(35 days)
No
The document describes a standard fiber ultrasound gastroscope with optical and ultrasonic imaging capabilities and therapeutic access. There is no mention of AI, ML, or any advanced image processing beyond basic ultrasound signal processing for display. The predicate devices are also standard ultrasound gastroscopes and scanners from the 1990s.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "therapeutic access." Additionally, the "Device Description" mentions a "working channel through which biopsy devices, or other devices, may be introduced," and that the instrument "is supplied with two biopsy forceps," indicating its use for therapeutic procedures like biopsies.
Yes
The device is described as providing "optical visualization" and "ultrasonic visualization" of the Upper Gastrointestinal Tract, and it collects "ultrasonic image data" for "display." It is also explicitly stated that the device receives "reflections of the pulses" and passes "signals ... for display." This collection and display of internal body information for observation and analysis fits the definition of a diagnostic device. Furthermore, one of its predicate devices is explicitly named "EUB-6000, Ultrasound Diagnostic Scanner".
No
The device description clearly outlines multiple hardware components including an insertion tube, control body, umbilicus, light source connections, air/water/suction controls, angulation controls, accessory elevator, ports, viewing occular, light guides, and an ultrasound transducer. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide optical and ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. This is a direct examination of the body, not an analysis of samples taken from the body.
- Device Description: The device is a gastroscope with ultrasound capabilities. It is used to visualize internal anatomy and facilitate therapeutic procedures. It does not perform tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue biopsies after they are removed from the body for testing). The ultrasound and optical visualization are performed in vivo.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly within the body.
N/A
Intended Use / 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.
Product codes
IYN, ODG
Device Description
The FG-36UX, Fiber Ultrasound Gastroscope, can be used with any Lightsource (with the 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic image data
Anatomical Site
Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small
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
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.
Key Metrics
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
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
1
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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 (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
2
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)
3
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
Control Number: PS-726