(91 days)
No
The description focuses on standard imaging and processing techniques (CCD, color filtering, ultrasound transducer) and does not mention any AI/ML algorithms or capabilities.
Yes
The device's intended use explicitly states "therapeutic access to, the Upper GI tract." Additionally, the description mentions a "working channel through which biopsy devices, or other devices, may be introduced," and specifies that the instrument is "supplied with two biopsy forceps," indicating a direct therapeutic capability beyond just visualization.
Yes
The device provides "ultrasonic and optical visualization of... the Upper GI tract," which is a diagnostic function to help understand the condition of the internal organs. The inclusion of "Image data and other screen display information are formatted and presented to the video outputs of the Video Processor for display" and "The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and signals are passed to the Ultrasound Scanner for display" further supports its role in gathering visual and ultrasonic diagnostic information.
No
The device description clearly outlines multiple hardware components including a flexible insertion tube, control body, connectors, light carrying bundles, a CCD, a radial array ultrasound transducer, and a working channel. While it mentions software-controlled components (Video Processor and Ultrasound Scanner), the device itself is a physical instrument with significant hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Ultrasound Video Gastroscope EG-3630UR is used to directly visualize and access the Upper GI tract within the patient's body. It uses optical and ultrasonic imaging modalities to provide real-time information during a procedure.
- Lack of Specimen Testing: The description does not mention the collection or analysis of any specimens from the patient. While it has a working channel for introducing biopsy devices, the device itself is not performing the diagnostic testing on the biopsy sample. The biopsy sample would be sent to a laboratory for in vitro analysis.
Therefore, the EG-3630UR is an in vivo diagnostic and therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EG-3630UR, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.
Product codes
74JOP, 78KOG
Device Description
The EG-3630UR, Ultrasound Video Gastroscope, must be used with a Pentax Video Processor (software controlled device) and must be used with Ultrasound Scanner (software controlled device). The endoscope has a Flexible Insertion Tube, a Control Body, PVE Umbilical Connector, and Scanner Umbilical Connector. The PVE Connector connects to the Video Processor and has connections for illumination, video signals, air/water and suction. The Scanner Connected at the Ultrasound Scanner. The Control Body includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, balloon insufflation, and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect image data, and a radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). The Video Processor contains a lamp that provides white light that is filtered, via a Red, Green, and Blue color filter wheel, and is focused at the PVE Connector Lightguide Prong. The endoscope light carrying bundles present the color strobes to the body cavity and the CCD collects image data for each strobe of color. The Video Processor stores the CCD information until all three color strobes are completed and a full color image frame is compiled. Image data and other screen display information are formatted and presented to the video outputs of the Video Processor for display. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and signals are passed to the Ultrasound Scanner for display. The instrument is immersable (with the use of supplied cleaning accessories) except for the Ultrasound Scanner Connector (as described in the Endoscope operator Manual cleaning instructions).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical, Ultrasound
Anatomical Site
Upper Gastrointestinal Tract (Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas)
Indicated Patient Age Range
Adult and pediatric patient populations.
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 submission for substantial equivalence was not based on an assessment of clipical performance data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K961974, K961564, K934918, K981434, K994026
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.
0
KD13640
510(k )Summary EG-3630UR. Ultrasound Video Gastroscope for use with EUB-525 and EUB-6000 Ultrasound Diagnostic Scanner
Submitter Information:
Pentax Precision Instrument Corporation (PPIC) 30 Ramland Road Orangeburg, NY, 10962 Tel: (845)-365-0700
FEB 0 4 2002
Name of Device:
| Trade Name: | EG-3630UR, Ultrasound Video Gastroscope |
|---|---|
| Classification Name: | Diagnostic Ultrasound Transducer (74JOP) {892.1570}, |
| Endoscope and Accessories (78KOG) {876.1500} |
Predicated Device(s) Information:
| Model, Description | Manufacturer | PMN# |
|---|---|---|
| FG-36UX, Fiber Ultrasound Gastroscope | PPIC | K961974 |
| EG-2940, Video Gastroscope | PPIC | K961564 |
| EPM-3300, Video Processor | PPIC | K934918 |
| EUB-525, Ultrasound Diagnostic Scanner | Hitachi America | K981434 |
| EUB-6000, Ultrasound Diagnostic Scanner | Hitachi America | K994026 |
The EG-3630UR, Ultrasound Video Gastroscope, must be used with a Pentax Video Device Description: Processor (software controlled device) and must be used with Ultrasound Scanner (software controlled device). The endoscope has a Flexible Insertion Tube, a Control Body, PVE Umbilical Connector, and Scanner Umbilical Connector. The PVE Connector connects to the Video Processor and has connections for illumination, video signals, air/water and suction. The Scanner Connected at the Ultrasound Scanner. The Control Body includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, balloon insufflation, and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect image data, and a radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). The Video Processor contains a lamp that provides white light that is filtered, via a Red, Green, and Blue color filter wheel, and is focused at the PVE Connector Lightguide Prong. The endoscope light carrying bundles present the color strobes to the body cavity and the CCD collects image data for each strobe of color. The Video Processor stores the CCD information until all three color strobes are completed and a full color image frame is compiled. Image data and other screen display information are formatted and presented to the video outputs of the Video Processor for display. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and signals are passed to the Ultrasound Scanner for display. The instrument is immersable (with the use of supplied cleaning accessories) except for the Ultrasound Scanner Connector (as described in the Endoscope operator Manual cleaning instructions).
Intended Use: The EG-3630UR, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.
Comparison To Predicated Device(s):
The submission for substantial equivalence included EG-3630UR literature including specifications, the identification of standard set components, and identification of optional accessories, comparison tables were novided to illustrate the comparisons to the predicated devices in summary. The submission for substantial equivalence was not based on an assessment of clipical performance data.
Prepared by: Paul Silva
Signature: Paul Silva
Date: 11-01-01
Control Number: PS-726
Revision. a
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 4 2002
Mr. Paul Silva Regulatory Affairs Coordinator PENTAX Precision Instrument Corp. 30 Ramland Road ORANGEBURG NY 10962-2699
Re: K013640 Trade/Device Name: Ultrasound Video Gastroscope EG-3630UR Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Procode: 76 FDS Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasound transducer Procode: 90 ITX Dated: November 1, 2001 Received: November 5, 2001
Dear Mr. Silva:
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 (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); 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.
2
This letter will allow you to begin marketing your device as described in your 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
3
| Page | of |
|---|---|
| __________ | __________ |
510(k) Number (if known): K013640
Device Name: Ultrasound Video Gastroscope EG-3630UR
Indications For Use: The Ultrasound Video Gastroscope EG-3630UR is intended to provide ultrasonic and optical visualization of, and therapeutic access to, the Upper GI tract including esophagus, stomach, duodenum/small bowel in adult and pediatric patient populations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segerson
(Optional Format 3-10-98)
Prescription Use