(206 days)
Not Found
No
The document describes a standard bronchovideoscope and its intended use, focusing on hardware components and basic functionality. There is no mention of AI, ML, image processing beyond basic video capture, or any data processing that would suggest the use of such technologies. The performance studies listed are standard for medical devices and do not indicate AI/ML evaluation.
No
The device is described for "endoscopic diagnosis and treatment" and as a "video scope used for endoscopic diagnosis and and treatment,". While it can be used with "EndoTherapy accessories," the device itself is a bronchoscope, which is primarily a diagnostic and visualization tool, even when used to facilitate treatment. It does not inherently provide a therapeutic effect.
Yes
The device description explicitly states, "The bronchovideoscope (BF-XP190, BF-P190) is a video scope used for endoscopic diagnosis and treatment within the respiratory organs."
No
The device description explicitly details physical components like a control section, insertion section, and connector section, indicating it is a hardware device. While it mentions software verification and validation, this is in the context of a hardware device that includes software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a bronchovideoscope. It is used for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. This involves directly visualizing the internal structures of the respiratory system.
- Lack of Sample Analysis: The device description and intended use do not mention the analysis of any biological samples taken from the patient. Its primary function is visualization and potentially facilitating procedures using accessories like biopsy forceps (which would then be used to collect a sample for subsequent IVD testing, but the bronchoscope itself is not performing the diagnostic test).
Therefore, the EVIS EXERA III BRONCHOVIDEOSCOPE is an endoscopic device used for visualization and intervention within the body, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190 This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
This EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190, OLYMPUS BF-P190) is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The bronchovideoscope (BF-XP190, BF-P190) is indicated for use within the airways and tracheobronchial tree.
The bronchovideoscope (BF-XP190, BF-P190) is a video scope used for endoscopic diagnosis and treatment within the respiratory organs and modification of the BF-XT190 which was previously cleared under K183419.
The endoscope consists of three parts: the control section, the insertion section, and the connector section. The basic principle including user interface and operation for the procedure of the endoscope is identical to that of the predicate device, BF-XT190.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways and tracheobronchial tree
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)
The following performance data was provided in support of the substantial equivalence determination:
- Reprocessing validation testing: Reprocessing instruction and reprocessing method validation testing was conducted and documentations were provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling issued on March 17, 2015".
- Biocompatibility testing: Biocompatibility testing was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process issued on June 16, 2016". The biocompatibility testing included the following tests: Cytotoxicity Study Using the Colony Assay (ISO 10993-5), Intracutaneous Study in Rabbits (ISO 10993-10), Guinea Pig Maximization Sensitization Test (ISO 10993-10), Systemic Toxicity Study in Mice (ISO 10993-11)
- Software verification and validation testing: Software verification and validation testing was conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices issued on October 2, 2014".
- Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing was conducted in accordance with ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for electrical safety and the IEC 60601-1-2:2014 standards for EMC.
- Performance testing - Bench: Bench testing as listed below was conducted to ensure that the subject devices were carried out to demonstrate their safety and effectiveness. Thermal Safety Test, Mechanical durability test, Photobiological Safety Test.
- Performance testing - Animal: No animal study was performed to demonstrate substantial equivalence.
- Performance testing - Clinical: No clinical study was performed to demonstrate substantial equivalence.
- Risk management: Risk management was performed in accordance with ISO 14971: 2007 (Second edition) and the human factors validation was conducted in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices issued on February 3, 2016". The design verification tests and their acceptance criteria were identified and performed as a result of this risk management.
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.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 21, 2021
Olympus Medical Systems Corp. % Anne-Marie Keefe Program Manager Olympus Surgical Technologies of America 118 Turnpike Road, Suite 120 Southborough, Massachusetts 01772
Re: K201758
Trade/Device Name: EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ Dated: December 18, 2020 Received: December 21, 2020
Dear Anne-Marie Keefe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201758
Device Name
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
Indications for Use (Describe)
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. There is a thin yellow line underneath the word. The registered trademark symbol is located to the right of the letter "S".
Date prepared: January 21, 2021 K201758
510(k) Summary
1. GENERAL INFORMATION
| ■ 510(k) Submitter: | OLYMPUS MEDICAL SYSTEMS CORP. |
|---|---|
| 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507 Japan | |
| ■ Contact Person: | Anne-Marie Keefe |
| Olympus Surgical Technologies of America | |
| 118 Turnpike Road, Suite 120 | |
| Southborough, MA 01772 | |
| Phone: (508) 804-2448 | |
| Fax: 484-896-7128 | |
| Mobile: (508) 244-1921 | |
| Email: Anne-Marie.Keefe@olymus.com | |
| ■ Manufacturing site: | Aizu Olympus Co., Ltd., |
| 500 Muranishi, Niidera, Monden-machi, Aizuwakamatsu-shi | |
| Fukushima 965-8520, Japan |
2. DEVICE IDENTIFICATION
| ■ Device Name: | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS
BF-XP190
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS
BF-P190 |
|-------------------------|-------------------------------------------------------------------------------------------------------------|
| ■ Common Name: | BRONCHOVIDEOSCOPE |
| ■ Regulation Number: | 874.4680 |
| ■ Regulation Name: | Bronchoscope (flexible or rigid) and accessories |
| ■ Regulatory Class: | Class II |
| ■ Product Code: | EOQ (Bronchoscope (Flexible or rigid)) |
| ■ Classification Panel: | Ear, Nose and Throat |
4
Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The letters are closely spaced together, creating a solid block of text. Below the word "OLYMPUS" is a horizontal stripe of yellow, which serves as a base or underline for the text. There is a registered trademark symbol to the right of the word.
3. PREDICATE DEVICE
■ Predicate device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| OLYMPUS BF-XT190 | OLYMPUS MEDICAL | K183419 |
| EVIS EXERA III BRONCHOVIDEOSCOPE | SYSTEMS CORP. |
4. DEVICE DESCRIPTION
= General Description of the subject device
This EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190,
OLYMPUS BF-P190) is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The bronchovideoscope (BF-XP190, BF-P190) is indicated for use within the airways and tracheobronchial tree.
The bronchovideoscope (BF-XP190, BF-P190) is a video scope used for endoscopic diagnosis and treatment within the respiratory organs and modification of the BF-XT190 which was previously cleared under K183419.
■ Principle of Operation
The endoscope consists of three parts: the control section, the insertion section, and the connector section. The basic principle including user interface and operation for the procedure of the endoscope is identical to that of the predicate device, BF-XT190.
5. INDICATIONS FOR USE
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190 .
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.
5
. EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 This instrument is intended to be used with an Olympus video system center. light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.
6. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE
The EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190 has the same technological characteristics and design as the predicate device except for the following new features:
- 1.2 mm Inner Diameter of Instrument Channel
- 3.1 mm Outer Diameter of Distal End -
- 2.8 mm Outer Diameter of Insertion Tube ।
The EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 has the same technological characteristics and design as the predicate device except for the following new features:
- 2.0 mm Inner Diameter of Instrument Channel
- 4.2 mm Outer Diameter of Distal End
- 4.1 mm Outer Diameter of Insertion Tube
All other technological characteristics of both the subject and predicate device are identical. Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.
A side-by-side comparison of the subject device and the predicate device is provided below.
6
OLYMPUS
| Item | Subject Device
BF-XP190 | Subject Device
BF-P190 | Predicate Device
BF-XT190
(K183419) |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use | This instrument is
intended to be used
with an Olympus video
system center, light
source, documentation
equipment, monitor,
EndoTherapy
accessories (such as a
biopsy forceps), and
other ancillary
equipment for
endoscopy and
endoscopic surgery.
This instrument is
indicated for use
within the airways and
tracheobronchial tree. | This instrument is
intended to be used
with an Olympus video
system center, light
source, documentation
equipment, monitor,
EndoTherapy
accessories (such as a
biopsy forceps), and
other ancillary
equipment for
endoscopy and
endoscopic surgery.
This instrument is
indicated for use
within the airways and
tracheobronchial tree. | This instrument is
intended to be used
with an Olympus video
system center, light
source, documentation
equipment, monitor,
EndoTherapy
accessories (such as a
biopsy forceps), and
other ancillary
equipment for
endoscopy and
endoscopic surgery.
This instrument is
indicated for use
within the airways and
tracheobronchial tree. |
| Depth of
Field | 2 - 50 mm | 2 - 50 mm | 2 - 50 mm |
| Direction of
Forward
View | 0° (Forward viewing) | 0° (Forward viewing) | 0° (Forward viewing) |
| Field of View | 110° | 110° | 110° |
| NBI
observation | Available | Available | Available |
| Outer
Diameter of
Distal End | $Φ$ 3.1mm | $Φ$ 4.2mm | $Φ$ 6.1mm |
| Outer
Diameter of | $Φ$ 2.8mm | $Φ$ 4.1mm | $Φ$ 6.3mm |
| | | | |
| Insertion
Tube | | | |
| Bending
Section
Angulation | UP:210°, DOWN:130° | UP:210°, DOWN:130° | UP:180°, DOWN:130° |
| Working
Length | 600mm | 600mm | 600mm |
| Instrument
Channel
inner
diameter | $Φ$ 1.2mm | $Φ$ 2.0mm | $Φ$ 3.2mm |
| Configuration
of Control
section and
location of
scope switch | Image: Olympus control section and scope switch 1 | Image: Olympus control section and scope switch 2 | Image: Olympus control section and scope switch 3 |
7
Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. A small registered trademark symbol is located in the upper right corner of the word, next to the letter "S".
7 PERFORMANCE DATA
The following performance data was provided in support of the substantial equivalence determination.
1) Reprocessing validation testing
Reprocessing instruction and reprocessing method validation testing was conducted and documentations were provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling issued on March 17, 2015".
2) Biocompatibility testing
Biocompatibility testing was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO
8
10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process issued on June 16, 2016". The biocompatibility testing included the following tests:
- Cytotoxicity Study Using the Colony Assay (ISO 10993-5)
- Intracutaneous Study in Rabbits (ISO 10993-10) ।
- Guinea Pig Maximization Sensitization Test (ISO 10993-10) ।
- Systemic Toxicity Study in Mice (ISO 10993-11)
3) Software verification and validation testing
Software verification and validation testing was conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices issued on October 2, 2014".
4) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing was conducted in accordance with ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for electrical safety and the IEC 60601-1-2:2014 standards for EMC.
5) Performance testing - Bench
Bench testing as listed below was conducted to ensure that the subject devices were carried out to demonstrate their safety and effectiveness.
- Thermal Safety Test
- । Mechanical durability test
- Photobiological Safety Test
6) Performance testing - Animal
No animal study was performed to demonstrate substantial equivalence.
7) Performance testing - Clinical
No clinical study was performed to demonstrate substantial equivalence.
9
8) Risk management
Risk management was performed in accordance with ISO 14971: 2007 (Second edition) and the human factors validation was conducted in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices issued on February 3, 2016". The design verification tests and their acceptance criteria were identified and performed as a result of this risk management.
8. CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device, the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190 and BF-P190 raise no new issue of safety and effectiveness and are substantially equivalent to the predicate device in terms of safety, effectiveness, and performance.