(259 days)
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.
SteriZign Signatur Device Protection System are used to organize, transport, store and protect between uses of surgical and other medical devices that are sterilized by a healthcare provider. SteriZign Signatur Device Protection System are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycles. The SteriZign Signatur Device Protection System are not intended on their own to maintain sterility. The SteriZign Signatur Device Protection System have perforations and intended to be used in conjunction with legally marketed, validated FDA cleared sterilization wrap.
Autoclave Sterilization Parameter Cycle: Pre-vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Dry Time: 30 minutes
The total weight of a tray (e.g. tray, insert and instruments) should never exceed 25 lbs.
Validated sizes of stainless steel instrument lumens include:
1 each 1mm x 76 mm
1 each 1mm x 400 mm
1 each 2mm x 400 mm
1 each 3mm x 400 mm
1 each 5mm x 400 mm
SteriZign Signatur Device Protection System are cassettes/trays used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes/trays by themselves do not maintain sterility. The cassettes/trays are different sizes of the same basic configuration: a rectangular base with a cover. The cassettes/trays have perforations to allow sterilant penetration. The cassettes/trays contain silicone inserts in the base and/or cover to hold, organize and protect the surgical instruments within the cassettes/trays.
Here's a breakdown of the acceptance criteria and study information for the SteriZign Signatur Device Protection System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantifiable, pass/fail format within the provided document. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (K133015 Summit Medical, Instrument Protection System) by comparing various characteristics and performance data. The device performance listed below is what was reported and presumably met the internal criteria for substantial equivalence.
| Characteristic / Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (SteriZign Signatur Device Protection System) |
|---|---|---|
| Intended Use | To organize and protect medical devices intended for sterilization within a healthcare setting. Allows sterilization of enclosed medical devices during pre-vacuum steam sterilization cycles. Not intended to maintain sterility on its own. To be used with legally marketed, validated FDA cleared sterilization wrap. | Used to organize, transport, store, and protect surgical and other medical devices that are sterilized by a healthcare provider. Intended to allow sterilization of enclosed medical devices during pre-vacuum steam sterilization cycles. Not intended on its own to maintain sterility. Intended to be used in conjunction with legally marketed, validated FDA cleared sterilization wrap. |
| Autoclave Sterilization Cycle | Pre-vacuum | Pre-vacuum |
| Temperature | 270°F (132°C) | 270°F (132°C) |
| Exposure Time | 4 minutes | 4 minutes |
| Dry Time | 30 minutes | 30 minutes |
| Max Weight of Tray (tray, insert, instruments) | 17 lbs (Predicate) | Never exceed 25 lbs |
| Validated Stainless Steel Instrument Lumen Sizes (ID x Length) | 1mm x 76mm, 1mm x 65mm, 1mm x 400mm, 2mm x 300mm, 3mm x 177mm, 3mm x 200mm, 3mm x 400mm, 5mm x 241mm (Predicate) | 1mm x 76mm, 1mm x 400mm, 2mm x 300mm, 3mm x 400mm, 5mm x 400mm |
| Material Composition | Anodized Aluminum lid and base, silicone brackets, Stainless Steel latch, Stainless Steel handles, Anodized aluminum bar holders, Polypropylene feet, Silicone dividers, Silicone mats, Stainless steel brackets, Locating post (High performance plastic), Accessory box (High performance plastic). | Base: Aluminum Anodized; Insert: Aluminum Anodized; Lid: Aluminum Anodized; Latch: 300 Series SS Passivated; Handle: 300 Series SS Passivated; Shelf Bracket: 300 Series SS Passivated; Mat(s): Silicone; Brackets: Polypropylene. |
| Microbial Barrier Properties | Intended to be used in conjunction with a legally marketed wrap. Not intended on its own to maintain sterility. | Intended to be used in conjunction with a legally marketed wrap. Not intended on its own to maintain sterility. |
| Sterilant Penetration Performance | Allows for sufficient sterilant penetration. | Verified that the system allows for sufficient sterilant penetration when exposed to a pre-vacuum steam 132°C two (2) minute sterilization, half cycle with no BI growth. |
| Toxicological Properties (Biocompatibility) | (Implied acceptable performance for predicate) | MEM Elution Cytotoxicity (ISO 10993-5): Test samples meet USP and ISO 10993-5 requirements. PASSED, considered NON-CYTOTOXIC. |
| Material Compatibility with Steam Sterilization | (Implied acceptable for predicate) | Materials of construction are compatible with steam sterilization. |
2. Sample Size Used for the Test Set and Data Provenance
The document only explicitly mentions a "half cycle" sterilization test for sterilant penetration performance.
- Sample Size for Test Set: Specific sample sizes for each test (e.g., number of cassettes/trays, number of lumens tested) are not provided.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It describes tests conducted for the purpose of demonstrating substantial equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set. For a medical device like a sterilization container, the "ground truth" for sterilization effectiveness is typically determined by established biological indicator (BI) tests and physical/chemical indicator results, often interpreted by microbiologists and sterilization experts, but this is not detailed here.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned or performed. This type of study is typically relevant for interpretative diagnostic devices, not for a sterilization container.
6. Standalone (Algorithm Only) Performance
No standalone (algorithm only) performance was done. This concept is not applicable to a physical medical device like a sterilization container system, which does not employ algorithms or AI.
7. Type of Ground Truth Used
The ground truth for the device's performance is established based on:
- Sterilization Effectiveness: Demonstrated absence of biological indicator (BI) growth after sterilization cycles, which is a standard method for validating sterilization.
- Material Compatibility: Laboratory testing (e.g., MEM Elution Cytotoxicity) proving the materials are non-cytotoxic and compatible with steam sterilization.
- Physical Properties: Verification of ability to hold instruments, meet weight limits, and allow sterilant penetration through perforations.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this type of medical device (physical sterilization container) as it does not involve machine learning or AI algorithms that require training data.
9. How the Ground Truth for the Training Set was Established
As there is no training set for this physical device, this question is 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).