(272 days)
Not Found
No
The summary describes a standard endoscopic video system and scopes with updated technology (LED lighting, waterproof connector) but makes no mention of AI or ML capabilities, image processing beyond basic video display, or any performance metrics typically associated with AI/ML algorithms.
Yes
The device is intended for "endoscopic diagnosis, treatment, and video observation," indicating its use in therapeutic procedures. This is further supported by the mention of "EndoTherapy accessories (such as a biopsy forceps)" for endoscopic surgery.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the system is intended for "endoscopic diagnosis" within the upper and lower digestive tracts.
No
The device description clearly outlines multiple hardware components including video system centers, gastrointestinal videoscopes, and colonovideoscopes. The submission also includes performance studies related to the mechanical and functional performance of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "endoscopic diagnosis, treatment, and video observation" within the upper and lower digestive tract. This involves directly visualizing internal body structures.
- Device Description: The description details a video system center and endoscopes (gastroscopes and colonoscopes) used for internal examination.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is an endoscopic system used for direct visualization and intervention within the body, which falls under the category of medical devices used for diagnosis and treatment in vivo.
N/A
Intended Use / Indications for Use
VIDEO SYSTEM CENTER OLYMPUS CV-V1
This video system center is intend to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
The indications include the applicability of endoscopy and endoscopic treatment.
GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-LV1
This instrument is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery and is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
COLONOVIDEOSCOPE OLYMPUS CF-LV1L and CF-LV1L
This instrument is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery and is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, and ileocecal valve).
Product codes
FDF, FDS
Device Description
The primary components of the V1 SYSTEM consists of two Olympus colonovideoscopes; CF-LV1L and CF-LV11 (which are identical except for their working) lengths, an Olympus gastrointestinal videoscope; GIF-LV1 and a video system center. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract. The V1 SYSTEM is designed to be used with specified monitors, EndoTherapy accessories and other ancillary equipment.
The primary components of the subject system, which are part of this submission, are: VIDEO SYSTEM CENTER OLYMPUS CV-V1 GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-LV1 COLONOVIDEOSCOPE OLYMPUS CF-LV1L COLONOVIDEOSCOPE OLYMPUS CF-LV11
CV-V1
CV-V1 can be used with Olympus endoscope models, such as gastorointestinal videoscope GIF-LV1 and colonovideoscope CF-LV1L/I. The subject premarket notification is specific for gastrointestinal videoscopes and colonovideoscopes.
GIF-LV1, CF-LV1L/I
The GIF-LV1, CF-LV1L/I can be used with VIDEO SYSTEM CENTER OLYMPUS CV-V1. The light source and the LG bundle are not used, instead, there are LEDs in the distal end of the scope that runs by electric power from the CV-V1 and light up the distal end. The newly designed one-touch connector is water proof.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper digestive tract (including the esophagus, stomach, and duodenum), lower digestive tract (including the anus, rectum, sigmoid colon, and ileocecal valve).
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 non-clinical test and usability studies were performed.
Basic safety and performance testing was performed in accordance with IEC 60601-1, 60601-1-1, 60601-1-2. 60601-2-18. In addition, verification and comparison studies were conducted to evaluate the mechanical and functional performance. Specially, test results in the following areas were provided. Biocompatibility
Intracutaneous Reactivity Test.doc Cytotoxicity Study.doc Skin Sensitization Test.doc
The newly lighting method has been confirmed that the safety and effectiveness are equivalent i compare with the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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MAR 2 0 2012
510(k) SUMMARY
V1 SYSTEM
1 General Information
■ Applicant:
I Official Correspondent:
● Manufacturer:
Device Identification 2
- Device Trade Name:
- 의 Common Name:
트 Regulation Number:
■ Regulation Name:
■ Regulatory Class:
Classification Panel: ●
Product Code: ■
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 FAX: 484-896-7128 Email: stacy.kluesner@olympus.com
OLYMPUS MEDICAL SYSTEMS CORP. 34-3 Hirai, Hinode-machi, Nishitama-gun, Tokyo, JAPAN 190-0182 Establishment Registration Number: 3003637092
V1 SYSTEM
Endoscopic Video Imaging System
21 CFR 876.1500
Endoscope and accessories
ll
Gastroenterology and urology
FDF, FDS
1
K111756
-2
3 Predicate Device Information
| Subject Device
(Part of this Submission) | Predicate Device | PD's
510(k)
No. |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------|
| VIDEO SYSTEM CENTER OLYMPUS | EVIS EXERA II XENON LIGHT
SOURCE OLYMPUS CLV-180 | K100584 |
| CV-V1 | EVIS EXERA II VIDEO SYSTEM
CENTER OLYMPUS CV-180 | K100584 |
| GASTROINTESTINAL VIDEOSCOPE
OLYMPUS GIF-LV1 (Hereinafter referred | EVIS EXERA II GASTROINTESTINAL
VIDEOSCOPE OLYMPUS GIF TYPE
Q180 | K100584 |
| COLONOVIDEOSCOPE OLYMPUS
CF- LV1L (Working Length: 1680mm)
and
CF-LV1I (Working Length: 1330mm) | EVIS EXERA II
COLONOVIDEOSCOPE
OLYMPUS CF TYPE Q180AL | K100584 |
4 Device Description
V1 SYSTEM
The primary components of the V1 SYSTEM consists of two Olympus colonovideoscopes; CF-LV1L and CF-LV11 (which are identical except for their working) lengths, an Olympus gastrointestinal videoscope; GIF-LV1 and a video system center. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract. The V1 SYSTEM is designed to be used with specified monitors, EndoTherapy accessories and other ancillary equipment.
The primary components of the subject system, which are part of this submission, are: VIDEO SYSTEM CENTER OLYMPUS CV-V1 GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-LV1 COLONOVIDEOSCOPE OLYMPUS CF-LV1L COLONOVIDEOSCOPE OLYMPUS CF-LV11
CV-V1
CV-V1 can be used with Olympus endoscope models, such as gastorointestinal videoscope GIF-LV1 and colonovideoscope CF-LV1L/I. The subject premarket notification is specific for gastrointestinal videoscopes and colonovideoscopes.
GIF-LV1, CF-LV1L/I
The GIF-LV1, CF-LV1L/I can be used with VIDEO SYSTEM CENTER OLYMPUS CV-V1. The light source and the LG bundle are not used, instead, there are LEDs in the distal end of the scope that runs by electric power from the CV-V1 and light up the distal end. The newly designed one-touch connector is water proof.
2
5 Indications for Use
VIDEO SYSTEM CENTER OLYMPUS CV-V1
This video system center is intend to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
The indications include the applicability of endoscopy and endoscopic treatment.
GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-LV1
This instrument is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery and is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
COLONOVIDEOSCOPE OLYMPUS CF-LV1L and CF-LV1L
This instrument is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery and is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, and ileocecal valve).
6 Comparison of Technological Characteristics
· The V1 SYSTEM is basically identical to the predicate device in intended use, and similar in specifications.
Video System Center:
When compared to the predicate device, the subject device has the similar technological features such as the video signal output, automatic gain control/ iris mode function and air feeding pump. There are differences in the input current and compatible endoscopes, however, these differences are considered as minor.
Endoscope:
When compared to the predicate device, the subject device has the similar technological features such as the depth of field, direction of forward view, bending section and inner diameter of instrument channel. There are differences in the field of view, lighting method and outer of distal end/ insertion tube, however, these differences are considered as minor. The following non-clinical test and usability studies were performed.
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7 Substantially Equivalent Discussion
The subject device, V1 SYSTEM, is a modification to LED lightning system. The indications for use, principles of operation and fundamental technology of the V1 SYSTEM are similar to the predicate devices.
The maior difference from the predicate devices is lighting method as follow:
- The subject device is provided LED in the endoscopes and the Video Processor is able to supply ー power for the LED.
- The predicate device (K100584) has the light guide cable in endoscopes and the light source is able to supply light.
The newly lighting method has been confirmed that the safety and effectiveness are equivalent i compare with the predicate devices.
The CV-V1 and the GIF-LV1 and CF-LV1L/I are similar in method of operation and design as the predicate devices. In addition, similar or identical materials are used and biocompatibility results were provided.
Summary of Non-Clinical Testing 8
The following non-clinical test and usability studies were performed.
Basic safety and performance testing was performed in accordance with IEC 60601-1, 60601-1-1, 60601-1-2. 60601-2-18. In addition, verification and comparison studies were conducted to evaluate the mechanical and functional performance. Specially, test results in the following areas were provided. Biocompatibility
Intracutaneous Reactivity Test.doc Cytotoxicity Study.doc Skin Sensitization Test.doc
The following standards were used during the design and validation of the subject devices.
-
IEC 60601-1: 1988, A1: 1991, A2: 1995 2) IEC 60601-1-1: 2000, 3) IEC 60601-1-2: 2007 4) IEC 60601-2-18: 1996, A1: 2000
-
ISO 14971: 2007
-
- ASTM E1837-96: 2007
-
ANSI/AAMI/ISO 11135-1: 2007
-
ISO 10993-1: 2009
-
ISO 10993-5: 2009
-
ISO 10993-10: 2002
-
ISO 10993-11: 2006
The risk analysis was carried out I 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 their risk analysis assessment.
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9 Conclusion
.
When compared to the predicate device, the V1 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.
、
:
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OLYMPUS MEDICAL SYSTEMS CORP. % Ms. Stacy Abbatiello Kluesner, M.S., RAC Project Manager Olympus America Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034
MAR 2 0 2012
Re: K111756
Trade/Device Name: V1 SYSTEM Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: February 24, 2012 Received: February 27, 2012
Dear Ms. Kluesner:
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
6
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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" (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,
Benjamin R. Fisher, Ph.D.
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
7
Indications for Use
510(k) Number (if known):
Device Name: V1 SYSTEM
Indications For Use:
VIDEO SYSTEM CENTER CV-V1
This video system center is intend to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-LV1
This instrument is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery and is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
COLONOVIDEOSCOPE OLYMPUS CF-LV1L and CF-LV11
This instrument is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery and is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
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)
Heidi Leum
Page 1 of 1
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number L11756