(114 days)
Not Found
Not Found
No
The device is a sterilization pouch with chemical indicators, and the description does not mention any computational or analytical capabilities that would involve AI or ML.
No
The device is a sterilization pouch intended to enclose other medical devices for sterilization, not to treat a health condition.
No
Explanation: The device described is a sterilization pouch used to enclose other devices for sterilization. Its function is to facilitate the sterilization process, not to diagnose medical conditions or provide diagnostic information.
No
The device described is a physical sterilization pouch and reel pouch, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The described device is a sterilization pouch/reel intended to enclose medical devices for sterilization using steam or Ethylene Oxide. Its purpose is to facilitate the sterilization process and indicate that sterilization has occurred.
- Lack of Biological Specimen Interaction: The device does not interact with or analyze biological specimens from the human body. It is used to package and sterilize other medical devices.
- Intended Use: The intended use clearly states its purpose is to "enclose devices intended for sterilization." This is a function related to the preparation and processing of medical devices, not the diagnosis or monitoring of a patient's health through the analysis of biological samples.
Therefore, the Disposable Medical Device Self-Seal Sterilization Pouch and Disposable Medical Device Sterilization Reel Pouch fall under the category of medical devices used in the sterilization process, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FRG, JOJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care workers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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.
3
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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