(10 days)
Not Found
No
The document describes a bronchoscope and related accessories, focusing on sterilization methods and image sensor specifications. There is no mention of AI or ML.
No
The device is described as being used with "endo-therapy accessories (such as biopsy forceps)" and for "endoscopic surgery," indicating it is an accessory and viewing system, not a therapeutic device itself.
No
The device is described as an instrument for endoscopy and endoscopic surgery, used with accessories like biopsy forceps. While it provides visualization, its primary stated purpose is for surgical intervention and therapy, not solely for diagnosis. The Intended Use mentions "[...] endoscopy and endoscopic surgery within the airways and tracheobronchial tree".
No
The device description clearly outlines physical hardware components (bronchovideoscopes, sterilization tray, forceps, etc.) and their physical characteristics (compatibility with sterilization, CCD pixels). There is no mention of the device being solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these instruments are for "endoscopy and endoscopic surgery within the airways and tracheobronchial tree." This describes a procedure performed on the patient's body for visualization and intervention, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a bronchoscope and related accessories used for visualization and manipulation within the airways. This aligns with an endoscopic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is used for direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
EVIS EXERA Bronchovideoscope
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Accessories to the EVIS EXERA Bronchovideoscope
XMAJ-178 (Sterilization Tray)
The XMAJ-178 is a sterilization tray intended for use in medical facilities to accommodate the Olympus autoclavable Bronchovideoscopes during autoclaving.
MAJ-1214 (Water-resistant Cap)
The MAJ-1214 is attached to the electrical connector on the endoscope to protect the connector from water penetration during reprocessing.
FB-52C-1 (Biopsy Forceps)
The FB-52C-1 has been designed to be used with an Olympus endoscope to collect tissue within the thoracic and abdominal cavities and the airways and tracheobrochial tree.
FG-36D (Grasping Forceps)
This instrument has been designed to be used with Olympus endoscopes to retrieve foreign r not morth has been specimens from the digestive tract, urinary tract, female reproductive tract and respiratory organs.
IE-2P (Magnetic Extractor)
The Olympus IE-2P magnetic Extractor has been specially designed to be used within the airways and tracheobrochial tree.
NM-8L-1/NM-9L-1 (Injector)
These instruments have been designed to be used with an Olympus endoscope to perform r noo internaments have bomucosal injection within the thoracic and abdominal cavities and the airways and tracheobrochial tree.
M1-1C/M2-1C/M2-2C (Measuring Device)
These measuring devices have been designed for measuring leisions within the thoracic and abdominal cavities and the airways and tracheobochial tree.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
The subject devices, Olympus EVIS EXERA Bronchovideoscope XBF-160Y3AC, XBF-1T160Y3AC, and I XBF-Q160Y2AC are identical to the predicate devices, BF-160 and BF-1T160, in intended use. These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. As for the device specifications, they are basically identical to the BF-160 and BF-1T160 with the exception that the subject devices are now compatible with steam sterilization (autoclave) in addition to ETO gas sterilization. The XBF-Q160Y2AC is loaded with higher pixels in the CCD compared to the predicate device, BF-160. The increase of the number of pixels has contributed to the expansion of image size. However, the resolution at optimum working distance of the XBF-Q160Y2AC is basically the same as that of the predicate device. Therefore, optical performance of the XBF-Q160Y2AC before and after clinical use is identical to the predicate device.
In addition to the above scopes, this submission also includes the following devices:
- XMAJ-178 (Sterilization Tray) MAJ-1214 (Water-resistant Cap) FB-52C-1 Biopsy Forceps FG-36D Grasping Forceps IE-2P Magnetic Extractor NM-8L-1 Injector NM-9L-1 Injector M1-1G Measuring Device M2-1C Measuring Device
M2-2C Measuring Device
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways and tracheobronchial tree
thoracic and abdominal cavities
digestive tract, urinary tract, female reproductive tract and respiratory organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
SMDA 510(k) SUMMARY EVIS EXERA Bronchovideoscope Olympus XBF-1T160Y3AC, XBF-160Y3AC, XBF-Q160Y2AC, its accessories and ancillary equipment
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.
1. GENERAL INFORMATION
| Applicant | Olympus Corporation
34-3 Hirai Hinode-machi,
Nishitama-gun, Tokyo, 190-0182, Japan
Establishment Registration No.: 3003637092 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Correspondent | Akiko Fukagawa
Olympus Corporation
2951 Ishikawa-cho,
Hachioji-shi, Tokyo, 192-8507, Japan
Phone: +81-426-2891
Fax: +81-426-3174
E-mail: akiko_fukagawa@ot.olympus.co.jp
Establishment Registration No.: 8010047 |
| Official Correspondent | Tina Steffanie-Oak
Associate Manager, Regulatory Affairs/Clinical Monitor
Olympus America Inc.
Two Corporate Center Drive, Melville,
NY 11747-9058
Phone: 631-844-5477
Fax: 631-844-5554
Establishment Registration No.: 2429304 |
2. Device Identification
| Trade Name: | EVIS EXERA Bronchovideoscope Olympus XBF-160Y3AC,
XBF-1T160Y3AC, XBF-Q160Y2AC, its accessories and ancillary
equipment |
|--------------------|------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bronchoscope |
| Regulation Name: | Bronchoscope (flexible or rigid) and accessories |
| Regulation Number: | 21 CFR 874.4680 |
| Class: | II |
| Product Code: | EOQ |
1
3. Predicate Device
| Predicate Device Name | Manufacturer | 510(k) Number |
|---|---|---|
| EVIS EXERA Bronchovideoscope | ||
| Olympus BF type 160 | Olympus Corporation | K023984 |
| EVIS EXERA Bronchovideoscope | ||
| Olympus BF type 1T160 | Olympus Corporation | K023984 |
| Olympus Sterilization Trays | Olympus Winter & Ibe GMBH | K033222 |
4. Device Description
The subject devices, Olympus EVIS EXERA Bronchovideoscope XBF-160Y3AC, XBF-1T160Y3AC, and I XBF-Q160Y2AC are identical to the predicate devices, BF-160 and BF-1T160, in intended use. These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. As for the device specifications, they are basically identical to the BF-160 and BF-1T160 with the exception that the subject devices are now compatible with steam sterilization (autoclave) in addition to ETO gas sterilization. The XBF-Q160Y2AC is loaded with higher pixels in the CCD compared to the predicate device, BF-160. The increase of the number of pixels has contributed to the expansion of image size. However, the resolution at optimum working distance of the XBF-Q160Y2AC is basically the same as that of the predicate device. Therefore, optical performance of the XBF-Q160Y2AC before and after clinical use is identical to the predicate device.
In addition to the above scopes, this submission also includes the following devices:
- XMAJ-178 (Sterilization Tray) MAJ-1214 (Water-resistant Cap) FB-52C-1 Biopsy Forceps FG-36D Grasping Forceps IE-2P Magnetic Extractor NM-8L-1 Injector NM-9L-1 Injector M1-1G Measuring Device M2-1C Measuring Device
M2-2C Measuring Device
5. Intended Use of the device
EVIS EXERA Bronchovideoscope
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Accessories to the EVIS EXERA Bronchovideoscope
XMAJ-178 (Sterilization Tray)
The XMAJ-178 is a sterilization tray intended for use in medical facilities to accommodate the Olympus autoclavable Bronchovideoscopes during autoclaving.
2
MAJ-1214 (Water-resistant Cap)
The MAJ-1214 is attached to the electrical connector on the endoscope to protect the connector from water penetration during reprocessing.
FB-52C-1 (Biopsy Forceps)
The FB-52C-1 has been designed to be used with an Olympus endoscope to collect tissue within the thoracic and abdominal cavities and the airways and tracheobrochial tree.
FG-36D (Grasping Forceps)
This instrument has been designed to be used with Olympus endoscopes to retrieve foreign r not morth has been specimens from the digestive tract, urinary tract, female reproductive tract and respiratory organs.
IE-2P (Magnetic Extractor)
The Olympus IE-2P magnetic Extractor has been specially designed to be used within the airways and tracheobrochial tree.
NM-8L-1/NM-9L-1 (Injector)
These instruments have been designed to be used with an Olympus endoscope to perform r noo internaments have bomucosal injection within the thoracic and abdominal cavities and the airways and tracheobrochial tree.
M1-1C/M2-1C/M2-2C (Measuring Device)
These measuring devices have been designed for measuring leisions within the thoracic and abdominal cavities and the airways and tracheobochial tree.
6. Comparison of Technological Characteristics
Below is the comparison table between the subject devices and predicate device.
| Specifications | Subject Device
XBF-160Y3AC | Subject Device
XBF-1T160Y3AC | Subject Device
XBF-Q160Y2AC | Predicate Device
BF-160 (K023984) |
|----------------------------------|-------------------------------|---------------------------------|--------------------------------|--------------------------------------|
| Reprocessing | ETO/Autoclaving | ETO/Autoclaving | ETO/Autoclaving | ETO |
| Distal end Outer
Diameter | $\phi$ 4.9 mm | $\phi$ 5.9 mm | $\phi$ 5.5 mm | $\phi$ 5.3 mm |
| Insertion Tube
Outer Diameter | $\phi$ 4.9 mm | $\phi$ 6.0 mm | $\phi$ 5.3 mm | $\phi$ 5.2 mm |
| Inner Channel
Diameter | $\phi$ 2.0 mm | $\phi$ 2.8 mm* | $\phi$ 2.0 mm | $\phi$ 2.0 mm |
*Inner Channel Diameter of XBF-1T160Y3AC is identical to that of the other predicate device, BF-1T160.
7. Materials
Biocompatibility testing was performed in accordance with Japan's Ministry of Health and Welfare notification "GUIDELINES FOR BASIC BIOLOGICAL EVALUATION OF MEDICAL DEVICES" (issued on June 27 1995), YAKKI No.99.
3
8. Conclusion
When compared to the predicate device, XBF-160Y3AC, XBF-1T160Y3AC and XBF-Q160Y2AC vvien oompared the prodicant changes in intended use, method of operation, material, or do hot most portule any organisativeness. Therefore, clinical data is not necessary for its evaluation of safety and efficacy.