ManoScan System

K151086 · Given Imaging , Ltd. · FFX · Apr 28, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K151086
• Device Name: ManoScan System
• Applicant: Given Imaging , Ltd.
• Product Code: FFX · Gastroenterology, Urology
• Decision Date: Apr 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2

Indications for Use

The ManoScan System provides mapping of pressures and, optionally, impedance within organs of the human gastrointestinal tract. These include the pharynx, upper esophageal sphincter (UES), esophageal sphincter (LES), stomach, Sphincter of Oddi, small bowel, colon, duodenum and anorectal organs. It is used in a medical clinical setting to acquire pressures and then store the corresponding data for visualization and analysis. The real-time data as well as the analysis information can be viewed by trained personnel for diagnostic and analytic purposes. The ManoScan HRM modules provide high-resolution mapping of the pressure and impedance data. The ManoScan CLT module provides conventional line trace mapping of the pressure data.

Device Story

ManoScan System performs gastrointestinal, sphincter of Oddi, and colorectal manometry. Inputs include pressure and impedance signals from specialized catheter probes (water-perfused, solid-state, air-charged, HRM, 3D). System comprises HRM modules (A120, A200, A300, A400) for high-resolution mapping and CLT module (A550) for conventional line trace mapping. Optional A400 module integrates external medical video inputs. Software (ManoScan 3.0, ManoView CLT) processes, stores, and displays real-time data concurrently with video for physiological review. Used in clinical settings by trained personnel. Output enables visualization and analysis of motility function, aiding diagnostic decision-making. Benefits include improved physiological assessment of esophageal or anorectal motility.

Clinical Evidence

Bench testing only. Includes electrical safety and EMC testing per IEC 60601-1 and IEC 60601-1-2. Hardware verification performed for CLT A550 module. Pressure mapping performance verified against Polygraf ID predicate. Software verification and validation conducted per FDA guidance for moderate level of concern software.

Technological Characteristics

System includes HRM modules (A120, A200, A300, A400) and CLT module (A550). Supports water-perfused, solid-state, air-charged, HRM, impedance, and 3D catheters. Safety Class 1. Input 110-230 VAC 50/60 Hz. Connectivity via transducer cables to modules. Software supports Windows 7/8/8.1. Calibration: 2-point linear for CLT, multi-point for HRM.

Indications for Use

Indicated for mapping pressures and optionally impedance within the human GI tract (pharynx, UES, LES, stomach, Sphincter of Oddi, small bowel, colon, duodenum, anorectal organs) in a clinical setting for diagnostic and analytic purposes by trained personnel.

Regulatory Classification

Identification

A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.

Predicate Devices

• ManoScan Motility with Impedance Visualization System (K091070)
• Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry Application, Polygraf ID (K011472)

Submission Summary (Full Text)

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

April 28, 2016

Given Imaging, Ltd. Hilla Debby Director, Clinical & Regulatory 2 Hacarmel St. New Industrial Park POB 258 Yoqneam, 20962 Israel

Re: K151086 Trade/Device Name: ManoScan® System Regulation Number: 21 CFR 876.1725 Regulation Name: Gastrointestinal Motility Monitoring System Regulatory Class: II Product Code: FFX Dated: April 6, 2015 Received: April 8, 2015

Dear Hilla Debby,

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.

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

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) K151086

Device Name ManoScan® System

#### Indications for Use (Describe)

The ManoScan System provides mapping of pressures and, optionally, impedance within organs of the human gastrointestinal tract. These include the pharynx, upper esophageal sphincter (UES), esophageal sphincter (LES), stomach, Sphincter of Oddi, small bowel, colon, duodenum and anorectal organs. It is used in a medical clinical setting to acquire pressures and then store the corresponding data for visualization and analysis. The real-time data as well as the analysis information can be viewed by trained personnel for diagnostic and analytic purposes. The ManoScan HRM modules provide high-resolution mapping of the pressure and impedance data. The ManoScan CLT module provides conventional line trace mapping of the pressure data.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image contains the logo for Given Imaging. The logo is in blue and white, with the word "GIVEN" in large, white letters and the word "IMAGING" in smaller, white letters below it. There are also several blue squares of varying shades to the right of the logo. The background is white.

Given Imaging, LTD. 2 Hacarmel St. New Industrial Park Yoqneam 20692 lsrael

## 510(k) Summary

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 I.

| Submitter Name and Address: | Given Imaging Ltd. (GI Solutions, Medtronic) |
|------------------------------------|----------------------------------------------|
| | 2 Hacarmel Street |
| | New Industrial Park |
| | PO Box 258 |
| | Yokneam 20692 |
| | Israel |
| | Tel.: [phone] |
| | Fax: [phone] |
| Contact Person: | Hilla Debby |
| | Director, Clinical & Regulatory |
| | Email: [e-mail] |
| Phone Number: | 972 (4) 909-7774 |
| Fax Number: | (972) 73-2501533 |
| Establishment Registration Number: | 9710107 |
| Date Prepared: | April 21, 2016 |
| | |
| II. DEVICE | |
| Device Trade Name(s): | ManoScan® System |
| Device Common Name: | Gastrointestinal motility monitoring system |

Panel:

Classification:

FFX – System, Gastrointestinal Motility (Electrical)

Regulation No: 876.1725, Class: II

Gastroenterology/Urology

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Image /page/4/Picture/0 description: The image shows the logo for Given Imaging. The logo is in a blue box with the word "GIVEN" in white, with a stylized "V" that looks like a camera lens. Below the word "GIVEN" is the word "IMAGING" in smaller white letters. To the right of the logo are several blue squares in different shades of blue.

Given Imaging, LTD. 2 Hacarmel St. New Industrial Park Yogneam 20692 Israel

#### PREDICATE DEVICE(S) III.

- · ManoScan Motility with Impedance Visualization System (K091070) Primary Predicate
- · Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry Application, Polygraf ID (K011472) - Secondary Predicate

#### IV. DEVICE DESCRIPTION:

The ManoScan System provides hardware and software for performing gastrointestinal (GI), sphincter of Oddi, and colorectal manometry.

The ManoScan System comprises two sub-systems: the ManoScan HRM System and the ManoScan CLT System. The ManoScan HRM modular series is a high resolution manometry system used for GI manometry. The base system includes a manometric catheter probe, a ManoScan HRM module (A120 module), and software for data acquisition and analysis. Various probe configurations are available depending on the application (esophageal or anorectal manometry), size (regular or small), and catheter diameter. The ManoScan A200 module enables measuring pressure and impedance data using different dedicated catheters. The ManoScan A300 module is used for high-definition 3D catheters which pass pressure data through to the ManoScan A120 module. When enabled, the optional ManoScan A400 module will enable video acquisition through video inputs that originate in typical medical imaging equipment. The ManoScan 3.0 software supports display of video from the ManoScan A400 module (or other video input) and displays it concurrently with pressure (and impedance if enabled) to allow for improved physiological review of the esophageal or anorectal motility function.

The ManoScan CLT series is a conventional line trace system used for GI manometry. The system includes a manometric catheter probe, the ManoScan CLT module (A550), and software for data acquisition and analysis. The system is supplied as an integrated cart system consisting of:

- a cart -
- । manometric catheter
- ManoScan CLT A550 module -

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Image /page/5/Picture/0 description: The image features the logo for Given Imaging, a medical technology company. The logo is set against a blue background and includes the company name in white lettering, with the 'V' in 'Given' stylized in a light green color. To the right of the logo are several blue squares in varying shades, arranged in a scattered pattern.

Given Imaging, LTD. 2 Hacarmel St. New Industrial Park Yogneam 20692 Israel

- Computer, monitor and computer peripherals (keyboard, mouse, etc.) -
- power isolation station -
- ManoScan 3.0 and ManoView CLT software -

The ManoScan CLT A550 module acquires pressure data from three catheter types: waterperfused, solid state, and air-charged, manufactured by specific vendors. Each catheter type is connected to the ManoScan CLT A550 module by means of corresponding transducer cable.

### V. INDICATIONS FOR USE:

The ManoScan System provides mapping of pressures and, optionally, impedance within organs of the human gastrointestinal tract. These include the pharynx, upper esophageal sphincter (UES), esophagus, lower esophageal sphincter (LES), stomach, sphincter of Oddi, small bowel, colon, duodenum and anorectal organs. It is used in a medical clinical setting to acquire pressures and then store the corresponding data for visualization and analysis. The realtime data as well as the analysis information can be viewed by medically trained personnel for diagnostic and analytic purposes. The ManoScan HRM modules provide high-resolution mapping of the pressure and impedance data. The ManoScan CLT module provides conventional line trace mapping of the pressure data.

### VI. TECHNOLOGICAL CHARACHTERISTICS:

A comparison of the technological characteristics of the device and predicate devices is presented below in tables 1 and 2:

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Image /page/6/Picture/0 description: The image shows the logo for Given Imaging. The logo is in a blue box and has the words "GIVEN" and "IMAGING" in white letters. The "V" in "GIVEN" is stylized to look like a medical device. To the right of the logo are several blue squares in different shades of blue.

Table 1 – ManoScan System specifications in comparison to Polygraf ID System and ManoScan System:

| | Device | Primary<br>Predicate | Secondary Predicate |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | ManoScan System | ManoScan Motility<br>with Impedance<br>Visualization System | Polygram 98<br>Anorectal Function<br>Testing Application,<br>Polygram 98<br>Esophageal<br>Manometry<br>Application, Polygraf<br>ID |
| System<br>Components | HRM modules (A120,<br>A200, A300, A400)<br>CLT Module (A550)<br>Catheters (HRM,<br>impedance, 3D and<br>SUM)<br>Software | HRM modules (A120,<br>A200, A400)<br>Catheters (HRM and<br>impedance)<br>Software | Polygraf ID Module<br>Polygram 98 software<br>SUM catheters |
| Catheter type | CLT:<br>Water-perfused catheters<br>Solid-state catheter<br>Air-charged catheter<br>HRM:<br>HRM catheter<br>Impedance catheter<br>3D catheter | HRM catheter<br>Impedance catheter | Water-perfused<br>catheters<br>Solid-state catheter<br>Air-charged catheter |
| Signals collected | Pressure and Impedance | Pressure and Impedance | Pressure, pH, EMG,<br>respiration and swallow |
| Recording<br>control | Real time monitoring of<br>signals | Real time monitoring of<br>signals | Real time monitoring of<br>signals |
| Channels | CLT: 1-16<br>HRM:<br>Number of pressure<br>sensors: 8-256<br>Number of impedance<br>sensors: 19 (18 channels) | CLT: NA<br>HRM:<br>Number of pressure<br>sensors: 8-36 | CLT: 4-16<br>HRM:<br>NA |
| Dimensions | CLT:<br>(A550): | CLT: NA | CLT:<br>(A500): |

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Given Imaging, LTD. 2 Hacarmel St. New Industrial Park Yoqneam 20692
Israel

| | Device | Primary<br>Predicate | Secondary Predicate |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | ManoScan System | ManoScan Motility<br>with Impedance<br>Visualization System | Polygram 98<br>Anorectal Function<br>Testing Application,<br>Polygram 98<br>Esophageal<br>Manometry<br>Application, Polygraf<br>ID |
| | Width: 331 mm<br>Depth: 245.5 mm<br>Height: 98.5 mm<br>Weight 3.4 kg | | Width: 370 mm<br>Depth: 225 mm<br>Height: 73mm<br>Weight: 3 Kg |
| | HRM:<br>(A120, A200, A300,<br>A400):<br>Width: 341 mm<br>Depth: 245.5 mm<br>Height: 54.5 - 98.5 mm<br>Weight 2.1 - 4.0 kg | HRM:<br>(A120, A200, A400):<br>Width: 331 mm<br>Depth: 245.5 mm<br>Height: 54.5 - 98.5 mm<br>Weight 2.1 - 4.0 kg | HRM: NA |
| Degree of<br>Protection | Safety Class 1 | Safety Class 1 | Safety Class 1 |
| Input | 110-230 VAC ~ 50/60<br>Hz | 110-230 VAC ~ 50/60<br>Hz | 110-230 VAC ~ 50/60<br>Hz |

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Image /page/8/Picture/0 description: The image features the logo for Given Imaging, a medical technology company. The logo is displayed in a blue box and includes the company name in white lettering. To the right of the logo are several blue squares of varying shades, arranged in a pattern.

| | Device | Primary Predicate | Secondary<br>Predicate |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| | ManoScan System | ManoScan Motility<br>with Impedance<br>Visualization<br>System | Polygram 98<br>Anorectal Function<br>Testing Application<br>Polygram 98<br>Esophageal<br>Manometry<br>Application,<br>Polygraf ID |
| 510(k) Number | | K091070 | K011472 |
| Operating system<br>compatibility | Microsoft Windows<br>7, Windows 8/8.1 | Windows XP<br>Professional Service<br>Pack 2 | Microsoft Windows<br>98, Windows 2000<br>and Windows XP |
| SW licensing | Yes | No | Yes |
| pH, EMG, respiration,<br>swallow and EGG<br>applications supported | No | No | Yes |
| Multi language support | Yes | Yes | Yes |
| Guide wizard | Yes | Yes | No |
| Clinical<br>modality/procedure<br>selection | Yes | Yes | Yes |
| Patient information set<br>up | Yes | Yes | Yes |
| Calibration | 2 point linear<br>calibration for CLT,<br>multiple point<br>calibration for HRM.<br>Monitoring of<br>calibration result for<br>range and resolution<br>requirement. | Multiple point<br>calibration for HRM.<br>Monitoring of<br>calibration result for<br>range and resolution<br>requirement | 2 point linear<br>calibration.<br>Monitoring of<br>calibration result for<br>range and resolution<br>requirement |
| Acquire circumferential<br>data from 3D probe | Yes | No | No |
| Support visualizations<br>for 3D data | Yes | No | No |

Table 2: Description of software features in comparison to predicate devices:

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Image /page/9/Picture/0 description: The image features the logo for Given Imaging, a medical technology company. The logo is displayed in a blue rectangle with the word "GIVEN" in white, with a stylized "V" that resembles a medical device. Below "GIVEN" is the word "IMAGING" in a smaller font, also in white. To the right of the logo are several blue squares of varying shades, arranged in a scattered pattern.

Given Imaging, LTD. 2 Hacarmel St. New Industrial Park Yogneam 20692 lsrael

The main mechanical differences in the ManoScan CLT A550 module are in comparison to the Polygraf ID module and new software versions to support line trace manometry applications. However, it may be concluded from the Substantial Equivalence Summary that none of the presented changes raise any new safety issues.

Both the subject and predicate devices have the same intended use for mapping pressure levels within the tubular organs of the GI tract. The predicate device, ManoScan System for high resolution manometry, also has an additional use of recording impedance data.

#### VII. PERFORMANCE DATA:

The following performance data was provided in support of the substantial equivalence determination.

#### Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and Electromagnetic compatibility (EMC) testing were conducted on the ManoScan System, consisting of the modules and supported catheters, the system complies with IEC 60601-1 standard for electrical safety and the IEC 60601-1-2 standard for EMC.

#### Bench Testing - Hardware Verification

A Hardware verification test was performed to evaluate the performance of the ManoScan CLT A550 module hardware and embedded software.

#### Bench Testing - Pressure Mapping

Pressure mapping test was conducted to verify that the mapping of pressure data of ManoScan CLT A550 module is equivalent to that of the predicate device, Polygraf ID module.

#### Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The software for this device is considered as a "moderate" level of concern, since a malfunction or a latent design flaw in the Software could lead to an erroneous diagnosis or a delay in delivery of appropriate

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Image /page/10/Picture/0 description: The image shows the logo for Given Imaging. The logo is in blue and white, with the word "GIVEN" in large, white letters. Below the word "GIVEN" is the word "IMAGING" in smaller, white letters. To the right of the logo are several blue squares of varying shades.

Given Imaging, LTD. 2 Hacarmel St. New Industrial Park Yoqneam 20692 Israel

medical care that would likely lead to Minor Injury.

The proposed changes in this submission do not raise new performance or safety issues.

### VIII. CONCLUSION:

Based on the technological characteristics of the devices, Given Imaging Ltd. believes that the ManoScan System and the predicate devices selected are substantially equivalent and do not raise new issues of safety or effectiveness.

Given Imaging Ltd. 510(k) Submission – ManoScan® System