(86 days)
Not Found
No
The description focuses on the electro-optical measurement of CO2 ratios and the computation of the Delta over Baseline (DOB) using established Molecular Correlation Spectroscopy™ (MCS) technology. There is no mention of AI, ML, or any learning algorithms used in the device's operation or data analysis.
No
The device is described as an aid in diagnosis and monitoring, meaning it helps identify a condition or track its progress, rather than providing direct treatment.
Yes
The intended use of the device is to aid in the initial diagnosis and post-treatment monitoring of H. pylori infection.
No
The device description explicitly states the system consists of an "electro-optical medical device with embedded software" and an "Auto Sampler," in addition to the software components. This indicates the presence of significant 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 1300/14CO2 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 disease state (H. pylori infection).
- Device Description: The device 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 is performed in vitro (outside the body) on the collected breath sample.
- Components: The system includes a "test kit" with components like a 13C-urea tablet and citric acid, which are used to facilitate the diagnostic test performed on the breath sample.
- Diagnostic Aid: The intended use states it is "indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection." This clearly positions the device as a tool used in the diagnostic process.
The analysis of a biological sample (exhaled breath) outside the body to aid in the diagnosis of a disease is the core definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Exalenz BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 300/14CO2 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 Lab 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 Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device. Auto Sampler and Lab Application.
To be administered by trained personnel as ordered by a licensed healthcare practitioner.
Product codes (comma separated list FDA assigned to the subject device)
MSQ, JJQ
Device Description
The BreathID® Hp Lab 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 1202 concentrations in the patient's exhalation, an Auto Sampler, a Lab Application, and a test kit. The IDkit Hp™ Two kit consists of:
- A 75mg 13C-urea tablet
- A 4.3g package of powdered Citrica (citric acid) ●
- Drinking straw
- Package Insert (Instructions for Use) ●
- Quick User Guide
- 2 Breath Sample Bags (Baseline and Post Ingestion) with bar code labels and a large Sample Transport Bag
Using bags for breath collection along with the Auto Sampler enables off site and deferred testing as well as testing of multiple breath sample bags sequentially in a batch. The BreathID® Hp Lab System measures and computes the ratio between 13CO2 and 12 CQ2 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 Lab systems 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 personnel as ordered by a licensed healthcare practitioner.
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 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 Lab System using breath sample bags 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), diverse in experience representing both point of care testing as well as sites utilizing a clinical laboratory. Local site personnel were trained on administering the breath test. To represent point of care and clinical laboratory settings, the bagged sample analysis was performed either on site or at a central laboratory using a BreathID® Hp Lab System.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Validation
Study type: A multi-center, non-randomized, open label study.
Sample size: 54 subjects screened, 53 enrolled (full analysis - FA set), 42 completed full study protocol requirements.
Key results:
- Primary study endpoint: Confirm safety of 13C-urea substrate (75mg 13C-urea and 4g citric acid) in pediatric population. One adverse event of vomiting was experienced by one subject (1.89%) and resolved on the same day. No major safety concerns.
- Secondary endpoint: Performance, assessed as positive percent agreement and negative percent agreement between the BreathID® Hp Lab System (predefined threshold of 5 DOB) and stool antigen test results.
- The positive percent agreement between the breath test and the stool antigen test results was 93.3% [95% C1:68.05:99.83].
- The negative percent agreement was 100% [95% CI: 87.23%;100%].
- These study results met predefined success criteria for confirming safety and providing further evidence of performance in the pediatric population, considering prior supportive clinical performance in the adult population.
Software Verification and Validation
- Software testing conducted to evaluate performance and verify according to specifications.
- Verifications involved functionality testing, timing analysis, integration with hardware, and error detection and handling.
- Verification achieved by design reviews, code walkthroughs, functional testing of sub-components, and integration testing with hardware.
- Software extensively verified at the system level.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive percent agreement: 93.3% [95% C1:68.05:99.83]
Negative percent agreement: 100% [95% CI: 87.23%;100%]
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
March 8, 2018
Exalenz Bioscience Ltd. % George Hattub Senior Staff Consultant Medicsense USA 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K173777
Trade/Device Name: BreathID Hp Lab 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:
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 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
1
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 medical devices and radiation-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)
K173777
Device Name
BreathID® Hp Lab System
Indications for Use (Describe)
The Exalenz BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 300/14CO2 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 Lab 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 Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device. Auto Sampler and Lab Application.
To be administered by trained personnel as ordered by a licensed healthcare practitioner.
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 K173777
Purpose of this 510(k):
The primary purpose of this 510(k) submission is to expand the indications for use of the BreathID® Hp Lab System to include use with pediatric patients ages 3-17 years old. 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 Lab System
Classification Name: Test, urea (breath or blood)
Product Code: MSQ, JJQ
Device Class: I
Regulation Number: 866.3110
4
Panel:
Microbiology
Predicate Device:
Exalenz BreathID® Hp Lab System [Exalenz Bioscience Ltd.] cleared under K162150
Device Description:
The BreathID® Hp Lab 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 1202 concentrations in the patient's exhalation, an Auto Sampler, a Lab Application, and a test kit. The IDkit Hp™ Two kit consists of:
- A 75mg 13C-urea tablet
- A 4.3g package of powdered Citrica (citric acid) ●
- Drinking straw
- Package Insert (Instructions for Use) ●
- Quick User Guide
- 2 Breath Sample Bags (Baseline and Post Ingestion) with bar code labels and a large Sample Transport Bag
Using bags for breath collection along with the Auto Sampler enables off site and deferred testing as well as testing of multiple breath sample bags sequentially in a batch. The BreathID® Hp Lab System measures and computes the ratio between 13CO2 and 12 CQ2 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 Lab systems 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 Lab System is intended for use to non-invasively measure changes in the 1302/12CO2 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 Lab 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 Lab System consists of the appropriate IDkit Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application.
To be administered by trained personnel as ordered by a licensed healthcare practitioner.
5
Substantial Equivalence:
The following table summarizes the data on the Exalenz BreathID® Hp Lab System (subject of this 510(k) submission) and compares to the Exalenz BreathID® Lab Hp System cleared under K162150 (the predicate).
| | BreathID® Hp Lab System
(The Subject Device) | BreathID® Hp Lab System
(The Predicate Device) |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K173777 | K162150 |
| 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
Lab System is intended for use
to non-invasively 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
Lab 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 Lab System
consists of the appropriate
IDkit HpTM kit, and the
BreathID® Hp device, Auto
Sampler and Lab Application.
To be administered by trained
personnel as ordered by a
licensed healthcare
practitioner. | The Exalenz BreathID® Hp
Lab System is intended for
use to non-invasively 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
Lab 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 Lab
System consists of the IDkit
HpTM kits, and the BreathID®
Hp device, Auto Sampler and
Lab Application
To be administered by trained
personnel as ordered by a
licensed healthcare
practitioner. |
| | BreathID® Hp Lab System
(The Subject Device) | BreathID® Hp Lab System
(The Predicate Device) |
| System
Hardware
Components | BreathID® Hp Lab device Auto Sampler IDkit Hp™ Two PC | Same |
| System
Software
Components | BreathID® Hp Lab device embedded SW BreathID® Hp Lab Application Auto Sampler embedded SW | Same |
| Test Sample | Human breath exhaled into breath sample bags | Same |
| Sample
Collection
Method | Two breath sample bags: for baseline and for post ingestion | Same |
| Organism | Helicobacter pylori | Same |
| Reagent | 13C Urea (NDA 21-314) | Same |
| Test Duration | 15-20 minutes | Same |
| Indications | Initial diagnosis and post treatment monitoring | Same |
| Detection
Method | Measuring levels of 13CO2 and 12CO2 using Molecular Correlation Spectroscopy (MCS) | Same |
| 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 | Adult |
6
Comparison of Intended Use:
The intended use of the BreathID® Hp Lab 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 Lab System which is the subject device is indicted for use on both adult and pediatric patients
7
ages 3-17 years old, while the predicate device is only indicated for adult patients. In addition, the subject device has minor software and hardware 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 Lab System IDkit Hp™ Two 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 Lab System kit.
Comparison of Technological Characteristics:
The BreathID® Hp Lab 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 13CO2/12CO2 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).
Like its predicate device, the BreathID® Hp Lab System includes an analyzer device with embedded SW and a test kit. In addition, the subject system and predicate system also includes the Auto Sampler with its embedded SW and the BreathID® Lab Application with its Work Station. These components directly relate to the use of breath bags in the subject system, are designed for the convenience of the operator and are used in the FDA cleared predicate device (K162150). As with the predicate device, the subject system uses breath bags, where the breath is exhaled through the mouth into the bag.
Summary of Performance Testing:
Exalenz has performed extensive and well-executed verification and validation to verify the performance of the BreathID® Hp Lab 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.
8
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 Lab System using breath sample bags 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), diverse in experience representing both point of care testing as well as sites utilizing a clinical laboratory. Local site personnel were trained on administering the breath test. To represent point of care and clinical laboratory settings, the bagged sample analysis was performed either on site or at a central laboratory using a BreathID® Hp Lab 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 | Lab 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-two 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: 87.23%;100%].
These study results met the predefined success criteria for confirming the safety of the 13C-urea substrate in the pediatric population, and for providing further evidence of BreathID Hp Lab System performance in this population taking into consideration prior supportive clinical performance in the adult population.
9
Conclusion:
The information submitted in this premarket notification is complete and demonstrates that the BreathID® Hp Lab System is as safe and effective as the predicate device and supports a substantial equivalence decision.