(38 days)
The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam or ethylene oxide (EtO). It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is a device composed of medical paper. It is a bleached wet strength paper conforming to recognized material standards and can be sterilized by steam, ethylene oxide gas and irradiation.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH.
Based on the provided document, the device described is a sterilization pouch, not an AI-powered diagnostic device. Therefore, many of the typical acceptance criteria and study details associated with AI medical devices (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training/test set sizes for algorithms) are not applicable.
The "acceptance criteria" for this type of device primarily revolve around demonstrating substantial equivalence to predicate devices and meeting established material and performance standards for sterilization pouches.
Here's an interpretation of the information requested, adapted to the context of this traditional medical device:
Acceptance Criteria and Study for MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria/Performance Goal | Reported Device Performance / How Met |
|---|---|---|
| Intended Use | To enclose another medical device for sterilization by a health provider (steam or ethylene oxide), allow sterilization, and maintain sterility until use. | The device's stated "Indications for Use" directly match this. Substantial equivalence relies on the identical intended use compared to predicate devices. |
| Composition | Composed of medical paper, bleached wet strength paper, conforming to recognized material standards. | The device description explicitly states it is "composed of medical paper. It is a bleached wet strength paper conforming to recognized material standards." This is directly compared to predicate devices which also use "identical materials." |
| Sterilization Compatibility | Can be sterilized by steam, ethylene oxide gas, and irradiation. | The device description states it "can be sterilized by steam, ethylene oxide gas and irradiation." This capability is inherent to the material and design, matching that of the predicate devices. |
| Substantial Equivalence | Demonstrated to be substantially equivalent to legally marketed predicate devices. | The submission claims the device is "substantially equivalent to the Global Healthcare Self-Sealing Sterilization Pouch (K990567) and the Defend Self-Sealing Sterilization Pouch (K932056)." The FDA's letter (K993764) confirms this determination. |
| Manufacturing Quality | Compliance with Good Manufacturing Practice (GMP) regulations (21 CFR Part 820). | The FDA letter explicitly states, "A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions." The manufacturer is ISO9002-EN46002 CERTIFIED FACTOR. |
| Material/Performance Standards | Implicitly, performance standards related to barrier properties, seal strength, and material integrity post-sterilization (though not explicitly detailed in the summary). | The summary states, "all specifications and test results are applicable to each [predicate device] as well as to the MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH." This indicates that the new device meets the same performance specifications as the predicate devices, which would have undergone such testing. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a separate "test set" in the context of an algorithmic assessment. The product's acceptance is based on its identical nature to established predicate devices already on the market.
- Data Provenance: The "data" (specifications and test results) are derived from the same manufacturer producing identical products (Medipack Medical Packaging Manufacturing Co.) for Global Healthcare (K990567) and Defend (K932056). This implies existing, possibly retrospective, test results for those predicate devices are being leveraged.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable for this type of device. The "ground truth" here is compliance with material specifications and functional performance (e.g., maintaining sterility), which are typically assessed through laboratory testing and engineering standards, not expert consensus on diagnostic images.
4. Adjudication method for the test set:
- Not applicable. There is no expert adjudication process described, as this is not a diagnostic device requiring interpretation of data.
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 device is a sterilization pouch, not an AI system. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's acceptance is primarily based on engineering specifications, material science standards, and performance testing data (e.g., sterility maintenance, seal strength, compatibility with sterilization methods) that were established for the predicate devices. This data demonstrates that the materials and design lead to a functional product that meets its intended purpose.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that uses training sets.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set or ground truth in the context of AI was established.
In summary, the approval of the MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is based on its substantial equivalence to already approved predicate devices. This equivalence is established because the device has the same intended use, is composed of identical materials, and is produced by the same manufacturer, implying it meets the same specifications and test results as the predicate devices. The FDA affirmation means they found sufficient evidence to conclude that the new device is as safe and effective as the predicate devices already on the market.
§ 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).