RAPID Web

K170839 · Given Imaging , Ltd. · NEZ · May 26, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K170839
• Device Name: RAPID Web
• Applicant: Given Imaging , Ltd.
• Product Code: NEZ · Gastroenterology, Urology
• Decision Date: May 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1300
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The PillCam Capsule Endoscopy System with a PillCam SB 2 and SB 3 capsules is intended for visualization of the small bowel mucosa. PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy. PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy. PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy. The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas. The PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age. The PillCam Capsule Endoscopy System with PillCam ESO 3 capsules is intended for the visualization of esophageal mucosa in adults and children from 18 years of age. The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at least 18 years of age. The PillCam COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower GI origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.

Device Story

RAPID Web is a client-server software application for reviewing and analyzing capsule endoscopy videos. It functions as a web-based interface for studies previously captured by PillCam systems and stored in a central repository. Physicians access the system via secure internet or intranet browsers on workstations, laptops, or tablets (Apple iPads > 9.7"). The software allows clinicians to view, manage, and report on capsule endoscopy findings. By enabling remote access to study data, it facilitates efficient clinical review and decision-making regarding GI abnormalities, potentially improving diagnostic workflows and patient management. It does not perform initial capsule initialization or video creation, which are handled by the cleared RAPID 8.0 workstation software.

Clinical Evidence

Comparative performance study conducted with trained professionals identifying pathologies in identical video segments using both RAPID Web and RAPID 8.0 across various platforms (workstations, laptops, iPads). Analysis of matched and unmatched pathologies demonstrated that RAPID Web met pre-specified sensitivity requirements. Software validation performed per FDA guidance.

Technological Characteristics

Client-server software architecture; web-based deployment. Compatible with Windows (Chrome, Firefox, IE) and MacOS (Safari) environments. Supports viewing on workstations, laptops, and iPads (minimum 9.7" screen). Requires specific display standards (e.g., 20" monitor, 1600x900 resolution for workstations; 107 PPI for laptops). Connectivity via private intranet or secure internet. Does not include hardware; relies on existing PillCam capsule imaging hardware.

Indications for Use

Indicated for visualization of GI mucosa (small bowel, esophagus, upper GI, or colon) in adults and children (age 2+ for SB, 18+ for ESO/UGI/COLON). Used for monitoring Crohn's, obscure bleeding, iron deficiency anemia, or polyp detection post-incomplete colonoscopy. Contraindicated for patients unable to tolerate colonoscopy/sedation if required for follow-up.

Regulatory Classification

Identification

An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”

Predicate Devices

• RAPID 8.0 Software (K123864)

Reference Devices

• UGI Capsule (K140284)
• COLON 2 Capsule (K153466)

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

May 26, 2017

Given Imaging Ltd. Hilla Debby Director Clinical & Regulatory 2 Hacarmel St. New Industrial Park POB 258 Yoqneam, 20692 Israel

Re: K170839 Trade/Device Name: RAPID Web Regulation Number: 21 CFR§ 876.1300 Regulation Name: Ingestible Telemetric Gastrointestinal Capsule Imaging System Regulatory Class: II Product Code: NEZ, NSI, PGD Dated: March 16, 2017 Received: March 21, 2017

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.

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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 devicerelated 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,

Joyce M. Whang -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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RAPID Web

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

K170839

Device Name

### RAPID Web

Indications for Use (Describe)

With PillCam SB 2 and SB 3 Capsules

The PillCam Capsule Endoscopy System with a PillCam SB 2 and SB 3 capsules is intended for visualization of the small bowel mucosa.

- o PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
- PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules ● may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
- PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.

The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.

The PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.

### With PillCam ESO 3 Capsule

The PillCam Capsule Endoscopy System with PillCam ESO 3 capsules is intended for the visualization of esophageal mucosa in adults and children from 18 years of age..

### With PillCam UGI Capsule

The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at least 18 years of age.

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### With PillCam COLON Capsule

The PillCam COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower GI origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.

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

区 Prescription Use (Part 21 CFR 801 Subpart D) CFR 801 Subpart C)

_ Over-The-Counter Use (21

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# 510(k) SUMMARY

#### I. SUBMITTER

| Submitter Name and Address: | Given Imaging Ltd.(GI Solutions,<br>Medtronic) |
|----------------------------------|------------------------------------------------|
| 2 Hacarmel Street | |
| New Industrial Park | |
| PO Box 258 | |
| Yokneam 20692 | |
| Israel | |
| Contact Person: | Hilla Debby |
| Director, Clinical & Regulatory | |
| Email: [e-mail] | |
| Phone Number: | 972 (4) 909-7774 |
| Fax Number: | 972 (73) 2501533 |
| Date Prepared: | March 16, 2017 |

#### II. DEVICE

Device Trade Name: RAPID Web

Common or Usual Name, Classification Name, Regulatory Class, and Product Code:

21 CFR 876.1300 Ingestible telemetric gastrointestinal capsule imaging system 21 CFR 876.1330 Colon capsule endoscopy system NEZ - System, imaging, gastrointestinal, wireless, capsule, class II

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NSI - System, imaging, esophageal, wireless, capsule, class II

PGD - colon capsule imaging system, class II

#### III. PREDICATE DEVICES

RAPID 8.0 Software (K123864)

Reference Devices: UGI Capsule (K140284) and COLON 2 Capsule (K153466)

#### DEVICE DESCRIPTION IV.

The RAPID Web is a client server based version of the RAPID video review and report creation components of the cleared RAPID 8 software. The RAPID Web is designed to allow users to review and analyze videos created using the cleared RAPID software, and to create reports over a private intranet network or over a secure internet connection. The PillCam capsule studies are created at workflow-relevant locations and stored at a central repository. The RAPID Web server is installed on a central server in an intranet or internet environment with access to the study repository. After the capsule endoscopy procedure was conducted using the cleared RAPID software, Given Workstation/User PC, PillCam capsule, and DR 3 PillCam recorder, end users will use an internet browser with authorization login to access, review, and manage the studies in the repository using workstation, user PC, a laptop or an Apple™ (screen size > 9.7").

#### INTENDED USE / INDICATIONS FOR USE V.

### With PillCam SB 2 and SB 3Capsules

The PillCam Capsule Endoscopy System with a PillCam SB 2 and SB 3 capsules is intended for visualization of the small bowel mucosa.

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- · PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
- · PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
- PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsule may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.

The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.

The PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.

### With PillCam ESO 3 Capsule

The PillCam Capsule Endoscopy System with PillCam ESO 3 capsules is intended for the visualization of esophageal mucosa in adults and children from 18 years of age.

## With PillCam UGI Capsule

The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at least 18 years of age.

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# With PillCam COLON Capsule

The PillCam COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower GI origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.

#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS VI.

The RAPID Web and RAPID 8.0 have the same intended use and indications, and similar technological characteristics and principles of operation. The only technological differences between the RAPID Web and its predicates are: relocation of software from local hard drive to web-based server, increased range of viewing platforms, removal of features intended for use on mainframes and PCs, removal of viewing modes and features not critical to diagnosis, and the addition of several user friendly features. These differences do not present any new issues of safety or effectiveness because they are not critical to diagnosis and primarily affect convenience. Thus, the RAPID Web is substantially equivalent to the RAPID 8.0.

| Intended Use | RAPID Web<br>(subject) | RAPID 8.0<br>(K123864) |
|---------------------------------------------------------------------------------|-----------------------------------------|--------------------------------------------|
| Viewing of capsule<br>endoscopy studies | Viewing of capsule<br>endoscopy studies | Viewing of<br>capsule endoscopy<br>studies |
| Capsule endoscopy procedure<br>(Check-in, initialization, video<br>creation) | Not supported | Supported |
| Capsule endoscopy post-procedure<br>steps (Video review and report<br>creation) | Supported | Supported |
| Installation | Installed on a server | Installed on a<br>work station |

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| Hardware | Workstation, PC,<br>laptops, Apple iPads ><br>9.7" screen | Workstation, PC |
|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------|
| Main video reading features (Open,<br>play, viewing modes, FICE & Blue | Supported | Supported |
| Workstation related features<br>(keyboard, CD, etc.) | Not supported | Supported |
| Optional viewing aids (mosaic view,<br>image enhancement control options,<br>Lewis score, atlas, compare<br>thumbnails etc.) | Not supported | Supported |
| Additional features (dynamic player<br>control, findings preview) | Supported | Not Supported |

### Minimum Requirements

Minimum Display Requirements for Workstations Monitors

| | Minimum<br>Requirement |
|-------------------|------------------------|
| Diagonal | 20" |
| Response time | 8 ms |
| Advanced contrast | 15,000:1 |
| Resolution max | 1600x900 |

# Minimum Display Requirements for Laptops

| | Minimum Requirement |
|-----------------|--------------------------|
| Diagonal | 12.5" |
| Static contrast | 300:1 |
| Brightness | 200 nits |
| PPI | 107 PPI |
| Resolution max | 1366 x 768<br>1280 x 800 |
| Refresh rate | 60 Hz |

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Minimum Display Requirements for iPads

| | Minimum<br>Requirement |
|----------------|------------------------|
| Diagonal | 9.7" |
| Resolution max | 264 PPI |
| Diagonal | 2048 x 1536 |

Compatible operating systems and browsers:

- 1. For Windows 7 SP1, and Windows 8 or win 8.1:
- 1.1. Chrome v38.
- 1.2. Firefox v33.
- 1.3. Internet Explorer 11.0.4.

Hardware specifications: All Windows related tests were performed on Intel x86-based computer hardware that meets the operating system minimum requirements.

- 2. For MacOS v10.10 "Yosemite":
- 2.1. Safari 8.0
- 3. For MacOS v10.8 "Mountain Lion" and v10.9 "Mavericks": 3.1. Safari 7.1

MAC Hardware specifications:

- -MacBook Pro 13", 2.4GHz dual-core Intel Core i5 processor, 4GB RAM
- Macbook air 13", 1.8HGZ dual-core Intel Core i7, 4GB RAM -
- 4. For iPad with iOS 8.1:
- 4.1. Safari 8.0

iPad Hardware specifications:

- iPad 4: Dual-core A6X with quad-core graphics and 16GB storage
- iPad air: A7 chip with 64-bit architecture and 16GB storage -
- 5. Color depth: 24 bit

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#### VII. PERFORMANCE DATA

A comparative performance study wherein trained professionals identified pathologies in the same video and video segments that we displayed using RAPID Web and RAPID 8.0 was performed. RAPID 8.0 performance was assessed on multiple platforms, including workstations, laptops, and iPads. An analysis assessing the matched and un-matched pathologies showed that RAPID 8.0 met the pre-specified sensitivity.

In addition, the software was validated and documented per FDA's software guidance document.

#### VIII. CONCLUSIONS

The RAPID Web is as safe and effective as the RAPID 8.0. The RAPID Web has the same intended uses and indications, and similar technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended diagnostic use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the RAPID Web and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the RAPID Web is as safe and effective as the RAPID 8.0. Thus, the RAPID Web is substantially equivalent.