(47 days)
Not Found
No
The summary describes a standard gastrointestinal videoscope and its intended use and components. There is no mention of AI, ML, image processing beyond basic visualization, or any performance studies related to algorithmic analysis of images. The software validation is described as "Minor Level of Concern," which is typical for devices without complex analytical algorithms.
No
The device description indicates it is an instrument used for endoscopy and endoscopic surgery, and it can be used with "EndoTherapy accessories (such as a biopsy forceps)"; however, the device itself is a videoscope for visualization, not a device that directly provides therapy or treatment.
Yes
The device is a videoscope for examining the upper digestive tract, which involves observing and assessing the internal condition of organs for diagnostic purposes. It is explicitly indicated for use "within the upper digestive tract (including the esophagus, stomach, and duodenum)", suggesting its role in visualizing these areas to identify abnormalities.
No
The device description explicitly states it is a "GASTROINTESTINAL VIDEOSCOPE" and an "additional component of the EVIS EXERA III VIDEO SYSTEM," which are hardware components. The summary also mentions "design verifications tests" and "software validation activities," indicating both hardware and software are part of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use within the upper digestive tract for endoscopy and endoscopic surgery. This involves direct visualization and potentially intervention within the body.
- Device Description: The description reinforces its use as an endoscope for examining the upper digestive tract.
- Lack of IVD Characteristics: There is no mention of the device being used to examine samples outside of the body (in vitro) to diagnose conditions. IVD devices typically analyze biological samples like blood, urine, tissue, etc.
Therefore, the EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-XP190N is an in vivo diagnostic and therapeutic device, not an in vitro diagnostic device.
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.
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-XP190N is indicated for use transorally or transnasally within the upper digestive tract (including the esophagus, stomach, and duodenum).
Product codes (comma separated list FDA assigned to the subject device)
FDS, NWB
Device Description
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE, GIF-XP190N is an additional component of the EVIS EXERA III VIDEO SYSTEM.
The subject endoscope could be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment within the upper digestive tract.
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)
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.
The software validation activities were performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."
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
§ 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.
0
K123317
DEC 1 1 2012
510(k) SUMMARY
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N
October 24, 2012
General Information 1
- OLYMPUS MEDICAL SYSTEMS CORP. I Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047 l Official Correspondent: Sheri L. Musgnung · Regulatory Affairs & Quality Assurance 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 Aizu Olympus Co., Ltd. . Manufacturer: 500 Aza-Muranishi, Ooaza-lidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No .: 9610595
2 Device Identification
- 체 GASTROINTESTINAL VIDEOSCOPE Device Trade Name: ENIS EXERA 111 OLYMPUS GIF-XP190N
- Common Name: GASTROINTESTINAL VIDEOSCOPE
- 미 Regulation Number: 876.1500
- 트 Regulation Name: Endoscope and Accessories
- . Regulatory Class:
l
-
트 Classification Panel: Gastroenterology and urology
ll -
Product Code: FDS (gastroscope and accessories, flexible/rigid) NWB (endoscope, accessories, narrow band spectrum)
25
1
Predicate Device Information 3
| Subject Device
(Part of this submission) | Predicate Device | Predicate
Device
510(k) No. |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------|
| EVIS EXERA III GASTROINTESTINAL
VIDEOSCOPE
OLYMPUS GIF TYPE XP190N | EVIS EXERA II GASTROINTESTINAL
VIDEOSCOPE
OLYMPUS GIF TYPE XP180N | K100584 |
Device Description 4
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE, GIF-XP190N is an additional component of the EVIS EXERA III VIDEO SYSTEM.
The subject endoscope could be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment within the upper digestive tract.
5 Indications for Use
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N
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.
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-XP190N is indicated for use transorally or transnasally within the upper digestive tract (including the esophagus, stomach, and duodenum).
Comparison of Technological Characteristics 6
· The endoscope incorporates the following features compared to the predicate device: (1) A new Integrated scope connector that includes both the Light-quide and electronic-contact (video scope connection), (2) New nozzle, (3) Compatibility with High-Frequency Electrocautery.
7 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 for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."
2
The following standards have been applied to the EVIS EXERA III GASTOROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N of EVIS EXERA III VIDEO SYSTEM:
- · IEC 60601-2-18
- · IEC 60601-1-2
- י ISO 14971
8 Conclusion
When compared to the predicate device, the EVIS EXERA III GASTOROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N of 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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 11, 2012
OLYMPUS MEDICAL SYSTEMS CORPORATION % Ms. Sheri L. Musgnung Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway, P.O. Box 610 CENTER VALLEY PA 18034-0610
K123317 Re:
Trade/Device Name: GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDS, NWB Dated: November 27, 2012 Received: November 28, 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
Page 2 - Ms. Sheri L. Musgnung
You must comply with all the Act's requirements, including, but not limited to: registration and I va mast 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 medial as not requality systems (QS) regulation (21 CFR Part 820); and if applicable, the as set form in and 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 n you desire speeffice and 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 note the 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 -S
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): 4123319
Device Name: GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N Indications For Use:
GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N
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.
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-XP190N is indicated for use transorally or transnasally within the upper digestive tract (including the esophagus, stomach, and duodenum).
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Benjamin R. Fjisher -S 2012.12.11 14:50:23 -05'00'
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number
23