PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS

K130247 · Pentax of America, Inc. · ODG · Mar 20, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K130247
• Device Name: PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
• Applicant: Pentax of America, Inc.
• Product Code: ODG · Gastroenterology, Urology
• Decision Date: Mar 20, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Device Story

System consists of PENTAX EG-3870UTK ultrasound video gastroscope (curved linear array transducer) paired with Hitachi HI VISION PREIRUS diagnostic ultrasound scanner. Device provides optical and ultrasonic visualization of upper GI tract; enables therapeutic access. Operated by clinicians in clinical settings. Inputs include optical video signals and ultrasonic echoes; scanner processes signals to produce real-time images for clinical assessment. Output assists physicians in diagnosing and treating GI conditions. Modification involves replacing legacy Hitachi HI VISION 900 scanner with newer HI VISION PREIRUS scanner. No changes to endoscope hardware, software, or core technology. Compatibility verified via design control activities.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation activities confirmed compatibility between the PENTAX EG-3870UTK endoscope and the Hitachi HI VISION PREIRUS scanner.

Technological Characteristics

System comprises a curved linear array ultrasound video gastroscope and a diagnostic ultrasound scanner. Connectivity via standard endoscopic/ultrasound interface. Operates using B-mode, M-mode, PWD, Color Doppler, and Amplitude Doppler imaging modes. No changes to materials or sensing principles compared to predicate. Sterilization per standard endoscopic reprocessing protocols.

Indications for Use

Indicated for optical and ultrasonic visualization and therapeutic access to the upper gastrointestinal tract (esophagus, stomach, duodenum, small bowel, and underlying areas) in adult and pediatric patients. Diagnostic ultrasound imaging or fluid flow analysis for endoscopic applications.

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

• PENTAX EG-3870UTK Ultrasound Video Gastroscope + HI VISION 900 (K090197)

Reference Devices

• Hitachi HI VISION PREIRUS Diagnostic Ultrasound Scanner (K093466)
• Hitachi HI VISION 900 Diagnostic Ultrasound Scanner (K063518)

Submission Summary (Full Text)

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K130247/Page 1 of 2

PENTAX

PENTAX Medical Company

A Division of PENTAX of America, Inc.

**MAR 20.2013**

510(k) Summary

The following summary is provided in accordance with 21 CFR 807.92:

Date: 28 February 2013

Submitter:

PENTAX Medical Company, A Division of PENTAX America, Inc. 3 Paragon Drive Montvale, New Jersey 07645-1782

Contact:

Krishna Govindarajan Requlatory Manager PENTAX Medical Company, A Division of PENTAX America, Inc. 3 Paragon Drive Montvale, New Jersey 07645-1782 Phone: [phone] x 2125, 201-251-2300 x 2125 Fax: [phone] Email: [e-mail]

| Device – Trade Name: | PENTAX EG-3870UTK Ultrasound Video Gastroscope (Curved<br>Linear Array Type) + HI VISION PREIRUS |
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Endoscopic Ultrasound |
| Classification Name: | Endoscopic ultrasound system, gastroenterology/urology |
| Regulation Number:<br>Regulation Description:<br>Medical Specialty:<br>Regulatory Class:<br>Product Code: | 21 CFR Part 876.1500<br>Endoscope and accessories<br>Gastroenterology/Urology<br>Class II<br>ODG and ITX |
| Predicate Device: | PENTAX EG-3870UTK Ultrasound Video Gastroscope + HI<br>VISION 900 (K090197) |

# Intended Use:

The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

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Image /page/1/Picture/0 description: The image shows the text "K130247 - Page 2 of 2" written in cursive at the top. Below that is the word "PENTAX" in large, bold letters. Underneath "PENTAX" is the text "PENTAX Medical Company" in a smaller font. The image appears to be a document header or a logo for Pentax Medical Company.

## Device Description:

PENTAX EG-3870UTK Ultrasound Video Gastroscope + HI VISION PREIRUS are the endoscopic ultrasound system consists of an ultrasound endoscope with a curved linear array type ultrasound transducer, video processor, and Hitachi ultrasound scanner. This modified new system configuration is to work together with the already cleared latest Hitachi HI VISION PREIRUS Diagnostic Ultrasound Scanner (K093466).

## Device Modification & Substantial Equivalence:

The PENTAX EG-3870UTK Ultrasound Video Gastroscope with HITACHI Hi VISION 900 (HV900) Ultrasound Scanner system configuration has been previously cleared (K090197). This Special 510(k) submission is a modification with new system configuration to work together with the already cleared latest Hitachi HI VISION PREIRUS Diagnostic Ultrasound Scanner (K093466) instead of old Hitachi HI VISION 900 Diagnostic Ultrasound Scanner (K063518).

There are no software or hardware changes between the PENTAX EG-3870UTK Ultrasound Video Gastroscope subject and predicate device in connecting with the new Hitachi HI VISION PREIRUS Diagnostic Ultrasound Scanner. In addition, there are no change in technology, including features, materials, and principles of operation.

The system configuration modification does not impact the intended use, safety and/or effectiveness. The modified system configuration has been verified and validated according to the company's design control activities as certified in this Special 510(K) Submission's declaration of conformity with design control to ensure the compatibility between the PENTAX EG-3870UTK Ultrasound Video Gastroscope and the HITACHI HI VISION PREIRUS Ultrasound Scanner.

This modified system configuration is substantially equivalent to the predicate device/system with regards to both intended use and technological characteristics.

## Conclusion:

The PENTAX Medical Company believes that the PENTAX EG-3870UTK Ultrasound Video Gastroscope + HI VISION PREIRUS system modification as indicated in this special 510(k) premarket notification submission is to be as safe, as effective and substantially equivalent in performance to the above identified cleared predicate device/system.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 20. 2013

PENTAX Medical A Division of PENTAX America, Inc. % Mr. Krishna Govindarajan Regulatory Manager 3 Paragon Drive MONTVALE NJ 07645

Re: K130247

Trade/Device Name: PENTAX EG-3870UTK Ultrasound Video Gastroscope (Curved Linear Array Type) + HI VISION PREIRUS Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODG and ITX Dated: March 1, 2013 Received: March 4, 2013

Dear Mr. Govindarajan:

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.

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 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

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Page 2 - Mr. Govindarajan

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 Office of In Vitro Diagnostics and Radiological Health at [phone]. 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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Smh7)

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K130247

Device Name: PENTAX EG-3870UTK Ultrasound Video Gastroscope (Curved Linear Array Type) + HI VISION PREIRUS

#### Indications for Use:

### Endoscope

The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

### Diaqnostic Ultrasound

| System: | Hitachi HI VISION PREIRUS | | | | | | | |
|----------------------------|-------------------------------------------------------------------------------------------------|---|---|-------------------|-----|------------------|----------------------|--|
| Probe: | EG-3870UTK (Curved Linear Array Type) | | | | | | | |
| | Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows | | | | | | | |
| Clinical Application | | | | Mode of Operation | | | | |
| General | Specific | | M | PWD | CWD | Color | Amplitude | |
| Trool I anly | IT rool I 0 HIN | | | | | Donnlar | Donnor | |
| (Track I only) | Specific<br>(Track I & III) | B | M | FWD | 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 | P | P | P | | P | P | |
| 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; K090197 E = added under Appendix E

AND/OR

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

> K130247 510(k)