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Laparoscopic surgical manual instruments are designed to be used endoscopically through cannula to perform cutting, grasping, dissecting, retracting, and manipulating functions. The Ergonomic handle is intended to be used with 5mm inserts available from K&W and previously cleared under K973259.

Symmetry® laparoscopic surgical manual instruments consist of a handle and a 5mm shaft, which hold various 5 mm inserts cleared under K973259. The shaft comes in two lengths: 33 cm and 45 cm. One handle can be used in combination with a variety of different 5 mm inserts. The handles have monopolar posts which allow them to be used for electrosurgery.

The ergonomic laparoscopic handles have an adjustable grip. They may be used in one of the three handle positions: pistol grip, hybrid, and inline. To change the handle position, retract the position adjustment button and lock the grip in the chosen position. The handle comes in two sizes.

This document describes the Ergonomic Handle (K173272), which is an accessory to laparoscopic surgical manual instruments. The device allows for adjustable grip angles to improve surgeon comfort. The information provided is for regulatory clearance (510(k)) and focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The Symmetry Sharp Kerrison® Rongeur is indicated for cutting bony tissue of the spine. The Symmetry Sharp Kerrison® Rongeur is a manually operated instrument that consists of a Handle and Tips (available in single use or reusable).

The Symmetry Sharp Kerrison Rongeur is designed to have detachable tips that are disposable. The detachable tips are provided as either sterile single use or as nonsterile reusable tips. The reusable tips must be cleaned and sterilized before use. The sterile, disposable tips are available in 4 cup sizes: (1, 2, 3, and 4 mm); which are identifiable by etchings on each device. The Reusable Tips for the Symmetry Sharp Kerrison® Rongeur Handle are available in 3 cup sizes: (2, 3, and 4 mm); which are identifiable by etchings on each device. The reusable tips have a mating code etched on each pair to ensure that only matched pairs are used. Each tip is designed with a shaft key that fits into its mating slot on the detachable instrument handle. The tip has cups, one within the stationary footplate and the other within the upper sliding shaft, performing the cutting of the bony tissue in the spine area. The various cup sizes within the working tips provide the surgeon various cutting configurations needed for the different characteristics of the bony tissue within the spine. The Symmetry Sharp Kerrison® Rongeur Handle operates with a cup and ball assembly for smooth motion of the footplate when the handle is squeezed. The detachable, reusable instrument handles of this device are provided non-sterile and must be cleaned and sterilized prior to use. The instrument handles are available in three shaft lengths: (5, 6, and 7 inches).

Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on the device "Symmetry Sharp Kerrison® Rongeur":

This document describes a medical device called the "Symmetry Sharp Kerrison® Rongeur," which is a manual rongeur used for cutting bony tissue of the spine. The information provided heavily emphasizes comparison to a predicate device (K130541 Kerrison Disposable Tip Rongeur) to establish substantial equivalence for FDA 510(k) clearance. The testing described primarily focuses on validating the safety and performance characteristics for a mechanical surgical instrument, not an AI/ML-driven device. Therefore, many standard questions related to AI/ML device studies (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance) are not applicable or directly addressed in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test (e.g., number of rongeurs tested for cleaning, sterilization, or durability). It refers to standard validation activities but doesn't quantify the number of units or cycles performed for each test.

• Data Provenance: The studies are described as "Design verification and validation testing" which are prospective tests conducted by the manufacturer specifically for this submission. The origin (e.g., country) is not specified beyond the manufacturer's location (Antioch, TN, USA).

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

This information is not applicable and not provided. The "ground truth" for a mechanical device like a rongeur is based on objective performance metrics (e.g., sterilization efficacy, cutting performance, corrosion resistance) measured against defined standards or engineering specifications, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements against defined standards, not subjective assessments 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

Not applicable. This is a mechanical surgical instrument, not an AI/ML diagnostic or assistive device.

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

Not applicable. This is a mechanical surgical instrument.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the performance tests relies on:

• Established Standards: Primarily ISO standards for sterilization (SAL of 10-6), ASTM standards for shelf life.
• Engineering Specifications: Criteria for residual proteins/hemoglobin/carbohydrates, number of cuts/reuse cycles for durability, and absence of corrosion. These are objective, measurable parameters.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no training set for this mechanical device.

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The Symmetry Surgical Quad-Lock® Container System is indicated for use by hospitals and by health care facilities to: · organize and protect stainless steel, aluminum, plastic* and silicone surgical instruments that will be sterilized · allow sterilization of the contained instruments by prevacuum steam, ethylene oxide, and low temperature hydrogen peroxide sterilization cycles (validated modalities and parameters are shown in Table 1) · When sterilized by prevacuum steam sterilization, the Quad-Lock® Containers maintain the sterility of the contents for up to 180 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised · When sterilized by ethylene oxide or low temperature hydrogen peroxide cycle types the Quad-Lock® Containers maintain the sterility of the contents when sterilized by any of the above for up to 30 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised The system has not been tested for maintenance of sterility after transportation outside the health care facility. The system is intended for use with stainless steel, aluminum, plastic and silicone surgical instruments. *The use of plastic instruments has only been confirmed for steam sterilization. For effective sterilization and drying of any size Symmetry Surgical Quad-Lock® Sterilization Container, the recommended maximum combined weight of the single container, lid. basket/tray contents is defined in Table 1. For each cvcle type the qualified lumen size is the minimum length that has been qualified for use are shown in Table 1. Container System Compatibility by Cycle Type details are shown in Table 2.

The Symmetry Surgical Quad-Lock® Container System provides a means to organize and protect stainless steel, aluminum, titanium, plastic and silicone surgical instruments during sterilization and storage. The filter lids, security lids, and container bottoms are made from anodized aluminum. The security lids help ensure sterility during storage and protect the container lid when the containers are stacked. The Container System includes the container base, filter lid, security lid, filters and other accessories.

The provided text describes the acceptance criteria and a study to demonstrate the performance of the Symmetry Surgical Quad-Lock™ Container System.

Here's an organized breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Temperature: 132°C
• Exposure Time: 4 minutes
• Drying Time: 30 minutes
• Stackable: Yes, up to three containers
• Qualified Lumen Size (Full/Three Quarter): 3mm x 400mm
• Qualified Lumen Size (Half Size): 3mm x 250mm
• Maximum Quantity: 4 lumen per container
• Load Requirements: 25 lbs (all sizes)
  Ethylene Oxide:
• Concentration: 725mg/L
• Temperature: 55°C
• Exposure Time: 60 minutes
• Humidity: 50-70%
• Aeration Time: 8 hours at 110°F (43°C)
• Stackable: No
• Qualified Lumen Size (Full/Three Quarter): 3mm x 400mm
• Qualified Lumen Size (Half Size): 2mm x 250mm
• Maximum Quantity: 4 Lumen per container
• Load Requirements: 25 lbs (all sizes)
  Low Temperature H2O2 Sterilizers: (Parameters are set by sterilizer manufacturer)
  • STERRAD 100NX Standard/DUO: Fixed Cycle Type, Stackable: No
    • Qualified Lumen Size (Full Size): 2mm x 400mm
    • Qualified Lumen Size (Three Quarter/Half Sizes): 2mm x 250mm
    • Maximum Quantity: 5 Lumen per container
    • Load Requirements (Full): 21.4 lbs
    • Load Requirements (Three Quarter/Half): 13.85 lbs (DUO: 13.2 lbs)
  • STERRAD 100NX FLEX: Fixed Cycle Type, Stackable: No
    • Qualified Lumen Size (All Sizes): One 1mm x 850mm Flexible Endoscope per container
    • Load Requirements (Full): 16.65 lbs
    • Load Requirements (Three Quarter): 12.40 lbs
    • Load Requirements (Half): 10.75 lbs
  • STERRAD NX Standard/Advanced: Fixed Cycle Type, Stackable: No
    • Qualified Lumen Size (Full Size): 1mm x 400mm (Standard) / 2mm x 250mm (Advanced)
    • Qualified Lumen Size (Three Quarter/Half Sizes): 2mm x 250mm
    • Maximum Quantity: 5 Lumen per container
    • Load Requirements (Full): 21.4 lbs
    • Load Requirements (Three Quarter/Half): 13.85 lbs
  • STERRAD 100S Standard: Fixed Cycle Type, Stackable: No
    • Qualified Lumen Size (Full Size): 3mm x 400mm
    • Qualified Lumen Size (Three Quarter/Half Sizes): 2mm x 250mm
    • Maximum Quantity: 5 Lumen per container
    • Load Requirements (All Sizes): 18.2 lbs
  • STERIS V-PRO™ 1 PLUS Lumen/No Lumen: Cycle time = 55 minutes, Stackable: No
    • Qualified Lumen Size (Full Size): 3mm x 400mm
    • Qualified Lumen Size (Three Quarter/Half Sizes): 2mm x 250mm
    • Maximum Quantity: 10 lumen per container
    • Load Requirements (All Sizes): 19.65 lbs
      All sterilization efficacy and simulated use testing to achieve SAL of 10-6 passed. |
      | Maintenance of Sterility (Shelf Life) | Maintain sterility for up to 180 days with prevacuum steam sterilization.
      Maintain sterility for up to 30 days with ethylene oxide and low-temperature hydrogen peroxide sterilization cycles. | Prevacuum Steam: Sterility maintained for up to 180 days during storage and transport within the healthcare facility, as long as container integrity is not compromised.
      Ethylene Oxide & Low Temperature H2O2: Sterility maintained for up to 30 days during storage and transport within the healthcare facility, as long as container integrity is not compromised.
      The shelf life testing for 30 days of storage passed. |
      | Reuse Testing | Demonstrate microbial challenge following multiple sterilization cycles for up to 100 sterilization cycles. | Microbial Challenge following multiple sterilization cycles verified for up to 100 sterilization cycles passed. |
      | Biocompatibility | In vitro evaluations for biocompatibility, extractables, and leachables must have acceptable results. | In vitro evaluations for these tests had acceptable results. |
      | Functional Strength of Handles | Testing performed in accordance with ST77 (presumably ANSI/AAMI ST77, a standard for sterile packaging). | Testing performed in accordance with ST77 had acceptable results. |

2. Sample size used for the test set and the data provenance:
The document does not specify numerical sample sizes for the test set for its performance studies (sterilization efficacy, shelf life, reuse testing, biocompatibility, or functional strength).
The data provenance is not explicitly mentioned as a country of origin or whether it's retrospective or prospective; however, the submission is from "Symmetry Surgical, Inc." which is based in Antioch, TN, USA, suggesting the studies likely occurred in the US. The studies are described as "performance testing" and "non-clinical tests," implying they were conducted specifically for this submission, making them prospective in nature for this application.

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 studies are described as laboratory-based performance testing rather than studies requiring expert interpretation of results for ground truth establishment (e.g., medical image analysis).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and therefore not provided in the document. The studies described are objective performance tests (e.g., sterilization assurance levels, material properties) that do not typically involve human adjudication in the way medical diagnostic studies do.

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 information is not applicable and therefore not provided in the document. The device is a sterilization container system, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and therefore not provided in the document. The device is a physical medical device (sterilization container), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance studies appears to be based on objective, measurable criteria derived from scientific and engineering principles for sterilization, material integrity, and functionality. For instance, "sterilization efficacy" ground truth is defined by achieving a specified Sterilization Assurance Level (SAL of 10-6), which is typically confirmed through validated microbiological testing (e.g., biological indicators). Shelf life is determined by maintaining sterility over time, also verified through microbiological methods. Biocompatibility relies on established in vitro evaluation standards.

8. The sample size for the training set:
This information is not applicable and therefore not provided in the document. The product is a physical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this type of device.

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