(100 days)
Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider by the following modalities:
- Pre-vacuum steam at 270°F/132°C for 4 minutes
- STERRAD® 100S system. .
- 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). Maintenance of package sterility was validated with real-time testing for the following durations:
- 180 days following sterilization by STERRAD 100S and Amsco® V-PRO™ (Lumen, Non Lumen, . and Flexible Cycles).
- 30 days following sterilization by pre-vacuum steam at 270°F/132°C for 4 minutes. .
Cardinal Health DuraBlue™ Sterilization Wrap is not indicated for use with gravity steam sterilization.
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 lumens 3 mm in diameter or larger and 400 mm in length or less. All models have been validated for 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 following Amsco® V-PRO™ cycles. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the preprogrammed Amsco® V-PRO® sterilization cycles.
Cardinal Health DuraBlue™ Sterilization Wraps are double layer sterilization wraps made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. They are intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 270°F/132°C for 4 minutes, STERRAD® 100S System and the Lumen, Non Lumen, or Flexible Cycles in 270 17102 0 for 4 mililates, STERM 1 Plus and Amsco® V-PRO™ MAX Low Temperature Sterilization Systems. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically.
This submission covers six different models of Cardinal Health DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.
The Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose medical devices for sterilization and to maintain sterility for specified durations. The acceptance criteria and supporting studies are detailed below, primarily focusing on the sterility maintenance aspect, as this is the key modification highlighted in the submission, and sterilization efficacy as a fundamental performance requirement.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study that Proves the Device Meets Acceptance Criteria |
|---|---|---|
| Sterility Maintenance Duration: | ||
| STERRAD 100S and Amsco V-PRO (Lumen, Non Lumen, and Flexible Cycles) | 180 days | Event-Related Shelf Life testing |
| Pre-vacuum steam at 270°F/132°C for 4 minutes | 30 days | Event-Related Shelf Life testing |
| Sterilization Efficacy: | ||
| Allow sterilization of enclosed medical devices | Demonstrated successful completion of sterilization performance tests | Extensive performance testing on Cardinal Health DuraBlue™ Sterilization Wrap in predicate Premarket Notifications (K112211, K112283, K112918) |
| Physical Properties Integrity after Sterilization and Storage: | ||
| Not compromised | Integrity of wrap properties is not compromised, as the polypropylene material is inert and very stable. Data included in predicate Premarket Notifications. | Physical Properties testing included in predicate Premarket Notifications (K112211, K112283, K112918) |
| Dry Times for Pre-vacuum Steam Sterilization: | ||
| Models CH100/CH200: 20 minutes | Validated for 20 minutes | Validation study (not detailed here, but referenced in the Indications for Use) |
| Models CH300, CH400, CH500, CH600: 30 minutes | Validated for 30 minutes | Validation study (not detailed here, but referenced in the Indications for Use) |
| Lumen Sterilization Capacity (Pre-vacuum Steam): | ||
| Models CH400, CH500, CH600: lumens 3mm diameter or larger and 400mm length or less | Validated for these lumens | Validation study (not detailed here, but referenced in the Indications for Use) |
| Lumen Sterilization Capacity (STERRAD 100S): | ||
| All models: lumens 2.5mm diameter or larger and 250mm length or less | Validated for these lumens | Validation study (not detailed here, but referenced in the Indications for Use) |
| Amsco V-PRO Cycles Validation: | Demonstrated effective aeration | Validation study (not detailed here, but referenced in the Indications for Use) |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not explicitly state the sample size for the "Event-Related Shelf Life testing" (which would be the primary test set for the sterility maintenance claim) or the "Extensive performance testing" for sterilization efficacy.
- Data Provenance: The studies are described as "real-time testing" for sterility maintenance and "extensive performance testing" for sterilization efficacy. The data is internally generated by Cardinal Health 200, LLC, a US-based company, suggesting the studies were conducted domestically. They are retrospective in the sense that the data is being presented post-collection as part of a 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide information about the number or qualifications of experts used to establish ground truth. For sterility and sterilization efficacy testing, ground truth is typically established through microbiological methods (e.g., sterility testing, biological indicators) and physical/chemical tests, rather than expert consensus on interpretation.
4. Adjudication Method for the Test Set
Not applicable. The tests described (sterility testing, physical properties testing) involve objective measurements rather than subjective assessments requiring adjudication or consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The device is a sterilization wrap, not an imaging or diagnostic device that typically involves human readers interpreting results.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "Event-Related Shelf Life testing" and "Extensive performance testing" demonstrate the performance of the wrap itself (the "algorithm only without human-in-the-loop performance" equivalent for this type of device) in achieving and maintaining sterility. The efficacy of the wrap is evaluated independently of human interpretation of a diagnostic output.
7. Type of Ground Truth Used
The ground truth used for these studies would be based on:
- Sterility: Absence of microbial growth in sterility tests (microbiological cultures).
- Sterilization Efficacy: Inactivation of biological indicators (spore tests) and successful passage of physical/chemical indicators for sterilization.
- Physical Properties: Objective measurements of material integrity (e.g., tensile strength, tear resistance, barrier properties) before and after sterilization/storage.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here as this is a physical medical device (sterilization wrap) undergoing performance testing, not an AI/machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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).