(189 days)
Not Found
No
The document describes standard video signal processing for image enhancement and display, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data. The performance studies focus on risk analysis, reprocessing validation, and software validation according to established standards, not on the performance metrics typically associated with AI/ML algorithms (e.g., sensitivity, specificity, AUC).
Yes
The device is described as being used for "endoscopic diagnosis, treatment and video observation," and specifically mentions "EndoTherapy accessories (such as a biopsy forceps)" for "endoscopic surgery." The term "treatment" indicates a therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the OLYMPUS CV-190 EVIS EXERAIII VIDEO SYSTEM CENTER and the OLYMPUS CLV-190 EVIS EXERATI XENON LIGHT SOURCE are intended for "endoscopic diagnosis."
No
The device description explicitly lists multiple hardware components (Video System Center, XENON LIGHT SOURCE, RENON ENOVIDEOSCOPE) as the primary components of the system. While there is mention of software validation, the device is clearly a system of hardware and software, not software only.
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 clearly states that the system is for "endoscopy and endoscopic surgery," "endoscopic diagnosis, treatment and video observation," and use within the "airways and tracheobronchial tree." These are all procedures performed in vivo (within the living body).
- Device Description: The description focuses on the components used for visualizing and manipulating within the body (endoscopes, light source, video system center for image processing).
- Lack of IVD Characteristics: There is no mention of analyzing samples in vitro (outside the body), such as blood, urine, tissue, or other biological specimens. The system's function is to provide visual information from inside the body.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This system's purpose is direct visualization within the body.
N/A
Intended Use / Indications for Use
- Endoscopes (OLYMPUS BF-Q190, OLYMPUS BF-H190, OLYMPUS BF-1TH190 EVIS EXERAM BRONCHOVIDEOSCOPE)
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. - OLYMPUS CV-190 EVIS EXERAIII VIDEO SYSTEM CENTER
This video system center is intended to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. - OLYMPUS CLV-190 EVIS EXERAIII XENON LIGHT SOURCE
This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Product codes (comma separated list FDA assigned to the subject device)
EOQ, NWB
Device Description
The EVIS EXERA III VIDEO SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. The primary components of the subject system, which are part of this submission, are: Video System Center OLYMPUS CV-190, XENON LIGHT SOURCE OLYMPUS CLV-190, and XENON ENOVIDEOSCOPE OLYMPUS BF-Q190, BF-H190, BF-H190, BF-1TH190. The CV-190 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The OLYMPUS CV-190 allows image display on HDTV (16:9). The XENON LIGHT SOURCE OLYMPUS CLV-190 is intended for endoscopic diagnosis, treatment and video observation. In addition, both the CV-190 and CLV-190 can be used with any specified Olymous flexible and rigid endoscope models, including gastroscopes, ultrasound gastroscopes, duodenoscopes, colonoscopes, sigmoidscopes, choledochoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes. The subject endoscopes are 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.
Mentions image processing
Yes
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)
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment. Reprocessing validation was carried out in accordance with "Labeling Reusable Medical Devices Reprocessing Vallaulton was camose of the FDA Reviewer Guidance - April 1996." The software validation activities were performed in accordance with the FDA Guidance . for the Contained of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern." The following standards have been applied to the EVIS EXERA II VIDEO SYSTEM: IEC 60601-1, IEC 60601-1-1, IEC 60601-2-18, IEC 60601-1-2, ISO 14971, ASTM E1837-96, ANSI/AAMI/ISO 11135-1, ISO 10993-1, ISO 10993-5, ISO 10993-10.
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.
K061313, K051645, K062049, K100584
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
510(k) SUMMARY EVIS EXERA III VIDEO SYSTEM
JAN 1 0 2013
ENDOSCOPIC VIDEO IMAGING SYSTEM
January 8, 2013
1 General Information
- OLYMPUS MEDICAL SYSTEMS CORP. 배 Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047 Laura Storms-Tyler Official Correspondent: 월 Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5688 FAX: 484-896-7128 Email: laura.storms-tyler@olympus.com (Endoscopes) 트 Manufacturer: Aizu Olympus Co , Ltd. 500 Aza-Muranishi, Ooaza-lidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No .: 9610595 (CV-190, CLV-190) SHIRAKAWA OLYMPUS CO., LTD.3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No: 3002808148
2 Device Identification
| Device Trade Name: | EVIS EXERA III VIDEO SYSTEM |
|---|---|
| Common Name: | ENDOSCOPIC VIDEO IMAGING SYSTEM |
| Regulation Number: | 874.4680 |
| 876.1500 | |
| Regulation Name: | Bronchoscope (flexible or rigid) and accessories |
| Endoscope and Accessories | |
| Regulatory Class: | II |
1
- Ear, Nose and Throat ■ Classification Panel:
- EOQ and NWB 를 Product Code:
Predicate Device Information 3
| Subject Device
(Part of this submission) | Predicate Device | PD's
510(k) No. | Manufacturer |
|----------------------------------------------------------|----------------------------------------------------------------|-------------------------------|----------------------------------------|
| OLYMPUS BF-Q190
EVIS EXERA III
BRONCHOVIDEOSCOPE | EVIS EXERA II
BRONCHOVIDEOSCOPE
OLYMPUS BF TYPE
P180, | K061313 | Aizu Olympus Co.,
Ltd. |
| OLYMPUS BF-H190
EVIS EXERA III
BRONCHOVIDEOSCOPE | EVIS EXERA II
BRONCHOVIDEOSCOPE
OLYMPUS BF TYPE
Q180, | | |
| OLYMPUS BF-1TH190
EVIS EXERA III
BRONCHOVIDEOSCOPE | EVIS EXERA II
BRONCHOVIDEOSCOPE
OLYMPUS BF TYPE
1T180 | | |
| OLYMPUS CLV-190
EVIS EXERA III XENON
LIGHT SOURCE | EVIS EXERA Xenon Light
OLYMPUS
Source
CLV-160A | K051645 | SHIRAKAWA
OLYMPUS CO., LTD.
3-1, |
| | EVIS EXERA II XENON
LIGHT SOURCE
OLYMPUS CLV-180 | K061313
K062049
K100584 | |
| OLYMPUS CV-190
EVIS EXERA III VIDEO
SYSTEM CENTER | EVIS EXERA Video
System Center
OLYMPUS CV-160A | K051645 | |
| | EVIS EXERA II VIDEO
SYSTEM CENTER
OLYMPUS CV-180 | K061313
K062049
K100584 | |
Device Description 4
The EVIS EXERA III VIDEO SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
The primary components of the subject system, which are part of this submission, are:
-
Video System Center OLYMPUS CV-190
-
XENON LIGHT SOURCE OLYMPUS CLV-190
-
RENON ENOVIDEOSCOPE OLYMPUS BF-Q190, BF-H190, BF-H190, BF-1TH190
The CV-190 contains the video signal processing technology which enables the endoscope to
2
illuminate, enhance, view, record and transmit video data of endoscopic images. The OLYMPUS CV-190 allows image display on HDTV (16:9).
The XENON LIGHT SOURCE OLYMPUS CLV-190 is intended for endoscopic diagnosis, treatment and video observation.
In addition, both the CV-190 and CLV-190 can be used with any specified Olymous flexible and rigid including gastroscopes, ultrasound gastroscopes, duodenoscopes, endoscope models, colonoscopes, sigmoidscopes, choledochoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes.
The subject endoscopes are 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.
Indications for Use 5
- Endoscopes (OLYMPUS BF-Q190, OLYMPUS BF-H190, OLYMPUS BF-1TH190 EVIS EXERAM BRONCHOVIDEOSCOPE)
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.
- OLYMPUS CV-190 EVIS EXERAIII VIDEO SYSTEM CENTER
This video system center is intended to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
- OLYMPUS CLV-190 EVIS EXERAIII XENON LIGHT SOURCE
This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Comparison of Technological Characteristics હ
The CV-190 incorporates the following features that are different from the compared predicate device: (1) Provides high quality endoscopic image by using the subject device with new endoscopes and light sources, (2) Noise reduction, (3) Color correction, (4) Pre-freeze, (5) Brighter and more contrasted NBI observation, (6) Ethernet interface.
The CLV-190 incorporates the following features compared to the predicate device: (1) User friendly new connector, (2) Built-in type power fuse, (3) High-definition images, (4) IR absorbing filter removed.
The endoscopes contains the following features compared to the predicate device: (1) Light-guide
3
and electronic-contact Integrated connector (2) Insertion function (3) Wider angulation range (4) Improved image quality (as a result of a new CCD)
Summary of non-clinical testing . 7
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Reprocessing validation was carried out in accordance with "Labeling Reusable Medical Devices Reprocessing Vallaulton was camose of the FDA Reviewer Guidance - April 1996."
The software validation activities were performed in accordance with the FDA Guidance . for the Contained of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."
The following standards have been applied to the EVIS EXERA II VIDEO SYSTEM:
- · IEC 60601-1
- · IEC 60601-1-1
- · IEC 60601-2-18
- · IEC 60601-1-2
- · ISO 14971
- · ASTM E1837-96
- · ANSI/AAMI/ISO 11135-1
- · ISO 10993-1
- · ISO 10993-5
- · ISO 10993-10
8 Conclusion
When compared to the predicate device, the EVIS EXERA III VIDEO SYSTEM does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three wing-like shapes extending upwards and to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
January 10, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Laura Storms-Tyler Executive Vice President RA/QA Olympus America, Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Re: K121959
.
Trade Name: Evis Exera III Video System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ, NWB Dated: November 30, 2012 Received: December 3, 2012
Dear Ms. Storms-Tyler:
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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Ms. Laura Storms-Tyler
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eric A. Mann for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K121959 Device Name: EVIS EXERA III 190 SYSTEM
Indications For Use:
- Endoscopes (OLYMPUS BF-Q190, OLYMPUS BF-H190, OLYMPUS BF-1TH190 EVIS EXERA BRONCHOVIDEOSCOPE) Ш
This instrument is intended to be used with an Olympus video system center, light source, rinst instration equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and documentation Cquipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.
- OLYMPUS CV-190 EVIS EXERAIII VIDEO SYSTEM CENTER
This video system center is intended to be used with Olympus camera heads, endoscopes, light mis video bytion. endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
- OLYMPUS CLV-190 EVIS EXERATI XENON LIGHT SOURCE
This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Prescription Use . (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AS
(Division Sign-Off)
Division of Neurological and Physical
Medicine Devices
510(k) Number K121959
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