(16 days)
Not Found
No
The summary describes standard image processing and ultrasound technology without mentioning any AI/ML components or capabilities.
Yes
The Intended Use / Indications for Use section states that the device is intended to provide "therapeutic access to, the Upper Gastrointestinal Tract."
Yes
The device provides optical and ultrasonic visualization of the Upper Gastrointestinal Tract, allowing for the observation of indications for procedures. It collects image data and ultrasonic image data, which are displayed for observation and assessment. Furthermore, one of its predicate devices is explicitly named an "Ultrasound Diagnostic Scanner". This combination of visualization, data collection for assessment, and direct connection to a diagnostic predicate device indicates its role in diagnosis.
No
The device description clearly outlines physical hardware components such as a flexible insertion tube, control body, connectors, light carrying bundles, a CCD, and an ultrasound transducer. While it interacts with software-controlled devices (Video Processor and Ultrasound Scanner), the device itself is a physical instrument with hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The EG-3670URK, Ultrasound Video Gastroscope, is a device used for direct visualization (optical and ultrasonic) and therapeutic access within the Upper Gastrointestinal Tract. It is introduced directly into the body.
- Lack of Sample Analysis: The description does not mention the device analyzing any samples taken from the patient's body. It is used for imaging and intervention in situ.
Therefore, the device's function and intended use fall outside the scope of an in vitro diagnostic. It is an endoscopic device used for direct examination and treatment within the body.
N/A
Intended Use / Indications for Use
The EG-3670URK, 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, 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 (comma separated list FDA assigned to the subject device)
KOG, ITX
Device Description
The EG-3670URK, 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 Connector is connected at the Ultrasound Scanner. The Control Body includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, balloon injection/ evacuation, 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, may be introduced. The Video Processor contains a lamp that provides white light that is focused at the PVE Connector Lightguide Prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects image data. 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 as described in the Endoscope operator Manual cleaning instructions).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, Optical
Anatomical Site
Upper Gastrointestinal Tract Includes, but is not restricted to: 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 clinical, performance, data.
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
KD61068
510(k) Summary EG-3670URK, Ultrasound Video Gastroscope for use with EUB-5500 Ultrasound Diagnostic Scanners
| Submitter Information: | Pentax Medical Company
102 Chestnut Ridge Road | MAY | 3 2006 |
|------------------------|---------------------------------------------------|-----|--------|
| | Montvale, NJ 07645-1856
Tel: 800-431-5880 | | |
Name of Device:
| Trade Name: | EG-3670URK, Ultrasound Video Gastroscope |
|---|---|
| Classification Name: | Diagnostic Ultrasound Transducer (90ITX) (892.1570), |
| Endoscope and Accessories (78KOG) (876.1500) |
Predicated Device(s) Information:
| Model, Description | Manufacturer | PMN# |
|---|---|---|
| EG-3630UR, Video Ultrasound Gastroscope | Pentax Corporation | K041395 |
| EUB-5500, Ultrasound Diagnostic Scanner | Hitachi America | K032503 |
The EG-3670URK, 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 Connector is connected at the Ultrasound Scanner. The Control Body includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, balloon injection/ evacuation, 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, may be introduced. The Video Processor contains a lamp that provides white light that is focused at the PVE Connector Lightguide Prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects image data. 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 as described in the Endoscope operator Manual cleaning instructions).
Intended Use: The EG-3670URK, 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, 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-3670URK literature including specifications, the identification of standard set components, and identification of optional accessories, comparison tables were provided to illustrate the comparisons to the predicated devices in summary. The submission for substantial equivalence was not based on an assessment of clinical, performance, data.
Signature: Paul Silie
Date: 2-6-2006
Control Number: EG-3670URK.EUB-5500
Prepared by: Paul Silva
page I of 1
Revision: a
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pentax Medical Company % Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America, Inc. 12 Commerce Road NEWTOWN CT 06470
Re: K061068
Trade Name: EG-3670URK Ultrasound Video Gastroscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: KOG and ITX Dated: Apri 13, 2006 Received: April 17, 2006
Dear Mr. Borsai:
We have reviewed your Section 510(k) premarket 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 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). 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.
3 2006
MAY
This determination of substantial equivalence applies to the EG-3670URK Ultrasound Video Gastroscope with the EUB-5500 Ultrasound Scanner.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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.
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
Image /page/1/Picture/12 description: The image is a circular logo with the letters "FDA" in the center. Above the letters, the numbers "120" and "XXX" are displayed. Below the letters, the word "Centennial" is written in a cursive font. The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
2
Page 2 - Mr. Borsai
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 determination of substantial equivalence is granted 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 September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special reror 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.
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 results 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Andrew Kang at (301) 594-1212.
Sincerely vours.
David h. Ingram
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
510(k) Number (if known): Device Name:
EG-3670URK, Ultrasound Video Gastroscope
Endoscope Intended Use Statement
The EG-3670URK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic I is a sualization of, and therapeutic access to, the Upper Gastrointestinal Track includes but is not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small mendes but is not roursed to the organism is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Diagnostic Ultrasound Indications For Use Statement
EUB-2200 System: EG-3670URK Probe:
I 1000.
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| General | |||||||
| (Track I only) | Specific | ||||||
| (Track I & III) | B | M | PWD | CWD | Color | ||
| Doppler | Amplitude | ||||||
| Doppler | |||||||
| Ophthalmic | |||||||
| Fetal Imaging | |||||||
| and other | Fetal | ||||||
| Abdominal | |||||||
| Intra-operative (Spec.) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laproscopic | |||||||
| Pediatric | |||||||
| Small Organ | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vagina | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convert.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Endoscopy | N | N | N | N | N | ||
| Cardiac | Cardiac Adult | ||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral | |||||||
| Vessel | Peripheral vessel | ||||||
| Other (Spec.) |
P = previously cleared by FDA; E = added under Appendix E N = new application;
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Timt A. Layson
(Division Sign-Off)
Division of Seproductive, Abdominal,
and Panological Devices
510(k) Number K061068
Prescription Use (Per 21 CFR 801.109)