(278 days)
Gemini Bonded Sterilization Wraps are 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 such content until used. Gemini Bonded Sterilization Wrap is validated for use in steam or STERRAD sterilization processes in the following sterilization modes and cycles:
TABLE 1: Pre-vacuum team at 270°F/132°C for 4 minutes with the following dry times by weight
TABLE 2: Gravity steam at 250°F/121°C for 30 minutes with the following dry times by weight
TABLE 3: STERRAD® Sterilization
As previously described in K143147. Gemini Bonded Sterilization Wrap is offered to the marketplace as bulk packages of two ply sheets which are ultrasonically bonded together for use by customers in accordance with standard hospital practices which require that two sheets are used each time a medical device or collection of medical devices are wrapped. The Gemini Bonded Sterilization Wrap provides the protection of double-wrapping in an efficient manner; cutting wrap/unwrap time in half, compared to traditional doublewrapping methods.
Gemini Bonded Sterilization Wrap are square or rectangular sheets of fabric produced using a five-layer SSMMS (spunbond-spunbond-meltblown-meltblown-spunbond) process.
The standard blue wrap fabric is made of polypropylene with the addition of less than 2% of phthalocyanine blue pigmentation and less than 0.35% titanium dioxide white pigmentation. The wrap allows for aseptic opening of the sterilized package.
The two-tone blue/pink wrap fabric is made of polypropylene with the addition of less than 2% of phthalocyanine blue pigmentation, less than 0.5% of titanium dioxide white pigmentation and less than 2% of disazocondensation red pigmentation. The wrap allows for aseptic opening of the sterilized package.
Gemini Bonded Sterilization Wrap is available in sizes ranging from 12"x12" across the five different material weights/models.
The provided text describes the acceptance criteria and study results for the "Gemini Bonded Sterilization Wrap" (K152458) by Medline Industries, Inc. The device's primary function is to enclose other medical devices for sterilization and maintain their sterility until use.
The submission is a Traditional 510(k) and asserts substantial equivalence to a predicate device, Gemini Bonded Sterilization Wrap cleared under K143147.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion / Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Modalities & Cycle Parameters | ||
| Pre-Vacuum Steam Sterilization (270°F/132°C) | Exposure: 4 minutes; Minimum Dry Time: 20-30 minutes (depending on weight) | Passed (validated) |
| Gravity Steam Sterilization (250°F/121°C) | Exposure: 30 minutes; Minimum Dry Time: 20-30 minutes (depending on weight) | Passed (validated) |
| STERRAD® 50 Sterilization | Validated for specific intended loads and lumen dimensions | Passed (validated) |
| STERRAD® 200S Sterilization | Validated for specific intended loads and lumen dimensions | Passed (validated) |
| STERRAD® 100NX™ DUO Cycle Sterilization | Validated for specific intended loads and lumen dimensions | Passed (validated) |
| Maintenance of Sterility (Shelf Life) | ||
| Pre-Vacuum & Gravity Steam Sterilization | 2 years | Passed |
| STERRAD® 50, 200S, and 100NX™ Cycles | 180 days | Passed |
| Package Integrity (non-specific, implied by "Maintenance of Sterility" study) | N/A (implied successful maintenance of sterility) | Passed |
| Sterilant Penetration (Pre-Vacuum Steam & Gravity) | Adequate penetration for sterilization | Passed |
| Sterilant Penetration (STERRAD® cycles) | Adequate penetration for sterilization | Passed |
| Post Sterilization Biocompatibility (Primary Skin Irritation Testing - ISO 10993-10) | Non-irritating | Passed |
| Physical Properties (conducted on lightest and heaviest wraps, pre- and post-sterilization) | ||
| Air permeability (ASTM D737-04 R2012) | Met specifications | Passed |
| Basis weight (ASTM D3776) | Met specifications | Passed |
| Material burst strength (ASTM D3786) | Met specifications | Passed |
| Resistance to water penetration (AATCC127) | Met specifications | Passed |
| Tensile strength and elongation (ASTM D5034) | Met specifications | Passed |
| Tear strength (ASTM D5587) | Met specifications | Passed |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific "sample size for the test set" in terms of number of wraps tested for each validation. The validation studies for sterilization efficacy likely involved multiple cycles and packages to demonstrate repeatable results.
- Data Provenance: The studies appear to be internal validation studies conducted by or for Medline Industries, Inc. The document does not specify a country of origin for the data beyond the company's location in Mundelein, IL, USA. The studies are prospective as they were conducted to validate the device's performance for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. For device validation studies like sterilization wraps, "ground truth" would typically be established through microbiology lab results (sterility testing, biological indicator kill) and physical testing according to relevant standards. These processes usually involve trained laboratory personnel rather than clinical "experts" like radiologists.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation (e.g., image reading), not for laboratory or performance testing of a physical product like a sterilization wrap.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted and is not applicable for this type of device. This device is a sterilization wrap, not an AI or diagnostic imaging device that involves human interpretation.
6. Standalone Performance Study
Yes, standalone performance was conducted for the device. The "Summary of Non-Clinical Testing" (Table 8 and subsequent paragraphs on page 13) describes various performance tests performed on the Gemini Bonded Sterilization Wrap. These tests evaluate the wrap's physical properties, sterilant penetration, and ability to maintain sterility without human intervention during the sterilization or storage phases.
7. The Type of Ground Truth Used
The ground truth used for this device's validation is primarily based on technical performance standards and objective measurements:
- Sterility: Absence of microbial growth after sterilization, typically confirmed through biological indicators and sterility testing.
- Physical Properties: Measurable values for air permeability, basis weight, burst strength, water penetration resistance, tensile strength, elongation, and tear strength, compared against predefined specifications and industry standards (e.g., ASTM, AATCC).
- Biocompatibility: Absence of adverse biological reactions (e.g., skin irritation) as tested against ISO 10993-10 standards.
- Shelf Life: The ability of the package to maintain sterility over a specified period, verified through real-time stability studies which likely involved package integrity testing and sterility checks over time.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. Training sets are relevant for machine learning or AI models. This device is a physical product, and its performance is validated through traditional engineering and scientific testing, not by training an algorithm.
9. How the Ground Truth for the Training Set Was Established
As the concept of a training set is not applicable, the method for establishing its ground truth is also not applicable.
§ 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).