(326 days)
No
The document describes a standard endoscopic system with a balloon control unit and splinting tube to facilitate insertion. There is no mention of AI, ML, or any advanced image analysis beyond standard NBI observation.
No.
The device is indicated for "endoscopic diagnosis and endoscopic surgery" and "endoscopy and endoscopic surgery," which are diagnostic and interventional procedures, not therapeutic ones. While it mentions "endo-therapy accessories," the primary function described for the system itself is related to visualization and surgical access, not direct therapy.
Yes
The "Intended Use / Indications for Use" section states: "for endoscopic diagnosis and endoscopic surgery within the upper and lower digestive tract". The mention of "endoscopic diagnosis" directly indicates a diagnostic purpose.
No
The device description explicitly states the system is composed of hardware components: Small Intestinal Videoscope, Single Use Splinting Tube, and Balloon Control Unit and its accessories.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The primary purpose of this system is for endoscopic diagnosis and endoscopic surgery within the digestive tract. This involves directly visualizing the internal anatomy and performing procedures.
- Device Description: The description focuses on the components of an endoscope system (videoscope, splinting tube, balloon control unit) used for endoscopy and endoscopic surgery.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device operates in vivo (inside the body) for direct visualization and intervention.
The device is clearly an endoscopic system used for direct examination and treatment within the body, not for testing biological samples in a laboratory setting.
N/A
Intended Use / Indications for Use
SMALL INTESTINAL VIDEOSCOPE SYSTEM
This system is composed of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with an Olympus video system center, light source, balloon control unit, splinting tube, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral or anal insertion.
Indications for Use of the components are as follows:
SIF-Q180 (SMALL INTESTINAL VIDEOSCOPE)
This instrument has been designed to be used with an Olympus video system center, light source, single use splinting tube, balloon control unit, documentation equipment, video monitor, endotherapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract (including the esophagus, stomach, duodenum, colon, and small intestine) by either oral and anal insertion.
OBCU (BALLOON CONTROL UNIT)
This balloon control unit has been designed for inflating and deflating the balloon attached to the distal end of a single use splinting tube in order to assist the insertion of an Olympus -designated small intestinal endoscope.
Product codes
FDA, KNT & NWB
Device Description
The subject device, Small Intestinal Videoscope system, is designed for endoscopy and endoscopic surgery within the small intestine. This system is composed of Small Intestinal Videoscope, Single Use Splinting Tube, and Balloon Control Unit and its accessories. The subject system is compatible with NBI observation which utilizes narrow-band spectrum to enhance contrast of the surface structure and fine capillary patterns of the mucous membranes. Also, the subject system utilizes a balloon attached to the splinting tube to facilitate advancement of the endoscope well within the small intestine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small Intestine, esophagus, stomach, duodenum, colon, upper and lower digestive tract
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
K07/254
510(k) SUMMARY
SMALL INTESTINAL VIDEOSCOPE SYSTEM
MAR 2 5 2008
1. General Information
- Applicant 1
- 클 Official Correspondent:
. Manufacturer Small intestinal videoscope:
Splinting tube:
Balloon control unit:
2. Device Identification
- 1 Trade Name:
- 배송 Common Name:
- Regulation Number: 1
- 1 Regulation Name:
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No.: 8010047
Laura Storms-Tyler Executive Director Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 Phone: 484-896-5688 FAX: 484-896-7128 Email:Laura.storms-tyler@olympus.com Establishment Registration No .: 2429304
Aizu Olympus Co., Ltd. 500 Aza Muranishi Ooaza, Niidera, Monden-machi, Aizuwakamatsu-shi, Fukushima, Japan, 965-8502 Establishment Registration No .: 9610595
OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant 34-3 Hirai Hinode-machi, Nishitama-gun, Tokyo, Japan 190-0182 Establishment Registration No .: 3003637092
Shirakawa Olympus Co., Ltd. 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No.: 3002808148
SMALL INTESTINAL VIDEOSCOPE SYSTEM
Small Intestinal Videoscope
I
21CFR 876.1500 / 876.5980 Endoscope and accessories / Gastrointestinal tube and accessories
1
TO/1254
Pg. 2 of 3
- Regulatory Class: 트
- Product Code: 월 FDA, KNT & NWB
II
3. Predicate Device Information
| Model | 510(k) # | Manufacturer | Class | Product Code |
|---|---|---|---|---|
| Small Intestinal Videoscope System | K051551 | Olympus Medical Systems Corp. | II | FDA & KNT |
4. Device Description
The subject device, Small Intestinal Videoscope system, is designed for endoscopy and endoscopic surgery within the small intestine. This system is composed of Small Intestinal Videoscope, Single Use Splinting Tube, and Balloon Control Unit and its accessories. The subject system is compatible with NBI observation which utilizes narrow-band spectrum to enhance contrast of the surface structure and fine capillary patterns of the mucous membranes. Also, the subject system utilizes a balloon attached to the splinting tube to facilitate advancement of the endoscope well within the small intestine.
5. Indications for Use
SMALL INTESTINAL VIDEOSCOPE SYSTEM
This system is composed of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with an Olympus video system center, light source, balloon control unit, splinting tube, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral or anal insertion.
Indications for Use of the components are as follows:
SIF-Q180 (SMALL INTESTINAL VIDEOSCOPE)
This instrument has been designed to be used with an Olympus video system center, light source, single use splinting tube, balloon control unit, documentation equipment, video monitor, endotherapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract (including the esophagus, stomach, duodenum, colon, and small intestine) by either oral and anal insertion.
2
KO 71254
Ro 3665
OBCU (BALLOON CONTROL UNIT)
This balloon control unit has been designed for inflating and deflating the balloon attached to the distal end of a single use splinting tube in order to assist the insertion of an Olympus -designated small intestinal endoscope.
6. Comparison of Technological Characteristics
The subject system is basically identical to the predicate double-balloon system in intended use, and similar in specifications except for eliminating the balloon attached to the distal end of the small intestinal videoscope and addition of NBI function. The NBI observation function is identical to that of the EVIS EXERA 160A System which has been 510(k) cleared under K051645 for the use within the gastrointestinal tract.
7. Conclusion
When compared to the predicate devices, the SMALL INTESTINAL VIDEOSCOPE SYSTEM does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety and effectiveness.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Olympus Medical Systems Corporation % Ms. Laura Storms-Tyler Vice President Regulatory Affairs & Quality Assurance Olympus America, Incorporated 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610
MAR 2 5 2008
Re: K071254
Trade/Device Name: Small Intestinal Videoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDA, FED, NWB and OCS Dated: February 21, 2008 Received: February 22, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/10 description: The image is a circular seal with the text "ISO6-2006" at the top. The letters "FDA" are in the center of the seal in a bold, sans-serif font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are at the bottom of the seal.
Protecting and Promoting Public Health.
4
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally. marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K07/254
Indications for Use
510(k) Number (if known): Kd7/254
Device Name: SMALL INTESTINAL VIDEOSCOPE SYSTEM
Indications For Use:
SMALL INTESTINAL VIDEOSCOPE SYSTEM
This system is composed of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with an Olympus video system center, light source, balloon control unit, splinting tube, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopic diagnosis and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral anal insertion.
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)
Huls Lenn
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number
Page 1 of __ 2
6
Ko71254
Indications for Use
510(k) Number (if known):