(49 days)
The DISPOSABLE CYTOLOGY BRUSH BC-202D/203D Series is intended to be used to collect tissue specimens in the tracheobronchial tree in combination with a bronchoscope.
The DISPOSABLE CYTOLOGY BRUSH BC-202D-1210/2010/3010/5010, BC-203D-2006 have been designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes. The Subject Device (SD) is inserted into the bronchoscope through a biopsy valve to reach the target area, where, by rubbing the brush on the target area, specimens or cells can be collected. The Subject Device is then withdrawn from the bronchoscope channel with the collected samples.
The Subject Device consists of:
- Handle
- Insertion portion
The handle consists of a ring and a grip. The insertion portion consists of a plastic tube, stainless steel wire, nylon brush (length 6mm or 10mm, diameters 1.2 – 5 mm) and stainless steel distal tip. The grip is attached to the tube and the ring is attached to the wire. The user can move the brush at the tip of the wire back and forth by holding the grip and moving the ring back and forth. The distal tip is designed to prevent damage to the inside of the tube and/or bronchial wall.
This document is a 510(k) clearance letter for a medical device, specifically a disposable cytology brush. It is not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies for AI/ML performance (e.g., sample size for test/training sets, expert consensus, MRMC studies, standalone algorithm performance, effect size of human reader improvement with AI) are not applicable to this document.
The document focuses on demonstrating substantial equivalence to a legally marketed predicate device through:
- Biocompatibility testing: Ensuring the materials are safe for human contact.
- Performance testing (Bench/Non-Clinical): Evaluating the physical and mechanical performance of the brush.
- Sterilization and Shelf Life Testing: Confirming the device remains sterile and functional over its stated shelf life.
Here's how the provided information relates to the performance acceptance criteria and proof for this medical device:
Acceptance Criteria and Device Performance for Disposable Cytology Brush
For this medical device, substantial equivalence is proven by meeting established performance specifications through non-clinical (bench) testing, biocompatibility testing, and sterilization/shelf life validation. There are no AI-specific acceptance criteria or studies mentioned as this is a physical medical device, not an AI/ML software device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test/Criterion | Acceptance Criteria (Implied/Standard) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity Study (ISO 10993-5) | No significant cytotoxic effects. | Passed specifications. |
| Intracutaneous Irritation Study (ISO 10993-23) | No significant irritation. | Passed specifications. | |
| Guinea Pig Maximization Sensitization Test (ISO 10993-10) | No significant sensitization. | Passed specifications. | |
| Material-mediated Pyrogen Testing (USP ) | No pyrogenic response. | Passed specifications. | |
| Acute Systemic Toxicity Study (ISO 10993-11) | No significant systemic toxicity. | Passed specifications. | |
| Performance (Bench) | Expansion and Contraction of the Brush Section | Perform as intended (smooth movement, reaches full extension/retraction). | Passed specifications. |
| Insertion & Withdrawal (from Endoscope) | Smooth insertion and withdrawal without damaging the device or bronchoscope. | Passed specifications. | |
| Performance after Repeated Insertion & Withdrawal | Maintain functionality after multiple cycles. | Passed specifications. | |
| Performance after Repeated Brush Strokes | Maintain integrity and specified force during brushing (quantitative force measurement implies a range). | Passed specifications. | |
| Performance after Repeated Brushing (brush condition) | Brush maintains structural integrity and effective cell collection capability. | Passed specifications. | |
| Performance after Repeated Bending | Device withstands bending stress without kinking or failure. | Passed specifications. | |
| Brush Strength (Grip-Tube junction) | Withstand specified force without detachment or failure. | Passed specifications. | |
| Brush Strength (Tip-Brush Wire junction) | Withstand specified force without detachment or failure. | Passed specifications. | |
| Sterilization/Shelf Life | Sterilization Validation (ISO 11135:2014) | Achieves required Sterility Assurance Level (SAL). | Passed specifications. |
| Ethylene Oxide Residuals (ISO 10993-7:2008) | Residuals below specified limits. | Passed specifications. | |
| Package Integrity (ISO 11607-1/2:2019, ASTM F1980-21) | Package maintains sterile barrier after accelerated aging and simulated distribution. | Passed specifications. | |
| Product Performance (accelerated aging/simulated distribution) | Device functionality maintained over the stated shelf-life (5 years) after simulated stresses. | Passed specifications. (Supports 5-year shelf life) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each bench test. For these types of physical device tests, sample sizes are typically determined by established standards (e.g., ISO, ASTM) and statistical validity for mechanical testing (e.g., n=30, or as per specific test method requirements).
- Data Provenance: The tests are explicitly described as "Non-Clinical (Bench) Performance Testing" and "Biocompatibility Testing." This means the data comes from laboratory experiments and material testing, not human or observational data. There is no mention of country of origin for the data; it would be generated in the manufacturer's or contracted test labs. All tests are inherently "prospective" in the sense that they are conducted specifically to validate the device's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This is a physical medical device. Ground truth for its performance is established by objective engineering measurements, material science principles, and biological safety standards (e.g., ensuring a certain tensile strength, confirming sterility, testing for cytotoxicity per ISO standards). It does not involve human expert interpretation of images or patient data in the way an AI/ML device would.
4. Adjudication Method for the Test Set
- Not applicable. See point 3. Testing results are pass/fail based on predetermined numerical or qualitative specifications from recognized standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is not an AI/ML device used for diagnostic interpretation. Therefore, there is no human reader component to improve or compare against.
6. Standalone (Algorithm Only) Performance
- Not applicable. There is no algorithm or software for standalone performance evaluation. The device is a physical tool.
7. Type of Ground Truth Used
- Bench Test Specifications: The "ground truth" for this device's performance lies in its ability to meet predefined engineering specifications (e.g., force measurements, cyclical durability, material integrity) and biological safety standards (e.g., absence of toxicity, successful sterilization). This is determined through standardized laboratory testing methods rather than expert consensus on clinical cases or pathology.
8. Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/ML algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 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.