PEERSCOPE SYSTEM

K130718 · Peermedical , Ltd. · FDF · Apr 16, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K130718
• Device Name: PEERSCOPE SYSTEM
• Applicant: Peermedical , Ltd.
• Product Code: FDF · Gastroenterology, Urology
• Decision Date: Apr 16, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PeerScope System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The PeerScope System is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The PeerScope System consists of PeerMedical camera heads, endoscopes, video system, light source and other ancillary equipment.

Device Story

PeerScope System Model H is a GI platform for diagnostic visualization and therapeutic intervention of the lower digestive tract. System inputs include optical images captured by PeerMedical camera heads and endoscopes; processed by Main Control Unit (MCU H). System transforms optical inputs into high-resolution video output displayed on monitors. Used in healthcare facilities/hospitals by physicians. Provides wide field of view (up to 300°) and access for standard endoscopy tools. Output allows physicians to visualize anatomy and perform interventions, aiding clinical decision-making and patient diagnosis/treatment. Modification of predicate Model B includes high-definition video, software-based GUI, I/O communication ports, digital/analog video output, and single/triple monitor configurations.

Clinical Evidence

No clinical data. Bench testing and usability testing performed. Usability testing conducted in a US medical center with seven experienced GI physicians. Bench testing verified compliance with electrical safety (AAMI/ANSI ES 60601-1), electromagnetic compatibility (IEC 60601-1-2), and endoscope-specific standards (IEC 60601-2-18, ISO 8600 series). Software validation performed per FDA guidance.

Technological Characteristics

GI endoscopic platform. Materials: biocompatible per ISO 10993. Sensing: optical camera heads. Energy: electrical light source and video processor. Connectivity: I/O communication ports, digital/analog video output. Software: GUI-based control. Standards: AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 62304, ISO 10993, ISO 8600, ASTM E 1837.

Indications for Use

Indicated for diagnostic visualization and therapeutic intervention of the lower digestive tract (anus, rectum, sigmoid colon, colon, ileocecal valve) in adult patients.

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

• PeerScope System (K120289)

Submission Summary (Full Text)

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This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92

### Submitter Details

PeerMedical Ltd. 2 Hatochen St., POB 3161 Business and Industrial Park (North), Caesarea, 38900, Israel Tel: [phone], Fax: [phone] Date prepared: March 13, 2013 Submission Contact: Tamar Fuerst PeerMedical Ltd Caesarea, 38900, Israel.

#### Device Details

| Proprietary Name: | PeerScope System (Model H) |
|---------------------|---------------------------------------------------|
| Common Name: | Colonoscope and accessories, flexible / rigid |
| Classification Name | Endoscope accessories, 21 CFR 876.1500 |
| Product Code: | FDF (colonoscope and accessories, flexible/rigid) |
| Committee/Panel: | Gastroenterology/Urology |
| Device Class: | II |

Reason for 510(k) Submission: Change in Technology

#### Identification of Legally Marketed Predicate Devices

PeerScope System -K#120289 - Manufactured by PeerMedical Ltd.

#### Device Description

The PeerScope system Model H is a GI platform for diagnostic visualization and therapeutic intervention of the lower digestive tract. The PeerScope system Model H is a modification of the legally marketed (K 120289) PeerScope system Model B (the predicate device). The system consists of endoscopic Main Control Unit (MCU H) and of the PeerScope CS colonoscope, enabling physicians to view a high resolution wide field of view of up to 300°. The system is labeled for use in healthcare facilities / hospitals for adult patients.

#### Intended use and indications for Use

The PeerScope System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The PeerScope System is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The PeerScope System consists of PeerMedical camera heads, endoscopes, video system, light source and other ancillary equipment.

#### Technological characteristics

PeerScope System Model H Submission -Section 7_510(k) Summary

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Rev 01

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The MCU Model H video processor incorporates the following additional features compared to the predicate device:

| Category | Predicate Device -<br>PeerScope system<br>Model B K120289 | Subject Device<br>PeerScope system<br>Model H | Impact of the differences<br>on device performance |
|------------------------------------------|-----------------------------------------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Video resolution | Standard definition | High definition | Both designs utilize<br>industry accepted standard<br>for video resolution. |
| User interface | Hardware based | Hardware based and<br>Software based<br>(GUI) | Both designs utilize<br>industry accepted standard<br>for User interface. |
| I/O Communication<br>Ports | Not Included | Included | I/O Communication Ports<br>are an industry accepted<br>standard for basic<br>communication which<br>were not included in the<br>MCU B design. |
| Video Signal Output | Analog | Analog and Digital | Both designs utilize<br>industry accepted standard<br>for Video Signal Output. |
| Video Signal Input | Not Included | Included | Video Signal Input is an<br>industry accepted standard<br>which was not included in<br>the MCU B design. |
| Monitor Display<br>Configuration options | Triple | Triple and Single | Single Monitor Display<br>Configuration is an<br>additional<br>alternative/option for<br>Display Configuration. |

Based on the results of verification and performance testing, the impact of the above differences is insignificant in terms of the device safety and effectiveness for the device intended use.

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#### Performance data

#### Bench data:

Risk analysis was conducted in accordance with ISO 14971. Design verification tests and their acceptance criteria were identified, performed and met.

Software validation was carried out in accordance with FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)".

Reprocessing validation was carried out in accordance with FDA Guidance Document "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Draft Guidance (May 2011)".

Device safety and performance were verified by PeerMedical and accredited third party laboratories.

The following standards were used / relied upon for testing:

AAMI / ANSI ES 60601-1:2005/(R) 2012 and C1:2009/(R) 2012 AAMI / ANSI ES60601-1:2005/A1:2012 IEC 60601-1-2:2007 IEC 60601-2-18 Edition 3.0 2009-08 IEC 62304:2006 ISO 10993:2009 Part #1 -ISO 10993:2009 Part #5 ISO 10993:2010 Part #10 ISO 10993:2007 Part #12 ISO 8600-1 Second edition 2005-05-01 ISO 8600-3 First edition 1997-07-01 ISO 8600-4 First edition 1997-07-01 ISO 8600-6 First edition 2005-03-15 ASTM E 1837- 96 (reapproved 2007)

#### Usability Data:

Device Usability was carried out by means of testing within a clinical environment in a US medical center by seven experienced GI physicians.

The conclusions drawn from the bench and usability tests demonstrate that the device meets its specifications, and supports a determination that the device is at least as safe and effective for its intended use as the predicate device.

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K130718

#### Substantial Equivalence

The above presented data demonstrate that:

- The predicate device the PeerScope System Model B (K120289) is legally marketed. તે.
- The PeerScope System Model H and the predicate device have the same intended use. b.
- The PeerScope System Model H does not raise different questions of safety and c. effectiveness.
- The data provided support a determination that the PeerScope System Model H is at d. least as safe and effective for its intended use as the predicate device.

Conclusion: It is the opinion of PeerMedical that the PeerScope system Model H is substantially equivalent to the predicate device, in terms of safety and effectiveness.

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Image /page/4/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 entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

#### Public Health Service

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

April 16, 2013

PeerMedical Ltd. % Ms. Tamar Fuerst RA Manager 2 Hatochen Street, Business Industrial Park (North) CAESAREA ISRAEL 38900

Re: K130718

Trade/Device Name: PeerScope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: March 18, 2013 Received: March 19, 2013

Dear Ms. Fuerst:

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. Iisting 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.

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Page 2 - Ms. Tamar Fuerst

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 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/Reportal?roblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

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): K130718

Device Name: PeerScope System

#### Indications For Use:

The PeerScope System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The PeerScope System is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The PeerScope System consists of PeerMedical camera heads, endoscopes, video system, light source and other ancillary equipment.

Prescription Use X (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)

# Herber - Bagerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130718 510(k) Number

PeerScope System Model H Submission -20 - 11 - 15 Page 1 of 1 Section 6 Indication for Use Statement

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