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510(k) Data Aggregation
(114 days)
Disposable Medical Device Self-Seal Sterilization Pouch The Disposable Medical Device Self-Seal Sterilization Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO).
The intended sterilization cycles are listed below:
Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%;100% ethylene oxide at dosage of 759mg/L, 12 hours aeration time at 55℃.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
The Disposable Medical Device Self-Seal Sterilization Pouch are not intended use for any load with lumer/channels and complex device.
The dimension range for each of the weights used in testing: Size 57×102mm: Maximum load weight 400g Size 140x280mm: Maximum load weight 900g Size 305×455mm: Maximum load weight 1600g
Disposable Medical Device Sterilization Reel Pouch
The Disposable Medical Device Sterilization Reel Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO).
The intended sterilization cycles are listed below:
Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%;100% ethylene oxide at dosage of 759mg/L, 12 hours aeration time at 55°C.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
The Disposable Medical Device Self-Seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device.
Disposable Medical Device Self-Seal Sterilization Pouch The Disposable Medical Device Self-Seal Sterilization Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO).
The intended sterilization cycles are listed below:
Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%;100% ethylene oxide at dosage of 759mg/L, 12 hours aeration time at 55℃.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
The Disposable Medical Device Self-Seal Sterilization Pouch are not intended use for any load with lumer/channels and complex device.
The dimension range for each of the weights used in testing: Size 57×102mm: Maximum load weight 400g Size 140x280mm: Maximum load weight 900g Size 305×455mm: Maximum load weight 1600g
Disposable Medical Device Sterilization Reel Pouch
The Disposable Medical Device Sterilization Reel Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO).
The intended sterilization cycles are listed below:
Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%;100% ethylene oxide at dosage of 759mg/L, 12 hours aeration time at 55°C.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
The Disposable Medical Device Self-Seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device.
The provided document is a 510(k) clearance letter from the FDA for a medical device: "Disposable Medical Device Self-Seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch."
This document does not contain the acceptance criteria or a study proving the device meets those criteria in the format usually associated with assessing the performance of AI/ML or diagnostic devices (e.g., sensitivity, specificity, accuracy, F1 score).
Instead, it's a regulatory clearance stating that the device is "substantially equivalent" to legally marketed predicate devices. The "Indications for Use" section describes the intended purpose of the sterility pouches, the sterilization cycles they are compatible with, and lists the sizes/models available. It also mentions the maximum load weights for different pouch sizes as part of the testing performed, which are effectively performance specifications for the physical product.
Therefore, I cannot extract the requested information regarding acceptance criteria and a detailed study proving the device meets those criteria in the context of an AI/ML or diagnostic device using the provided text. The document is about regulatory clearance for a physical sterilization pouch, not a computational device.
However, if we interpret "acceptance criteria" for this physical device, it would relate to its ability to maintain sterility and indicate successful sterilization, and the "study" would be the validation testing performed to demonstrate this. Based on the text, the following can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied from Indications for Use) | Reported Device Performance (Implied from Clearance) |
|---|---|
| Effective enclosure for sterilization (Steam & EtO) | Device is found substantially equivalent for this use. |
| External chemical ink indicators function for Steam | Indicators are designed to indicate steam process. |
| External chemical ink indicators function for EtO | Indicators are designed to indicate EtO process. |
| Accommodate specific loads (max weight) | Load weights tested for various sizes (e.g., 400g for 57x102mm, 900g for 140x280mm, 1600g for 305x455mm). |
| Compatible with Prevacuum steam (4 min at 134℃, 10 min dry) | Intended for this sterilization cycle. |
| Compatible with Ethylene oxide (1 hr at 55°C, RH 40-80%, 759mg/L EtO, 12 hr aeration at 55°C) | Intended for this sterilization cycle. |
| Not intended for lumen/channels and complex devices | Device labeling specifies this limitation. |
2. Sample size used for the test set and the data provenance:
- The document does not provide specific sample sizes (e.g., number of pouches) used in the testing for sterility or indicator function.
- The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. It would be manufacturer-supplied data as part of the 510(k) submission.
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 and not provided. The testing for sterilization pouches involves laboratory validation (e.g., microbiological challenge tests, physical integrity tests, indicator performance tests) rather than expert interpretation of data.
4. Adjudication method for the test set:
- Not applicable and not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Not applicable. This is for a physical medical device, not an AI/ML or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
7. The type of ground truth used:
- For a sterilization pouch, the "ground truth" would be established through laboratory testing and validated sterilization processes. This would include:
- Sterility testing: Verifying that devices sterilized within the pouches indeed achieve sterility (e.g., biological indicator kill, microbiological challenge tests).
- Physical integrity testing: Ensuring the pouch maintains its barrier properties before, during, and after sterilization.
- Chemical indicator performance testing: Verifying the color change of the indicators accurately reflects exposure to the specified sterilization process parameters.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of a physical sterilization pouch.
9. How the ground truth for the training set was established:
- Not applicable.
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(258 days)
The Disposable Medical Device Self-seal Sterilization Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves.
The intended sterilization cycles are listed below: Prevacuum steam: 4 minutes at 134 ℃; 10 minute dry time.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process.
The Disposable Medical Device Self-seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1600g of metal instruments.
The Disposable Medical Device Sterilization Reel Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves.
The intended sterilization cycles are listed below: Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process.
The Disposable Medical Device Self-seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1600g of metal instruments.
There are 2 models of the Sterilization Pouches in this application with different physical specification. The Disposable Medical Device Seff-seal Sterilization Pouch is made from a medical grade plastic film that is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the pouch. 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 or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.
The Disposable Medical Device Sterilization Reel Pouch are made from a medical grade paper and plastic (PP/PET) film that are heat sealed on opposite two sides. It will be cut to suitable length and the opened sides will be heat-sealed. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.
The provided document is a 510(k) Summary for a medical device, which is an application to demonstrate substantial equivalence to an existing legally marketed device. It describes the device, its intended use, and the non-clinical tests conducted. However, it does not detail specific acceptance criteria for a study in the way one might expect for a clinical trial or a performance study with numerical thresholds.
Instead, the document primarily focuses on verifying that the proposed device (Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch) meets design specifications and complies with recognized standards and validation tests. The "acceptance criteria" can be inferred from the successful completion of these tests as per the relevant standards.
Here's an attempt to extract the requested information, acknowledging that the document doesn't explicitly present acceptance criteria and reported performance in a table format for a single study, but rather refers to various validation methods.
Acceptance Criteria and Device Performance for Disposable Medical Device Self-seal Sterilization Pouch and Disposable Medical Device Sterilization Reel Pouch
The device's performance is demonstrated through non-clinical testing against various international and ASTM standards. The acceptance criteria are implicit in the successful fulfillment of these standards and validation tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from standards and test objectives) | Reported Device Performance |
|---|---|
| Internal Pressurization Failure Resistance (ASTM F1140/f1140M-13): The package must resist internal pressure without failure. | "Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with... ASTM F1140/f1140M-13 Standard Test Methods for internal pressurization failure resistance of unrestrained package." (Implies successful resistance to pressure). |
| Microbial Ranking of Porous Packaging Materials (ASTM F1608-00): The material must demonstrate microbial barrier properties sufficient for sterilization. | "The test results demonstrated that the proposed device complies with... ASTM F1608-00 Standard test methods for Microbial Ranking of Porous packaging materials." (Implies successful demonstration of microbial barrier). |
| Chemical Indicators - General Requirements (ISO 11140-1:2009): The external chemical ink indicators must exhibit the specified color change after sterilization. | "The test results demonstrated that the proposed device complies with... ISO 11140-1:2009 Sterilization of Health Care Products – Chemical Indicators – Part 1: General Requirements." |
| Chemical Indicator Efficacy: "Steam Sterilization Indicating Ink Initial Color: Blue -> Signal Color: Ash Black" (Implies successful color change as per standard). | |
| Accelerated Aging of Sterile Barrier Systems (ASTM F1980-07): The device must maintain integrity and function after accelerated aging equivalent to its shelf life. | "The test results demonstrated that the proposed device complies with... ASTM F1980-07 Standard guide for accelerated aging of sterile barrier systems for medical device." |
| Shelf Life: 2 years (validated via accelerated aging). | |
| Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration (ASTM F1929-12): The seals must be free of leaks. | "The test results demonstrated that the proposed device complies with... ASTM F1929-12 Standard test methods for detecting seal leaks in porous medical packaging by dye penetration." (Implies no detectable leaks). |
| Cytotoxicity (ISO 10993-5:2009): The device must not exhibit cytotoxicity. | "The test results demonstrated that the proposed device complies with... ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity." (Implies acceptable biocompatibility in terms of cytotoxicity). |
| Irritation and Skin Sensitization (ISO 10993-10:2010): The device must not cause irritation or skin sensitization. | "The test results demonstrated that the proposed device complies with... ISO 10993-10:2010 Biological Evaluation of Medical Devices – Part 10: Tests for irritation and skin sensitization." (Implies acceptable biocompatibility in terms of irritation and sensitization). |
| Shelf Life Validation (Real-time aging method): The device must perform as intended for its specified shelf life. | "Shelf Life Validation Test, validate the shelf life performance to the proposed device as real time aging method." |
| Maintenance of Sterility: 6 months | |
| Shelf Life: 2 years (Supported by real-time aging). | |
| Steam Sterilization Process Validation (Half cycle overkill & Full cycle dry time): |
- Half cycle overkill: No microbiological growth after half-cycle sterilization.
- Dry time validation: Samples free of visible moisture with no significant weight gain after full cycle sterilization and specified dry time. | "Half cycle overkill validation of the claimed steam sterilization cycle: Challenge loads consisted of scalers, hemostatic forceps and tooth probes. No cavities or complex devices. All loads showed no growth at 1/2 cycle."
"Dry time validation: Full cycle sterilization testing showed samples to be free of visible moisture with no signification weight gain following sterilization and stated dry time." (Both criteria were met). |
| Material Compatibility: Materials must not degrade after sterilization. | "After sterilization, the materials were not degraded." (Reported as met for the proposed device, predicate, and reference devices). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each non-clinical test. It lists the standards and types of validation performed. The data provenance is not specified beyond the tests being conducted for submission to the U.S. FDA, likely implying internal company testing or testing by certified labs for the manufacturer (Weihai Xingtai Packaging Products Co., Ltd. from China). The tests are retrospective in the sense that they were performed on manufactured devices to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a sterilization packaging material, and its performance is evaluated against engineering, material, microbiological, and chemical standards, not by human interpretation of medical images or diagnoses. Ground truth is established by the specified test methods and criteria within the aforementioned standards.
4. Adjudication Method for the Test Set
Not applicable for this type of non-clinical testing. The outcomes of the tests are objective measurements and observations (e.g., color change, absence of microbial growth, resistance to pressure, absence of leaks, material integrity).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a Class II medical device (sterilization wrap) and the validation is based on non-clinical performance standards. MRMC studies are typically for diagnostic imaging devices where human reader performance is a key metric.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
This concept is not directly applicable. The device itself is not an algorithm. Its performance is inherent in its physical and chemical properties when subjected to sterilization processes. The "standalone" performance here refers to the device's ability to meet its functional requirements (e.g., maintain sterility, indicate sterilization) independent of human variability in the use of the device, assuming proper handling and sterilization procedures are followed. The non-clinical tests validate these inherent properties.
7. Type of Ground Truth Used
The ground truth used for evaluating this device's performance is based on established scientific and engineering standards and validation protocols. This includes:
- Physical measurements (e.g., pressure resistance, seal integrity).
- Microbiological challenge testing (e.g., absence of growth).
- Chemical reactions (e.g., specific color change of indicators).
- Biocompatibility assessments (e.g., cytotoxicity, irritation).
- Material science evaluations (e.g., material degradation, aging).
8. Sample Size for the Training Set
Not applicable. The device is not an AI/ML algorithm that requires a training set. The "training" for this device comes from its design and manufacturing process, optimized to meet the performance standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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