(80 days)
Intended to remove, by cutting, a specimen of tissue for microscopic examination from the lungs or bronchial passageways. Patient population; Any patient demonstrating an abnormality or condition indicative of malignancy or benign obstruction as noted through bronchoscopy, x-ray, MRI, etc.
Figure A-1 depicts all but a few reusable biopsy forceps designs. All operate on a 4-bar linkage arrangement as shown. Transverse motion of the control cable results in the pendulum motion of the handle consists of a slide, finger spool or finger ring arrangement and a thumb ring. The jaws are actuated by transverse motion of the finger spool that connects to the control cable is connected to the clevis. The linkages are hinged on small pins, the jaws rotate about an axle pin that is supported by the fork. With the exception of the handle, all the components are fabricated from ASTM 302, 303 or 304 stainless steel. The handle components are fabricated from a suitable material able to withstand several reprocessing cycles.
Here's a breakdown of the acceptance criteria and study information for the Ballard Reusable Bronchial Biopsy Forceps, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a table of "acceptance criteria" with quantitative targets for each test. Instead, it describes various tests performed and implies that the device met the necessary performance for substantial equivalence. The "reported device performance" is primarily qualitative, stating that the device passed the tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence | Similar general design characteristics and function to predicate device. |
| Sheath Length | 120cm (similar to predicate's 105cm, deemed acceptable) |
| Sheath Diameter | 1.6mm (matches predicate) |
| Jaw Diameter | 1.8mm (matches predicate) |
| Jaw Geometry | Ellipsoid, fenestrated, no spike (similar to predicate) |
| Reprocessing Effectiveness | Successfully withstood recommended reprocessing cycles (Soak, Enzymatic wash, Ultrasonic cleaning, Rinse, Autoclave) |
| - Soak | Immediately after use (matches predicate) |
| - Enzymatic wash | Thoroughly clean, dry (no direct comparison, but implies effectiveness) |
| - Ultrasonic cleaning | 40KHz, 10 minutes (predicate: 30 minutes, implies 10 min effectively cleans) |
| - Rinse | Clean running tap water (matches predicate) |
| - Autoclave | Pre-vacuum cycle: 134°C, 4min, .2Mpa pressure; Gravity cycle: 134°C, 15 min, .310Mpa pressure (different from predicate's 132-134°C, 5min, but implies effectiveness) |
| Sterilization Effectiveness | Passed sterilization tests (no specific details provided) |
| Tensile Strength | Passed tensile tests (no specific details provided) |
| Overall Safety & Effectiveness | "Safe and effective for its intended use" based on submitted data. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not provide details on the sample size for the test set used in the functional, sterilization, reprocessing, or tensile equivalence tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).
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 conducted are primarily engineering/performance tests (functional, sterilization, reprocessing, tensile) directly comparing the device to a predicate, not clinical studies requiring expert ground truth for interpretation of observational data.
4. Adjudication Method (for the test set)
This information is not applicable as the tests performed are not clinical trials requiring adjudication of expert interpretations but rather performance tests against defined specifications or predicate device characteristics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and its Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing against a predicate device.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was Done
This question is not applicable as the device is a physical medical instrument (biopsy forceps), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests appears to be:
- Performance Specifications/Benchmarks: For functional tests, this would be the expected performance of a biopsy forceps.
- Predicate Device Characteristics: For sheath length, diameter, jaw geometry, and reprocessing parameters, the Olympus FB Series Biopsy Forcep (K962555) served as the direct comparator for substantial equivalence.
- Established Industry Standards/Protocols: For sterilization, reprocessing, and tensile strength, the tests would have been performed according to accepted methods to demonstrate safety and effectiveness.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical medical instrument, not a learning algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as above.
§ 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.