(38 days)
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Not Found
No
The device is a sterilization pouch with a chemical indicator, and the description focuses on its physical properties and performance in maintaining sterility and indicating sterilization parameters. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a pouch used for sterilizing other medical devices and maintaining their sterility, not for treating any condition or disease.
No
The device, a sterilization pouch, is designed to enclose and maintain the sterility of other medical devices, and potentially includes a chemical indicator to monitor the sterilization process; it does not diagnose a medical condition in a patient.
No
The device is a physical pouch made of Tyvek® and film, with a self-seal tape closure and potentially a chemical indicator. It is a hardware device used for sterilization and maintaining sterility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to enclose and sterilize another medical device. It also includes a chemical indicator to monitor the sterilization process. Neither of these functions involves testing a sample taken from the human body to provide information about a physiological state, health, or disease.
- Device Description: The description focuses on the materials and construction of the pouch and the chemical indicator. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays
The device is a sterilization packaging system and a sterilization process indicator, which are considered medical devices but not IVDs.
N/A
Intended Use / Indications for Use
The Rexam Self-Seal Tyvek® Pouch is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider using a sterilization process where a non-cellulose pouch is indicated. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
The chemical process indicator on the Rexam Self-Seal Tyvek® Pouch is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.
Product codes
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Device Description
The Rexam Self-Seal Tyvek® Pouch is constructed of medical grade Tyvek® sealed to polyethylene/polyester film. A chemical sterilization process indicator may be incorporated to monitor one or more of the sterilization process parameters. The final seal of the pouch is applied by the health care provider using the pressure sensitive self-seal tape closure. The self-seal tape closure facilitates manual sealing as an alternate method to heat sealing.
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 provider
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The performance of the self-seal tape closure on the Rexam Self-Seal Tyvek® Pouch was measured by seal strength and seal integrity tests, and compared to the performance of the self-seal tape on the Medi-Oxide™ Pouch. The seal strength test results were statistically analyzed at a 95% confidence level, and the test results indicate that both products were significantly above the minimum seal strength limit. The Rexam Self-Seal Tyvek® Pouch performed as well as the Medi-Oxide™ Pouch on the seal integrity tests.
Key Metrics
seal strength, seal integrity
Predicate Device(s)
Medi-Oxide™ Pouch
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
0
REXAM
AUG - 9 1996
510(k) Summary
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K962600
Applicant Information:
| Date Prepared: | August 5, 1996 |
|---|---|
| Name: | Rexam Medical Packaging |
| Address: | 1919 S. Butterfield Road |
| Mundelein, IL 60060-9735 | |
| Contact Person: | Quality and Regulatory Manager |
| Phone Number: | (847) 362-9000 |
| Fax Number: | (847) 918-4660 |
Device Information:
| Trade Name: | Rexam Self-Seal Tyvek1 Pouch |
|---|---|
| Common Name: | Self-Seal Tyvek®/Film Sterilization Pouch |
| with or without Chemical Sterilization Process Indicator | |
| Classification Name: | Sterilization Wrap, Chemical Sterilization Process Indicator |
Predicate Device:
| Trade Name: | Medi-Oxide™ Pouch |
|---|---|
| Manufacturer: | Cur*Med, Curwood, Inc., a Bemis Company |
Device Description:
The Rexam Self-Seal Tyvek® Pouch is constructed of medical grade Tyvek® sealed to polyethylene/polyester film. A chemical sterilization process indicator may be incorporated to monitor one or more of the sterilization process parameters. The final seal of the pouch is applied by the health care provider using the pressure sensitive self-seal tape closure. The self-seal tape closure facilitates manual sealing as an alternate method to heat sealing.
1Tyvek is a registered trademark of E.I. duPont de Nemours & Company.
1
REXAM
Intended Use:
The Rexam Self-Seal Tyvek® Pouch is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider using a sterilization process where a non-cellulose pouch is indicated. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
The chemical process indicator on the Rexam Self-Seal Tyvek® Pouch is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.
Comparison of Technological Characteristics:
The Rexam Self-Seal Tyvek® Pouch and the Medi-Oxide™ Pouch are both constructed of medical grade Tyvek® sealed to polyethylene/polyester film. The pressure sensitive tape closure on the Rexam Self-Seal Tyvek® Pouch and the Medi-Oxide™ Pouch are both one inch in width, and the seal is applied by the customer in the same manner for both products. The Medi-Oxide™ Pouch is manufactured without a chemical sterilization process indicator, and the Rexam Self-Seal Tyvek® Pouch may be manufactured with or without a chemical sterilization process indicator.
The performance of the self-seal tape closure on the Rexam Self-Seal Tyvek® Pouch was measured by seal strength and seal integrity tests, and compared to the performance of the self-seal tape on the Medi-Oxide™ Pouch. The seal strength test results were statistically analyzed at a 95% confidence level, and the test results indicate that both products were significantly above the minimum seal strength limit. The Rexam Self-Seal Tyvek® Pouch performed as well as the Medi-Oxide™ Pouch on the seal integrity tests.
The information submitted includes data that demonstrates that the Rexam Self-Seal Tyvek® Pouch is as safe and effective as the legally marketed Medi-Oxide™ Pouch, and that there are no new issues raised of safety and efficacy.