← Product Code [ODG](/productcode/ODG) · K010740
# FG-36UX, FIBER ULTRASOUND GASTROSCOPE (K010740)
_Pentax Precision Instrument Corp. · ODG · Apr 17, 2001 · Gastroenterology, Urology · SESE_
**Canonical URL:** https://fda.innolitics.com/device/K010740
## Device Facts
- **Applicant:** Pentax Precision Instrument Corp.
- **Product Code:** [ODG](/productcode/ODG.md)
- **Decision Date:** Apr 17, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Therapeutic, Pediatric
## Indications for Use
The FG-36UX, Fiber Ultrasound 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 There monded out is not room to introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.
## Device Story
FG-36UX is a fiber ultrasound gastroscope used with EUB-6000 scanner. Device features insertion tube, control body, and umbilicus. Inputs: optical light for visualization and ultrasonic pulses via convex linear array transducer for imaging. Operation: physician inserts device per-orally; controls angulation, air/water, suction, and accessory elevator; ultrasound signals processed by EUB-6000 for display. Working channel allows introduction of biopsy forceps or other therapeutic instruments. Used in clinical settings for diagnostic imaging and therapeutic access to upper GI tract. Output: real-time optical and ultrasonic images for physician interpretation to guide diagnosis and therapeutic interventions. Benefits: enables minimally invasive visualization and biopsy of GI anatomy.
## Clinical Evidence
No clinical data. Substantial equivalence was determined based on bench testing and comparison of specifications.
## Technological Characteristics
Fiber-optic gastroscope with integrated convex linear array ultrasound transducer. Features include accessory elevator, air/water delivery, suction control, and working channel. Immersible design for cleaning. Connectivity via umbilicus to light source and ultrasound scanner. Operates as an endoscopic ultrasound system.
## Regulatory 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.
## Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
## Predicate Devices
- FG-36UX, Fiber Ultrasound Gastroscope ([K961974](/device/K961974.md))
- EUB-6000, Ultrasound Diagnostic Scanner ([K994026](/device/K994026.md))
## Submission Summary (Full Text)
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>
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Pentax Precision Instrument Corporation Mr. Paul Silva Regulatory Affairs Coordinator 30 Ramland Road Orangeburg, NY 10962-2699
Re: K010740
Trade/Device Name: FG-36UX Fiber Ultrasound Gastroscope/ EUB-6000 Ultrasound Diagnostic Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ODG Dated (Date on orig SE ltr): March 12, 2001 Received (Date on orig SE ltr): March 13, 2001
Dear Mr. Silva,
This letter corrects our substantially equivalent letter of April 17, 2001.
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
ON
JUL 2 7 2015
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Page 2 -
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 (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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## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE
System: Probe:
FG-36UX
EUB-6000
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
& 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.) | | | | | | |
| Peripheral
Vessel | 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)
Thrist li. Syam
wision Sign-Off ivision of Reproductive, A. . minal, BN and Radiological Devices 510(k) Number.
Perscription Use (Per 21 CFR 801.109)
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## 510(k )Summary
FC-36UX, Fiber Ultrasound Gastroscope for use with EUB-6000 Ultrasound Diagnostic Scanner
Submitter Information:
APR 1 7 2001
Pentax Precision Instrument Corporation (PPIC) 30 Ramland Road Orangeburg, NY, 10962 Tel: (914)-365-0700
FG-36UX, Fiber Ultrasound Gastroscope Name Of Device: Trade Name: Diagnostic Ultrasound Transducer (74JOP) {892.1570}, Classification Name: Endoscope and Accessories (78KOG) {876.1500}
#### Predicated Device(s) Information:
| Model, Description | Manufacturer | PMN# |
|---------------------------------------------------------------------|-----------------|---------|
| FG-36UX, Fiber Ultrasound Gastroscope (with EUB-410,-515,-565,-555) | PPIC | K961974 |
| EUB-6000, Ultrasound Diagnostic Scanner | Hitachi America | K994026 |
The FG-36UX, Fiber Ultrasound Gastroscope, can be used with any Lightsource (with the Device Description: Device Description. appropriate itemble insertion tube, a control body, and Umbilicus . The umbilicus is bifurcated where one connector is connected to the Lightsource and contains connections for air/water and suction. The other umbilicus Comments is connected at the ultrasound scanner. The control body includes controls for up/ down/ left/ right angulation an accessory elevator control, air/water delivery, suction selection/ control, forward water jet port, allyon insulflation, an accessory inlet port, and the endoscopic image viewing occular. The device contains light oundon insurrition, and to illuminate the body cavity another to optically visualize the anatomy, and an ultrasound carrying out 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). A convex linear array transducer delivers ultrasonic pulses, reflections of the pulses are received and signals are passed to the allay aunsation on for display. The instrument is immersable (with the use of supplied cleaning accessories) Onazound Deminer for Gisplay : The measur (as described in the Endoscope operator Manual cleaning instructions).
Intended Use: The FG-36UX, Fiber Ultrasound 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 There monded out is not room to 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 FG-36UX literature including specifications, the identification I ho submission for substancer equinosis of optional accessories, comparison tables were provided to illustrate Or sumand sot out predicated devices in summary. The substantial equivalence was not based on an assessment of clinical performance data.
Prepared by: Paul Silva
Signature: Paul Shultz
Date: 05.09.01
K010740
Control Number: PS-726
---
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