(76 days)
The Given® Diagnostic System with the PillCam™ SB2 Capsule is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 10 years of age and up. The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
The Given® Diagnostic System is comprised of three subsystems PillCam™ Capsule (SB, ESO), Data Recorder Set, and RAPID® Workstation or RAPID® Software. The modifications to the Given® Diagnostic System, which are the subject of this Special 510(k), include: Addition of a new model of small bowel capsule, the PillCam™ SB2 capsule. Addition of three new features to the RAPID Software: Lewis Score (optional), Study Management, Installation for End-User Computers (optional).
The provided text is a 510(k) summary for the Given® Diagnostic System with the PillCam™ SB2 Capsule. This document describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not include detailed information regarding acceptance criteria, study performance results, sample sizes for test or training sets, expert qualifications, ground truth establishment, or specific study types like MRMC or standalone performance evaluations.
The document primarily focuses on regulatory approval by demonstrating substantial equivalence, rather than presenting a detailed performance study against specific acceptance criteria.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be inferred or explicitly stated based on the input:
Acceptance Criteria and Device Performance Study Information
1. Table of Acceptance Criteria and Reported Device Performance:
No specific acceptance criteria (e.g., sensitivity, specificity thresholds) or quantitative performance results for the device (PillCam™ SB2 Capsule or SBI feature) against such criteria are presented in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study against pre-defined acceptance criteria.
2. Sample Size for the Test Set and Data Provenance:
No information regarding the sample size used for a test set, nor the provenance (country of origin, retrospective/prospective) of such data, is provided in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
No information about experts used for ground truth establishment or their qualifications for a test set is provided.
4. Adjudication Method for the Test Set:
No information about an adjudication method for a test set is provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done, or any effect size for human readers with vs. without AI assistance, is present in this 510(k) summary.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance):
No information is provided about a standalone performance study for the device's features (such as the SBI feature).
7. Type of Ground Truth Used:
The document does not specify the type of ground truth used for any performance evaluation.
8. Sample Size for the Training Set:
No information regarding the sample size for a training set is provided.
9. How the Ground Truth for the Training Set Was Established:
No information regarding how ground truth for a training set was established is provided.
Summary of Device and Intended Use from the document:
- Trade Name: Given® Diagnostic System
- Device Name: Given® Diagnostic System with PillCam™ SB2 Capsule
- Classification Name: Ingestible Telemetric Gastrointestinal Capsule Imaging System
- Intended Use: Visualization of the small bowel mucosa. May be used as a tool in the detection of abnormalities of the small bowel in adults and children from 10 years of age and up.
- Specific Feature (SBI): The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
- Modifications subject to 510(k):
- Addition of a new model of small bowel capsule: PillCam™ SB2 capsule.
- Addition of three new features to the RAPID Software: Lewis Score (optional), t Study Management, Installation for End-User Computers (optional).
Key Takeaway: This 510(k) summary asserts "substantial equivalence" to a predicate device (Given® Diagnostic System cleared under multiple previous K numbers) and refers to compliance with FDA's "Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System." It does not present detailed performance data from a specific study designed to meet quantitative acceptance criteria, which is common for special 510(k)s and substantial equivalence claims where the new device is very similar in performance to an already cleared device.
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Page 1 of 2
ATTACHMENT 6-1
510(K) SUMMARY
MAY -- 7 2007
Expanding the scope of C++
Given® Diagnostic System with PillCam™ SB2 Capsule
510(k) Number K070475
Applicant's Name:
Given Imaging Ltd. Hermon Building (Shaar Yoqneam) New Industrial Zone P.O. Box 258 Yoqneam 20692, Israel Tel.: 011-972-4-9097730 Fax: 011-972-4-9592466
Contact Person:
Shosh Friedman, RAC Senior Consultant 91 Rokyspring Cir. NW Calgary, AB T3G 6A1, Canada Tel: (403) 208-4916 Fax: (403) 208-4953 Email: Shosh.Friedman@givenimaging.com
Trade Name:
Given® Diagnostic System
Classification Name:
Ingestible Telemetric Gastrointestinal Capsule Imaging System
Classification:
FDA has classified Ingestible Telemetric Gastrointestinal Capsule Imaging System as class II devices (product code 78NZE, regulation CFR 876.1300) and they are reviewed number 21 bv the Gastroenterology Panel.
Predicate Device:
Given® Diagnostic System cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248, K052184, K060805 and K062786
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K070475 Page 2 of 2
Performance Standards and Special Controls:
The Given® Diagnostic System complies with the requirements presented in "Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA" issued on November 28, 2001
Intended Use:
The Given® Diagnostic System with the PillCam™ SB2 Capsule is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 10 years of age and up
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas
Device Description:
The Given® Diagnostic System is comprised of three subsystems PillCam™ Capsule (SB, ESO), Data Recorder Set, and RAPID® Workstation or RAPID® Software.
The modifications to the Given® Diagnostic System, which are the subject of this Special 510(k), include:
- Addition of a new model of small bowel capsule, the PillCam™ (1) SB2 capsule.
- (2) Addition of three new features to the RAPID Software
- Lewis Score (optional) .
- t Study Management
- Installation for End-User Computers (optional) .
Substantial Equivalence:
Given Imaging Ltd. believes that the modified Given® Diagnostic System is substantially equivalent to the market cleared Given® Diagnostic System without raising any new safety and/or efficacy issue.
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Image /page/2/Picture/0 description: The image shows a logo with a stylized bird-like figure composed of three curved lines, suggesting movement or flight. To the left of the bird, there is text arranged vertically along a curved path, likely the name of an organization or department. The text is somewhat blurry, making it difficult to read the exact words.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Shoshana Friedman, RAC V.P. Regulatory and Medical Affairs Given® Imaging Ltd. 91 Rockyspring Cir. N.W. Calgary, Alberta T3G6A1 CANADA
- 7 2007 MAY
Re: K070475
KU/0475
Trade/Device Name: Given® Diagnostic System with PillCam™ SB2 Capsule Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NEZ Dated: April 3, 2007 Received: April 6, 2007
Dear Ms. Friedman:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image shows a circular stamp with the text "1906-2006" at the top. Inside the circle, the letters "FDA" are prominently displayed in a stylized font. Below the letters, the word "Centennial" is written in a cursive font. At the bottom of the circle, there are three stars.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I least of advisou mail 1221 i issumines 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) I this lotter will and in your finding of substantial equivalence of your device to a legally promation from the results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you done if compliance at one of the following numbers, based on the regulation number at the top of this letter:
21 CFR 876.xxxx 21 CFR 884.xxxx 21 CFR 892.xxxx Other
(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology);
240-276-0115 240-276-0115 240-276-0120 240-276-0100
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 Also, picase note the regulation other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 6-3
INDICATIONS FOR USE STATEMENT
510(k) Number: K0 70475
Device Name:
Given® Diagnostic System
Indications for Use:
The Given® Diagnostic System with the PillCam™ SB2 Capsule is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 10 years of age and up
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number K070475
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use_
Ruta Phillips
Division Sign Off
Division Sign-Off Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
§ 876.1300 Ingestible telemetric gastrointestinal capsule imaging system.
(a)
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.(b)
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.”