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The PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid are used to store, organize, and transport PUREVUE™ Quick Connect Cannula System instruments during sterilization and surgical procedures. The tray and lid are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier wrap.

The tray and lid were validated for a maximum load of 22.1 lb (tray + contents + lid + wrap).

The PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid are a modular, reusable tray and lid system intended for use in health care facilities for the purpose of containing medical devices for sterilization. The system is composed of two pieces, designed to be integrated into a single unit that contains and protects PUREVUE™ Quick Connect Cannula System instruments during sterilization and transport. All components are perforated for steam penetration.

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The Stainless Steel Surgical Kits are intended for organizing, sterilizing and storing of drills, instruments, and prosthetic accessories.
The Stainless Steel Surgical Kits are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.

Sterilization parameters

• Pre-vacuum Steam at 132 °C (270 °F) for 4 minutes with a 20 minute dry time.
• Do not exceed the worst-case validated maximum load:

The Stainless Steel Surgical Kits are reusable containers that are used to store and organize drills, instruments, and prosthetic accessories needed before, during and after the implantation and the prosthetic procedure.

The Stainless Steel Surgical Kits are also designed to hold the drills, instruments, and prosthetic accessories during the sterilization process. The kits are intended to be used in conjunction with a legally marketed, validated sterilization pouch that is intended to maintain sterility of the items placed inside the kits.

The proposed Stainless Steel Surgical Kits must be cleaned and sterilized before the first use and after each use according to the Instructions for Use (IFU) included with each kit.

The proposed Stainless Steel Surgical Kits can be divided into two types of kits: Open and Closed Kits.

Open kits consist of a lid and base with holders. Open kits cannot be closed with a lid to cover the items, but contain a lid that is always open and can be moved to a horizontal position. Open kits also do not contain an insert; the instrument holders are integrated on the base of the kit. In addition, in Open kits, the base is open and the holders can be seen through the bottom of the base.

By contrast, Closed kits consist of a lid, removable insert with holders, and base. Closed kits have a lid that can be closed. The lid has perforations that allows for steam penetration. In addition, one of the proposed Closed kits also contains a removable bath. The bath is used to hold soiled items after use during the surgical procedure.

The lid, base, insert, and bath of these kits are made of stainless steel. Silicone holders hold the kit components in each surgical kit. The role of the holders is to properly hold the items during transportation, sterilization and before use by the dentist.

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The Sterilization Pouch/Roll is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

• Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• Ethylene Oxide (EO) with a concentration of 695 mg/L at 50°C (122°F) and 30% to 90% relative humidity for 4 hour. Aeration time of 7 days at room temperature.

The Sterilization Pouch/Roll is made with medical grade paper and medical compound film. The Sterilization Pouch/Roll maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from Pink before sterilization to Yellow after sterilization. The steam sterilization indicator color change from Blue before sterilization to Black after sterilization.

The Sterilization Pouch/Roll is composed of medical grade paper(60g/m2) and medical compound film(50μm), it is intended to be used to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process.

The recommended sterilization cycle parameter is:

Steam: 4 minutes at 132°C(270°F); 20 minutes dry time.

Ethylene oxide: 4 hours at 50 °C(122°F); relative humidity between 30%- 90%; ethylene oxide concentration is 695 mg/L, 7 days aeration time at room temperature.

The medical devices are inserted into the Pouch/ Roll, sealed, and then sterilized for the EtO or Steam Sterilization Process. The pouch is self-sealed prior to sterilization processing. The roll is heat-sealed by a plastic sealing machine. 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 6 months post sterilization.

The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to yellow (EtO) or Blue to Black (Steam) when exposed to EtO gas or Steam vapor during process. The EtO and Steam 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. The EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.

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The Companion Spine DIAM™ Instrumentation is indicated for the insertion and positioning of the Companion Spine DIAM™ Spinal Stabilization System devices, or if required, removal of the implantable device.

The Companion Spine DIAM™ Instrumentation are non-implant devices that consist of device-specific instruments for use in implantation of Companion Spine DIAM™ Spinal Stabilization System devices. These instruments are manual and non-powered surgical tools with implant specific geometry that are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process spacer devices for non-fusion use.

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The Self-Seal Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

• Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• Ethylene Oxide (EO) with a concentration of 695 mg/L at 50°C (122°F) and 30% to 90% relative humidity for 4 hour. Aeration time of 7 days at room temperature.

The Self-Seal Sterilization Pouch and Roll are made with medical grade paper and medical compound film. The Self Sealing Sterilization Pouch and Roll maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color changes from red before sterilization to brown after sterilization. The steam sterilization indicator color changes from blue before sterilization to greenish black after sterilization.

The Self-Seal Sterilization Pouch and Roll is composed of medical grade paper (60g/m²) and PET/CPP medical compound film (52 μm), it is intended to be used to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process.

The recommended sterilization cycle parameter is:

• Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• Ethylene Oxide (EO) with a concentration of 695 mg/L at 50°C (122°F) and 30% to 90% relative humidity for 4 hour. Aeration time of 7 days at room temperature.

The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the EtO or Steam Sterilization Process. The pouch is self-sealed prior to sterilization processing. The roll is not self-sealed; use a plastic sealing machine to seal it, and the temperature of the plastic sealing machine needs to reach 205°C, 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 6 months post sterilization.

The Pouch/Roll is printed with a chemical indicator bar that changes from blue to greenish black (Steam) or red to brown (EtO) when exposed to EtO gas or Steam vapor during process. The EtO and Steam 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. The EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.

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The Sterilization Trays are designed to hold various dental surgical and prosthetic instruments to organize, steam sterilize and transport the instruments between uses. The kit is to be enclosed in an FDA cleared steam sterilizable pouch large enough to fit a tray, and sterilized in an FDA cleared sterilizer for the following cycles:

1. Gravity Steam Cycle – At 132°C for 15 minutes with a 30-minute dry time
2. Pre-vacuum Steam Cycle – At 132°C for 4 minutes with a 20-minute dry time

• The kits are intended for sterilization of non-porous loads
• The tested kit represents the worst-case validated load of 497.1 grams

Paragon sterilization trays are divided into the following types:

• Complete Surgical Kit
• Standard Surgical Kit
• Drill Stop Kit
• Prosthetic Kit

The Surgical, Drill Stop, and Prosthetic Kits are reusable perforated instrument cassette systems, composed of an outer case (base), cover (lid), and insert, that is designed to hold dental instruments in place during transport, steam sterilization, and storage. The Surgical Kits are designed to support Paragon implant/prosthetic placement protocols, as well as hold various dental instruments such as: Surgical Drills, Drill Stops, Paralleling Tools, Implant Drivers, Drill Extender, Prosthetic Drivers and Torque Wrenches. The insert contains markings and colors to indicate either the surgical workflow or the position of the instruments within the cassette.

The Standard Surgical Kit includes a removable stainless-steel pan, which functions as a storage receptacle for used surgical instruments.

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Chex-All® Sterilization Pouches and Tubes are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:

Hospital size sterilizer cycles

• Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
• Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
• Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time

Tabletop sterilizer cycles:

• Pre-vacuum steam at 132°C (270°F) for 4 minutes; 30 minutes dry time

Ethylene Oxide sterilization cycles:

• Ethylene Oxide (EO) with a concentration of 736 mg/L at 55°C (131°F) and 50% to 60% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).

Chex-All sterilization pouches and tubes can be used for steam sterilization of devices with lumens at maximum load as the following:

Metal lumen: 7 inch long, 3.2mm internal diameter
Plastic lumen: 5 inch long, 2.0 mm internal diameter.

Suitable Lumen cycles:
Hospital size sterilizers: pre-vacuum cycles with 132°C-4.0 min exposure (20 minutes dry time) and 135°C-3.0 min exposure (16 minutes dry time).
Table-top sterilizers: pre-vacuum cycle with 132°C-4.0 min exposure (30 minutes dry time).

Chex-All sterilization pouches and tubes can be used for steam sterilization in double pouch configuration, in gravity 250°F-30 min exposure cycles (25 minutes dry time) and in pre-vacuum 270°F-4 min exposure cycles (20 minutes dry time).

The Process chemical indicators on the Chex-All sterilization pouches and tubes are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed and unprocessed pouches. The chemical indicators change from crème to gray/black after exposure to steam and from beige-pink to green after exposure to ethylene oxide.

If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and to maintain sterility (SAL≥10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 30 months after steam sterilization and 12 months after EO sterilization.

The maximum pouch load is 2.65 lb. (1.2 kg) or less. The maximum pouch load for table-top sterilizers is 1.10 lb. (0.5 kg) or less. The maximum pouch size for use in table-top sterilizers is 13"x18".

The Chex-All® Sterilization pouches and tubes are made from a medical grade porous paper thermally sealed to a plastic film on the left, right, and bottom of the pouch. The top side is open to insert medical devices to be sterilized and to seal the pouch. They are available either pre-manufactured self-seal or heat-seal sizes or in a roll of heat-seal tubing for the customer to cut the pouches to their required size.

The pouches also contain chemical process indicators used to demonstrate that the pouches have been a subject of either a steam or ethylene oxide sterilization process.

All Chex-All sterilization pouches and tubes are flat and include the following products: Chex-All Heat-seal sterilization pouch, flat; Chex-All Heat-seal sterilization tube, flat, sold in rolls; Chex-All II Self-seal sterilization pouch, flat; Chex-All III Self-seal sterilization pouch, flat.

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The TunnelVision Endoscopic Soft Tissue Release System is indicated for use in minimally invasive ligament or fascia release:

• Carpal tunnel release in the wrist
• Cubital tunnel release in the elbow

The HBL Blade Assembly is indicated for use with the TunnelVision Endoscopic Soft Tissue Release System, the 3M Agee Inside Job Carpal Tunnel Release System, or the MicroAire SmartRelease Endoscopic Soft Tissue Release System in minimally invasive ligament or fascia release:

• Carpal tunnel release in the wrist
• Cubital tunnel release in the elbow

Hand Biomechanics Lab's TunnelVision Endoscopic Soft Tissue Release System is a surgical system designed for minimally invasive soft tissue release procedures. The system includes the TunnelVision Endoscope, TunnelVision Handpiece, reusable manual surgical instruments (small and medium dilators, synovium elevator, coequal dilator), an instrument sterilization tray, and the HBL Blade Assembly.

The HBL Blade Assembly (Model CTR-455) was previously cleared under 510(k) K222490 for use with the 3M® and MicroAire® SmartRelease® systems. This submission expands indications for use to include compatibility with the TunnelVision platform. No changes were made to blade assembly materials, design, or sterilization method.

Reusable components (handpiece, endoscope, surgical instruments, sterilization tray) are supplied non-sterile, to be cleaned and steam sterilized by the end user. The HBL Blade Assembly is a sterile, gamma-irradiated, single-use device.

The subject device is comprised of two components:

1. TunnelVision Endoscopic Soft Tissue Release System – includes the endoscope, handpiece, manual surgical instruments, and sterilization tray. These components are reusable following validated cleaning and sterilization processes.
2. HBL Blade Assembly – a gamma-sterilized, single-use disposable device containing the cutting blade. The blade cuts in a retrograde direction to safely release the targeted soft tissue.

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Guided DAS Surgical Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Guided DAS Surgical Kit is intended to allow sterilization of the enclosed medical devices.

Guided DAS Surgical Kit requires the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kit is to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: dynamic air removal steam sterilization- Exposure at 132 °C for 4 minutes and 30 minutes dry time.

Guided DAS Surgical Kit is intended for sterilization of non-porous loads.

Guided DAS Surgical Kit is recommended not to be stacked during sterilization.

The combined weight of the Guided DAS Surgical Kit and the associated instruments is 760 grams.

The weight of the empty Guided DAS Surgical Kit is 600 grams.

This tray is designed to hold various dental surgical drills and tools to organize and protect the instruments that are sterilized in the trays by the healthcare provider.

The provided text is a 510(k) clearance letter and summary for the "Guided DAS Surgical Kit," which is a sterilization wrap/container. It outlines the device's indications for use, classification, and a comparison to a predicate device.

However, the provided document does not contain information relevant to AI/ML device performance, such as:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes for AI/ML test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect sizes of AI assistance on human readers.
• Standalone (algorithm-only) performance metrics.
• Type of ground truth used (expert consensus, pathology, outcome data).

The "Summary of Nonclinical Testing Table" on page 8 focuses on validation tests typical for medical devices related to cleaning, sterilization, dry time, life cycle, and biocompatibility, which are hardware-related and not AI/ML performance metrics. The conclusion explicitly states, "No clinical data were included in this submission."

Therefore, based solely on the provided text, it's impossible to describe the acceptance criteria and the study that proves an AI/ML device meets them, as the document is about a physical medical device (sterilization kit) and not an AI/ML algorithm.

If the request assumes this document should or would contain information about an AI/ML component, then the answer is that the document explicitly does not provide such information.

To answer your request within the confines of the provided text, I must state that the document does not contain the information needed to describe the acceptance criteria and study for an AI/ML device.

The document describes the testing performed for a physical medical device (sterilization kit). The listed tests are for material and functional validation, not for an AI/ML algorithm's analytical or clinical performance.

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The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for steam sterilization. The recommended sterilization cycle is as follows:
• Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.

The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintain the sterility of the enclosed devices for up to 6 months post steam sterilization. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The steam sterilization indicator color will change from blue before sterilization to dark grey after sterilization.

The subject Sterilization Pouch and Roll device has five types:
(1) Self-sealing sterilization pouches:
These pouches are made from a medical grade plastic film that is heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.

(2) Sterilization pouches, Flat:
These pouches have the same components with the Self-sealing sterilization pouches, except the fourth side is left opened instead of an adhesive strip and will be heat-sealed when using.

(3) Sterilization pouches, Gusseted:
These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.

(4) Sterilization rolls, Flat:
These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.

(5) Sterilization rolls, Gusseted:
These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.

The Sterilization pouch and roll is composed of medical grade paper (60g/m2) and medical compound film (52μm), it is intended to be used to contain medical devices to be terminally sterilized by the Steam sterilization process. The recommended sterilization cycle parameters are:
Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.

The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. 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 to maintain sterility of the enclosed devices until used up to 6 months post sterilization. The shelf life of the device is 3 months.

The Pouch/Roll is printed with a chemical indicator bar that changes from Blue to Dark grey when exposed to steam during the sterilization process. The steam chemical Indicator offers an addition way to verity processing in the sterilization cycle. The endpoint stability of the chemical indicator color change to dark grey is 3 months. The chemical Indicator should be used in addition to, not in place of, the biological indicator. The steam chemical indicator does not signify sterilization; it only indicates that the indicator has been exposed to steam.

The provided FDA 510(k) clearance letter and summary describe a Sterilization Pouch and Roll device, which is a Class II medical device. This is NOT an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, such as effect size of human readers improving with AI, standalone algorithm performance, number of experts for ground truth, and training set information, are not applicable.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document details various performance tests such as sterilant penetration, biocompatibility, package integrity, and chemical indicator testing. However, it does not explicitly state the sample sizes used for each of these test sets. The tests are "bench testing" (non-clinical) and do not involve human subjects.

The data provenance is from non-clinical bench testing. The tests were performed to evaluate the performance and functionality of the device against a requirement specification. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms are typically relevant for clinical studies or data collection in human populations.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a physical sterilization pouch and roll, and its performance is evaluated through standardized laboratory and bench testing against established physical, chemical, and biological criteria, not by human expert interpretation of data or images. Ground truth is established by objective measurements and standardized test methods.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation relies on objective measurements and established standards rather than expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where human performance with and without AI assistance is being compared. This document is for a physical sterilization product.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This device is a physical product, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

The ground truth for this device's testing is based on:

• Standardized Test Methodologies and Acceptance Criteria: As outlined in the "Test Methodology" and "Acceptance Criteria or End Point" columns in Table 3 of the 510(k) summary. These include standards like ISO 17665-1, ISO 10993 series, ASTM F1886, ASTM F2251, ISO 1924-2, ASTM F1140, ASTM F1929, ASTM F88, ASTM D3078, DIN 58953-6, ISO 11140-1, and ASTM F1980.
• Physical and Chemical Measurement: For properties like thickness, tensile strength, burst strength, seal strength, and the color change of the chemical indicator.
• Microbiological Evaluation: For the microbial barrier test (e.g., 0 CFU No growth).
• Biocompatibility Testing: Evaluating potential toxicity, irritation, and sensitization in laboratory settings (e.g., L-929 cells).
• Sterilization Effectiveness: Meeting a specified Sterility Assurance Level (SAL 10-6).

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML component described for this device, so there is no training set in the context of machine learning.

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

Not applicable, as there is no training set.

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