(83 days)
The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended to enclose and organize Stryker Endoscopy reusable medical instruments during sterilization at a healthcare facility. The trays are optional accessories to the Stryker Endoscopy instruments for which they are not intended to mantain sterlity; they are intended to be used in conjunction with legally marketed, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended for use in any of the following standard sterilization machines / cycles:
| No | Method | Cycle |
|---|---|---|
| 1 | Ethylene Oxide (EtO) | Preconditioning Parameters |
| Temperature (°C) | ||
| 55°C (131°F) | ||
| Chamber Humidity | ||
| 70% RH | ||
| Vacuum Set Points | ||
| 1.3 psia | ||
| Time | ||
| 30 minutes | ||
| Exposure | ||
| Concentration | ||
| 725 mg/L, 100% EO | ||
| Temperature (°C) | ||
| 55°C ±2°C (131°F ±5°F) | ||
| Time | ||
| 1 hour | ||
| Chamber Humidity (%) | ||
| 70% RH (50-80%) ±5% | ||
| Aeration | ||
| Aeration Time | ||
| 12 hours | ||
| Temperature | ||
| 35°C - 54°C (95°F - 129°F) | ||
| 2 | Prevacuum Steam | Cycle 1 |
| Cycle 2 | ||
| Wrapping | ||
| Double | ||
| Double | ||
| Temperature | ||
| 132°C (270°F) | ||
| 134°C (273°F) | ||
| Sterilization Time | ||
| 4 minutes | ||
| 3 minutes | ||
| Dry Time | ||
| 30 minutes | ||
| 30 minutes | ||
| 3 | Gravity Steam | Cycle 1 |
| Cycle 2 | ||
| Wrapping | ||
| Double | ||
| Double | ||
| Temperature | ||
| 132°C (270°F) | ||
| 134°C (273°F) | ||
| Sterilization Time | ||
| 15 minutes | ||
| 10 minutes | ||
| Dry Time | ||
| 30 minutes | ||
| 30 minutes | ||
| 4 | STERIS® V-PRO® 1 | Standard |
| 5 | STERIS® V-PRO® 1 Plus | Non-Lumen or Lumen |
| 6 | STERIS® V-PRO® maX | Non-Lumen or Lumen |
| 7 | STERRAD® 100S | Standard |
| 8 | STERRAD® NX® | Standard |
| 9 | STERRAD® 100NX® | Standard |
In addition, the Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are validated for the following Immediate Use Steam Sterilization cycles for emergency situations ONLY.
| Method | Cycle | Cycle 1 | Cycle 2 |
|---|---|---|---|
| Immediate Use Steam | |||
| Sterilization (“Flash”) | |||
| Prevacuum Steam | Wrapping | None | None |
| Temperature | 132°C | ||
| (270°F) | 134°C | ||
| (273°F) | |||
| Sterilization Time | 4 minutes | 3 minutes | |
| Dry Time | None | None |
The maximum product loads for the trays are as follows:
| Tray Description | Catalog Number | Maximum Tray
Product Load | Total Loaded
Tray Weight |
|----------------------------------------------------|----------------|---------------------------------------------------------------------------------------------------|-----------------------------|
| Advanced Imaging Modality (AIM) Sterilization Tray | 0233-032-301 | Camera (Qty. 1)
Light Cable (Qty. 1)
Coupler (Qty. 1)
Scope (Qty. 2)
Adapter (Qty. 2) | 10.58 lbs |
| Endoscope and Camera Sterilization Tray | 233-032-302 | Camera (Qty. 1)
Light Cable (Qty. 1)
Coupler (Qty. 1)
Scope (Qty. 2)
Adapter (Qty. 2) | 10.58 lbs |
| Camera Sterilization Tray | 0233-410-002 | Camera (Qty. 1)
Light Cable (Qty. 1)
Coupler (Qty. 1) | 8.83 lbs |
- Validated worst case loading configuration included the Advanced Imaging Modality (AIM) Sterilization Tray containing a camera (Qty. 1), light cable (Qty. 1), coupler (Qty. 2), scope (Qty. 3) and adapter (Qty. 3).
The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are stainless steel, perforated sterilization trays to allow sterilization gases to penetrate the tray and sterilize the enclosed devices. They are used to enclose and protect particular Stryker endoscopy products during sterilization. The tray is compatible with the following sterilization methods:
- Ethylene Oxide (EtO)
- Prevacuum Steam, Immediate Use Prevacuum Steam, and Gravity Steam .
- Steris V-PRO 1 (Standard Cycle), Steris V-PRO 1 Plus (Non-Lumen or Lumen Cycles), Steris V-. PRO maX (Non-Lumen or Lumen Cycles)
- STERRAD 100S, STERRAD NX, and STERRAD 100NX (all with Standard Cycle) .
The trays are not intended to maintain sterility; they are intended to be used in conjunction with legally marketed, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The trays are comprised of a stainless steel base and removable stainless steel lid. The base includes silicone brackets for Stryker endoscopy device fixation within the tray and two (2) latches to affix the lid to the base. Handles on the sides of the base facilitate carrying of the trays are reusable and provided in a non-sterile condition.
This document describes the premarket notification for sterilization trays and does not concern a medical device that relies on algorithms or AI for its function. Therefore, the requested information about acceptance criteria for device performance, sample sizes, expert ground truthing, MRMC studies, or standalone algorithm performance is not applicable in the context of this submission.
The document focuses on demonstrating substantial equivalence of the sterilization trays to a predicate device through physical and chemical performance testing related to sterilization cycles and material biocompatibility.
Here's an overview of the information that is available in the provided text:
Acceptance Criteria and Reported Device Performance:
The document broadly states that "All results met acceptance criteria" for non-clinical testing and that "Performance testing demonstrated the subject device met pre-set acceptance criteria." However, it does not explicitly define specific numerical acceptance criteria for each test or detail the quantitative results beyond stating they were met.
For example, for biocompatibility:
- Cytotoxicity (pre-sterilization and post-sterilization): "no cytotoxicity or cell lysis using the grading system of ISO 10993-5, indicating the materials are non-cytotoxic" and "grade 2 or less cell lysis and none to mild reactivity, indicating the materials met acceptable cytotoxicity levels (grade 2 or less) post-sterilization."
- ISO intracutaneous reactivity: "overall mean difference in erythema and edema scores scores between control and test articles was 0.0 (0.9% sodium chloride extract) and 0.1 (sesame oil extract), indicating the materials are non-irritating."
The key performance aspect relates to the efficacy of various sterilization methods when used with the trays and the physical integrity/biocompatibility of the trays themselves.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Not explicitly defined with quantitative metrics, but implicitly: devices enclosed in the tray must be sterile after designated cycles. Compatibility with specific cycles is the main criterion. | The trays are compatible with and were validated for a range of sterilization methods and cycles, including: |
- Ethylene Oxide (EtO)
- Prevacuum Steam (Cycle 1: 132°C/4min/30min dry; Cycle 2: 134°C/3min/30min dry)
- Gravity Steam (Cycle 1: 132°C/15min/30min dry; Cycle 2: 134°C/10min/30min dry)
- Immediate Use Steam Sterilization ("Flash")/Prevacuum Steam (Cycle 1: 132°C/4min/no dry; Cycle 2: 134°C/3min/no dry)
- STERIS® V-PRO® (1 Standard, 1 Plus Non-Lumen/Lumen, maX Non-Lumen/Lumen)
- STERRAD® (100S Standard, NX Standard, 100NX Standard)
"Performance testing demonstrated the subject device met pre-set acceptance criteria." This implies successful sterilization outcomes using these methods with the trays. |
| Cleaning Validation | Not explicitly defined, but implicitly: trays must be effectively cleaned. | "cleaning validations (automated and manual)" were conducted. "All results met acceptance criteria." |
| Life Cycle Evaluation | Not explicitly defined, but implicitly: material and mechanical functionality must endure. | Life cycle evaluations of materials and mechanical functionality of the latch were performed. "All results met acceptance criteria." |
| Strength Testing of Tray Handles| Not explicitly defined, but implicitly: handles must withstand typical use without failure. | "strength testing of tray handles" was conducted. "All results met acceptance criteria." |
| Latch Force Testing | Not explicitly defined, but implicitly: latches must function correctly. | "latch force testing" was conducted. "All results met acceptance criteria." |
| Biocompatibility: | | |
| * Pre-sterilization Cytotoxicity* | No cytotoxicity or cell lysis (ISO 10993-5 grading system). | "test article extracts showed no cytotoxicity or cell lysis using the grading system of ISO 10993-5, indicating the materials are non-cytotoxic." |
| * ISO Intracutaneous Reactivity* | Mean difference in erythema and edema scores between control and test articles must be minimal (based on ISO 10993-10). | "the overall mean difference in erythema and edema scores scores between control and test articles was 0.0 (0.9% sodium chloride extract) and 0.1 (sesame oil extract), indicating the materials are non-irritating." |
| * Post-sterilization Cytotoxicity*| Acceptable cytotoxicity levels (grade 2 or less cell lysis). | "test article extracts showed grade 2 or less cell lysis and none to mild reactivity, indicating the materials met acceptable cytotoxicity levels (grade 2 or less) post-sterilization." |
Regarding the other questions:
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified in the document. These are physical product tests, not data-driven AI performance evaluations.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests would be objective measurements (e.g., sterility indicators, strength measurements, chemical analyses for biocompatibility).
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. These are physical product tests, not subjective expert reviews.
- 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 document is not about an AI-powered diagnostic/interpretive device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI-powered device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests (sterilization, cleaning, lifespan, strength, latch force), the ground truth would be established by objective, verifiable measurements according to validated test protocols and industry standards (e.g., AAMI standards for sterilization, ISO standards for biocompatibility).
- 8. The sample size for the training set: Not applicable. This refers to an AI/machine learning context, which is not relevant here.
- 9. How the ground truth for the training set was established: Not applicable. This refers to an AI/machine learning context, which is not relevant here.
§ 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).