(269 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on the hardware and intended use without suggesting advanced image analysis or decision-making capabilities.
Yes
The device description states its use for "endoscopic diagnosis and treatment." The mention of "EndoTherapy accessories (such as a biopsy forceps)" also indicates its role in therapeutic procedures, such as taking biopsies.
Yes
The "Device Description" states that the device is a "video scope used for the endoscopic diagnosis and treatment within the respiratory organs." The mention of "diagnosis" clearly indicates a diagnostic function for the device.
No
The device description explicitly states it is a "BRONCHOVIDEOSCOPE" and details hardware components like a video scope, indicating it is a physical medical device, not software-only. The performance studies also include hardware-related testing such as reprocessing validation, biocompatibility, electrical safety, EMC, and various bench performance tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. This involves direct visualization and potentially therapeutic interventions within the body.
- Device Description: The device is described as a "video scope used for the endoscopic diagnosis and treatment within the respiratory organs." This aligns with an endoscopic device, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to diagnose a condition. IVD devices are specifically designed for such purposes.
The device is clearly an endoscope used for direct visualization and intervention within the patient's body, which falls under the category of a medical device but not an IVD.
N/A
Intended Use / 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.
Product codes
EOQ
Device Description
This EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 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 BF-XT190 is indicated for use within the airways and tracheobronchial tree. The BF-XT190 is a video scope used for the endoscopic diagnosis and treatment within the respiratory organs and modification of the BF-MP190F which was previously cleared under K172726.
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
- Reprocessing validation testing: Reprocessing instruction and reprocessing method validation testing for the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 were performed.
- Biocompatibility testing: Biocompatibility testing for the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 were performed, including Cytotoxicity Study, Intracutaneous Study in Rabbits, Guinea Pig Maximization Sensitization Test, and Acute Systemic toxicity.
- Software verification and validation testing: Software verification and validation testing for the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 were performed.
- Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were performed on the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190. The system complies with specified standards for safety and EMC.
- Performance testing - Bench: Bench testing for the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 was carried out to demonstrate the safety and the effectiveness of the subject device, including Thermal Safety Test, Mechanical Durability Test, Photobiological Safety Test, and Optical Performance 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 analysis: Risk analysis for the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 was carried out.
Key results: Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device, the EVIS EXERA III BRONCHO VIDEOSCOPE OLYMPUS BF-XT190 raised no new issue of safety and effectiveness and are substantially equivalent to the predicate device in terms of safety, efficacy and performance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
September 5, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Olympus Medical Systems Corp. % Sheri Musgnung Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610
Re: K183419
Trade/Device Name: EVIS EXERA III Bronchovideoscope Olympus BF-XT190 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: August 1, 2019 Received: August 2, 2019
Dear Sheri Musgnung:
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.
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
1
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 Srinivas Nandkumar, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183419
Device Name EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
Indications for Use (Describe)
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are a sans-serif font and are evenly spaced. There is a registered trademark symbol to the right of the letter "S". The background is white, with a gradient of yellow at the bottom.
September 3, 2019
510(k) Summary
5.1 GENERAL INFORMATION
- 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
- Sheri L. Musgnung Contact Person: Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 Fax: 484-896-7128 Email: sheri.musgnung@olympus.com
5.2 DEVICE IDENTIFICATION
- Device Name EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
- OLYMPUS BF-XT190 ■ Model Name
II
- Common Name Bronchoscope, its accessories and ancillary equipment
- Regulation Number 874.4680
- Regulation Name Bronchoscope (flexible or rigid) and accessories
- Regulatory Class
- Product Code EOQ, Bronchoscope (Flexible Or Rigid)
- Classification Panel Ear, Nose, and Throat
5.3 PREDICATE DEVICE
■ Predicate device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| OLYMPUS BF-MP190F | OLYMPUS MEDICAL SYSTEMS CORP. | K172726 |
4
Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, and the word is slightly curved. There is a registered trademark symbol to the right of the word. Below the word is a yellow bar.
5.4 DEVICE DESCRIPTION
■ General Description of the subject device
This EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 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 BF-XT190 is indicated for use within the airways and tracheobronchial tree. The BF-XT190 is a video scope used for the endoscopic diagnosis and treatment within the respiratory organs and modification of the BF-MP190F which was previously cleared under K172726.
■ Principle of Operation
The BF-XT190 consists of three parts: the control section, the insertion section, and the connector section. The basic principal, the user interface and operation for the bronchoscopic procedure of the BF-XT190 is identical to the predicate BF-MP190F.
5
Image /page/5/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. A thin, horizontal, yellow line is located directly below the word. The font is sans-serif and the letters are evenly spaced.
5.5 INDICATIONS FOR USE
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
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.
5.6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE
The EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 has the same technological characteristics and design as the predicate device except for the following new features:
- Instrument channel is wider
- Insertion tube is wider
- Optical specification has been altered
- Bending section angulation is narrower
- Function of narrow band imaging (NBI) observation is available
- Patient contact materials have been altered
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.
| Item | Subject Device EVIS
EXERA III
BRONCHOVIDEOSCOPE
OLYMPUS BF-XT190 | Predicate Device EVIS EXERA III
BRONCHOFIBER VIDEOSCOPE
OLYMPUS BF-MP190F
(K172726) |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | This instrument is intended to be
used with an Olympus video system
center, light source, documentation | 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. | 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 |
| Direction of Forward
View | 0° (Forward viewing) | 0° (Forward viewing) |
| Field of View | 110° | 90° |
| NBI observation | Available | Not Available |
| Outer Diameter of Distal
End | $Φ$ 6.1mm | $φ$ 3.0mm |
| Outer Diameter of
Insertion Tube | $Φ$ 6.3mm | $φ$ 3.7mm |
| Bending Section
Angulation | UP:180°, DOWN:130° | UP:210°, DOWN:130° |
| Working Length | 600mm | 600mm |
| Instrument Channel
inner diameter [mm] | $φ$ 3.2 | $φ$ 1.7 |
| Configuration of Control
section and location of
scope switch | Image: OLYMPUS endoscope control section | Image: OLYMPUS endoscope control section |
6
Image /page/6/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The registered trademark symbol is located to the right of the word. A gradient yellow line is located underneath the word.
7
Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are a sans-serif font and are closely spaced together. There is a registered trademark symbol to the right of the word. A thin, horizontal, yellow line is located underneath the word.
5.7 PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
1) Reprocessing validation testing
Reprocessing instruction and reprocessing method validation testing for the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 were performed in accordance with the FDA guidance "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 for the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 were performed in accordance with the FDA Guidance "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, 2013". The biocompatibility testing includes 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 ।
- Acute Systemic toxicity ISO 10993-11
3) Software verification and validation testing
Software verification and validation testing for the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 were performed in accordance with the FDA guidance, "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 were performed on the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190. The system complies with the ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
5) Performance testing - Bench
Bench testing for the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 was carried out to demonstrate the safety and the effectiveness of the subject device.
- Thermal Safety Test
8
Image /page/8/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. A registered trademark symbol is located to the right of the letter "S". A gradient of yellow and orange is located underneath the word.
- Mechanical Durability Test
- Photobiological Safety Test
- Optical Performance 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.
8) Risk analysis
Risk analysis for the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
5.8 CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device, the EVIS EXERA III BRONCHO VIDEOSCOPE OLYMPUS BF-XT190 raised no new issue of safety and effectiveness and are substantially equivalent to the predicate device in terms of safety, efficacy and performance.