PENTAX EPK-I5020 VIDEO PROCESSOR

K113873 · Pentax of America, Inc. · FET · Jun 22, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K113873
• Device Name: PENTAX EPK-I5020 VIDEO PROCESSOR
• Applicant: Pentax of America, Inc.
• Product Code: FET · Gastroenterology, Urology
• Decision Date: Jun 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The EPK-i5020 Video Processor is used for endoscopic observation, diagnosis, treatment, and image recording, It is intended to be used with PENTAX Video Endoscopes to provide illumination, control air pump to supply air through the video endoscope to help clear visualization, convert data from video endoscope into standard video output for visualization via video monitor, and interfacing with external peripheral devices.

Device Story

EPK-i5020 Video Processor functions as endoscopic imaging system; utilizes 300W Xenon lamp for illumination; processes data from video endoscopes into standard video output for monitor visualization. Device controls lamp brightness, white/color balance, and air pump for visualization clearing; interfaces with external peripherals. Used in clinical settings by medical professionals for endoscopic procedures. Output allows real-time visualization and recording to assist clinical diagnosis and treatment.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including software/hardware verification, integration testing, performance testing, and simulated use testing.

Technological Characteristics

300W Xenon lamp illumination; video processing unit; air pump control. Operates at 120 VAC, 50-60 Hz. Complies with IEC 60601 (electrical safety) and IEC 62304 (software validation).

Indications for Use

Indicated for endoscopic observation, diagnosis, treatment, and image recording when used with PENTAX Video Endoscopes. No specific patient population or contraindications defined.

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

• Fuilnon EPX-4440HD Digital Processor and Light Source (K102466)

Submission Summary (Full Text)

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JUN 2 2 2 2012

Image /page/0/Picture/1 description: The image shows the text "page 1 of 2" at the top, followed by the word "PENTAX" in large, bold letters. Below that, it says "PENTAX Medical Company" and "A Division of PENTAX of America, Inc." The text appears to be part of a document or advertisement for PENTAX Medical Company.

# Section 5: 510(k) Summary

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

Date: 28 Dec 2011

- Submitter: PENTAX Medical Company, A Division of PENTAX America, Inc. 3 Paragon Drive Montvale, New Jersey 07645-1782 Krishna Govindarajan Contact: Regulatory 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 201-799-4117 Fax: Email: Krishna [e-mail]
- Device Trade Name: PENTAX EPK-i5020 Video Processor

Endoscopic Video Processor and Light Source Common/Usual Name:

Endoscopic video imaging system/component, gastroenterology-urology Classification Name:

| Regulation Number: | 21 CFR Part 876.1500 |
|-------------------------|---------------------------|
| Regulation Description: | Endoscope and accessories |
| Medical Specialty: | Gastroenterology/Urology |
| Regulatory Class: | Class II |
| Product Code: | FET and GCT |

Fuilnon EPX-4440HD Digital Processor and Light Source Predicate Device: (K102466 dated May 25, 2011)

## Device Description:

The EPK-i5020 Video Processor is consists of light source with 300 W Xenon Lamp to provide illumination, video processor to convert data from video endoscope into standard video output for visualization via video monitor, and interfacing with external peripheral devices. The processor controls the lamp brightness, white and color balance adjustments, and air pump to supply air through the video endoscope to help clear visualization. In addition, the EPK-i5020 Video Processor indicates the operating status and lamp life in the front panel. This device operates with 120 ±10% VAC, 50 -60 Hz power supply.

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K113873
page 2 of 2

Image /page/1/Picture/1 description: The image shows the logo for PENTAX Medical Company. The word "PENTAX" is written in large, bold letters at the top of the image. Below the logo, the words "PENTAX Medical Company" are written in a smaller font. The text "A Division of PENTAX of America, Inc." is written in an even smaller font below the company name.

#### Intended Use:

The EPK-i5020 Video Processor is used for endoscopic observation, diagnosis, treatment, and image recording, It is intended to be used with PENTAX Video Endoscopes to provide illumination, control air pump to supply air through the video endoscope to help clear visualization, convert data from video endoscope into standard video output for visualization via video monitor, and interfacing with external peripheral devices.

### Technology Characteristics:

The EPK-i5020 Video Processor has the same fundamental scientific technology as commercially available endoscope video processor and the substantially equivalent predicate device.

### Substantial Equivalence Determination:

### 1. Summary of Nonclinical Tests

The PENTAX EPK-i5020 Video Processor complies with voluntary standards as detailed in this premarket notification submission. The following quality assurance measures were applied to the design and development:

- Risk Management (Analysis & Mitigation) ♥
- Requirements Reviews .
- Design Reviews �
- Unit Testing (Software & Hardware Verification) ●
- Integration testing (Software & Hardware Verification) .
- Performance testing (Software & Hardware Verification) .
- Safety testing (System level Verification & Validation) .
- Simulated use testing (System level QA Validation) �
- Electrical testing according to IEC 60601 .
- Software validation performed in accordance with IEC 62304 .

#### 2. Summary of Clinical Tests

Not Applicable to support substantial equivalence.

#### 3. Conclusion

The PENTAX Medical Company believes that the intended use of the EPK-i5020 Video Processor as indicated in this premarket notification submission is to be as safe, as effective and substantially equivalent in performance to the above identified predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

#### Public Health Service

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

# JUN 2 2 2 2012

PENTAX of America, Inc. % Robert Schiff, Ph.D. President and CEO Schiff & Company, Inc. 1129 Bloomfield Avenue WEST CALDWELL NJ 07006

Re: K113873

> Trade/Device Name: EPK-i5020 Video Processor Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET, GCT Dated: May 30, 2012 Received: May 31, 2012

Dear Dr. Schiff:

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 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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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Civiletti

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

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#### Indications for Use

510(k) Number (if known): K113873

Device Name: ﺭ

EPK-i5020 Video Processor

Indications For Use:

The EPK-15020 Video Processor is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to be used with PENTAX Video Endoscopes to provide illumination, control air pump to supply air through the video endoscope to help clear visualization, convert data from video endoscope into standard video output for visualization via video monitor, and interfacing with external peripheral devices.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of *_*_

(Division Sign-On)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number. K113873