(172 days)
The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with Olympus bronchoscopes with channel φ1.7mm or larger.
The single use cytology brush BC-205D has been designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes. Identical to the predicate device, the subject device is inserted into bronchoscope channel to collect specimens with the brush which is equipped at the distal end of the subject device. Then users withdraw the subject device from bronchoscope channel and collect samples for cytology examination.
The provided document is a 510(k) summary for the Olympus Single Use Cytology Brush BC-205D, demonstrating its substantial equivalence to a predicate device. It focuses on the device's design, materials, and non-clinical performance, rather than a clinical study involving human patients or complex algorithms requiring extensive performance criteria.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone algorithm performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission because the demonstrated substantial equivalence is primarily based on bench testing and material characteristics, not clinical performance against a complex diagnostic ground truth.
Here's a breakdown of what can be extracted and why other parts are not applicable:
1. A table of acceptance criteria and the reported device performance:
The document mentions several tests and standards applied, along with the statement "The technological differences between the predicate device and the subject device have been verified and validated by means of the following tests and standards to endorse the claims of substantial equivalence to the predicate device." However, it does not provide a specific table of quantitative acceptance criteria or detailed numerical results for each test. Instead, it lists the types of tests performed.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Risk Analysis | In accordance with ISO 14971:2007; Design verification tests and acceptance criteria identified and performed based on risk analysis assessment. |
| Biocompatibility | Performed in accordance with FDA Guidance (ISO-10993 Part 1); Passed ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation & Skin Sensitization), ISO 10993-7 (Ethylene Oxide Residuals), ISO 10993-11 (Systemic Toxicity), ASTM F756 (Hemolytic Properties), ISO 10993-4 (Interactions with blood), USP (Pyrogen Test), USP 42, NF 37, Gen Chapters & (Kinetic-Chromogenic Limulus Amebocyte Lysate). Implies successful meeting of biocompatibility standards. |
| Sterilization Validation | Half-cycle approach in accordance with ISO 11135:2014. Validated. |
| Shelf-life Testing | Validated for three years by accelerated testing according to ASTM F1980-16. Validated. |
| Packaging Requirements | Per AAMI/ANSI/ISO 11607-1/2. Validated. |
| Performance Testing | Bench tests carried out to demonstrate performance, including: |
- Brush operation with compatible endoscope
- Dimension of each part of the brush
- General durability
- Joint/tensile strength
- Package integrity. Implies successful meeting of performance criteria. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes (number of units) used for each individual bench test (e.g., durability, tensile strength). It only states that tests were performed.
- Data Provenance: The tests are "non-clinical testing" conducted by or for Olympus Medical Systems Corp. and Aomori Olympus Co., Ltd. (Japan). The specific location where the testing was physically conducted (e.g., country of origin of the data/testing) is not explicitly stated beyond the manufacturing location. These are laboratory/bench tests, not patient data.
- Retrospective or Prospective: Not applicable, as these are bench tests, not involving patient data or clinical follow-up.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of diagnostic device performance based on expert consensus, is not relevant here. The "ground truth" for the engineering and material tests is defined by the physical or chemical properties being measured (e.g., tensile strength, biocompatibility standards, dimensions).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in clinical studies with human readers/interpreters to establish a consensus ground truth. Here, the "truth" is determined by engineering test methods and established standards.
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 physical medical device (cytology brush), not an AI/software algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering and material standards, physical measurements, and biological compatibility tests. For example:
- Dimensions: Met specified dimensions.
- Strength/Durability: Passed defined stress tests (e.g., joint/tensile strength, general durability).
- Biocompatibility: Demonstrated non-toxicity, non-irritation, non-hemolysis, etc., as per ISO 10993 series and USP standards.
- Sterilization: Demonstrated effective sterilization and maintenance of sterility over shelf-life per ISO 11135 and ASTM F1980.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.