(83 days)
No
The description focuses on electro-optical measurement and computation of ratios using Molecular Correlation Spectroscopy, with no mention of AI or ML algorithms for data processing or interpretation.
No.
Explanation: The device is intended for the diagnosis and monitoring of H. pylori infection, not for treating it.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection."
No
The device description explicitly states it consists of an "electro-optical medical device with embedded software" and a test kit with physical components, indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "continually and non-invasively measure changes in the 1302 / 1202 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach." This involves analyzing a sample (exhaled breath) taken from the human body to provide information about a physiological state (H. pylori infection).
- Device Description: The device description details how it measures and computes the ratio of isotopes in exhaled breath after the ingestion of a substance (13C-urea). This is a classic example of an in vitro diagnostic test where a sample (breath) is analyzed outside the body to aid in diagnosis.
- Test Kit: The inclusion of a "test kit" with components like the 13C-urea tablet and citric acid further supports its classification as an IVD. These are reagents and materials used in the diagnostic process.
- Clinical Validation: The performance studies include clinical validation comparing the device to a predicate device for diagnosing H. pylori infection, which is a typical requirement for IVDs.
While the device itself is an electro-optical system, its function is to analyze a biological sample (exhaled breath) to provide diagnostic information. This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Exalenz BreathID® Hp System is intended for use to continually and non-invasively measure changes in the 1302 / 1202 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The Exalenz BreathID® Hp System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. The Exalenz BreathID® Hp System consists of the IDkit:Hp™ and the BreathID® Hp test device.
The device is for use by trained health care professionals. To be administered under a physician's supervision.
Product codes
MSQ
Device Description
The modified BreathID® Hp System is a non-invasive breath test system for detecting the presence of Helicobacter pylori (H. pylori). The system consists of an electro-optical medical device with embedded software designed to measure and compute the changes in the ratio between 1302 and 1202 concentrations in the patient's exhalation and a test kit. The test kit consists of:
- IDcircuit™ Oridion Nasal FilterLine™ (nasal cannula) (K980325) ■
- . A 75mq 13C-urea tablet
- A 4.3g package of powdered Citrica (citric acid) l
- 트 Drinking straw
- . Package Insert (Instructions for Use)
The modified BreathID® Hp System measures and computes the ratio between 1302 and 1202 in the patient's exhalation before and after the ingestion of 13C-urea. The change in the 1302 / 14002 ratio before and after ingestion of "C-urea is referred to as the Delta over Baseline (DOB).
The basis of the 13C measurement method for both the modified versions of the BreathID® System is a technology called Molecular Correlation Spectroscopy™ (MCS™), MCS™ is based on the concept of optical absorption of specific radiation emitted from CO2 discharge lamps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Stomach
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Trained health care professionals, under a physician's supervision, in the clinical setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Verification and Validation Bench Testing
- Gas Collection Verification: 20 tests with breath samples from 10 subjects. Verified adequate replacement of Capnograph by the 1202 and 1302 measurement subsystem.
- System Check Verification: 20 tests with breath samples from 11 subjects. Verified that operator breath or pre-dose patient breath could adequately replace the gas canister for System Check. Verified calibration process effectiveness.
- Software Verification and Validation: Evaluations of system functionality, unit integration, system level testing, code reviews, and various test cases (H. Pylori Patient Mode Tests, System Test, Utilities, System Failures). All test cases passed.
- Comparative Validation: Evaluated agreement of modified BreathID® Hp System DOB measurements to the unmodified BreathID® System.
- Sample Size: 20 DOB measurements for each of 3 expected DOB values (4.5‰, 5.8‰, 13‰).
- Key Results: Pearson's correlation coefficient r = 0.9944 (95% Cl: [0.9904, 0.9966]), p
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).
0
Exalenz Bioscience Ltd. – Traditional 510(k) – Modified BreathID® Hp System Section 7: 510(k) Summary
Section 7: 510(k) Summary
MAY 2 2 2013
Introduction:
This document contains the 510(k) Summary for the modified BreathID® Hp System. The content of this summary is based on the requirements of 21 CFR 807.92(c).
| Applicant / Manufacturer
Name and Address: | Exalenz Bioscience Ltd.
4 Ha' Maayan St.
Modiin, Israel 71700 | | |
|-----------------------------------------------|-----------------------------------------------------------------------------|--|--|
| 510(k) Contact Person: | Clay Anselmo
President
Reglera LLC | | |
| | Email: anselmoc@reglera.com
Phone: (303) 223-4303
Fax: (303) 832-6700 | | |
| Date Prepared: | February 27, 2013 | | |
| Device Name: | BreathID® Hp System | | |
| Classification: | Class I | | |
| Classification Name: | Campylobacter fetus serological agents | | |
| Regulation Number: | 21 CFR 866.3110 | | |
| Product Code: | MSQ | | |
Predicate Devices:
The modified BreathID® Hp System is claimed to be substantially equivalent to the following legally marketed predicate device:
BreathID® System, Exalenz Bioscience Ltd., K011668 트
General Description:
The modified BreathID® Hp System is a non-invasive breath test system for detecting the presence of Helicobacter pylori (H. pylori). The system consists of an electro-optical medical device with embedded software designed to measure and compute the changes in the ratio between 1302 and 1202 concentrations in the patient's exhalation and a test kit. The test kit consists of:
- IDcircuit™ Oridion Nasal FilterLine™ (nasal cannula) (K980325) ■
- . A 75mq 13C-urea tablet
- A 4.3g package of powdered Citrica (citric acid) l
- 트 Drinking straw
- . Package Insert (Instructions for Use)
1
Exalenz Bioscience Ltd. - Traditional 510(k) - Modified BreathID® Hp System Section 7: 510(k) Summary
The modified BreathID® Hp System measures and computes the ratio between 1302 and 1202 in the patient's exhalation before and after the ingestion of 13C-urea. The change in the 1302 / 14002 ratio before and after ingestion of "C-urea is referred to as the Delta over Baseline (DOB).
The basis of the 13C measurement method for both the modified versions of the BreathID® System is a technology called Molecular Correlation Spectroscopy™ (MCS™), MCS™ is based on the concept of optical absorption of specific radiation emitted from CO2 discharge lamps.
Intended Use / Indications for Use:
The Exalenz BreathID® Hp System is intended for use to continually and non-invasively measure changes in the 1902 / 1202 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The Exalenz BreathID® Hp System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. The Exalenz BreathID® Hp System consists of the IDkit:Hp™ and the BreathID® Hp test device.
The device is for use by trained health care professionals. To be administered under a physician's supervision.
Comparison of Technological Characteristics:
The key characteristics of the modified BreathID® Hp System are substantially equivalent to the prior cleared version of the device in all regards. Any differences are minor, are supported by testing, and do not raise new types of questions of substantial equivalence.
The modified Breath!D® Hp System has the same fundamental scientific technology and principle of operation utilized in the unmodified BreathID® System. The technological modifications of the BreathID® Hp System are modifications to the configuration of the system and software revisions as a result of the modified hardware configuration.
This modified BreathID® Hp System is designed to be more compact, less expensive and easier to maintain than the unmodified system. In addition, the modified BreathID® Hp System either eliminates or consolidates components that have become redundant or obsolete.
Comparison of Intended Use:
There are no significant changes in the intended use or the indications for use between the modified BreathID® Hp System and the unmodified BreathID® System. The use environment, target user, and patient population of the modified BreathlD® Hp System are the same as the unmodified device.
Substantial Equivalence:
The following tables summarize the similarities and differences of the Exalenz BreathID® System cleared in K011668 to the modified Exalenz BreathID® Hp System that is the subject of this 510(k) submission.
2
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n 7: 510(k) Summary
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3
Exalenz Bioscience Ltd. – Traditional 510(k) – Modified BreathID® Hp System
Section 7: 510(k) Summary
:
| Specification /
| Characteristic | Exalenz Modified BreathID® Hp System | Exalenz BreathID® System (K011668) |
|---|---|---|
| Test Meal | 4.3g Citrica (citric acid) dissolved in water | 4.3g Citrica (citric acid) dissolved in water |
| Test Duration | 10-30 minutes | 10-30 minutes |
| Breath Collection | Continually over test duration | Continually over test duration |
| Cut-off Point | 5.0 DOB per mil (post dose minus pre dose) | 5.0 DOB per mil (post dose minus pre dose) |
| Organism | Helicobacter pylori in vivo | Helicobacter pylori in vivo |
| Reagent | 13C Urea | 13C Urea |
| Result | 13CO2/12CO2 ratio – Molecular Correlation | |
| Spectroscopy™ (MCS™) | 13CO2/12CO2 ratio – Molecular Correlation | |
| Spectroscopy™ (MCS™) |
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4
nz Bioscience Ltd. – Traditional 510(k) – Modified BreathlD® H
n 7: 510(k) Summary
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5
Exalenz Bioscience Ltd. - Traditional 510(k) - Modified BreathID® Hp System Section 7: 510(k) Summary
Discussion of Differences
All differences between the modified and unmodified versions of the device have been formally verified or validated to ensure that the changes do not impact device specifications or performance.
The device instructions for use have been updated to reflect the changes made to the operator / device interface and to incorporate the clinical performance characteristics of the device itself. The changes made do not alter the Indications / Contraindications or Warnings / Precautions.
The hardware / physical configuration has been modified in comparison to the unmodified BreathlD® System. As demonstrated by the results of verification and validation, the modified hardware / physical configuration of the modified BreathID® Hp System does not have an effect on performance or substantial equivalence as compared to the unmodified BreathID® System.
Software changes have been implemented for the modified BreathID® Hp System related to the modified hardware configuration of the device. The software changes do not affect the safety and effectiveness of the modified BreathID® Hp System as compared to the unmodified BreathID® System.
Summary of Performance Bench Testing
Exalenz has performed verification and validation bench testing for demonstration of substantial equivalence of the modified BreathID® Hp System to the unmodified BreathID® System. The following key verification and validation bench tests are the most significant for establishing substantial equivalence:
- · Gas Collection Verification
- . System Check Verification
- . Comparative Validation
- . Analytical Studies
- o Precision Validation
- Reproducibility Validation o
- Software Verification and Validation
A summary of the Gas Collection, System Check Verification, Software Verification and Validation, Comparative Validation, Precision Validation and Reproducibility Validation is provided below.
Gas Collection Verification
A Gas Collection Verification was performed to verify that the 1202 and 1302 measurement subsystem of the BreathID® Hp System could adequately replace the Capnograph of the unmodified BreathID® System for measuring the CO2 concentration in incoming gases. Twenty (20) tests were performed with breath samples that were not 130 enriched from ten (10) different Each of the twenty (20) tests also included seven (7) DOB measurements from the subiects. measurement phase (MP) in various calibration ranges. The results of the Gas Collection Verification demonstrated that the DOB standard deviation of all measurement phase (MP) test results were within the specifications, all MP test sample concentrations were within the calibration range, and that all MP sample concentrations had a standard deviation of less than 0.2. Therefore, the 1202 cell of the 1302 and 1202 measurement subsystem of the BreathID® Hp System has been verified to adequately replace the Capnograph of the unmodified BreathID® System for measuring the CO2 concentration in incoming gases.
System Check Verification
A System Check Verification was performed to verify that operator breath or pre-dose patient breath could adequately replace the gas canister containing approximately 100% CO2 for the purposes of the System Check, one of the Quality Control functions of the BreathID® Hp System and the unmodified BreathID® System. Twenty (20) tests were performed with breath samples from eleven (11) different subjects. Each of the twenty (20) tests also included seven (7) DOB measurements. The results of the System Check Verification demonstrated that in all cases where the 12C curves
6
Exalenz Bioscience Ltd. - Traditional 510(k) - Modified BreathID® Hp System Section 7: 510{k} Summary
were randomly changed and a calibration was then required, the situation was correctly identified by the BreathID® Hp System and a calibration was performed. In all cases where the 14C curves were unchanged and the calibration process was unable to expand the calibration range, the BreathlD® Hp System correctly identified the situation and did not perform a calibration. In the case where the 12 curve was unchanged, but the calibration range was expanded and a calibration was then required the BreathID® Hp System correctly identified the situation and performed a calibration. All test results following a System Check and calibration were within the specifications of the Breath!D® Ho System. Additionally, all test results following a System Check that did not require calibration were within the specifications of the BreathID® Hp System. Therefore, the System Check Verification not only demonstrated that operator breath or pre-dose patient breath could be adequately used for the System Check procedure, but it also demonstrated that the calibration process was effective.
Software Verification and Validation
Software Verification evaluated all system functionality and consisted of evaluations of the software through unit integration and system level testing, as well as code reviews. Software Validation consisted of various test cases to qualitatively test the software system of the BreathID® Hp System. The test case categories that were utilized for the software validation of the BreathID® Hp System were:
- l H. Pylori Patient Mode Tests
- l System Test
- . Utilities, and
- 트 System Failures
All test cases were implemented with a known input and an expected output. The expected output was visually compared against the actual output. All test cases were verified to have passing results.
Comparative Validation
A Comparative Validation was performed to evaluate the agreement of the modified BreathID® Hp System DOB measurements to its predicate device, the unmodified BreathID® System. The Comparative Validation was performed in accordance with the following standard:
- Clinical and Laboratory Standards Institute EP09-A2 Method Comparison and Bias u Estimation Usina Patient Samples: Approved Guideline - Second Edition
The Comparative Validation was performed with three H. pylori samples that included a high positive, low positive and moderate positive, as defined in the FDA Draft Guidance "Establishing Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori, September 23, 2010. The Comparative Validation was performed with one modified BreathID® Hp System and one unmodified BreathlD® System, executing two runs per day for five days. Each test run included three different combinations of baseline / post-ingestion gases and each combination of baseline / post-ingestion gases was consecutively tested twice. The modified BreathlO® Hp System and the unmodified BreathID® System were evaluated simultaneously by connecting the two devices with a Y-Connector. Calibration was performed on the first day of the Comparative Validation. Table 7-3 below provides the results and analysis of the Comparative Validation.
7
| Expected
| DOB | Parameter | N | Mean | SD | Min | Median | Max |
|---|---|---|---|---|---|---|---|
| DOB: | |||||||
| 4.5‰ | DOB | ||||||
| Modified | |||||||
| BreathID® | 20 | 4.96 | 0.350 | 4.3 | 4.97 | 5.6 | |
| DOB | |||||||
| Unmodified | |||||||
| BreathID® | 20 | 4.69 | 0.233 | 4.2 | 4.65 | 5.2 | |
| Difference | |||||||
| in DOB | |||||||
| Between | |||||||
| Devices | 0.27 | 0.368 | -0.5 | 0.28 | 1.0 | ||
| DOB: | |||||||
| 5.8‰ | DOB | ||||||
| Modified | |||||||
| BreathID® | 20 | 6.37 | 0.297 | 6.0 | 6.33 | 7.0 | |
| DOB | |||||||
| Unmodified | |||||||
| BreathID® | 20 | 6.07 | 0.266 | 5.5 | 6.07 | 6.5 | |
| Difference | |||||||
| in DOB | |||||||
| Between | |||||||
| Devices | 0.30 | 0.366 | -0.3 | 0.20 | 0.9 | ||
| DOB: | |||||||
| 13‰ | DOB | ||||||
| Modified | |||||||
| BreathID® | 20 | 14.09 | 0.424 | 13.2 | 14.03 | 14.9 | |
| DOB | |||||||
| Unmodified | |||||||
| BreathID® | 20 | 13.32 | 0.358 | 12.4 | 13.37 | 13.8 | |
| Difference | |||||||
| in DOB | |||||||
| Between | |||||||
| Devices | 0.78 | 0.526 | -0.3 | 0.75 | 1.7 |
| Table 7-3: Distribution of DOB Measurements Between Modified and Unmodified BreathlD® Systems | |||
|---|---|---|---|
A Pearson's correlation coefficient was calculated between the DOB measurements from the unmodified and modified BreathID® Systems. A correlation plot of the DOB measurements from the modified and unmodified BreathID® Systems is provided in Figure 7-1 below. The following values were calculated:
l r = 0.9944 (95% Cl: [0.9904, 0.9966]
I p