(80 days)
No
The summary does not mention AI, ML, or any related concepts. The device description and intended use focus on standard endoscopic ultrasound imaging technology.
No
The device is described as being used for "endoscopic ultrasound imaging" and does not mention any therapeutic function.
Yes
The device is used for "endoscopic ultrasound imaging" of various internal organs, which is a method of obtaining images to provide information for diagnosis.
No
The device description explicitly states it is a "Gastrovideoscope" and mentions associated hardware like an "Endoscopic Ultrasound Center," "EVIS Video System Center," "light source," and "video monitor," indicating it is a hardware device with software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for "endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs." This is a diagnostic imaging procedure performed in vivo (within the living body).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The Olympus GF-UM130 Ultrasound Gastroscope is a medical device used for direct visualization and ultrasound imaging inside the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
Olympus GF-UM130 Ultrasound Gastroscope has been designed to be used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.
Product codes
78 FDS, 90 IYO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.
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)
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
Image /page/0/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird in flight, but upon closer inspection, it is composed of three human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 1997
Re: K971660 .. . . . . . . . . . . .
- Olympus GF-UM130 Ultrasound Gastrovideoscope, its associated accessories and ancillary equipment Dated: May 2, 1997 Received: May 6, 1997 Regulatory Class: II 21 CFR 876.1500/Procode: 78 FDS 21 CFR 892.1560/Procode: 90 IYO
Subhash R. Patel Regulatory Affairs Associate Endoscope Division OLYMPUS AMERICA, INC. Two Corporate Center Drive Melville, New York 11747-3157
Dear Mr. Patel:
We have reviewed your section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, 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 vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement , as set forth in the Ouality System Regulation (OS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that. through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This determination of substantial equivalence is granicd on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information. including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's February 17, 1993 "Revised 510(k) Diagnostic Uitrasound Guidance for 1993." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
1
Page 2 - Mr. Subhash Patel
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard ... _ ... ... ... ... ... ... .... ... Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Mary Joan Cornelius at (301) 594-2194.
Sincerely yours,
Robert R. Satting/
s
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
2
510 (k) SUMMARY OLYMPUS GF-UM 130 ULTRASOUND GASTROVIDEOSCOPE
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92.
| Device Name: | Olympus GF-UM130 Ultrasound Gastrovideoscope |
|---|---|
| Common/Usual Name: | Ultrasound Gastroscope |
| Classification Name: | Class II, 21 CFR 876.1500 |
| Endoscope and Accessories. | |
| Class II, 21 CFR 892-1560 | |
| Ultrasonic Pulsed Echo Imaging System | |
| Predicate Devices: | Olympus GF-UM20 Ultrasound Gastroscope (K926514) |
| Olympus GIF Type 140 Series Gastrovideoscopes (K954451) | |
| Prepared & Submitted By: | |
| (Contact Person) | Mr. Subhash Patel |
| Olympus America Inc. | |
| Endoscope Division | |
| Two Corporate Center Drive | |
| Melville, New York 11747-3157 | |
| (516) 844-5481 | |
| Summary Preparation Date: | 05/02/97 |
Statement of Intended Use:
Olympus GF-UM130 Ultrasound Gastroscope has been designed to be used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.
3
K 971660
Indications for Use Statement
510(k) Number (if known):
Device Name:.
Not assigned yet
Olympus GF-UM130 Ultrasound Gastrovideoscope, its . . . associated accessories and ancillary equipment.
Indications for Use:
Olympus GF-UM130 Ultrasound Gastroscope has been designed to be used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (per 21CFR 801.109) | |
|---|---|
| -------------------------------------- | ------------- |
OR
| Over-the Counter Use (Optional Format 1-2-96) | |
|---|---|
| ----------------------------------------------- | ------------- |
| (Division Sign-Off) | Duler R Sathy/ |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K971660 |