(252 days)
Double Duty Pro-Guard
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No
The device description and performance studies focus on the material properties and sterilization efficacy of a medical device wrap, with no mention of AI or ML technology.
No
The device is described as a medical wrap material used for sterilization processes and maintaining sterility of other medical devices. It does not directly treat or diagnose a disease or condition in a patient.
No.
The device is described as a medical wrap intended for sterilization processes, not for diagnosing medical conditions.
No
The device description clearly describes a physical product made of polyester/cellulose and polypropylene materials, intended for wrapping other medical devices. It does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to wrap other medical devices for sterilization and maintain sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description details the materials and construction of a sterilization wrap. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
- Using reagents or assays
The device is clearly intended for use in the sterilization process of other medical devices, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Pro-Guard Double Duty, like the other wrap products available, is intended to wrap other medical devices for exposure to saturated steam or ethylene oxide sterilization processes and to maintain sterilization for a reasonable time under reasonable conditions.
Product codes
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Device Description
Pro-Guard Double Duty joins two of these materials, polyester/cellulose and polypropylene, through the ultrasonically bonding of a sheet of one to a sheet of the other. This provides the traditional two sheets of wrap but allows the user to wrap the tray or pack with both sheets at the same time as in the Kimberly-Clark One Step product rather than sequentially. No additional materials are added as a bonding agent or for any other reason. Sheets of two different materials were used rather than two sheets of the same material in an effort to provide the best characteristics of each for the end user. The cellulose/polyester (Pro-Guard) is used as the outside sheet for its non-irritating handling properties and good biobarrier characteristics and 100% polypropylene is used on the inside as a strengthening member with its resistance to tear.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
Nonclinical testing was performed for this submission.
Primary Skin Irritation Testing: The scores for primary skin irritation in the rabbit testing were 0.00 which indicates that Double Duty Pro-Guard should not cause irritation to an operator.
Sterilant Penetration: All survival and all kill points for biological indicators contained in Double Duty Pro-Guard were lower or very close to those for other wraps existing on the market.
Six Month Biobarrier Shelf-life Testing: The only positives concerning Double Duty Pro-Guard were made with the double wrapped packs which were more difficult to test due to the extra layers. The positive test results were very probably caused by contamination.
Ethylene Oxide Residuals and Outgassing: The low level of residuals indicate that Double duty Pro-Guard allows free movement of EO.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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).
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PRO-GUARD DOUBLE DUTY CSR WRAP 510 (K) SUMMARY
SUBMITTED BY: (1)
MAR 1 1 1997
William B. Youngmark Director, QC Surgicot, Inc. 4018 Patriot Drive 27709 RTP, NC 919-361-0419 1/29/97
(2) RE: K962605 PRO-GUARD DOUBLE DUTY CSR WRAP
Single use non-woven wraps are well known and have been in (3) use by health care providers for many years. Materials commonly used in these wraps include pure cellulose (Dexter, Surgicot Surqiwrap), polyester/cellulose (Surgicot Pro-Guard Regular and Heavy Duty) and 100% polypropylene (Kimberly-Clark Kimguard Regular, Heavy Duty, Ultra and One Step; American Threshold Secure-Wrap). Pro-Guard Double Duty is substantially equivalent to all of these products.
Pro-Guard Double Duty joins two of these materials, (4) polyester/cellulose and polypropylene, through the ultrasonically bonding of a sheet of one to a sheet of the other. This provides the traditional two sheets of wrap but allows the user to wrap the tray or pack with both sheets at the same time as in the Kimberly-Clark One Step product rather than sequentially. No additional materials are added as a bonding agent or for any other reason.
( 5 ) Pro-Guard Double Duty, like the other wrap products available, is intended to wrap other medical devices for exposure to saturated steam or ethylene oxide sterilization processes and to maintain sterilization for a reasonable time under reasonable conditions.
(6a) Sheets of two different materials were used rather than two sheets of the same material in an effort to provide the best characteristics of each for the end user. The cellulose/polyester (Pro-Guard) is used as the outside sheet for its non-irritating handling properties and good biobarrier
1
characteristics and 100% polypropylene is used on the inside as a strengthening member with its resistance to tear. Both materials are non toxic when used as directed for the purpose intended. The resulting product is puncture resistant, offers the same biobarrier qualities as other premium wrap products while allowing the user to save time by wrapping an item intended for sterilization once rather than twice.
(6b) Below is a listing of the nonclinical testing performed for this submission and discussion of the results.
Primary Skin Irritation Testing
The scores for primary skin irritation in the rabbit testing were 0.00 which indicates that Double Duty Pro-Guard should not cause irritation to an operator.
Sterilant Penetration
All survival and all kill points for biological indicators contained in Double Duty Pro-Guard were lower or very close to those for other wraps existing on the market.
Six Month Biobarrier Shelf-life Testing
The only positives concerning Double Duty Pro-Guard were made with the double wrapped packs which were more difficult to test due to the extra layers. The positive test results were very probably caused by contamination.
Ethlyene Oxide Residuals and Outgassing
The low level of residuals indicate that Double duty Pro-Guard allows free movement of EO.