FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

. Pre-vacuum steam at 270°F/132°C for 4 minutes
. 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes
Advanced Sterilization Products (ASP) STERRAD® 100S system. .
. Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles
. Advanced Sterilization Products (ASP) STERRAD® 100NX system, Standard, Flex, Express, and DUO Cycles
. Lumen, Non Lumen, and Flexible Cycles in the Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus and Amsco® V-PRO® max Low Temperature Sterilization Systems

The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of ' the enclosed device(s) until used.

For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CH600. Models CH400, CH500 and CH600 have been validated for pre-vacuum steam sterilization of two lumens 3 mm in diameter or larger and 400 mm in length or less.

For EO sterilization, the wrap has been validated for an aeration time of 8 hours at 55 ℃. Models CH400, CH500 and CH600 have been validated for EO sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less.

All models of DuraBlue™ Sterilization Wrap have been validated for Advanced Sterlization Products (ASP) STERRAD® 100S sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less.

All models of DuraBlue™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX cycles in Table 1.

All models of DuraBlue™ Sterilization Wrap have been validated for use with the STERIS Amsco® V-PRO® cycles in Table 2. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS Amsco® V-PRO® sterilization cycles.

Device Description

DuraBlue™ Sterlization Wraps are made from 100% polypropylene spunbond-meltblown-spunbond (SMS) trilaminate nonwoven fabric. Each double-layer wrap is comprised of a single sheet of SMS fabric that has been folded in half and sealed to itself on the three non-folded edges. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically. This product is for over-the-counter use only.

They are intended to be used to enclose another medical device that is to be sterilized by a health care provider using:

Pre-vacuum steam at 270°F/132°C for 4 minutes .
. 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes
. Advanced Sterilization Products (ASP) STERRAD® 100S System
Advanced Sterilization Products (ASP) STERRAD® NX System, Standard and Advanced . Cycles
Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard, Flex, Express, and . DUO cycles
Lumen, Non Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO® 1, Amsco® V-. PRO® 1 Plus and Amsco® V-PRO® MAX Low Temperature Sterilization Systems

The modification to the predicate devices is the clarification to the sterility maintenance information provided in the Indications for Use portion of the Instructions for Use labeling and involves extending the real-time aging data from 180 days to 365 days. This change is being made in order to comply with 21CFR880.6850 which states "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 sterlized 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." Additionally, maintenance of package sterility was validated with realtime testing for a duration of 365 days for each indicated sterilization process.

Extensive performance testing has also been completed on DuraBlue™ Sterlization Wrap. Successful completion of the sterilization performance tests demonstrated that the wrap allows for sterlization of the enclosed contents and also maintains sterility of the enclosed devices. Physical properties testing included in this submission also supports the fact that the integrity of the wrap properties is not compromised after sterilization by the indicated sterilization processes and storage because the polypropylene material is inert and very stable.

This submission covers six different models of DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.

AI/ML Overview

The provided text describes the DuraBlue™ Sterilization Wrap and elaborates on its acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to predicate devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Properties	Acceptance Criteria (Implied by testing to "Pass" or "Compatible")	Reported Device Performance
Sterilization Efficacy	Pass	PASS
Microbial Barrier Properties (Aerosol Challenge)	Pass	PASS
Event Related Shelf Life	180 days (predicate) -> 365 days (proposed)	PASS - 365 days
Material Compatibility with Indicated Sterilization Method	Compatible	Compatible
Biocompatibility	Non-cytotoxic, Non-sensitizing, Non-irritating	Non-irritating (implies non-cytotoxic and non-sensitizing)
Configuration/Dimensions	Six basis weights, Fourteen sizes (same as predicate)	Same
Maximum Wrapped Package Content Weights	Specific weights per sterilization method and wrap model (same as predicate)	Same

Study Proving Device Meets Acceptance Criteria:

The device's performance was proven through "extensive performance testing" and "sterility validation studies" in accordance with applicable requirements recommended in the FDA's Guidance Document: "Premarket Notifications for Medical Sterilization Packaging System in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)."

The primary modification for this 510(k) submission was the extension of real-time aging data from 180 days to 365 days to comply with regulations regarding maintaining sterility.

2. Sample Size Used for the Test Set and Data Provenance:

The document provides details of specific loads used for each type of sterilization validation study and for each wrap model (CH100 - CH600). These loads vary in composition (huck towels, drapes, metal mass, lumens) and weight.

Pre-vacuum Steam Sterility Validation Studies:
- CH100: 16 huck towels
- CH200: 2 huck towels, 3 fluid-resistant drapes
- CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs of metal mass
- CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 8 lbs of metal mass
- CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 12 lbs of metal mass
- CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 20 lbs of metal mass
EO Sterility Validation Studies:
- CH100: 16 huck towels
- CH200: 2 huck towels, 2 fluid-resistant drapes, 2.5 lbs of metal mass
- CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs of metal mass
- CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 7.5 lbs of metal mass
- CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 11.5 lbs of metal mass
- CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 19.5 lbs of metal mass
Advanced Sterilization Products (ASP) STERRAD® 100S Sterility Validation Studies:
- CH100: Metal Instruments
- CH200 - CH600: 15 in. x 10 in. x 1.2 in. tray containing metal instruments
Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX Sterility Validation Studies:
- CH100 - CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments
STERIS Amsco® V-PRO® Sterility Validation Study:
- CH100: Metal Instruments
- CH200 - CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments

The "Note" section on page 6 states: "The loads used in the Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 3."

Data Provenance: The document does not specify the country of origin of the data. The studies are prospective in nature, as they involve testing the device's performance under various sterilization conditions and aging.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not explicitly provided in the document. The studies performed are laboratory-based performance tests and sterility validation studies rather than analyses requiring expert interpretation of medical images or clinical outcomes. Therefore, the "ground truth" would be established by the results of standardized biological and physical tests and measurements, often conducted by trained technicians in controlled environments.

4. Adjudication Method for the Test Set:

This information is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human readers in diagnostic studies. Here, the "test set" refers to physical samples undergoing rigorous laboratory tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output, and the AI's assistance to human readers is being evaluated. The DuraBlue™ Sterilization Wrap is a sterilization packaging device, not a diagnostic tool requiring human interpretation aided by AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

Not applicable in the context of an AI algorithm. The device itself is a physical product (sterilization wrap), and its performance is evaluated in a standalone manner (i.e., the wrap's ability to maintain sterility, its material properties, and compatibility with sterilization methods). There is no "algorithm" in the typical sense for this device.

7. The Type of Ground Truth Used:

The ground truth used for these studies is based on:

Sterilization Efficacy: Demonstrated by the ability to achieve and maintain sterility, likely through biological indicator (BI) testing or other validated methods to confirm the absence of viable microorganisms.
Microbial Barrier Properties: Assessed through aerosol challenge tests, measuring the ability of the wrap to prevent microbial ingress.
Event-Related Shelf Life: Determined by real-time aging studies over 365 days, followed by integrity and sterility testing at various time points.
Material Compatibility: Physical property testing (e.g., tensile strength, tear resistance) after sterilization, and chemical compatibility assessments to ensure the polypropylene material is not compromised.
Biocompatibility: Standardized tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993 or similar standards.

Essentially, the "ground truth" is established by objective, measurable results from validated laboratory tests and standards.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI/ML model that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for an AI/ML model, this question does not apply.

Summary

Regulation Number and Section

§ 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).