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510(k) Data Aggregation
(66 days)
Single Use Biopsy Forceps FB-456D
The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible Olympus bronchoscope.
The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible Olympus bronchoscope. The subject device is single-use biopsy forceps sterilized by Ethylene Oxide. The subject device is inserted into the channel of a bronchoscope to collect tissue by biting the surface of lesions with the pair of cups affixed to the distal end of the subject device. Users withdraw the subject device from the bronchoscope channel to collect the biopsy sample. The subject device consists of the Handle and the Insertion portion. The Handle consists of the Body and the Slider. The Insertion portion is divided into the Distal end including the Cups as well as other connection parts, and the Sheath portion including the Operation wire, the Coil sheath and other joint pipes. The Handle Slider is designed to connect to the Operation wire in the Insertion and the Cups, actuating the Cups to open/close by advancing and retracting the Slider.
This document describes the premarket notification (510(k)) for the Olympus Single Use Biopsy Forceps FB-456D. This device is a medical accessory and not an AI/ML powered device, therefore the typical AI/ML-related study criteria (data provenance, expert adjudication, MRMC studies, training/test set details, etc.) are not applicable here.
However, I can extract the relevant acceptance criteria and performance data for this device as detailed in the provided text.
Here's a breakdown of the acceptance criteria and the proof that the device meets them, based on the provided document:
Device: Single Use Biopsy Forceps FB-456D
Indications for Use: The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible Olympus bronchoscope.
1. Table of Acceptance Criteria and Reported Device Performance
The document outlines a series of non-clinical tests performed to demonstrate substantial equivalence to the predicate device. These tests serve as the acceptance criteria for various performance aspects.
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria (Implicit from passing test) | Reported Device Performance |
|---|---|---|---|
| Risk Management | ISO 14971:2007 | In accordance with established in-house acceptance criteria based on ISO 14971:2007. | Risk analysis conducted and design verification tests (identified through risk analysis) were performed. |
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11 | Compliance with FDA Guidance for ISO 10993-1. Specific tests for cytotoxicity, irritation/skin sensitization, and systemic toxicity. | Biocompatibility testing conducted in accordance with FDA guidance and relevant ISO 10993 parts. (Implies satisfactory results) |
| Sterilization | ISO 11135:2014, ISO 10993-7 | Sterilization validation using Half-cycle approach per ISO 11135:2014. Residuals assessed per ISO 10993-7. | Sterilization validation carried out with satisfactory results. |
| Shelf-Life | ASTM F1980-16 | Validation of shelf-life for three years. | Three-year shelf-life validated by accelerated testing per ASTM F1980-16. Long-term aging analyses will support these results. |
| Packaging | AAMI/ANSI/ISO 11607-1/2 | Requirements for terminally sterilized medical device packaging are met. | Packaging requirements validated. |
| Performance Testing | In-house tests | 1. Compatibility with the endoscope: Demonstrated functional compatibility. | Testing performed; device is compatible. (Implies satisfactory results) |
| 2. Open and close of the cups: Functional operation. | Testing performed; cups open and close as intended. (Implies satisfactory results) | ||
| 3. Performance after repeated operation: Maintains function over multiple uses (within single-use context, likely durability). | Testing performed; performance maintained. (Implies satisfactory results) | ||
| 4. Maximum insertion portion diameter: Conforms to specified dimensions. | Testing performed; diameter meets specifications. (Implies satisfactory results) | ||
| 5. Visual inspection of the insertion portion: No defects. | Testing performed; insertion portion passes visual inspection. (Implies satisfactory results) | ||
| 6. Strength of the junction and cups: Withstands expected forces. | Testing performed; junction and cups demonstrate adequate strength. (Implies satisfactory results) | ||
| 7. Strength when opening/closing the cups: Operational integrity. | Testing performed; sufficient strength during operation. (Implies satisfactory results) | ||
| 8. Package inspection: Maintains sterility barrier and integrity. | Testing performed; package passes inspection. (Implies satisfactory results) |
2. Sample Sizes and Data Provenance
- Sample Size for Test Set: This information is not explicitly provided in the document. For non-clinical, physical device testing, sample sizes are typically determined by engineering standards and statistical confidence levels, but the exact numbers are not detailed here.
- Data Provenance: The testing was conducted by Olympus Medical Systems Corp. and Aomori Olympus Co., Ltd., both located in Japan. The testing is performed prospectively as part of the device development and validation process before market clearance.
3. Number of Experts Used to Establish Ground Truth & Qualifications
Not applicable. This device is not an AI/ML diagnostic tool requiring human expert interpretation for ground truth establishment. The "ground truth" here is based on objective, quantitative measurements and adherence to established engineering and biocompatibility standards.
4. Adjudication Method for Test Set
Not applicable. As this is not a diagnostic AI/ML device, there are no human expert readings requiring adjudication. Performance is assessed against pre-defined engineering specifications and standard compliance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML-assisted diagnostic device, so no MRMC study looking at human reader performance with or without AI assistance was conducted.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical biopsy forceps, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective measurements, adherence to internationally recognized scientific and engineering standards (e.g., ISO, ASTM), and in-house established acceptance criteria. For example, biocompatibility is assessed against ISO standards, sterility against ISO standards, and mechanical performance against defined engineering thresholds.
8. Sample Size for Training Set
Not applicable. This is a physical medical device, not an AI/ML model that requires a "training set" of data.
9. How Ground Truth for Training Set Was Established
Not applicable. No training set for an AI/ML model.
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