(372 days)
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.
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, 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: water-perfused, 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.
The provided document, a 510(k) summary for the ManoScan® System, focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with detailed acceptance criteria and performance data for the current device. Therefore, much of the requested information regarding specific acceptance criteria, sample sizes, expert involvement, and ground truth types for a study proving device performance is not explicitly available in this document.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with corresponding performance data in the same way a clinical trial report might. Instead, it focuses on demonstrating equivalence through technical specifications and verification against standards.
| Acceptance Criterion (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety | Complies with IEC 60601-1 standard for electrical safety. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 standard for EMC. |
| Hardware Verification (CLT A550 module) | Performance evaluated and found acceptable. |
| Pressure Mapping Equivalence (CLT A550) | Verified that the mapping of pressure data is equivalent to the predicate device (Polygraf ID module). |
| Software Verification & Validation | Conducted according to FDA guidance; considered "moderate" level of concern, with no new safety/performance issues. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes bench testing for hardware and pressure mapping.
- Sample Size for Test Set: Not explicitly stated. The nature of bench testing typically involves testing a representative number of units or datasets to cover operational ranges and functionalities, but specific numbers are not provided.
- Data Provenance: This would be retrospective in the sense that physical devices and software were tested in a controlled bench environment, rather than prospective clinical data collection. The location is not explicitly stated beyond Given Imaging's location in Israel, implying the testing was performed internally or by a contracted lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For bench testing of hardware and software, "ground truth" would typically be established by comparing measurements to known physical standards, specifications, or the performance of a predicate device/golden standard, rather than expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of bench testing against standards and predicate devices, a formal adjudication method like "2+1" (which implies multiple human reviewers) is unlikely to have been used. Verification would be against objective technical criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The document focuses on technical equivalence and safety rather than comparative clinical effectiveness with human readers. Therefore, an effect size of human improvement with AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a Gastrointestinal Motility Monitoring System that acquires pressure and impedance data for visualization and analysis by trained personnel. It is not an AI algorithm intended for standalone diagnostic performance without human interpretation. Therefore, a standalone "algorithm only" performance study in the sense of an AI diagnostic tool is not applicable or reported for this device. The software performs data processing and visualization, not autonomous diagnostic decisions.
7. The Type of Ground Truth Used
For the bench testing, the ground truth would be:
- Technical Specifications/Standards: For electrical safety and EMC.
- Predicate Device Performance: For pressure mapping equivalence, the performance of the Polygraf ID module served as a reference. This is a form of measurement comparison rather than clinical ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable/not provided in the context of this 510(k) submission. The ManoScan® System is described as a data acquisition, visualization, and analysis system, not a machine learning or AI system that requires a "training set" to learn patterns for diagnostic prediction. The software is developed through traditional software engineering processes, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for an AI/ML model for this device.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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.: 00-972-4-9097774 | |
| Fax: 00-972-73-2501533 | |
| Contact Person: | Hilla Debby |
| Director, Clinical & Regulatory | |
| Email: Hila.Debby@covidien.com | |
| 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 | PrimaryPredicate | Secondary Predicate | |
|---|---|---|---|
| Device Name | ManoScan System | ManoScan Motilitywith ImpedanceVisualization System | Polygram 98Anorectal FunctionTesting Application,Polygram 98EsophagealManometryApplication, PolygrafID |
| SystemComponents | HRM modules (A120,A200, A300, A400)CLT Module (A550)Catheters (HRM,impedance, 3D andSUM)Software | HRM modules (A120,A200, A400)Catheters (HRM andimpedance)Software | Polygraf ID ModulePolygram 98 softwareSUM catheters |
| Catheter type | CLT:Water-perfused cathetersSolid-state catheterAir-charged catheterHRM:HRM catheterImpedance catheter3D catheter | HRM catheterImpedance catheter | Water-perfusedcathetersSolid-state catheterAir-charged catheter |
| Signals collected | Pressure and Impedance | Pressure and Impedance | Pressure, pH, EMG,respiration and swallow |
| Recordingcontrol | Real time monitoring ofsignals | Real time monitoring ofsignals | Real time monitoring ofsignals |
| Channels | CLT: 1-16HRM:Number of pressuresensors: 8-256Number of impedancesensors: 19 (18 channels) | CLT: NAHRM:Number of pressuresensors: 8-36 | CLT: 4-16HRM:NA |
| Dimensions | CLT:(A550): | CLT: NA | CLT:(A500): |
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Image /page/7/Picture/0 description: The image contains the logo for Given Imaging. The logo is in blue and white, and it features the company name in a stylized font. To the right of the company name are several blue squares with rounded corners. The logo is simple and modern, and it is likely used to represent the company's brand.
Given Imaging, LTD. 2 Hacarmel St. New Industrial Park Yoqneam 20692
Israel
| Device | PrimaryPredicate | Secondary Predicate | |
|---|---|---|---|
| Device Name | ManoScan System | ManoScan Motilitywith ImpedanceVisualization System | Polygram 98Anorectal FunctionTesting Application,Polygram 98EsophagealManometryApplication, PolygrafID |
| Width: 331 mmDepth: 245.5 mmHeight: 98.5 mmWeight 3.4 kg | Width: 370 mmDepth: 225 mmHeight: 73mmWeight: 3 Kg | ||
| HRM:(A120, A200, A300,A400):Width: 341 mmDepth: 245.5 mmHeight: 54.5 - 98.5 mmWeight 2.1 - 4.0 kg | HRM:(A120, A200, A400):Width: 331 mmDepth: 245.5 mmHeight: 54.5 - 98.5 mmWeight 2.1 - 4.0 kg | HRM: NA | |
| Degree ofProtection | Safety Class 1 | Safety Class 1 | Safety Class 1 |
| Input | 110-230 VAC ~ 50/60Hz | 110-230 VAC ~ 50/60Hz | 110-230 VAC ~ 50/60Hz |
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| Device | Primary Predicate | SecondaryPredicate | |
|---|---|---|---|
| ManoScan System | ManoScan Motilitywith ImpedanceVisualizationSystem | Polygram 98Anorectal FunctionTesting ApplicationPolygram 98EsophagealManometryApplication,Polygraf ID | |
| 510(k) Number | K091070 | K011472 | |
| Operating systemcompatibility | Microsoft Windows7, Windows 8/8.1 | Windows XPProfessional ServicePack 2 | Microsoft Windows98, Windows 2000and Windows XP |
| SW licensing | Yes | No | Yes |
| pH, EMG, respiration,swallow and EGGapplications supported | No | No | Yes |
| Multi language support | Yes | Yes | Yes |
| Guide wizard | Yes | Yes | No |
| Clinicalmodality/procedureselection | Yes | Yes | Yes |
| Patient information setup | Yes | Yes | Yes |
| Calibration | 2 point linearcalibration for CLT,multiple pointcalibration for HRM.Monitoring ofcalibration result forrange and resolutionrequirement. | Multiple pointcalibration for HRM.Monitoring ofcalibration result forrange and resolutionrequirement | 2 point linearcalibration.Monitoring ofcalibration result forrange and resolutionrequirement |
| Acquire circumferentialdata from 3D probe | Yes | No | No |
| Support visualizationsfor 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
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
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.(b)
Classification. Class II (performance standards).