(112 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard imaging and processing technologies.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "therapeutic access to" the Upper Gastrointestinal Tract. The "Device Description" also mentions a "working channel through which biopsy devices, or other devices, may be introduced," further supporting its therapeutic function beyond just diagnostic imaging.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy". Furthermore, the device description details how it collects both optical and ultrasonic image data for display, which are used for visualization.
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 medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The EG-3670URK, Ultrasound Video Gastroscope, is an in vivo device. It is introduced directly into the patient's body (per orally) to provide optical and ultrasonic visualization of the Upper Gastrointestinal Tract. It also provides therapeutic access.
- Lack of Specimen Analysis: The device does not analyze specimens (like blood, tissue, or urine) outside of the body. It directly visualizes and images the internal anatomy.
While the device is used for diagnostic purposes (imaging to help diagnose conditions), the method of diagnosis is through direct visualization and ultrasound imaging within the body, not through the analysis of samples in a laboratory setting.
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 Track including but 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 procedure are observed in adult and pediatric patient populations.
Product codes
ODG, ITX
Device Description
The EG-3670URK, Ultrasound Video Gastroscope, must be used with a Pentax Video processor (a software controlled device) and must be used with an Ultrasound Scanner (a software controlled device). The endoscope has a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water/ and suction. The ultrasound umbilical connector will be attached to the ultrasound scanner unit. The control body includes controls for up/ down/ left/ right angulation, air/ water delivery, suction selection control, balloon insufflation/ evacuation, and an accessory inlet port. The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect endoscopic 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 video processor contains a lamp that light and is focused at the PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic 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 the signals are passed to the ultrasound scanner for processing and 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
Ultrasound, Optical
Anatomical Site
Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: 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 is not based on an assessment of clinical perfermance data.
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
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
510(k) Summary
K 090196
Submitter Information:
Pentax Medical Company, A Division of Pentax America, Inc. 102 Chestnut Ridge Road Montvale, New Jersey 07645-1856
MAY 19 2009
Name of Device
| Trade Name: | EG-3670URK, Ultrasound Video Gastroscope |
|---|---|
| Classification Name: | Endoscopic Ultrasound System, Gastro-Urology (780DG) (876.1500); track3, tier2 |
Predicated Device(s) Information
| Model, Description | Manufacturer | PMN # |
|---|---|---|
| EG-3670URK, Ultrasound Video Gastroscope | Pentax Corporation | K061068 |
| Hi Vision 900 Diagnostic Ultrasound Scanner | Hitachi | K063518 |
Device Description
The EG-3670URK, Ultrasound Video Gastroscope, must be used with a Pentax Video processor (a software controlled device) and must be used with an Ultrasound Scanner (a software controlled device). The endoscope has a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water/ and suction. The ultrasound umbilical connector will be attached to the ultrasound scanner unit. The control body includes controls for up/ down/ left/ right angulation, air/ water delivery, suction selection control, balloon insufflation/ evacuation, and an accessory inlet port. The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect endoscopic 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 video processor contains a lamp that light and is focused at the PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic 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 the signals are passed to the ultrasound scanner for processing and 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-3670URK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but 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 procedure are observed in adult and pediatric patient populations.
Comparison to Predicated Device(s)
The submission for substantial equivalence was made to allow the use of the 510k cleared endoscope, EG-3670URK, with the 510k cleared ultrasound scanner, Hi Vision 900. The submission included mechanical drawings, material lists, labeling, the identification of standard set components and optional accessories, tables to summarize the comparisons to the predicated device(s), and system performance testing, and acoustic power data. The submission for substantial equivalence is not based on an assessment of clinical perfermance data.
Prepared by: Paul Silva
Signature: Paul Schulz
Date: 01.24.2009
Control Number: EG-3670URK.HIVision900
Page I of 1
Revision: c
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
MAY 19 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Paul Silva Director of Regulatory Affairs PENTAX Medical Company 102 Chestnut Ridge Road MONTVALE NJ 07645-1856
Re: K090196
Trade/Device Name: EG-3670URK Ultrasound Video Gastroscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODG and ITX Dated: January 24, 2009 Received: February 4, 2009
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 ..
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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
Page 2
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.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| 510(k) Number (if known): | K090196 |
|---|---|
| Device Name: | EG-3670URK |
EG-3670URK, Ultrasound Video Gastroscope
Endoscope Intended Use Statement
Ellussely Intended Use Battoscope, is intended to provide optical visualization of, ultrasonic I is 10 10 10 10 10 10 10 12 12 12 12 12 12 12 12 12 12 11 12 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 Visanzation of, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The organs, usused, and unory counter indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Diagnostic Ultrasound Indications For Use Statement
| System: | Hi Vision 900 | ||||||
|---|---|---|---|---|---|---|---|
| Probe: | EG-3670URK | ||||||
| Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows | |||||||
| 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.) |
E = added under Appendix E P = previously cleared by FDA; N = new application:
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Halid Temman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic
510(k) Number
Prescription Use (Per 21 CFR 801.109)