(86 days)
Not Found
No
The description focuses on the measurement of CO2 ratios using established spectroscopic technology and a simple calculation (Delta over Baseline). There is no mention of AI, ML, or complex pattern recognition beyond this direct measurement and calculation.
No
The device is indicated as an aid in diagnosis and post-treatment monitoring, not for direct treatment of a condition.
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 that the system consists of an "electro-optical medical device with embedded software" and a test kit, indicating the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is used to measure changes in the 13CO2 /12CO2 ratio of exhaled breath, which "may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach." This measurement is performed on a sample (exhaled breath) taken from the human body.
- Indications for Use: The indications state it is used "as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection." Diagnosis and monitoring of a disease are key functions of IVD devices.
- Device Description: The description details how the system measures and computes the ratio of isotopes in exhaled breath after the ingestion of a substance (13C-urea). This process of analyzing a biological sample to provide diagnostic information is characteristic of an IVD.
- Components: The system includes a "test kit" with a 13C-urea tablet and citric acid, which are reagents used in the diagnostic process.
The definition of an In Vitro Diagnostic (IVD) device generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits this definition by analyzing a biological sample (exhaled breath) to aid in the diagnosis and monitoring of H. pylori infection.
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 "CO /14CO2 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 and pediatric patients ages 3-17 years old. The Exalenz BreathID® Hp System consists of the appropriate IDkit:Hp™ kit 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, JJQ
Device Description
The 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 ratio between 13002 and 12CO2 concentrations in the patient's exhalation, and a test kit. The IDkit Hp™ One kit consists of:
- A 75mg 13C-urea tablet ●
- A 4.3g package of powdered Citrica (citric acid) ●
- One IDcircuit™ nasal cannula ●
- Drinking straw
- Package Insert (Instructions for Use) ●
- Quick User Guide
The BreathID® Hp System measures and computes the ratio between 13CO2 and 1202 in the patient's exhaled breath before and after the ingestion of 13C-urea. The change in the 13CO2 / 12CO2 ratio before and after ingestion of 13C-urea is used to compute the Delta over Baseline (DOB).
The 13C measurement method for both the subject and the cleared (predicate) versions of the BreathID® Hp System is based on Molecular Correlation Spectroscopy™ (MCS) technology. MCS technology 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 and pediatric patients ages 3-17 years old.
Intended User / Care Setting
Trained health care professionals. To be administered under a physician's supervision.
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
A multi-center, non-randomized, open label study was conducted. The study was conducted at 6 clinical sites that were geographically diverse, differing in size (from small private clinics to large hospitals) and diverse in experience. A central laboratory analyzed the stool specimens with an FDA cleared H. pylori stool antigen test. Local site personnel were trained on administering the breath test using a BreathID® Hp System.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation: Software testing was conducted to evaluate the performance of the subject system and to verify that it performs according to its specifications. Verifications involved functionality testing, timing analysis, integration with the hardware, and error detection and handling. Verification was achieved by design reviews, code walkthroughs, functional testing of sub-components and integration testing with the hardware. Additionally, the software was extensively verified at the system level.
Clinical Validation: A multi-center, non-randomized, open label study was conducted with 53 enrolled subjects for safety assessment. Forty-one subjects completed the full study protocol requirements for the FA set with evaluable breath and stool test endpoints.
- The primary study endpoint was to confirm the safety of the 13C-urea substrate using the standard dose of 75mg 13C-urea and 4g citric acid in the pediatric population. The safety endpoint included all adverse events (AEs).
- The secondary endpoint was performance, assessed as the positive percent agreement and negative percent agreement between the BreathID® Hp System, applying the predefined threshold of 5 DOB, and the stool antigen test results.
- A total number of 54 subjects were screened, of which 1 subject was a screening failure prior to any study related procedure. Fifty-three subjects were enrolled (full analysis - FA set) and were followed for the safety assessment. Forty-one of them completed the full study protocol requirements for the FA set with evaluable breath and stool test endpoints.
- Among the 53 pediatric subjects followed for the safety assessment, one adverse event of vomiting was experienced by one subject (1.89%) and resolved on the same day. There were no reportable major safety concerns due to adverse events.
- The positive percent agreement between the breath test and the stool antigen test results was 93.3% [95% C1:68.05;99.83] and the negative percent agreement was 100% [95% CI: 86.77%:100%].
- These study results met the predefined success criteria for confirming the safety of the 13 C-urea substrate in the pediatric population, and for providing further evidence of BreathID Hp System performance in this population taking into consideration prior supportive clinical performance in the adult population.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive percent agreement: 93.3% [95% C1:68.05;99.83]
Negative percent agreement: 100% [95% CI: 86.77%:100%]
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" and the words "U.S. Food & Drug Administration."
March 14, 2018
Exalenz Bioscience Ltd. % George Hattub Senior Staff Consultant Medicsense USA 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K173772
Trade/Device Name: BreathID Hp System Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: Class I Product Code: MSQ, JJQ Dated: December 1, 2017 Received: December 12, 2017
Dear George Hattub:
This letter corrects our substantially equivalent letter of March 8, 2018.
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
1
801 and Part 809); medical device 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar -S For
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K173772
Device Name
BreathID® Hp System
Indications for Use (Describe)
The Exalenz BreathID® Hp System is intended for use to continually and non-invasively measure changes in the "CO /14CO2 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 and pediatric patients ages 3-17 years old. The Exalenz BreathID® Hp System consists of the appropriate IDkit:Hp™ kit and the BreathID® Hp test device.
The device is for use by trained health care professionals. To be administered under a physician's supervision.
| Type of Use ( Select one or both, as applicable ) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY
510(K) Number K173772
Purpose of this 510(k):
The primary purpose of this 510(k) submission is to expand the indications for use of the BreathID® Hp System to include use with pediatric patients ages 3-17 years old. Both the predicate and the subject device are identical.
Applicant's Name:
Exalenz Bioscience Ltd. 4 Ha'Maayan Street Modiin, 7177872, Israel Tel: +972-8-9737502 Fax: +972-8-9737501
Contact Person:
George Hattub MedicSense USA 291 Hillside Avenue Somerset, MA 02726 Tel: 1-508-479-6116 Fax: 1-509-277-1418 Mail: george(@medicsense.com
Date Prepared:
March 7, 2018
Trade Name: BreathID® Hp System
Classification Name:
Test, urea (breath or blood)
Product Code:
MSQ
Device Class: I
Regulation Number: 866.3110
4
Panel:
Microbiology
Predicate Device:
Exalenz BreathID® Hp System [Exalenz Bioscience Ltd.] cleared under K130524
Device Description:
The 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 ratio between 13002 and 12CO2 concentrations in the patient's exhalation, and a test kit. The IDkit Hp™ One kit consists of:
- A 75mg 13C-urea tablet ●
- A 4.3g package of powdered Citrica (citric acid) ●
- One IDcircuit™ nasal cannula ●
- Drinking straw
- Package Insert (Instructions for Use) ●
- Quick User Guide
The BreathID® Hp System measures and computes the ratio between 13CO2 and 1202 in the patient's exhaled breath before and after the ingestion of 13C-urea. The change in the 13CO2 / 12CO2 ratio before and after ingestion of 13C-urea is used to compute the Delta over Baseline (DOB).
The 13C measurement method for both the subject and the cleared (predicate) versions of the BreathID® Hp System is based on Molecular Correlation Spectroscopy™ (MCS) technology. MCS technology is based on the concept of optical absorption of specific radiation emitted from CO2 discharge lamps.
Intended Use / Indication for Use:
The Exalenz BreathID® Hp System is intended for use to continually and noninvasively measure changes in the 13CO2/12CO2 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 and pediatric patients ages 3-17 years old. The Exalenz BreathID® Hp System consists of the appropriate IDkit Hp™ kit and the BreathID® Hp test device.
The device is for use by trained health care professionals. To be administered under a physician's supervision.
Substantial Equivalence:
The following table summarizes the data on the Exalenz BreathID® Hp System (subject
5
| | BreathID® Hp System
(The Subject Device) | BreathID® Hp System
(The Predicate Device) | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| 510(k) Number | K173772 | K130524 | |
| Product
Code/Class | MSQ/Class I | Same | |
| Regulation | Campylobacter fetus
serological reagents, 866.3110 | Same | |
| Manufacturer | Exalenz Bioscience Ltd. | Same | |
| Intended Use | The Exalenz BreathID® Hp
System is intended for use to
continually and non-invasively
measure changes in the
$^{13}CO_2/^{12}CO_2$ 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 and pediatric patients
ages 3-17 years old. | The Exalenz BreathID® Hp
System is intended for use to
continually and non-invasively
measure changes in the
$^{13}CO_2/^{12}CO_2$ 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. | |
| | BreathID® Hp System
(The Subject Device) | BreathID® Hp System
(The Predicate Device) | |
| | The Exalenz BreathID® Hp System consists of the appropriate IDkit Hp™ kit and the BreathID® Hp test device. The device is for use by trained health care professionals. To be administered under a physician's supervision. | 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 | |
| System
Hardware
Components | • BreathID® Hp device
• IDkit Hp™ One | Same | |
| System
Software
Components | • BreathID® Hp device embedded SW | Same | |
| Test Sample | Human breath collected using a nasal cannula | Same | |
| Sample
Collection
Method | Continual collection over the test duration through a nasal cannula | Same | |
| Organism | Helicobacter pylori | Same | |
| Reagent | 13C Urea (NDA 21-314) | Same | |
| Test Duration | 10-20 minutes | Same | |
| Indications | Initial diagnosis and post treatment monitoring | Same | |
| Detection
Method | Measuring levels of 13CO2 and 12CO2 using Molecular Correlation Spectroscopy (MCS) | Same | |
| | BreathID® Hp System
(The Subject Device) | BreathID® Hp System
(The Predicate Device) | |
| Test Output
(Reported
Result) | Delta Over Baseline (DOB) of
the 13CO2 / 12CO 2 ratio (before
and after ingestion of 13C Urea)
and positive/negative
determination for H. pylori
infection | Same | |
| | Cut-off Point | 5.0 DOB per mil (post dose
minus pre dose) | Same |
| | | Population | Adult and Pediatric |
of this 510(k) submission) and compares to the Exalenz BreathID® Hp System cleared under K130524 (the predicate).
6
7
Comparison of Intended Use:
The intended use of the BreathID® Hp System is substantially equivalent to its predicate; both are intended for the initial diagnosis and post treatment monitoring of H. pylori infection in patients, and both are prescription devices. The BreathID® Hp System which is the subject device is indicted for use on both adult and pediatric patients ages 3-17 years old, while the predicate device is only indicated for adult patients. In addition, the subject device has minor software changes which have no effect on the fundamental intended use or indications for use of the system nor do they alter the system diagnostic characteristics or raise any new safety issues.
Ingested Drug:
The ingested drug product used in the BreathID® Hp System IDkit Hp™ One kit, (13C-Urea tablet, 75mg and Citrica powder, 4g), was originally approved in NDA 21-314. The identical drug product with identical preparation and administration is used in the cleared predicate device BreathID® Hp System kit.
Comparison of Technological Characteristics:
The BreathID® Hp System shares with its predicate device the same technology, the same test substrate, and the same diagnostic capabilities. Both the subject and predicate systems use the MCS technology (Molecular Correlation Spectroscopy) and measure the ratio of 13 CO2/12 CO2 in exhaled breath prior to and after administration of the test substrate (13C-Urea). The MCS technology measures the light absorbance by an infrared spectrometry, which is correlative to CO2 concentration in the breath sample. The output result in both systems is the Delta Over Baseline (DOB) and a positive/negative determination is based on the same assay cut-off (≥5 DOB).
8
Like its predicate device, the BreathID® Hp System includes an analyzer device with embedded SW and a test kit that includes a nasal cannula for breath collection.
Summary of Performance Testing:
Exalenz has performed extensive and well-executed verification and validation to verify the performance of the BreathID® Hp System.
-
Software Verification and Validation
Software testing was conducted to evaluate the performance of the subject system and to verify that it performs according to its specifications. Verifications involved functionality testing, timing analysis, integration with the hardware, and error detection and handling. Verification was achieved by design reviews, code walkthroughs, functional testing of sub-components and integration testing with the hardware. Additionally, the software was extensively verified at the system level. -
Clinical Validation ●
A multi-center, non-randomized, open label study was conducted with the primary goal of confirming the safety of the 13C-urea substrate in pediatric subjects, and a secondary goal of assessing performance of the BreathID® Hp System using nasal cannula breath collection in this population, compared to stool antigen testing. Supported by existing clinical performance in the adult population, device performance was assessed in a limited clinical study in a pediatric population as described below. The study was not powered to assess efficacy. A central laboratory analyzed the stool specimens with an FDA cleared H. pylori stool antigen test. The study was conducted at 6 clinical sites that were geographically diverse, differing in size (from small private clinics to large hospitals) and diverse in experience. Local site personnel were trained on administering the breath test using a BreathID® Hp System.
The primary study endpoint was to confirm the safety of the 13C-urea substrate using the standard dose of 75mg 13C-urea and 4g citric acid in the pediatric population. The safety endpoint included all adverse events (AEs).
The secondary endpoint was performance, assessed as the positive percent agreement and negative percent agreement between the BreathID® Hp System, applying the predefined threshold of 5 DOB, and the stool antigen test results.
Main Results
A total number of 54 subjects were screened, of which 1 subject was a screening failure prior to any study related procedure. Fifty-three subjects were enrolled (full analysis - FA set) and were followed for the safety assessment. Forty-one of them
9
completed the full study protocol requirements for the FA set with evaluable breath and stool test endpoints.
Among the 53 pediatric subjects followed for the safety assessment, one adverse event of vomiting was experienced by one subject (1.89%) and resolved on the same day. There were no reportable major safety concerns due to adverse events.
The positive percent agreement between the breath test and the stool antigen test results was 93.3% [95% C1:68.05;99.83] and the negative percent agreement was 100% [95% CI: 86.77%:100%].
These study results met the predefined success criteria for confirming the safety of the 13 C-urea substrate in the pediatric population, and for providing further evidence of BreathID Hp System performance in this population taking into consideration prior supportive clinical performance in the adult population.
Conclusion:
The information submitted in this premarket notification is complete and demonstrates that the BreathID® Hp System is as safe and effective as the predicate device and supports a substantial equivalence decision.