(88 days)
Not Found
No
The description focuses on standard image processing functions (noise reduction, color correction, pre-freeze) and does not mention any AI/ML specific terms or capabilities. The software validation level is moderate, which is less common for devices with complex AI/ML algorithms.
No
The description states the device is for "endoscopic diagnosis, treatment, and video observation," with functions like NBI observation, LED lamp examination, noise reduction, pre-freeze, and color correction. While it assists in procedures where treatment may occur, the device itself is a video system center that processes images and provides light, indicating an enabling or diagnostic role rather than directly applying therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "endoscopic diagnosis."
No
The device description explicitly states that the CV-170 integrates a video processor and a light source, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "for endoscopic diagnosis, treatment, and video observation." This involves direct visualization of internal body structures, not the examination of specimens in vitro (outside the body).
- Device Description: The description focuses on capturing and processing endoscopic images, emitting light for visualization, and displaying images on a monitor. These are functions related to in vivo (within the body) procedures.
- Lack of IVD-specific elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnostic purposes. This device's function is to aid in direct visual examination of the body's interior.
N/A
Intended Use / Indications for Use
This video system center is intended to be used with OLYMPUS video camera heads. endoscopes. monitors. converter. EndoTherapv accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
Product codes
NTN, NWB, FET
Device Description
The VIDEO SYSTEM CENTER OLYMPUS CV-170 is intended for endoscopic diagnosis, treatment and video observation.
The CV-170 is a device which integrates the video processor and the light source. Thus, the CV-170 itself could emit light, capture and process the endoscopic image, and transmit signal to display it on the monitor.
The main function of the CV-170 is NBI observation, LED lamp examination, Noise reduction function, Pre-freeze feature, and Color correction.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic image
Anatomical Site
Not Found
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
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.
The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a MODERATE Level of Concern.
The following standards have been applied to the CV-170:
- IEC 60601-1
- IEC 60601-1-1
- IEC 60601-2-18
- IEC 60601-1-2
- ISO 14971
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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K122831 Page 1 of 3
Image /page/0/Picture/1 description: The image shows the text "510(k) SUMMARY" in bold, black font. The text is centered and appears to be the title or heading of a document. The letters are capitalized and evenly spaced.
DEC 1 4 2012
CV-170 VIDEO SYSTEM CENTER
September 14, 2012
General Information 1.
Applicant:
1
Official Correspondent:
. Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
Sheri L. Musgnung Associate Manager, Regulatory Affairs Olympus America Inc. 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
SHIRAKAWA OLYMPUS CO., LTD. 3-1 Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No: 3002808148
II. Device Identification
- 1 Device Trade Name: CV-170 VIDEO SYSTEM CENTER
- . VIDEO SYSTEM CENTER Common Name:
- 1 Regulation Number: 876.1500
- . Regulation Name: Endoscope and Accessories
==============================================================================================================================================================================
- 0 Regulatory Class:
- Classification Panel: Gastroenterology and urology
Product Code:
1
NTN (led light source) NWB (endoscope, accessories, band narrow spectrum)
1
III. Predicate Device Information
| Model name | Applicant | 510(k) No. |
|---|---|---|
| OLYMPUS CV-190 VIDEO | ||
| SYSTEM CENTER | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K112680 | |
| OLYMPUS CLV-190 XENON | ||
| LIGHT SOURCE | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K112680 |
IV. Device Description
The VIDEO SYSTEM CENTER OLYMPUS CV-170 is intended for endoscopic diagnosis, treatment and video observation.
The CV-170 is a device which integrates the video processor and the light source. Thus, the CV-170 itself could emit light, capture and process the endoscopic image, and transmit signal to display it on the monitor.
The main function of the CV-170 is NBI observation, LED lamp examination, Noise reduction function, Pre-freeze feature, and Color correction.
V. Indications for Use
This video system center is intended to be used with OLYMPUS video camera heads. endoscopes. monitors. converter. EndoTherapv accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
VI. Comparison of Technological Characteristics
The main difference of the subject device compared to the predicate devices is the examination lamp type. Unlike the predicate device, CLV-190 XENON LIGHT SOURCE, the subject device utilize LED as the examination lamp.
VII. Summary of non-clinical testing
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.
The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for
2
Software Contained in Medical Devices." The device software is considered a MODERATE Level of Concern.
The following standards have been applied to the CV-170:
- · IEC 60601-1
- · IEC 60601-1-1
- · IEC 60601-2-18
- · IEC 60601-1-2
- · ISO 14971
VIII. Conclusion
When compared to the predicate device, the CV-170 VIDEO SYSTEM CENTER does not incorporate any significant changes in intended use, method of operation, or design that could affect the safety or effectiveness of the device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2012
OL YMPUS MEDICAL SYSTEMS CORP. % Ms. Sheri L. Musgnung Associate Manager, Regulatory Affairs Olympus America, Inc. 3500 Corporate Parkway, P.O. Box 610 CENTER VALLEY PA 18034-0610
Re: K122831
Trade/Device Name: CV-170 VIDEO SYSTEM CENTER Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NTN, NWB, FET Dated: September 14, 2012 Received: September 17, 2012
Dear Ms. 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. 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.
4
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 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" (21 CFR 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,
Herbert R. Lerner
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
. 510(k) Number (if known):
Device Name: CV-170 VIDEO SYSTEM CENTER
Indications For Use:
This video system center is intended to be used with OLYMPUS video converter, camera heads, endoscopes, monitors, EndoTherapy accessories, 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)
Page 1 of
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert R. Lerner
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K122831
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