leak Test | ASTM F 2096-2011 (2019) (No Leakage) | No Leakage (Pass) |
| Seal Peel Test | ASTM F88/F88M-2023 (Min value= 1.89 N/15mm) | Min value= 1.89 N/15mm (Pass) |
| Dye Penetration Test | ASTM F1929-15 (No Infiltration) | No Infiltration (Pass) |
| Microbial Barrier Test | DIN 58953-6-2016 (CFU = 0) | CFU = 0 (Pass) |
| End Point Stability Testing (CI color pre/post-sterilization, at various time points) | Color holds as expected (e.g., EO CI: Blue -> Golden Brown after EO sterilized and 24 months shelf life; Steam CI: Pink -> Cocoa after steam sterilized and 24 months shelf life) | All specified color changes and stabilities met (Pass/Similar to predicate) |
| Maintenance of Sterility | Not explicitly stated as a test, but claimed as "12 months" | 12 months (validated for effectiveness) |
| Shelf Life | Not explicitly stated as a test, but claimed as "5 years from date of manufacture" | 5 years from date of manufacture (same as predicate) |
| Biocompatibility | ISO 10993-1, -5, -7, -10, -12 (Non-cytotoxic, non-irritative, non-sensitive to skin) | Non-cytotoxic, non-irritative, and non-sensitive to skin (Pass) |
Information Not Applicable or Not Found in the Provided Text:
- Sample size used for the test set and the data provenance: The document does not specify the sample sizes (number of pouches/reels) used for the non-clinical performance and biocompatibility tests. It also does not specify the provenance (country of origin, retrospective/prospective) of any "data" beyond general testing. The tests are laboratory-based performance tests of the device itself.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of this device, is adherence to established engineering and material science standards (e.g., ISO, ASTM), rather than expert consensus on medical image interpretation.
- Adjudication method: Not applicable, as there's no expert interpretation involved in the performance testing described.
- 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 an AI/software device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm.
- The type of ground truth used: For this device, the "ground truth" is adherence to established physical, chemical, and biological performance standards (e.g., seal strength, sterility barrier, chemical indicator color change, biocompatibility). It is determined by the results of specific standardized laboratory tests, not by expert consensus, pathology, or outcomes data in the traditional sense of medical diagnostics.
- The sample size for the training set: Not applicable. There is no AI/machine learning component, so no training set is used.
- How the ground truth for the training set was established: Not applicable. There is no AI/machine learning component, so no training set or its ground truth establishment is mentioned.
Summary of Applicable Information:
The study proving the device meets its acceptance criteria is primarily based on non-clinical performance testing as outlined by various international and national standards (ASTM, ISO, DIN). The document explicitly states: "Performance testing and Biocompatibility assessment were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device meet the following standards..."
The core method of verification is demonstrating "Pass" for each of the listed tests according to the requirements of the specified standards. This type of device relies on engineering and material science validation rather than clinical trials involving human subjects or AI performance metrics.
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(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.
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(246 days)
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used up to 365 days post sterilization.
Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
a) 100% ethylene oxide (EO) with a concentration of 725 - 735 mg/l at 131 F/55°C and 40%-80% relative humidity for 60 minutes.
b) Exhausting the EO gas vacuum depth: 157 mBar to 160 mBar
c) Aeration time: 12 hours
d) Aeration temperature: 55℃
e) Aeration pressure : 841 mBar to 864 mBar
Sterilization Wrap is single use, non-sterile provide. It is divided into single and double layers, with double layer edges closed by ultrasonic suture. The sterilization Wrap is made from 100% polypropylene spunbond- meltblown - spunbond (SMS), not made with natural rubber latex.
The provided text describes the regulatory clearance of a "Sterilization Wrap" device (K222151) and its comparison to a predicate device (K181174). The information focuses on the physical, chemical, and sterilization properties of the wrap. The document does not contain information related to a study involving an AI-powered medical device or human readers for image interpretation. Therefore, I cannot provide details on the sample size for a test set, expert qualifications, or MRMC studies, as these concepts are not applicable to the provided document.
However, I can extract the acceptance criteria and performance data for the Sterilization Wrap based on the provided text, as it relates to the device's functional and safety aspects.
Here's the analysis based on the provided text:
Analysis of Sterilization Wrap Acceptance Criteria and Performance
The "Sterilization Wrap" device (K222151) has undergone non-clinical testing to demonstrate its performance and establish substantial equivalence to a predicate device (K181174). The acceptance criteria and reported device performance are generally based on meeting recognized industry standards for medical device sterilization wraps.
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria | Proposed Device Performance | Predicate Device (K181174) Performance | Remark (from document) |
|---|---|---|---|---|
| Sterilant Penetration and Sterilization Efficacy | Achieving a 10⁻⁶ sterility assurance level (e.g., negative for growth) | Negative for growth | Negative for growth | SAME |
| Maintenance of package sterility | Maintain sterility for up to 365 Days | Negative for growth (tested for 365 days) | Negative for growth (tested for 365 days) | SAME |
| Residuals (Ethylene Oxide) | Meet ISO 10993-7 | Meet ISO 10993-7 (None detected) | Meet ISO 10993-7 | SAME |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic | Pass |
| Biocompatibility (Irritation) | Non-irritant (ISO 10993-10) | Non-irritant | Non-irritant | Pass |
| Biocompatibility (Sensitization) | Non-sensitizer (ISO 10993-10) | Non-sensitizer | Non-sensitizer | Pass |
| Material Compatibility (EO sterilization process) | Compatible to EO sterilization process | Compatible | Compatible | SAME |
| Tensile Strength | Complies with selected physical properties (ASTM D 5034 -09) | Passed (before and after EO sterilization) | (Not explicitly stated but implied by "SAME" for material properties) | Pass |
| Bursting Strength | Complies with selected physical properties (ASTM D3786/D3786M-18) | Passed (before and after EO sterilization) | (Not explicitly stated but implied by "SAME" for material properties) | Pass |
| Water Resistance Hydrostatic Pressure Test | Complies with selected physical properties (AATC127-18) | Passed (before and after EO sterilization) | (Not explicitly stated but implied by "SAME" for material properties) | Pass |
| Air Permeability | Complies with selected physical properties (ASTM D737-18) | Passed (before and after EO sterilization) | (Not explicitly stated but implied by "SAME" for material properties) | Pass |
| Mass per Unit Area | Complies with selected physical properties (ASTMD37776/D3776M-20) | Passed (before and after EO sterilization) | (Not explicitly stated but implied by "SAME" for material properties) | Pass |
| Tearing Strength | Complies with selected physical properties (ASTM D5587-15) | Passed (before and after EO sterilization) | (Not explicitly stated but implied by "SAME" for material properties) | Pass |
| Dimension | Meet ISO 11607:2019 | Passed (before and after EO sterilization) | (Not explicitly stated but implied by "SAME" for material properties) | Pass |
| Lint Generation Testing | Coefficient of linting log₁₀ ≤ 4.0 (EN 13795-1:2019) | ≤4.0 (before and after EO sterilization) | (Not explicitly stated) | Pass |
| Microbial Barrier Test | Product has good anti-bacterial permeability of the packaging material | Negative for growth | (Not explicitly stated but implied by "Maintenance of package sterility") | Pass |
| Shelf Life | Shelf Life 1 year | After 1 year accelerated aging, meets requirements and no significant change from 0 year's test results. | Not obtained (for predicate) | Passed |
2. Sample size used for the test set and the data provenance
The document refers to various standard tests (e.g., ASTM, ISO standards) for physical properties, sterilization validation, and biocompatibility. The specific sample sizes for each of these non-clinical tests are not provided in the document.
The data provenance is from non-clinical tests conducted by the manufacturer of the proposed device, Kenpax International Limited. The country of origin of the data is not explicitly stated beyond the manufacturer's address in Hong Kong and the contact person's address in Beijing, China. The studies are prospective in nature, as they involve testing the device to verify its performance against established standards.
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 "ground truth" for this device is established through quantitative measurements and adherence to international testing standards (e.g., sterility assurance level, physical property thresholds) rather than expert consensus on interpretation, as might be the case for an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessments, not for non-clinical, objective performance testing of a physical product like a sterilization wrap.
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 device is a sterilization wrap, not an AI-powered diagnostic tool, and therefore, an MRMC study with human readers is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on pre-defined, quantitative performance metrics and established international standards. For example:
- Sterility: Achieved a 10⁻⁶ sterility assurance level (objective microbial growth testing).
- Physical Properties: Meeting specific tensile strength, bursting strength, water resistance, air permeability, mass per unit area, tearing strength, and dimension parameters (objective physical measurements).
- Biocompatibility: Absence of cytotoxicity, irritation, and sensitization (objective biological tests against ISO standards).
- Residuals: Levels of ethylene oxide residuals below specified thresholds (objective chemical analysis).
8. The sample size for the training set
This question is not applicable. The device is a physical product, and there is no "training set" in the context of machine learning or AI models. Its design and manufacturing process would involve internal validation and quality control, but not a "training set" for an algorithm.
9. How the ground truth for the training set was established
This question is not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply.
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(230 days)
The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
• Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• Ethylene Oxide (EO) with a concentration of 800 mg/L at 55° C (131° F) and 40% to 90% relative humidity for 6 hour. Aeration time of 7 days at 20℃).
The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintains the sterility of the enclosed devices for up to 24 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from prink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark grey after sterilization.
The maximum validated pouch load is 1.1 lbs (0.5kg); The maximum validated roll load is 1.1 lbs (0.5kg).
The Sterilization pouch and roll is composed of medical grade paper(60g/m²) and medical compound film(52um), it is intended to be used to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process. The recommended sterilization cycle parameter is:
Steam: 4 minutes at 132°C (270°F); 20 minutes dry time.
Ethylene oxide: 6 hours at 55 ℃; relative humidity between 40%- 90%; ethylene oxide concentration is 800 mg/L, 7 days aeration time at 20 ℃.
The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the EtO or Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.
The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 24 months post sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to Yellow (EtO) or Blue to Dark grey (Steam) when exposed to EtO gas or Steam vapor during process. The EtO and Steam Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.
Based on the provided text, the device in question is a "Sterilization Pouch and Roll" and the document describes non-clinical performance testing rather than a study involving human subjects or AI algorithms. Therefore, many of the typical acceptance criteria and study design elements for AI/ML-based medical devices (like MRMC studies, expert adjudication for ground truth for training/test sets, effect sizes of human performance improvement with AI, etc.) are not applicable to this document.
The document discusses the physical and chemical performance of a sterilization packaging product. The studies described are bench testing and laboratory validation against established ISO and ASTM standards.
Here's the breakdown based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization Process Validation (EO) | ISO 11135:2014 | Ethylene oxide: 6 hours at 55 °C; relative humidity between 40%- 90%; ethylene oxide concentration is 800 mg/L, 7 days aeration time at 20°C. SAL=10-6 | SAL=10-6 (Pass) |
| Sterilization Process Validation (Steam) | ISO 17665-1:2006; ISO TS 17665-2:2009 | Steam: 8 minutes at 134°C; 8 minutes dry time. SAL=10-6 | SAL=10-6 (Pass) |
| EO/ECH Residuals | ISO 10993-7:2008 | EO < 4mg; ECH < 9mg | Pass |
| Biocompatibility Testing (Cytotoxicity) | ISO 10993-5:2009 | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. (Pass) |
| Biocompatibility Testing (Irritation) | ISO 10993-10:2010 | Non-irritating | Under the conditions of the study, not an irritant. (Pass) |
| Biocompatibility Testing (Sensitization) | ISO 10993-10:2010 | Non-sensitizing | Under conditions of the study, not a sensitizer. (Pass) |
| Package Integrity / Material Compatibility / Sterility Maintenance (Film Thickness) | ASTM F 2251-13 | 52μm±12% | Pass (Specific value not given, but stated as meeting requirements and passing) |
| Package Integrity / Material Compatibility / Sterility Maintenance (Burst Value) | ASTM F1140/F1140M-13 | Burst value > 3 Kpa or No Burst | Minimum of Burst pressure = 6.4 (kPa) (Pass) |
| Package Integrity / Material Compatibility / Sterility Maintenance (Dye Penetration) | ASTM F1929-15 | The dye solution is no any leakage across the seal width of sterile barrier system. (No Infiltration) | No Infiltration (Pass) |
| Package Integrity / Material Compatibility / Sterility Maintenance (Seal Strength) | ASTM F88/F88M-15 | Seal strength > 2.5 (N/15mm) | Minimum of Seal strength = 2.9 (Pass) |
| Package Integrity / Material Compatibility / Sterility Maintenance (Tensile Strength) | ISO 1924-2:2008 | Tensile strength: CD ≥ 2.2KN/m, MD ≥ 4.4KN/m | Pass |
| Package Integrity / Material Compatibility / Sterility Maintenance (Aging - Shelf Life) | Real time aging | 5 years real time aging (Incubation for empty pouch); 24 months real time aging Incubation for post steam/EO sterilization storage | The test results of all samples meet the requirements. (Pass) (Real-time test for empty pouch: Jan. 08, 2017 to Jan. 28, 2022. Real-time test for exposed pouch: Jan. 08, 2020 to Jan. 20, 2022). |
| Package Integrity / Material Compatibility / Sterility Maintenance (Leakage) | ASTM F2096-11 | No Leakage | No Leakage (Pass) |
| Package Integrity / Material Compatibility / Sterility Maintenance (Microbial Barrier) | DIN 58953-6 | CFU = 0 | CFU = 0 (Pass) |
| Chemical Indicator Efficacy Testing (Steam) | ISO 11140-1:2014 | The color of CI changes from Blue to Dark Grey, when exposed to Steam; Change the color: Color of indicator changes from blue to dark grey after Steam sterilization. Should remain stable before use (5 years shelf life) and maintain endpoint stability (24 months post-sterilization). | Color of indicator changes from blue to dark grey under indicated condition and no changed under other condition. (Pass). (Empty pouch: Original color maintained Jan. 08, 2017 to Jan. 28, 2022. Exposed pouch: Dark Grey color maintained Jan. 08, 2020 to Jan. 20, 2022). |
| Chemical Indicator Efficacy Testing (EO) | ISO 11140-1:2014 | The color of CI changes from Pink to Yellow, when exposed to EO gas. Color of indicator changes from pink to yellow after EO sterilization. Should remain stable before use (5 years shelf life) and maintain endpoint stability (24 months post-sterilization). | Color of indicator changes from pink to yellow under indicated condition and no changed under other condition. (Pass). (Empty pouch: Original color maintained Jan. 08, 2017 to Jan. 28, 2022. Exposed pouch: Yellow color maintained Jan. 08, 2020 to Jan. 20, 2022). |
Since this is a non-clinical device (sterilization pouch), the following points are not applicable as they relate to clinical studies, AI/ML models, and human expert evaluations of diagnostic imaging.
- Sample size used for the test set and the data provenance: Not applicable. This refers to physical samples of the sterilization pouches and rolls tested in a laboratory setting, not a "test set" in the context of an AI/ML model. The provenance would be the manufacturing site (China) and the tests are prospective lab tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is established by physical measurements and compliance with international standards (ISO, ASTM), not by human expert opinion.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Ground truth is determined by standardized test methods.
- 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 an AI/ML diagnostic device for human interpretation.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is based on the specified performance criteria defined by international standards (ISO, ASTM) and physical/chemical properties.
- The sample size for the training set: Not applicable. This device does not involve a training set for an algorithm.
- How the ground truth for the training set was established: Not applicable.
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(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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(84 days)
The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® 100S Sterilizer.
The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:
- Self-sealing sterilization pouches
- Sterilization pouches, Flat
- Sterilization pouches, Gusseted
- Sterilization rolls, Flat
- Sterilization rolls, Gusseted
Sterilization Pouch/Roll Made with Tyvek® is intended to contain medical devices to be terminally sterilized in the STERRAD® 100S Sterilization System. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the STERRAD® 100S Sterilization System (The recommended cycle parameter is 6 minutes (Injection volume: 2880µL) at 50°C.). After completion of the sterilization process, the Pouch/Roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® 100S Sterilization System.
The pouches are constructed from Tyvek®/plastic films, with H2O2 Chemical Indicator printed onto the Tyvek® film. The Self-seal pouch permits sealing of the pouch without need of heat- sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD® Sterilization Systems.
The H2O2 Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. H2O2 Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to blue (or lighter) when exposed to hydrogen peroxide.
The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:
- Self-sealing sterilization pouches
- Sterilization pouches, Flat
- Sterilization pouches, Gusseted
- Sterilization rolls, Flat
- Sterilization rolls, Gusseted
The provided text describes the regulatory submission for a medical device (Sterilization Pouch/Roll Made with Tyvek®) seeking 510(k) clearance from the FDA. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the safety and effectiveness of a novel AI/software-as-a-medical-device (SaMD).
Therefore, the information typically requested regarding acceptance criteria and study design for AI/SaMD devices (like sample size for test/training sets, data provenance, expert
qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance) is not applicable to this submission. This device is a physical product, and its performance is evaluated through material science, sterility, and packaging tests.
However, I can extract the acceptance criteria and reported performance for the physical device based on the non-clinical testing summaries.
1. A table of acceptance criteria and the reported device performance:
| Test Category | Test Method / Standard (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Sterilant Penetration | AAMI / ANSI / ISO 14937:2009, "Sterilization of Health Care Products - General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices" (Acceptance: Able to penetrate and sustain direct contact with the medical instrument inside) | Confirmed that the sterilant is able to penetrate the device and sustain direct contact with the medical instrument inside. |
| Sterilant Penetration | Half-Cycle Efficacy (Acceptance: 6 log reduction of Geobacillus stearothermophilus) | Showed a 6 log reduction of Geobacillus stearothermophilus. |
| Biocompatibility | ISO 10993-10:2010(E), "Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization" (Acceptance: Meets requirements, non-irritating) | Showed "negative reaction" (non-irritating) and met requirements. |
| Package Integrity | ASTM F2251-03, "Standard Test Method for Thickness Measurement of Flexible Packaging Material" (Acceptance: Passed) | Passed |
| Package Integrity | ASTM D882, "Standard Test Method for Tensile Properties of Thin Plastic Sheeting" (Acceptance: Passed) | Passed |
| Package Integrity | ASTM D 5035, "Standard Test Method for Breaking Force and Elongation of Textile Fabrics (Strip Method)" (Acceptance: Passed) | Passed |
| Package Integrity | ASTM D1922, "Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method" (Acceptance: Passed) | Passed |
| Package Integrity | ASTM F1140-07, "Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages" (Acceptance: Passed) | Passed |
| Package Integrity | ASTM F88/F88M; ISO 11607-1, "Standard Test Method for Seal Strength of Flexible Barrier Materials" (Acceptance: Passed) | Passed |
| Package Integrity | ASTM F1929-98 (04); ISO 11607-1, "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration" (Acceptance: Passed) | Passed |
| Material Compatibility | AAMI / ANSI / ISO 11607-1:2006//A1:2014, "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems" (Acceptance: Met criteria) | Met material compatibility acceptance criteria. |
| Sterility Maintenance | DIN 58953-6:2010-05, "Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized" (Acceptance: Passed) | Passed |
| Sterility Maintenance | AAMI / ANSI / ISO 11607-1:2006//A1:2014 (Acceptance: Met criteria for sterility maintenance after aging) | Met sterility maintenance acceptance criteria. |
| Sterility Maintenance | Durability: Accelerated Aging Test (ASTM F 1980-2007; ISO 11607-1) (Acceptance: Passed for 3 years accelerated aging, maintaining seal strength) | Passed (3 years accelerated aging, seal strength maintained). |
| Chemical Indicator Efficacy | AAMI / ANSI / ISO 11140-1:2014, "Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements" (Acceptance: Sterilant penetrated through pouch, CI color changed to endpoint color, color stability for 3 years, completeness/uniformity of color change) | The sterilant penetrated through the pouch, the CI color changed to the endpoint, indicator dye remained stable for 3 years real-time aging, and the color change was effective. |
For the following points, as explained, they are not applicable because this is a 510(k) submission for a physical medical device (sterilization pouches) based on substantial equivalence, not an AI/SaMD (Software as a Medical Device). The evaluation focuses on material properties and performance under sterilization conditions rather than algorithmic performance on complex data (like images or medical records).
2. Sample sizes used for the test set and the data provenance: Not applicable. The tests performed are engineering and material-science based, using samples of the device and specific test setups, not patient-derived data. The document does not specify a "test set" in the context of an AI algorithm, nor "data provenance" (e.g., country of origin) relevant to patient data. The non-clinical tests were likely conducted in a controlled laboratory environment.
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. Ground truth as typically defined for AI/SaMD (e.g., disease diagnosis from medical images) is not relevant here. The "ground truth" for these tests are objective measurements against established engineering and biological standards (e.g., quantitative measures of tensile strength, observable microbial growth, or chemical indicator color change).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve disagreements among human annotators/experts for ground truth establishment in AI/SaMD; this is not relevant for materials testing.
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 an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance evaluations are based on established industry standards and scientific principles for material properties (e.g., ASTM standards for mechanical properties), biological efficacy (e.g., 6-log reduction for sterilization), and chemical reactivity (e.g., color change of indicators). No human expert consensus or outcomes data in a clinical context is used as "ground truth" for this device's acceptance.
8. The sample size for the training set: Not applicable. There is no AI training set involved.
9. How the ground truth for the training set was established: Not applicable. There is no AI training set involved.
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(189 days)
The Sterilization Trays are used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems. Prior to placing in the Sterilizer, the trays must either be:
- wrapped with a legally marketed sterilization wrap for use in the V-PRO Low Temperature Sterilization Systems ● or
- placed inside a legally marketed pouch for enclosing trays in the V-PRO Low Temperature Sterilization Systems.
The Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.
Instrument organizers are optional accessories intended to stabilize cylindrical instruments within the Sterilization Trays.
Sterilization mats are optional accessories intended to cushion and stabilize instruments within the Sterilization Trays.
The Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems: V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems. The trays are available in various sizes, outlined in Table 10-1, to accommodate the loads to be processed. The proposed trays are similar in design to the predicate V-PRO Sterilization Tray (K140494) and are composed of a base and a lid. The lid includes clamping mechanisms designed to secure the lid onto the base. There are numerous holes in the base and lid for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or pouch to maintain sterility of the enclosed devices.
Optional instrument organizers are provided as accessories to the trays and allow stabilization of various cylindrical medical devices during processing. Table 10-2 lists the organizer sizes. The organizers are either "blank" and are used to partition the tray or have a device holding portion into which the devices are inserted. At the organizer base is a flapped groove that is used to position the organizer within a Sterilization Tray.
Optional sterilization mats are provided as accessories to the trays. The mats, which are used to cushion and stabilize devices placed into the trays, are available in sizes as shown in Table 10-3 to fit the nine Sterilization Trays. The mats are a diamond grid design with "fingers" that extend from each corner of the diamond and at the midpoint of each diamond side. The fingers cushion and stabilize instruments, helping to prevent the instruments from freely moving in the tray during packaging, sterilization and storage. The cushioning and stabilization qualities help protect delicate instruments placed into the trays.
The provided document is a 510(k) premarket notification for "Sterilization Trays" by STERIS Corporation. It outlines the device's intended use and includes a summary of nonclinical tests performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Demonstration of Effective Sterilant Penetration | Worst case test article packaged in the trays shall be reproducibly sterilized under worst case ½ cycle conditions. | PASS |
| Package Integrity Maintenance of Package Integrity | Not applicable, Trays to be used with legally marketed sterilization wrap or pouch. | N/A |
| Demonstration of Effective Drying and Aeration | Residual hydrogen peroxide levels shall be below acceptable levels after exposure to worst case Sterilizer Cycle conditions. | PASS |
| Demonstration of Effective Cleaning | Clean following automated and manual cleaning. | PASS |
| Demonstration of Material Compatibility | After processing through multiple worst case sterilization cycles, the trays and accessories shall retain functionality. | PASS |
| Demonstration of Biocompatibility | Component materials shall be non cytotoxic after exposure to worst case Sterilizer Cycle conditions. | PASS |
2. Sample size 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 exact sample sizes (e.g., number of trays, number of sterilization cycles) used for each test. It also does not explicitly state the data provenance (country of origin, retrospective or prospective). However, given that this is a 510(k) submission to the FDA, it is prospective testing conducted by the manufacturer, STERIS Corporation, likely in the USA, to support the device's market clearance.
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):
This information is not provided in the document. The tests described are laboratory-based performance tests (e.g., sterilization effectiveness, material compatibility, cleaning efficacy), not diagnostic accuracy studies requiring expert interpretation of images or clinical outcomes. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense may not directly apply here. Instead, ground truth would be established by validated analytical methods and scientific standards within a laboratory setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers interpreting data (e.g., medical images). Since the tests described are laboratory performance tests for a sterilization tray, an adjudication method for interpretations is not applicable and therefore not mentioned. Results would be determined by objective measurements and passing/failing pre-defined technical criteria (e.g., presence/absence of microbial growth, chemical residue levels, visual assessment of functionality).
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:
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable as the device (sterilization tray) is not an AI-powered diagnostic tool involving human readers. The document details performance tests for physical sterilization equipment, not AI assistance for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
A standalone algorithm performance study is not applicable as the device is a physical sterilization tray, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance tests would be established through scientific and objective measurements based on established standards and methods relevant to sterilization and material science. For example:
- Effective Sterilant Penetration: Ground truth would be the absence of microbial growth on biological indicators or test articles after sterilization, as per established sterilization protocols (e.g., ISO standards, AAMI guidelines).
- Effective Drying and Aeration: Ground truth would be hydrogen peroxide levels below a pre-determined safe threshold, measured using chemical analysis.
- Effective Cleaning: Ground truth would involve visual inspection and potentially chemical analysis to confirm removal of soil and contaminants according to established cleaning validation protocols.
- Material Compatibility: Ground truth would be the visual assessment or mechanical testing to confirm the trays and accessories retain their functionality and integrity after repeated sterilization cycles.
- Biocompatibility: Ground truth would be the absence of cytotoxic effects, determined by standardized in vitro (e.g., cell culture) or in vivo biocompatibility tests.
8. The sample size for the training set:
A training set is relevant for machine learning or AI models. Since this device is a physical sterilization tray and not an AI system, the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established:
As implied by point 8, a training set is not applicable for this device.
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