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The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.

The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.

Sterilization Pouch/Roll Made with Tyvek® is intended to contain medical devices to be terminally sterilized in the STERRAD® Sterilization Systems. The recommended Gas Plasma sterilization cycle parameter is 6 minutes (Injection volume: 2880µ L) at 50°C. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the STERRAD® Sterilization System. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.

The Pouch/Roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.

The proposed pouches are constructed from Tyvek® plastic films, with H2O2 Chemical Indicator printed onto the Tyvek" film. The Self-seal pouch permits sealing of the pouch without need of heat- sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD® Sterilization Systems.

The H2O2 Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. H2O2 Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to blue (or lighter) when exposed to hydrogen peroxide.

The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:

• Self-sealing sterilization pouches .
• . Sterilization pouches, Flat
• . Sterilization pouches, Gusseted
• Sterilization rolls, Flat
• Sterilization rolls, Gusseted

This document is a 510(k) premarket notification for a medical device called "Sterilization Pouch/Roll Made with Tyvek®". It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence, which is the basis for its FDA clearance.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document presents performance data primarily in a comparative table (Table 5-2, continued on subsequent pages in the original document) comparing the new device against its predicate. It also lists the standards used for testing throughout the "Effectiveness and Safety" section.

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The Oticon Medical Sterilization Cassette is intended to organize and protect non-disposable medical device instrumentation during handling and use in hearing health care surgery. It is intended to be sterilized and stored with non-disposable medical device instrumentation. The Sterilization Cassette is intended to be used in conjunction with a legally marketed sterilization wrap in order to maintain sterility of the enclosed instruments until use.

The sterilization cassette is intended for washing, either manually or in an automated process in a washer disinfector, and for sterilization in a pre-vacuum steam sterilizer (min. three pulse, standard) utilizing either of the following cycles:

The Oticon Medical Sterilization Cassette is a stainless steel cassette consisting of a base tray, a lid and an insert with instrument holders made of silicone. The lid is locked to the base tray by a locking tab. Once the lid is closed and locked, enclosed instruments are kept in place by the holders and a silicone rail in the lid.

The Sterilization Cassette is designed using materials that can be reused with steam sterilization methods. The base tray, lid and insert have evenly distributed perforations to allow for penetration of sterilant during steam sterilization. For the sterilization process, the cassette is to be used in conjunction with a legally marketed sterilization wrap.

This document is a 510(k) summary for the Oticon Medical Sterilization Cassette, demonstrating its substantial equivalence to predicate devices. It focuses on the device's intended use and performance in cleaning and sterilization.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

• 132°C (270°F) for 4 minutes exposure, 20 minutes drying
• 134°C (273°F) for 3 minutes exposure, 16 minutes drying
• 135°C (275°F) for 3 minutes exposure, 16 minutes drying. | Showed that under the selected processing parameters, excellent steam penetration was achieved within the wrapped cassettes. Sterilization testing further demonstrated a sterility assurance level (SAL) of 10⁻⁶ of the cassette and its contents when handled according to the recommended instructions. |
  | Wear Following Re-use and Processing | Testing for wear following re-use and repeated processing (no specific quantitative criteria mentioned, but implied satisfactory performance). | The Sterilization Cassette functioned as intended, and the performance observed was as expected. The document concludes that "further testing will not raise new issues of safety or efficacy," implying acceptable wear characteristics over repeated use. |
  | Material Compatibility | Material compatibility with sterilization process (based on comparison table). | "Yes" (stated in the comparison table, indicating compatibility). |
  | Microbial Barrier Properties | To be used in conjunction with a legally marketed sterilization wrap to maintain sterility (based on comparison table). | Confirmed that for the sterilization process, the cassette is to be used in conjunction with a legally marketed sterilization wrap. |

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (e.g., number of cassettes, number of cleaning cycles, number of sterilization cycles) used for the performance testing. It generally refers to "Testing... includes" and "The testing demonstrated."

The data provenance is from Oticon Medical AB, Sweden, as indicated by the submitter's address and manufacturer information. The testing is prospective, conducted specifically for the purpose of demonstrating 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. The performance data section describes the outcomes of the tests (efficiency, steam penetration, SAL of 10⁻⁶), but does not detail the methodology for establishing ground truth or the involvement of experts in that process. For a sterilization cassette, the "ground truth" would typically be established by validated test methods (e.g., biological indicators for sterility assurance) rather than expert consensus on subjective observations.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or subjective assessments by multiple readers. For performance testing of a sterilization cassette, the results are derived from objective physical and microbiological measurements/assays, not from human interpretation that requires adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, not for a sterilization cassette. The document does not describe any AI component in this device.

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 (sterilization cassette), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply. The device's performance is inherently tied to its physical design and the validated processes it enables.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance tests would be based on objective scientific measurements and validated industry standards. For example:

• Cleaning and Disinfection: Ground truth would be the reduction of specific microbial loads or removal of simulated soil to predefined levels, typically measured quantitatively in a lab setting according to standards (e.g., ASTM, ISO).
• Sterilization Validation: Ground truth is achieved when test results (e.g., from biological indicators or physical monitoring) demonstrate a sterility assurance level (SAL) of 10⁻⁶, meaning a one-in-a-million chance of a non-sterile unit, as per relevant sterilization standards (e.g., ANSI/AAMI ST79).
• Wear Testing: Ground truth would be the maintenance of physical integrity and functionality after a specified number of reprocessing cycles, conforming to design specifications or acceptable wear limits.

The document states "sterilization testing further demonstrated a sterility assurance level (SAL) of 10⁻⁶," which is a key ground truth metric for sterilization.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As mentioned above, there is no AI/ML algorithm or training set for this device.

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The sterilization mats are intended to be used in conjunction with the V-PRO™ Sterilization Trays (K070769) to cushion and stabilize instruments during sterilization in the Amsco V-PRO Low Temperature Sterilization Systems.

The sterilization mats have been validated for use in the three pre-programmed V-PRO sterilization cycles [Lumen Cycle (the only cycle of the V-PRO 1 Sterilizer), Non Lumen Cycle, and Flexible Cycle].

The sterilization mats are used to cushion and stabilize devices placed into the V-PRO Sterilization Trays (K070769). The mats are available in sizes to fit the four V-PRO Sterilization Trays. The mats are a diamond grid design with fingers that extend from each corner of the diamond and at the midpoint of each diamond side. The fingers cushion and stabilize instruments, helping to prevent the instruments from freely moving in the tray during packaging, sterilization and storage. The cushioning and stabilization qualities help protect delicate instruments placed into the V-PRO Trays.

The mats are designed to allow sterilization of cleaned and dried medical devices during the V-PRO Lumen (K062297), Non Lumen (K083097) and Flexible (K102330) Cycles in the V-PRO Sterilizers.

This document describes the acceptance criteria and study proving the STERIS Sterilization Mats meet these criteria for use in V-PRO Sterilizers.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample size for each test category. However, it does provide details about the validation loads used in the sterilization efficacy tests for the various V-PRO cycles:

• Lumen Cycle: Validation load consisted of two instrument trays (containing two mats and 20 instrument organizers) and two pouches for a total weight of 19.65 lbs. This testing used a maximum of twenty (20) lumens per load.
• Non Lumen Cycle: Validation load consisted of two instrument trays containing two mats, and 20 instrument organizers and two pouches for a total weight of 19.65 lbs.
• Flexible Cycle (Configuration 1 - Two endoscopes): Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. Each endoscope was packaged into a tray with a silicone mat, 20 instrument organizers, and a light cord.
• Flexible Cycle (Configuration 2 - One endoscope + non-lumened instruments): One flexible endoscope in a tray with a silicone mat, 20 instrument organizers, and a light cord. Also included was an additional instrument tray (containing a mat and 20 instrument organizers) and one pouch for a total load weight of 24.0 lbs.

The data provenance is not explicitly stated (e.g., country of origin). The studies appear to be prospective performance tests conducted by the manufacturer, STERIS Corporation, to demonstrate the device's efficacy and safety.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of submission (510(k) for sterilization accessories) typically relies on standardized test methods and quantitative measurements (e.g., microbial lethality assays, chemical analysis for residuals, visual inspection for material compatibility). Therefore, the "ground truth" is established through objective scientific measurements and established protocols, rather than expert consensus on diagnostic images or clinical outcomes. The document does not mention the involvement of external experts to establish ground truth for the test set.

4. Adjudication Method for the Test Set

Given the nature of the tests (sterilization efficacy, biocompatibility, material compatibility, cleaning evaluation), an adjudication method like 2+1 or 3+1 typically used for subjective diagnostic assessments is not applicable. The results are based on direct measurements and qualitative observations against predefined scientific criteria. A "PASS" or "FAIL" determination is likely made based on whether the measured outcomes meet the quantitative or qualitative acceptance criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) with and without AI assistance. The STERIS Sterilization Mats are a sterilization accessory, and their performance is assessed through objective physical and biological tests, not through human interpretation of diagnostic output.

6. Standalone Performance Study

Yes, the studies described are standalone performance studies (i.e., algorithm only without human-in-the-loop performance). The tests evaluate the performance of the sterilization mats themselves within the context of the V-PRO sterilization cycles, independent of human operators assisting an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for these studies is based on:

• Sterilization Efficacy: Demonstrated by reproducible sterilization of worst-case test articles under worst-case ½ cycle conditions. This implies the use of biological indicators or similar methods to confirm microbial kill, which is an objective outcome measure.
• Biocompatibility: Measured by assessing cytotoxicity and residual hydrogen peroxide levels. These are objective laboratory tests.
• Material Compatibility: Assessed by observing the absence of incompatibilities (e.g., degradation, discoloration) after exposure to multiple cleaning and sterilization cycles. This is based on qualitative visual assessment against established standards for material integrity.
• Cleaning Evaluation: Assessed by the ease of cleaning, likely through standardized cleaning protocols and visual inspection for cleanliness.

In summary, the ground truth is primarily based on objective scientific measurements, established chemical and biological testing protocols, and qualitative assessments of physical and material integrity.

8. Sample Size for the Training Set

The document does not mention a training set or any machine learning components. This device is a physical accessory evaluated through traditional engineering and biological performance testing, not an AI-powered device. Therefore, the concept of a "training set" is not applicable here.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set or AI component, the ground truth for a training set was not applicable and therefore not established.

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Winner® Self Seal Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam 121°C for 15 minutes or greater than or equal to 600 mg/l of ethylene oxide (EtO) for 1 hour at 55° C and 70%RH. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The process indicators on the pouches are intended to demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices.

These pouches are manufactured from a medical grade paper and plastic film that are heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Sterilization Pouch with indicators has the identical intended use, components, and manufacturing methods as our previous Self Seal Sterilization Pouch.

The provided text is a 510(k) summary for the "Winner® Self Seal Sterilization Pouch with Steam and Ethylene Oxide Process Indicators." This type of document is for medical device approval and focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria for a new, innovative AI/software device.

Therefore, much of the requested information (like sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance of an algorithm, etc.) is not applicable or available in this document because it describes a physical sterilization pouch, not a software or AI-driven diagnostic device.

Here's an analysis based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "The process indicators meet the performance requirements of ANSI/AAMI ST60:1996 standard entitled "Sterilization of health care products - Chemical indicators -Part 1: General requirements"." However, the specific quantitative acceptance criteria defined within ANSI/AAMI ST60:1996 and the detailed reported device performance against those criteria are not provided in this summary. Instead, a general statement of compliance is made.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The document mentions "physical testing of the medical grade paper... and film... as well as, performance of these finished devices." The number of units tested is not specified.
• Data Provenance: The testing was conducted as part of the submission process, likely by the manufacturer (Winner Industries Co., LTD & Winner Medical USA, Inc.). The country of origin of the data is not specified beyond where the company is based (Shenzhen, China, and Pomona, CA, USA). The testing is prospective in nature, as it relates to evaluating the newly manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the device is a physical sterilization pouch, not an AI/software diagnostic device requiring expert interpretation for ground truth. Performance is assessed against physical and chemical standards.

4. Adjudication method for the test set:

This information is not applicable for the same reasons as above.

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:

This is not applicable. The device is not an AI product and does not involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance is based on established material standards (e.g., medical grade paper and plastic film standards) and performance standards (e.g., ANSI/AAMI ST60:1996 for chemical indicators). It also involves demonstrating the ability to maintain sterility and allow sterilization, which would be verified through microbiology (sterilization of biological indicators) and physical integrity testing.

8. The sample size for the training set:

This is not applicable as the device is not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established:

This is not applicable for the same reasons as above.

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Medical device instrumentation cases, trays, and cassettes intended to hold instruments and accessories in place throughout the entire instrument use, cleaning, and sterilization cycle. These cases, trays, and cassettes are suitable for Pulsing High Vacuum (pre-vac) steam sterilization at 132 °C for a 4-minute minimum plus a minimum of 15 minutes drying time.

Sterilization cases, trays, and cassettes designed to hold various general dental, medical device instrumentation during the cleaning, use, and sterilization process. The design is a container (case) with separate lid, which has various methods of holding the instruments in place. These are trays and cassettes, which are made of metal and plastic. They are available in various sizes ranging from [width x length x height (depth)] 10.375 " x 21.75" x 21.75" x 21.75" x 5" with trays and cassettes of similar size, which are stacked inside the case.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Carr Sterilization Cases, Trays, and Cassettes:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly present a "table of acceptance criteria." The criteria are inferred from the "Indications for Use" and the "General Technical Characteristics" section which outlines the device's design, materials, and performance expectations. The reported device performance is essentially a restatement or confirmation that the device meets these inferred criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "The Carr Metal Products Sterilization Cases, Trays, and Cassettes were independently tested according to AAMI TIR No. 12-1994 for their performance with the Pulsing High Vacuum (prevacuum) Steam sterilization method."

• Sample Size: The document does not specify the sample size (e.g., number of cases, trays, cassettes or sterilization cycles) used for the performance testing.
• Data Provenance: The testing was conducted "independently." The country of origin of the data is not explicitly stated, but given the FDA submission, it's highly likely to be U.S.-based or conducted according to U.S. standards. The study appears to be prospective in nature, as it describes performance testing conducted specifically for the device's clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The testing was described as "independently tested," implying a qualified testing facility, but details on expert involvement or their qualifications are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the device (sterilization cases), adjudication in the context of expert review for image interpretation or diagnosis is not applicable. The testing would likely involve objective measurements (e.g., sterility indicators, temperature/pressure monitoring) rather than subjective human assessment requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or screening tools where reader performance is a key metric. This device is a medical device accessory (sterilization case) and does not involve AI or human "readers" in that context.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

No, a standalone algorithm performance study was not done. This device is a passive physical product, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on objective measurements and adherence to recognized performance standards for sterilization efficacy. Specifically:

• AAMI TIR No. 12-1994: This technical information report provides guidelines for designing and testing reusable medical device sterilization processing. Compliance with this standard implies that the device successfully maintained sterility, allowed steam penetration, and protected instruments during sterilization.
• Validation Study with Half Cycles: This indicates a robust sterilization validation process designed to confirm the effectiveness of the sterilization method even under stressed conditions. The "ground truth" would be the biological and physical indicators confirming sterility after these half-cycle challenges.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI or machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for this device, a method for establishing its ground truth is irrelevant.

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Summaries of Equivalence for 510(k) for life supporting, life sustaining and implantable devices. These summaries should: Specify the device or devices to which the manufacturer is claiming equivalence design, materials (for devices which are implants or which are designed to to come into contact with the body), performance and indications.

Not Found

This 510(k) summary (K943657) describes a change in a contract sterilization company for Telectronics Pacing Systems' leads, pacers, and accessories. It does not describe a diagnostic device or an AI/ML algorithm that would have acceptance criteria related to its performance in classifying or analyzing data.

Therefore, your request for the following information is not applicable to this specific 510(k) submission:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone performance study
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

This 510(k) is about demonstrating that a change in a manufacturing process (sterilization) does not alter the safety or effectiveness of an already approved device. The "study" described is the validation of the new contract sterilizer (Griffith Micro Science, Inc.) and the change to 100% EtO gas sterilization. The submission states: "The Documentation and data regarding the change to another contract sterilization company provided in this submission demonstrate that the change is safe and effective."

The acceptance criteria for this type of submission would revolve around:

• Sterility Assurance Level (SAL): Ensuring the new sterilization process achieves the required SAL (typically 10^-6 for implantable devices).
• Material Compatibility: Verifying that the new sterilization method (100% EtO) does not adversely affect the materials of the leads, pacers, and accessories (e.g., degradation, residue levels).
• Biocompatibility: Confirmation that EtO residuals on the device are within acceptable limits after sterilization and aeration.
• Functional Performance: Ensuring the device still functions as intended after the new sterilization process.

The "study" that proves the device meets these acceptance criteria would be the validation data provided by Telectronics Pacing Systems in conjunction with Cordis Corporation and Griffith Micro Science, Inc. This would typically involve:

• Microbiological challenge studies: To confirm SAL.
• Chemical residue testing: To measure EtO residuals.
• Physical and mechanical testing: To ensure device integrity and performance are maintained post-sterilization.

Since the provided text excerpt is a summary and doesn't contain the detailed validation report, it cannot provide specific numbers for these tests or the exact methodology beyond stating that "Documentation and data... demonstrate that the change is safe and effective."

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