(138 days)
Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is intended to protect the M/L-10 Clip Applier handpiece (Catalog #1002) and to facilization process by allowing steam penetration and air removal. When used in conjunction with 2 layers of FDA-cleared 1-ply polypropylene sterilization wrap, sterility of the enclosed sterilization tray (Catalog# 3706) is maintained until used.
The Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is used to secure the M/L-10 Clip Applier handpiece (Catalog #1002) which measures at 17.13" length, and 0.90"width in dimensional measurements, as the intended load during the transport, sterilization and storage between its intended uses.
The ML-10 Clip Applier Sterilization Tray (Catalog# 3706) has been validated with the M/L-10 Clip Applier handpiece (Catalog #1002) wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap weighing a calculated total weight of 1663.10 grams. The M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) has been validated with the following Steam Sterilization Parameters: Pre-vacuum, Time: 4 minutes at Temperature of 132 °C. The Gravity Cycle parameters include: Time: 15 minutes and Temperature of 132 °C.
Microline Surgical MIL-10 Clip Applier Sterilization Tray (Catalog #3706) intended purpose is to secure the M/L-10 Clip Applier device during its transportation, sterilization, and storage purposes.
The subject device ML - 10 Clip Applier Sterilization #3706) consists of a case, a cover and brackets. The MIL-10 Clip Applier Sterilization Tray (Catalog #3706) Lid is 19.875" (Width) x .450" (Height); and the Base is 19.875" (Length) x 5.50" (Width) x 1.450" (Height) in dimensions. The ML-10 Clip Applier Sterilization Tray (Catalog #3706) cover and lid (case) are constructed of Stainless Steel material, which could be reused with Steam Sterilization method. The brackets are constructed from Aluminum, Stainless Steel, and biomedical grade Silicone. The ML-10 Clip Applier Sterilization Tray surface is coated with Nylon Coating Powder. The sterilization tray cover is secured to the case by means of assembled hardware and a locking tab, designed as part of the case and cover have an evenly distributed hole pattern in relation to the tray size to support the steam sterilization process. The brackets are designed to secure the ML-10 Clip Applier for sterilization purpose. The subject device MIL-10 Clip Applier Sterilization Tray is non-patient and non-blood/fluid contact during its intended use. The ML - 10 Clip Applier Sterlization Tray (Catalog #3706) is a metal tray and packaged in bubble wrap, single wall, 32 lbsfinch edge, crushed corrugated brown cardboard shipping box, which does not need any special handling requirements during shipment.
This document describes the Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog #3706) and its substantial equivalence to a predicate device. The information provided focuses on the safety and effectiveness of the sterilization tray itself, rather than detailing a study that measures device performance against a specific clinical condition using AI.
Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, AI effect size, standalone algorithm performance) are not applicable or cannot be extracted from this document, as they relate to the evaluation of AI/algorithm performance in a clinical context, which is not the subject of this 510(k) submission.
However, I can provide the available information related to the acceptance criteria and the essential performance characteristics of the sterilization tray.
Acceptance Criteria and Reported Device Performance for Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog #3706)
The evaluation of the Microline Surgical M/L-10 Clip Applier Sterilization Tray focuses on its ability to protect a medical device and facilitate sterilization while maintaining sterility. The primary performance characteristic evaluated is its sterility assurance level (SAL).
1. Table of Acceptance Criteria and the Reported Device Performance
| Characteristic / Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterility Assurance Level (SAL) | A sterility assurance level of 10⁻⁶ using the biological indicator (BI) overkill method (in accordance with AAMI TIR12:2010 and EN ISO 17664:2004). | "The acceptance criteria required that the sterilization methods demonstrate a sterility assurance level (SAL) of 10⁻⁶ using the biological indicator (BI) overkill method, which met as required." The device was validated with the M/L-10 Clip Applier handpiece within the tray, wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap, under specific steam sterilization parameters: Pre-vacuum (4 min at 132°C, 20 min dry) and Gravity Cycle (15 min at 132°C, 45 min dry). |
| Material Compatibility and Durability | Not explicitly stated as acceptance criteria, but implied through substantial equivalence to predicate device and use of standard materials. | Constructed of Stainless Steel, Aluminum, and Biomedical Grade Silicone. Surface coated with Nylon Coating Powder. Intended for multiple use. |
| Dimensional Consistency | Not explicitly detailed as an acceptance criterion in the provided text, but implied through design specifications. | Lid: 19.875" (Length) x 5.632" (Width) x 0.450" (Height) inches. Base: 19.875" (Length) x 5.50" (Width) x 1.450" (Height) inches. Internal configuration designed to secure the M/L-10 Clip Applier (17.13" length, 0.90" width). Weight: 1663.10 grams (with contents and wrap). Hole size: Ø 0.250". Hole pattern: Six (6) rows with twenty-five (25) holes, with some centrally removed (50 for lid, 21 for base). |
| Air Permeability | Essential for steam penetration and air removal during sterilization. | The device is stated to have "Yes" for air permeability, similar to the predicate. The hole pattern is designed to "support the steam sterilization process." |
| Protection of Enclosed Device | Intended to protect the M/L-10 Clip Applier handpiece. | The tray's internal configuration secures the M/L-10 Clip Applier. The device's primary purpose is "to protect the M/L-10 Clip Applier handpiece". |
| Sterility Maintenance | Maintained until used, when used with 2 layers of FDA-cleared 1-ply polypropylene sterilization wrap. | The "sterility of the enclosed sterilization tray ... is maintained until used" when used as indicated. |
The Study Proving Device Meets Acceptance Criteria:
The document broadly states that Microline Surgical, Inc. "successfully completed a full sterilization using Steam Sterilization method" and that "The acceptance criteria required that the sterilization methods demonstrate a sterility assurance level (SAL) of 10⁻⁶ using the biological indicator (BI) overkill method, which met as required."
While the document references relevant standards (AAMI TIR12:2010 and EN ISO 17664:2004), it does not provide detailed methodology, specific protocol numbers, or raw data from this sterilization study. It summarizes the outcome of the study.
Additional Information (Based on the document's content):
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the sample size for the sterilization testing (e.g., number of trays or sterilization cycles tested).
- The data provenance is not explicitly stated beyond "Microline Surgical, Inc." completing the study. Given Microline Surgical is a US company, and the FDA submission, the testing would typically adhere to US/international regulatory standards. It's a prospective study in the sense that the testing was conducted specifically for this submission to demonstrate the device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is not a study requiring expert readers or ground truth establishment in a diagnostic context. The "ground truth" for sterilization is defined by achieving a 10⁻⁶ SAL, typically verified through biological indicators and laboratory analysis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This relates to the adjudication of diagnostic assessments, which is not relevant to sterilization validation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a sterilization tray, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the sterilization study, the "ground truth" is typically established by microbiological testing results (absence of viable microorganisms in biological indicators after sterilization), demonstrating a 10⁻⁶ Sterility Assurance Level, as per recognized sterilization standards (AAMI TIR12:2010, EN ISO 17664:2004).
8. The sample size for the training set
- Not applicable. There is no training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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).