(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.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).