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The Disposable Biopsy Valve is used to cover the biopsy/suction channel of Olympus® and Fujinon® or Pentax® gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

The Disposable Biopsy Valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Disposable Biopsy Valve provides sealable access via the working channel port of an endoscope for surgical instruments. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free. The valve is designed with a hollow body with a distal end that releasably attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted through the opening, preventing fluids from passing through the biopsy valve. The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.

The provided document is a 510(k) premarket notification for a medical device: the Disposable Biopsy Valve. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence.

However, the document does not contain any information regarding the acceptance criteria for a study proving the device meets those criteria, nor details of such a study.

Specifically, the document states under "7. Non-Clinical Testing":
"The device has undergone both bench testing of performance and laboratory biocompatibility testing for cytotoxicity, sensitization, intracutaneous injection test, and system injection test, in accordance with 21 CFR, Part 58. The Single Use Biopsy Valve results in no safety or efficacy concerns regarding biocompatibility or performance. Likewise, in conformance with 21 CFR 807.92(b)(3), the device performs as well as the predicate in all testing performed."

And under "Performance testing" in the comparison table (pages 7 and 8):
"Design verification Pressure test with valve closed - the device holds pressure for 1 Min at 10 PSI"
"Design verification Pressure test with instrument inserted - the device holds pressure for 1 Min at 10 PSI"
"Design verification Pressure test: Following removal of instrument the device holds pressure for 1 Min at 10 PSI"

While these are performance tests, they are described as "Design verification" and do not provide:

1. A table of acceptance criteria and reported device performance. The document lists the tests performed (pressure tests) and states the device "holds pressure for 1 Min at 10 PSI", but it doesn't explicitly state quantitative acceptance criteria (e.g., "must hold pressure for minimum of X minutes at Y PSI") against which a reported performance would be quantitatively compared.
2. Sample size used for the test set and data provenance: Not specified.
3. Number of experts used to establish ground truth and their qualifications: Not applicable for these types of physical performance and biocompatibility bench tests.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: No such study described. The device is a physical component (biopsy valve), not an AI/imaging device that would typically involve human reader studies.
6. Standalone (algorithm only) performance: Not applicable as this is a physical device, not an algorithm.
7. Type of ground truth used: For these bench tests, ground truth would be the physical measurements and observations of the device's performance under test conditions.
8. Sample size for the training set: Not applicable; this is a physical device, not a machine learning model.
9. How ground truth for the training set was established: Not applicable.

In summary, the document refers to "bench testing of performance" and "design verification pressure tests" but does not provide the detailed study information requested, such as specific acceptance criteria tables, sample sizes, or details typically associated with clinical or AI/imaging performance studies.

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The ScopeValet Disposable Biopsy Valves, Model Numbers 345BVO and 345BVP, are intended to provide access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

The Ruhof Corporation ScopeValet Disposable Biopsy Valves can be manufactured with a choice of two types - regular disposable biopsy valve and irrigating biopsy valve. Each of these types can be ordered for Olympus, Fujinon, and Pentax gastrointestinal endoscopes.

The provided text describes the non-clinical performance data for the ScopeValet Disposable Biopsy Valves. This device is a biopsy valve, not an AI/ML diagnostic device, so many of the requested fields (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance

• Insufflation air flow rate comparable to predicate device,
  delivering enough air for insufflation in typical time. |
  | Biocompatibility | - Passed cytotoxicity testing per ISO 10993-5.
• Made of TPE materials (GRAS for cytotoxicity, sensitization, irritation), USP Grade VI, cleared colorants. |
  | Shelf-Life | - Established for one (1) year based on physical testing data. |
  | Overall Design, Safety, and Effectiveness (General) | - Met all requirements for overall design and biocompatibility.
• Output meets design inputs and specifications.
• Passed all stated tests with acceptable results. |

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

• Sample Size: The document does not specify exact sample sizes (number of biopsy valves or test runs) for each non-clinical performance test (Leak testing, Insufflation air flow rate testing, Biocompatibility, Shelf-life). It states "ScopeValet Disposable Biopsy Valves" were tested, indicating multiple units were likely used, but no specific count is provided.
• Data Provenance: The data is generated from non-clinical performance testing conducted by Ruhof Corporation or its contracted labs. This is not patient-derived data, so terms like "country of origin" or "retrospective/prospective" are not applicable.

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

• Not Applicable. This is not an AI/ML diagnostic device, and thus, "ground truth" established by experts in the context of image interpretation or diagnosis is not relevant here. The ground truth for these tests is based on objective measurements against defined engineering and biological standards.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical performance testing, there is no "adjudication method" in the sense of resolving conflicting expert opinions. Results are presumably recorded and verified against test protocols and acceptance criteria by technical personnel.

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 not an AI/ML diagnostic device.

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

• Not Applicable. This is not an AI/ML diagnostic device.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical tests is based on:
  • Defined performance specifications: For leakage (no fluid leakage) and insufflation (minimum pressure/flow rate comparable to predicate).
  • International and national standards: ISO 10993-1 and ISO 10993-5 for biocompatibility.
  • Physical testing protocols: For shelf-life determination.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device that requires a training set.

Study Summaries for Each Test:

• Leak Testing:
  • Objective: To simulate withdrawal of biopsy samples, bowel irrigation, and bowel insufflation and assess fluid leakage.
  • Result: No evidence of fluid leakage was observed.
  • Conclusion: The device is effective in preventing fluid leakage.
• Insufflation Air Flow Rate Testing:
  • Objective: To simulate bowel insufflations and assess pressure maintenance and air flow rate.
  • Result: The device maintained a pressure of at least 10 psi and its air flow rate was comparable to the predicate device, delivering sufficient air for typical insufflation times.
  • Conclusion: The device is effective in achieving insufflation.
• Biocompatibility Testing:
  • Objective: To evaluate the biological safety of the device's materials.
  • Methodology: Conducted according to ISO 10993-1 and FDA/CDRH/ODE Blue Book Memorandum G95-1, classifying the device for mucosal membrane contact, limited duration (less than 24 hours). The device's TPE materials are GRAS, USP Grade VI, with cleared colorants. Specifically tested for cytotoxicity per ISO 10993-5.
  • Result: The device passed cytotoxicity testing.
  • Conclusion: The device is biocompatible as per ISO 10993-1.
• Shelf-Life Testing:
  • Objective: To establish the stability and functional life of the device.
  • Methodology: Based on physical testing data using a defined protocol.
  • Result: A shelf-life of one (1) year was established.
  • Conclusion: The device is stable for one year.

The submission concludes that the ScopeValet Disposable Biopsy Valves passed all testing, demonstrating acceptable results and meeting all requirements for safety, effectiveness, overall design, and biocompatibility, thereby supporting its substantial equivalence to the predicate device.

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