(125 days)
The EG-3830UT, 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 Pediatic patient populations.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy
The EG-3830UT, 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, 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 Lightenide Prong. The endoscope light carrying bundles present 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).
The provided document is a 510(k) summary for the PENTAX EG-3830UT Ultrasound Video Gastroscope, intended for use with the EUB-6000 and EUB-6500 Ultrasound Diagnostic Scanners. It details the device, its intended use, and a comparison to predicate devices, but does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document states: "The submission for substantial equivalence was not based on an assessment of clinical performance data." This explicitly indicates that no clinical study was performed to assess the performance of the device against specific acceptance criteria.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
- If a standalone (algorithm only) performance study was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on specifications, components, and indications for use, rather than on new performance data against acceptance criteria.
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Image /page/0/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with three lines representing the head, body, and legs. The figure is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
PENTAX Precision Instrument Corporation Mr. Paul Silva Director of Operations and Regulatory Affairs Coordinator 30 Ramland Road Orangeburg, NY 10962-2699
JUL 2 7 2015
K023401 Re:
Trade/Device Name: EUB-6000 and EUB-6500 Ultrasound Diagnostic Scanners Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODG, FET, FDS, ITX Dated (Date on orig SE ltr): January 7, 2003 Received (Date on orig SE ltr): January 9, 2003
Dear Mr. Silva.
This letter corrects our substantially equivalent letter of February 11, 2003.
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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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); medical device 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): Devico Name:
Ultrasound Video Gastroscope EG-3830UT
Endoscope Intended Use Statement:
The EG-3830UT, Ultrasound Video Gastroscope, is intended to provide optical visualization of , ultrasonic visualization of, and therapeutic access to, the Upper Gastroimestinal 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 Pediations.
Dingnostic Ultrasound Indications For Use Statement
| System: | EUB-6000 | |||||
|---|---|---|---|---|---|---|
| Probe: | EG-3830UTand the beginner and and the same of the same | |||||
| Callery of the country of the country of the county of the county of the county of the county of the county of the county of the county of the county of the county of the cou |
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 | ColorDoppler | AmplitudeDoppler |
| Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | ||||||
| Abdominal | |||||||
| Intra-operative (Spec.) | |||||||
| Intra-operativo (Neuro.) | |||||||
| Laproscopic | |||||||
| Pediatric | |||||||
| Small Organ | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vagina | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Endoscopy | N | N | N | N | N | ||
| Cardiac | Cardiac Adult | ||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| PeripheralVessel | Peripheral vessel | ||||||
| Other (Spec.) |
N = new application: P = proviously cleared by FDA: E = added under Appendix E
(Please do not write below this line - continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seaman
(Division Sign-Off) Division of Reproductive and Radiological Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109)
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510(k) Number (if known):
Device Name:
Ultrasound Video Gastroscope EG-3830UT
Endoscope Intended Use Statement:
The EG-3830UT, 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 Pediatic patient populations.
Diagnostic Ultrasound Indications For Use Statement
| System: | EUB-6500 |
|---|---|
| Probe: | EG-3830UT |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color Doppler | Amplitude Doppler |
| (Track I only) | (Track I & III) | ||||||
| Ophthalmic | |||||||
| Fetal Imaging& 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. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Endoscopy | N | N | N | N | N | ||
| Cardiac | Cardiac Adult | ||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| PeripheralVessel | Peripheral vessel | ||||||
| Other (Spec.) |
N = new application: P = previously cleared by FDA: E = added under Appendix E
(Please do not write below this line - continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lesman
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
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KD2 3401
510(k )Summary EG-3830UT, Ultrasound Video Gastroscope for use with EUB-6000 and EUB-6500 Ultrasound Diagnostic Scanner
Submitter Information:
Pentax Precision Instrument Corporation (PPIC) 30 Ramland Road Orangeburg, NY, 10962 Tel: (845)-365-0700
FEB 1 1 2003
Name of Device:
| Trade Name: | EG-3830UT, 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 | K021276 |
| EG-3630UR, Video Ultrasound Gastroscope | PPIC | K021278 |
| EUB-6000, Ultrasound Diagnostic Scanner | Hitachi America | K994026 |
| EUB-6500, Ultrasound Diagnostic Scanner | Hitachi America | K013723 |
Device Description: The EG-3830UT, 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, 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 Lightenide Prong. The endoscope light carrying bundles present 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-3830UT, 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, 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-3830UT 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.
Prepared by: Paul Silva
Signature: Paul Silva
Date: 03-06-2002
Control Number: EG-3830UT.510kS
page 1 of 1
Revision: a
§ 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.