Search Results

Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices are intended to be used by qualified physicians to provide access and visualization of internal structures such as bladder, urethra, kidneys, prostate and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing).

Endoservice Endoscopic Instruments & Accessories are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility. The urological-gastroenterological accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue, body cavities, hollow organs and canals (grasping, cutting, dissecting, coagulating and suturing). The Endoservice Endoscopic Instruments & Accessories and Minimally Invasive gastrointestinal GI and genitourinary GU Devices contain different components such as Scissors, Forceps, Connections (inner Rod, Sheath insulated), Handles, Sheaths, Endoscopes, Cystoscopes, Resectoscopes, Urethrotomy, Retractor, Forceps, Scissors, Punches, Tubes, Trocars, Trocar Sleeves, Sheat, Needle holder, and Inserts. The device is made out of following materials: Body: steel 1.4301; plastic PPSU Handle: adhesive hysol-resin Lens: saphir

The provided text describes a 510(k) submission for Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" here refer to demonstrating this substantial equivalence through various tests, primarily non-clinical, rather than specific performance metrics against a disease outcome.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are typically demonstrating equivalence in design, technical characteristics, intended use, indications for use, sterilization processes, and materials, as well as meeting established performance standards for safety and effectiveness.

• Tube: 3.5-12.5mm, 70-150cm
• Cystoscope, Resectoscope, Urethrotome: Length 298-310mm, Diameter 2.7mm, 2.8mm, 2.9mm, 4.0mm | Diameters & Lengths:
• Tube: 3.5-12.5mm, 40-105cm
• Laparoscope: Length 270-330mm, Diameter 5.0mm, 10mm, 11mm
• Cystoscope, Resectoscope, Urethrotome: Length 300mm, Diameter 4.0mm |
  | Materials | Steel 1.4301; plastic PPSU; adhesive hysol-resin; sapphire lens | Stainless Steel; Insulation material |
  | Components | Scissors, Forceps, Connections (inner Rod, Sheath insulated), Handles, Sheaths, Endoscopes, Cystoscopes, Resectoscopes, Urethrotomy, Retractor, Punches, Tube, Sheath, Needle holder, and Inserts. | Dismantable and Non-dismantable; Insulated and non-insulated; Forceps, Probes, Needle Holders, Clamps, Dissectors, Scissors, Knife, Hook, Knot Guide, Retractors, Divers and Blades. |
  | Intended Use & Indications for Use | Intended for qualified physicians to provide access and visualization of internal structures (e.g., bladder, urethra, kidneys, prostate) and manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing). | Identical to GIMMI ALPHA® Instruments (implied by "identical to the predicate device...in terms of...intended use, indications for use"). |
  | Sterilization Processes | Identical to GIMMI ALPHA® Instruments (stated). Validation Tests of Sterilization, Disinfection and Cleaning (automatically) performed. | Follows predicate device's sterilization processes. |
  | Biocompatibility | Body contact portions composed of surgical grade stainless steel, "long history of biocompatibility." Cytotoxicity Test performed. | Implied by established predicate. |
  | Safety and Effectiveness (Non-clinical Performance) | Successfully tested according to ISO 8600, ISO 10993, ISO 11737, ISO 17665, ISO 15883, and ISO 14971. Bending Tests, Material Tests, Bench Tests, and Microbiological Test for determination of microorganisms performed. Conclusions: devices are as safe and as effective, and perform as well as or better than the legally marketed device, and do not raise new issues regarding safety and effectiveness. | Legally marketed predicate device. |

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

The document does not explicitly state the "sample size" in terms of number of devices or components used for each non-clinical test. It lists the types of tests conducted (Bending Tests, Material Tests, Bench Tests, Validation Tests of Sterilization, Disinfection and Cleaning, Cytotoxicity Test, Microbiological Test). The data provenance is implied to be from internal testing conducted by Endoservice Optical Instruments GmbH (a German company), and it is retrospective in the sense that these tests were performed and results compiled for the 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. For a non-clinical 510(k) submission for instruments like these, "ground truth" as it's typically understood in diagnostic AI studies (e.g., expert consensus on medical images) is not directly applicable. The "ground truth" here is adherence to engineering standards and safety tests, which are objective measurements rather than subjective expert interpretations.

4. Adjudication Method for the Test Set

This information is not provided and is not typically relevant for non-clinical testing of medical instruments. Adjudication methods (like 2+1 or 3+1) are usually found in clinical studies involving interpretation of data where disagreements among reviewers need resolution.

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 devices, especially those using AI, where human performance with and without assistance is measured. This submission is for direct-use endoscopic instruments, not a diagnostic AI system.

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

No, a standalone (algorithm-only) performance study was not done. This is not an AI or algorithm-based device. The device itself is the instrument used by a human physician directly.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the objective measurements and results from the non-clinical performance tests conforming to recognized international standards (e.g., ISO 8600, ISO 10993). This includes:

• Material properties: Verifying that materials meet specified compositions and strength.
• Dimensional accuracy: Ensuring diameters and lengths are within acceptable ranges.
• Biocompatibility: Results of cytotoxicity tests.
• Sterilization efficacy: Validation of cleaning and sterilization processes.
• Functional integrity: Results from bending and bench tests demonstrating durability and performance.
• Microbiological tests: Confirming absence of microorganisms where required.

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI/ML algorithm requiring a training set. This is a conventional medical instrument.

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.

Ask a specific question about this device