EG-3630UR
Device Facts
| Record ID | K041395 |
|---|---|
| Device Name | EG-3630UR |
| Applicant | Pentax Precision Instrument Corp. |
| Product Code | ITX · Radiology |
| Decision Date | Jun 9, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric, 3rd-Party Reviewed |
Indications for Use
The EG-3630UR, 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.
Device Story
EG-3630UR is an ultrasound video gastroscope used with Pentax video processors and Hitachi EUB-5500/8500 ultrasound scanners. Device features flexible insertion tube, control body for angulation, air/water delivery, suction, balloon insufflation, and accessory inlet port. Input: optical image data via CCD and ultrasonic pulses via radial array transducer. Processor compiles RGB strobe images into full-color video frames; ultrasound scanner displays reflected ultrasonic signals. Used in clinical settings by physicians for endoscopic procedures; provides optical/ultrasonic visualization and therapeutic access (e.g., biopsy). Output: real-time video and ultrasound images on external monitors. Benefits: enables diagnostic imaging and therapeutic intervention within the upper GI tract.
Clinical Evidence
No clinical data. Substantial equivalence was based on bench testing and comparison of technical specifications to predicate devices.
Technological Characteristics
Radial array ultrasound transducer; CCD for optical imaging; flexible insertion tube; control body for angulation, suction, and air/water delivery. Compatible with Pentax video processors and Hitachi EUB-5500/8500 scanners. Immersible design (excluding scanner connector).
Indications for Use
Indicated for adult and pediatric patients requiring optical and ultrasonic visualization of, and therapeutic access to, the upper gastrointestinal tract (esophagus, stomach, small bowel, and underlying areas) via per-oral introduction.
Regulatory Classification
Identification
A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.
Predicate Devices
- FG-36UX, Fiber Ultrasound Gastroscope (K010740)
- EUB-5500, Ultrasound Diagnostic Scanner (K032503)
- EUB-8500, Ultrasound Diagnostic Scanner (K013722)
Submission Summary (Full Text)
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K041395
JUN = 9 2004
### 510(k )Summary EG-3630UR, Ultrasound Video Gastroscope for use with EUB-5500 and EUB-8500 Ultrasound Diagnostic Scanners
Pentax Precision Instrument Corporation (PPIC) Submitter Information: 30 Ramland Road Orangeburg, NY, 10962 Tel: (845)-365-0700
#### Name of Device:
| Trade Name: | EG-3630UR, Ultrasound Video Gastroscope |
|----------------------|------------------------------------------------------------------------------------------------------|
| Classification Name: | Diagnostic Ultrasound Transducer (74JOP) (892.1570),<br>Endoscope and Accessories (78KOG) (876.1500) |
#### Predicated Device(s) Information:
| Model, Description | Manufacturer | PMN# |
|-----------------------------------------|-----------------|---------|
| FG-36UX, Fiber Ultrasound Gastroscope | PPIC | K010740 |
| EUB-5500, Ultrasound Diagnostic Scanner | Hitachi America | K032503 |
| EUB-8500, Ultrasound Diagnostic Scanner | Hitachi America | K013722 |
The EG-3630UR, 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 The endosoppe the PVE Connects to the Video Processor and has connections for illumination, video commoner 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 insufflation, and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity, a marge 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, or other 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 winte right the endoscope light carrying bundles present the color strobes to 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 eonbes mage 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-3630UR, 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-3630UR literature including specifications, the identification of standard set components, and identification of optional accessories, comparison tables were rorovided 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: 11-25-2003
page 1 of 1 Control Number: EG-3630UR.EUB-5500&8500
Revision: a
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three horizontal lines that curve downwards, resembling an abstract representation of a human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2004
PENTAX Precision Instrument Corporation % Mr. Matthias Heinze Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K041395
Trade Name: EUB-5500 and EUB 8500 Ultrasound Diagnostic Scanners Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 90 ITX and 78 FDS Dated: May 21, 2004 Received: May 26, 2004
Dear Mr. Heinze:
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 enact nent date of the Medical Device Amerade over and 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-5500 and EUB 8500 Ultrasound Diagnostic Scanners, as described in your premarket notification:
Transducer Model Number
#### EG-3630UR
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is Classified (300 a00 v) ifrols. Existing major regulations affecting your device . FFA It may be subject to such additional Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Code of I coolar regisming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuation of a base ince complies with other requirements of the Act that FDA has made a determination administered by other Federal agencies. You must of ally irederal statutes and regarations and limited to: registration and listing (21 comply with an the Act 3 requirements, netware, and manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 800); good if applicable, the electronic .
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1950 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping I his device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested information, merading accused of the Center's September 30, 1997 "Information for Manufacturers In Appendix O, (cherosod) of the Somer tic Ultrasound Systems and Transducers." If the special Secking Manketing Clearantes or Dacceptable 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 The special report should be submitted in duplicate to 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 I mis letter will anon-you word substantial equivalence of your device to a legally marketed nonification. The I Drin 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 If you desire specific of Compliance at (301) 594-4591. Additionally, for questions on the connact the Office of your device, please contact the Office of Compliance at (301) 594promotion and asse note the regulation entitled, "Misbranding by reference to premarket 4057. Also, prouse note the rogan. Other general information on your responsibilities under the nothreation (2) <1 < 1 > < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < Act inay oc obtained from the Drillion 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
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Page 3 - Mr. Heinze
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Daniel A. Syrom
for
Na
De
Ac
O
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: | Ultrasound Video Gastroscope EG-3630UR |
# Endoscope Intended Use Statement:
Endoscope Intended Use Statement:
The EG-3630UR, Ultrasound Video Gastroscope, is intended to provide optical visualization of , The EG-3630UR, Ultrasound Video Gastroscope, 15 the Upper Gastrointestinal Tract. The Upper ultrasonic visualization of, and therapeans accose tissues; and subsystems: Esophagus,
Gastrointestinal Tract includes but is not restricted to, the introduced ner orally whe Gastrointestinal Tract metudes out is not restriction of the instrument is introduced per orally when Stomach, Duodenum, Sman Bower, and underrying arouse in Adult and Pediatric patient populations.
# Diagnostic Ultrasound Indications For Use Statement
EUB-2500 System: EG-3630UR 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<br>Doppler | Amplitude<br>Doppler |
| (Track I only) | (Track I & III) | | | | | | |
| Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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<br>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)
David A. Lipton
(Division Sign-Off) Division of Reproductive, and Radiological Device 5104 Numno:
Prescription Use (Per 21 CFR 801.109)
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| 510(k) Number (if known): | |
|---------------------------|----------------------------------------|
| Device Name: | Ultrasound Video Gastroscope EG-3630UR |
## Endoscope Intended Use Statement:
The EG-3630UR, Ultrasound Video Gastroscope, is intended to provide optical visualization of ,
The EG-3630UR, Ultrasound Video Gastroscope, is intended to provide optical The I he EU-30300X, Ottrasound Video Gastrescope, to the Upper Gastrointestinal Tract. The Upper ultrasonic Visualization of, and metapoutie atores were and subsystems: Esophagus, Gastromestillar Tract Merides but is not reserving areas. The instrument is introduced per orally when Stomacil, Dubuchani, Sman Dowel, and anders Jugars. And and Pediatric patient populations.
# Diagnostic Ultrasound Indications For Use Statement
EUB-8200 System: EG-3630UR Probe:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| 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>& 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 | N |
| Cardiac | Cardiac Adult | | | | | | |
| | Cardiac Pediatric | | | | | | |
| | Trans-esophageal (card.) | | | | | | |
| | Other (spec.) | | | | | | |
| Peripheral<br>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)
David A. Leggon
(Division Sign-Off)
Prescription Use (Per 21 CFR 801.109)
