(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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April 15, 2020
Weihai Xingtai Packaging Products Co.,Ltd. % Ray Wang Official Correspondent Beijing Believe-Med Technology Service Co., Ltd Rm.912, Building #15, XiYueHui. No.5, YiHe North Rd., FangShan District Beijing, 102401 Cn
Re: K193561
Trade/Device Name: Disposable Medical Device Self-Seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: March 13, 2020 Received: March 16, 2020
Dear Ray Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Christopher K. Dugard, MS Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193561
Device Name
Disposable Medical Device Self-Seal Sterilization Pouch/Disposable Medical Device Sterilization Reel Pouch
Indications for Use (Describe)
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
Model(s):
57mm×102mm×130mm×70mm×230mm 83mm×165mm 90mm×260mm 133mm×191mm 133mm×279mm×279mm×279mm 133mm×290mm 140mm×280mm 140mm×30mm 190mm×330mm 190mm×360mm 255mm×380mm 279mm×406mm 300mm×400mm 300mm×474mm 305mm×455mm
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.
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The dimension range for each of the weights used in testing
Size 50mm×200mm: Maximum load weight 400g
Size 300mm×200mm: Maximum load weight 900g
Size 400mm×200mm: Maximum load weight 1600g
Model(s):
100mm×100m 150mm×100m 250mm×100m 300mm×100m 350mm×100m 400mm×100m 50mm×200m 55mm×200m 60mm ×200m 75mm×200m 125mm×200m 150mm×200m 200mm×200m 225mm×200m 250mm×200m 300mm×200m 350mm×200m 400mm×200m
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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).