EG-3670URK

K061068 · Pentax Medical Company · ODG · May 3, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K061068
• Device Name: EG-3670URK
• Applicant: Pentax Medical Company
• Product Code: ODG · Gastroenterology, Urology
• Decision Date: May 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

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 Tract. The Upper Gastrointestinal Tract includes but is not restricted to, the organs; tissues; and subsystems; Esophagus, 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

EG-3670URK is an ultrasound video gastroscope used for upper GI tract visualization and therapy. Device features flexible insertion tube, control body, and umbilical connectors for video processor and ultrasound scanner. Input: optical images via CCD and ultrasonic pulses via radial array transducer. Operation: light bundles illuminate body cavity; CCD captures video; transducer emits/receives ultrasonic pulses. Output: video and ultrasound images displayed on connected processor/scanner. Used in clinical settings by physicians. Working channel allows introduction of biopsy devices. Benefits: enables simultaneous optical and ultrasonic imaging for diagnostic and therapeutic procedures in esophagus, stomach, and small bowel.

Clinical Evidence

No clinical data. Substantial equivalence determination based on descriptive information, specifications, and comparison to predicate devices.

Technological Characteristics

Flexible endoscope with radial array ultrasound transducer and CCD sensor. Includes working channel for biopsy. Connects to external video processor and ultrasound scanner. Immersible design. Software-controlled via external processor/scanner. Sterilization via manual cleaning/disinfection per operator manual.

Indications for Use

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

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

• EG-3630UR, Video Ultrasound Gastroscope (K041395)
• EUB-5500, Ultrasound Diagnostic Scanner (K032503)

Submission Summary (Full Text)

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KD61068

# 510(k) Summary EG-3670URK, Ultrasound Video Gastroscope for use with EUB-5500 Ultrasound Diagnostic Scanners

| Submitter Information: | Pentax Medical Company<br>102 Chestnut Ridge Road | MAY | 3 2006 |
|------------------------|---------------------------------------------------|-----|--------|
| | Montvale, NJ 07645-1856<br>Tel: [phone] | | |

## Name of Device:

| Trade Name: | EG-3670URK, Ultrasound Video Gastroscope |
|----------------------|------------------------------------------------------------------------------------------------------|
| Classification Name: | Diagnostic Ultrasound Transducer (90ITX) (892.1570),<br>Endoscope and Accessories (78KOG) (876.1500) |

## Predicated Device(s) Information:

| Model, Description | Manufacturer | PMN# |
|-----------------------------------------|--------------------|---------|
| EG-3630UR, Video Ultrasound Gastroscope | Pentax Corporation | K041395 |
| EUB-5500, Ultrasound Diagnostic Scanner | Hitachi America | K032503 |

The EG-3670URK, Ultrasound Video Gastroscope, must be used with a Pentax Video Device Description: 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 Connector is connected at the Ultrasound Scanner. The Control Body includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, balloon injection/ evacuation, 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 Video Processor contains a lamp that provides white light that is focused at the PVE Connector Lightguide Prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects 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 signals are passed to the Ultrasound Scanner for display. The instrument is immersable (with the use of supplied cleaning accessories 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 Tract. The Upper Gastrointestinal Tract includes but is not restricted to, the organs; tissues; and subsystems; Esophagus, 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-3670URK 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.

Signature: Paul Silie

Date: 2-6-2006

Control Number: EG-3670URK.EUB-5500

Prepared by: Paul Silva

page I of 1

Revision: a

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pentax Medical Company % Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America, Inc. 12 Commerce Road NEWTOWN CT 06470

Re: K061068

Trade Name: EG-3670URK Ultrasound Video Gastroscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: KOG and ITX Dated: Apri 13, 2006 Received: April 17, 2006

Dear Mr. Borsai:

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.

3 2006

MAY

This determination of substantial equivalence applies to the EG-3670URK Ultrasound Video Gastroscope with the EUB-5500 Ultrasound Scanner.

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

Image /page/1/Picture/12 description: The image is a circular logo with the letters "FDA" in the center. Above the letters, the numbers "120" and "XXX" are displayed. Below the letters, the word "Centennial" is written in a cursive font. The logo is surrounded by a dotted border.

Protecting and Promoting Public Health

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Page 2 - Mr. Borsai

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.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special reror is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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" (21CFR Part 807.97). 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 [phone] or [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 Andrew Kang at [phone].

Sincerely vours.

David h. Ingram

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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510(k) Number (if known): Device Name:

EG-3670URK, Ultrasound Video Gastroscope

### Endoscope Intended Use Statement

The EG-3670URK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic I is a sualization of, and therapeutic access to, the Upper Gastrointestinal Track includes but is not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small mendes but is not roursed to the organism is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

# Diagnostic Ultrasound Indications For Use Statement

EUB-2200 System: EG-3670URK Probe:

I 1000.

| Clinical Application | | Mode of Operation | | | | | |
|----------------------------|-----------------------------|-------------------|---|-----|-----|------------------|----------------------|
| General<br>(Track I only) | Specific<br>(Track I & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler |
| Ophthalmic | | | | | | | |
| Fetal Imaging<br>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<br>Vessel | Peripheral vessel | | | | | | |
| | Other (Spec.) | | | | | | |

P = previously cleared by FDA; E = added under Appendix E N = new application;

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Timt A. Layson
(Division Sign-Off)

Division of Seproductive, Abdominal,
and Panological Devices
510(k) Number K061068

Prescription Use (Per 21 CFR 801.109)