FG-36UX FIBER ULTRASOUND GASTROSCOPE

K021276 · Pentax Precision Instrument Corp. · ODG · Sep 12, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K021276
• Device Name: FG-36UX FIBER ULTRASOUND GASTROSCOPE
• Applicant: Pentax Precision Instrument Corp.
• Product Code: ODG · Gastroenterology, Urology
• Decision Date: Sep 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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, 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.

Device Story

FG-36UX is a fiber ultrasound gastroscope used with EUB-6500 ultrasound scanner. Device features flexible insertion tube, control body, and umbilicus connecting to lightsource and ultrasound scanner. Contains light-carrying bundles for illumination/visualization and convex linear array ultrasound transducer for imaging. Physician operates device per-orally in clinical setting. Ultrasound transducer delivers pulses; reflections processed by scanner for display. Working channel allows introduction of biopsy forceps or other therapeutic instruments. Device provides real-time optical and ultrasonic visualization to assist in diagnosis and therapeutic access to upper GI tract; aids clinical decision-making by enabling targeted biopsies or interventions.

Clinical Evidence

No clinical data provided. Substantial equivalence determination based on bench testing and comparative specifications.

Technological Characteristics

Fiber-optic gastroscope with integrated convex linear array ultrasound transducer. Features include flexible insertion tube, accessory elevator, working channel, and air/water/suction controls. Immersible design (excluding scanner connector). Connectivity via dedicated scanner interface. Software-controlled ultrasound processing.

Indications for Use

Indicated for optical and ultrasonic visualization and therapeutic access to the upper gastrointestinal tract (esophagus, stomach, small bowel) in adult and pediatric patients. Used for endoscopic procedures requiring visualization or intervention.

Regulatory Classification

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.

Predicate Devices

• FG-36UX, Fiber Ultrasound Gastroscope (with EUB-410,-515,-565,-555) (K010740)
• EUB-6500, Ultrasound Diagnostic Scanner (K013723)

Submission Summary (Full Text)

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510(k )Summary

FG-36UX. Fiber Ultrasound Gastroscope for use with EUB-6500 Uttrasound Diagnostic Scanner

| Submitter Information: | Pentax Precision Instrument Corporation (PPIC)<br>30 Ramland Road<br>Orangeburg, NY, 10962<br>Tel: [phone] |
|------------------------|-------------------------------------------------------------------------------------------------------------------|
|------------------------|-------------------------------------------------------------------------------------------------------------------|

## Name Of Device:

| A T PROPERTY OF COLLECTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONS | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Trade Name: | FG-36UX, Fiber Ultrasound 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 (with EUB-410,-515,-565,-555) | PPIC | K010740 |
| EUB-6500, Ultrasound Diagnostic Scanner | Hitachi America | K013723 |

Device Description: The FG-36UX, Fiber Ultrasound Gastroscope, can be used with any Lightsource (with the appropriate lightguide receptacle) and must be used with Ultrasound Scanner (software controlled device). The endoscope has a flexible insertion tube, a control body, and Umbilicus is bifurcated where one connector is connected to the Lightsource and connections for air/water and suction. The other umbilicus bifurcation is connected at the ultrasound scanner. The controls for up/ down/ left/ right angulation, an accessory elevator control, air/water delivery, suction selection/ control, forward water jet port, balloon insufflation, an accessory inlet port, and the endoscopic image viewing ocular. The device contains light carrying bundles, one to illuminate the body cavity another to optically visualize the anatomy, and an ultrasound transducer 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 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 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, 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 FG-36UX 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 | and the comments of the comments of the comments of<br>Signature: | Pressure of American Comments of Construction of Consument of Children Companies of Children Comments of Children | | Date: 03-06-2002<br>was and the region and only for the first of the state of the comment of the first and the many of |
|-------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--|------------------------------------------------------------------------------------------------------------------------|
|-------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--|------------------------------------------------------------------------------------------------------------------------|

Control Number: PS-726

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Revision: a

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus-like symbol, with three intertwined strands, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

FEB 19 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Paul Silva Director of Operations and Regulatory Affairs Coordinator PENTAX Precision Instrument Corporation 30 Ramland Road ORANGEBURG NY 10962-2699

Re: K021276

Trade Name: FG-36UX Fiber Ultrasound Gastroscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulation Number: 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 78 ODG and 90 ITX Dated: June 18, 2002 Received: June 21, 2002

Dear Mr. Silva:

This letter corrects our substantially equivalent letter of September 12, 2002.

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.

This determination of substantial equivalence applies to the following transducers intended for use with the EUB-6500 Ultrasound Diagnostic Scanner, as described in your premarket notification:

## Transducer Model Number

## FG-36UX

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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 systems (OS) 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 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] 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 David S. Buckles, PhD, at [phone].

**Sincerely yours,**

Helmut Lachenmann

Vanine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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# Device Name: Ultrasound Video Gastroscope FG-36UX

## Endoscope Intended Use Statement:

510(k) Number (if known):

The FG-36UX, Tiber Ultrasound Gastroscope, is intended to provide optical visualization of , ultrasonic The F & C & S , and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract visualization. Vij a restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small mendos out is not received with introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

## Diagnostic Ultrasound Indications For Use Statement

System:

EUB-6500 FG-36UX

Probe: 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 | Amplitude |
| (Track I only) | (Track I & III) | | | | | Doppler | Doppler |
| Ophthalmic | | | | | | | |
| Fetal Imaging | Fetal | | | | | | |
| & Other | 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 | Peripheral vessel | | | | | | |
| 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)

Arind G. Symon

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number

Prescription Use (For 21 Circa 001.100)