(89 days)
The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.
The Bravo pH Monitoring System™ and Accessories is an ambulatory esophageal pH testing device. The Bravo system is a simple, minimally invasive outpatient procedure that involves the placement of a pH telemetry Capsule against the mucosal wall of the esophagus that simultaneously measures pH and transmits the data to a receiver attached to the patient's waist. The Bravo pH Monitoring System™ and Accessories consists of four main components: Bravo pH Capsule with Delivery System, Bravo pH Receiver, RAPID pH and PolygramNet software, and Bravo pH Delivery System Accessories.
The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the Bravo pH Monitoring System. It primarily focuses on the 510(k) submission for substantial equivalence to a predicate device.
However, based on the limited information, here's what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision) are provided in the document. The submission states that the device is substantially equivalent to a predicate device (Bravo pH Monitoring System™ and Accessories, K002028) and that "Performance Data: Clinical data has been summarized to show safety and effectiveness for the proposed indications for use." However, the actual summary of this clinical data or details of how effectiveness was measured are not present.
2. Sample Size Used for the Test Set and the Data Provenance:
The document mentions "Clinical data has been summarized," but it does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
The document describes the "RAPID pH and PolygramNet software" as intended to "record, store, view, and analyze gastroesophageal pH data, enabling physicians to interpret study results." However, it does not mention any MRMC comparative effectiveness study or any AI component that would assist human readers and quantify their improvement. The technological characteristics are stated to be "exactly the same as the predicate devices," suggesting the focus is on maintaining existing performance rather than demonstrating improvements through AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document mentions software for recording, storing, viewing, and analyzing data. However, it does not describe any standalone algorithm performance study without human interpretation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The document mentions "gastroesophageal pH measurement and monitoring of gastric reflux." The "ground truth" for this device would inherently be the pH values themselves, measured by the pH telemetry capsule. However, the exact methodology for establishing the accuracy or "truth" of these pH measurements (e.g., against a gold standard pH meter) is not detailed in this summary.
8. The Sample Size for the Training Set:
This information is not provided in the document. Given the device's nature (pH measurement and monitoring) and the indication of substantial equivalence to a predicate, it's unlikely a "training set" in the machine learning sense was a primary focus for this particular 510(k) submission, unless the software used advanced algorithms that are not explicitly mentioned.
9. How the Ground Truth for the Training Set was Established:
This information is not provided in the document.
In summary, the provided 510(k) summary is focused on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria, sample sizes, expert ground truth, or adjudication methods. The core claim is that the updated Bravo pH Monitoring System™ and Accessories has "technological characteristics... exactly the same as the predicate devices" and that "Clinical data has been summarized to show safety and effectiveness for the proposed indications for use," leading to the conclusion that it "does not raise new issues of safety or effectiveness."
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GI EN®
IMAGING
Given Imaging Limited New Industrial Park PO Box 258, Yoqneam 20692 Israel Voice 972 4 909 7777 Fax 972 4 959 2466
510(k) Summary
DEC 1 2010
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 Name and Address: | Given Imaging Ltd.Hermon BuildingNew Industrial ParkPO Box 258Yoqneam 20692IsraelTel.: 011-972-4-9097730Fax: 011-972-4-9938060 |
|---|---|
| Contact Person: | Tim ThomasVice President,Regulatory Affairs and Quality AssuranceEmail: tim.thomas@givenimaging.com |
| Phone Number: | 770-662-0870 ext. 1006 |
| Fax Number: | 770-662-0510 |
| Establishment Registration Number: | 9710107 |
| Date Prepared: | September 1, 2010 |
| Device Trade Name(s): | Bravo pH Monitoring System™ and Accessories |
| Device Common Name: | Stomach pH electrode |
| Classification: | Regulation No: 876.1400Class: IPanel: GastroenterologyFFT - Stomach pH electrode |
| Predicate Device(s): | Bravo pH Monitoring System™ and Accessories (K002028) |
| General Device Description: | The Bravo pH Monitoring System™ and Accessories is anambulatory esophageal pH testing device. |
Given Imaging Ltd. New Industrial Park, PO Box 258, Yoqneam 20692, Israel
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Given Imaging Limited New Industrial Park PO Box 258, Yogneam 20692 Israel Voice 972 4 909 7777 Fax 972 4 959 2466
The Bravo system is a simple, minimally invasive outpatient procedure that involves the placement of a pH telemetry Capsule against the mucosal wall of the esophagus that simultaneously measures pH and transmits the data to a receiver attached to the patient's waist. The Bravo pH Monitoring System™ and Accessories consists of
four main components:
Bravo pH Capsule with Delivery System
Bravo pH Capsule with Delivery System is an antimony pH sensor, in the form of a pH Capsule that is temporarily attached to the wall of the esophagus with a delivery system. The capsule is placed following an esophago- gastroduodenoscopy (EGD) at 6 cm above the Z-line. The capsule then transmits pH data via radiotelemetry to a receiver worn by the patient.
Bravo pH Receiver
The Bravo pH Receiver is lightweight and compact. It fits into a carrying case that comes with a strap and a belt clip allowing patients to carry it over the shoulder, attach it to a belt, or carry it in a pocket (without the carrying case). This flexibility allows the patient to carry the Receiver throughout the study period. The Receiver is designed with two separate interfaces: one for the patient and one for clinicians.
RAPID pH and PolygramNet software
The software is intended to record, store, view, and analyze gastroesophageal pH data, enabling physicians to interpret study results.
Bravo pH Delivery System Accessories:
Bravo pH Delivery System Accessories include calibration stand, vacuum pump, pH 1.07 and pH 7.01 calibration buffer solutions, Bravo DataLink, Bravo Adapter, and Bravo Pouch.
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Image /page/2/Picture/1 description: The image shows the logo for Given Imaging. The logo consists of the word "GIVEN" in large, bold letters, with a stylized image of a chalice or goblet in between the "GI" and "EN". Below the word "GIVEN" is the word "IMAGING" in smaller, bold letters. The logo is black and white.
Given Imaging Limited New Industriai Park PO Box 258, Yoqneam 20692 Israel Voice 972 4 909 7777 Fax 972 4 959 2466
| Intended Use: | The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry.The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data. |
|---|---|
| Technological Characteristics: | The technology characteristics are exactly the same as the predicate devices. |
| Performance Data: | Clinical data has been summarized to show safety and effectiveness for the proposed indications for use. |
| Conclusion: | Based on the technological characteristics and clinical performance of the devices, Given Imaging Ltd. believes that The Bravo pH Monitoring System™ and Accessories and the predicate device selected is substantially equivalent and does not raise new issues of safety or effectiveness. |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Tim Thomas Vice President Regulatory Affairs and Quality Assurance Given Imaging Limited New Industrial Park P.O. Box 258, Yogneam 20692 ISRAEL
DEC 1 2010
Re: K102543
Trade/Device Name: Bravo pH Monitoring System™ and Accessories Regulation Number: 21 CFR §876.1400 Regulation Name: Stomach pH electrode Regulatory Class: I Dated: September 1, 2010 Received: September 3, 2010
Dear Mr. Thomas:
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. 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 of medical device-related
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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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) 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
K102543 510(k) Number (if known):
Device Name: Bravo pH Monitoring System™ and Accessories
DEC 1 2010
Indications for Use:
The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
(Division Sign-Off)
Division of Reproductive, Gastro-Rend
Urological Devices
510(k) Number __ K102543
page 1 of 1
§ 876.1400 Stomach pH electrode.
(a)
Identification. A stomach pH electrode is a device used to measure intragastric and intraesophageal pH (hydrogen ion concentration). The pH electrode is at the end of a flexible lead which may be inserted into the esophagus or stomach through the patient's mouth. The device may include an integral gastrointestinal tube.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.