(121 days)
Not Found
No
The description focuses on electro-optical measurement and computation of gas ratios using Molecular Correlation Spectroscopy (MCS) technology. There is no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is designed for diagnostic purposes to detect H. pylori infection by measuring changes in exhaled breath, not for treating 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" and an "Auto Sampler," in addition to software and a test kit. This indicates 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 biological sample (exhaled breath) in vitro (outside the body).
- Device Description: The device description details a system that analyzes components of exhaled breath (13CO2 and 12CO2) using a specific technology (Molecular Correlation Spectroscopy™). This analysis is performed on the collected breath samples.
- Test Kit: The inclusion of a test kit with components like a 13C-urea tablet, citric acid, and breath sample bags further supports its use in an in vitro diagnostic procedure. The breath samples are collected and then analyzed by the device.
- Aid in Diagnosis and Monitoring: The indication for use states it is an "aid in the initial diagnosis and post treatment monitoring of H. pylori infection." This is a core function of an IVD.
Therefore, based on the provided information, the BreathID Hp Lab System and BreathID Smart System clearly fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BreathID Hp Lab System or BreathID Smart 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 BreathID Hp Lab System or BreathID Smart 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 BreathD Hp Lab System consists of the appropriate IDkit Ho kit, and the BreathID Hp device, Auto Sampler and Lab Application. The BreathID Smart System consists of the appropriate IDkit Hp kit and the BreathID Smart device. 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, IJQ
Device Description
The BreathID® Hp Lab System and the BreathID® Smart System are two non-invasive breath test systems for detecting the presence of Helicobacter pylori (H. pylori) based on the same technology. The systems consist of an electro-optical medical device designed to measure and compute the changes in the ratio between 13CO2 and 12CO2 concentrations in the patient's exhalation, an Auto Sampler, software, and a test kit.
The IDkit Hp™ Two test kit consists of:
- One 75mg 13C-urea tablet .
- One packet of 4.3g powdered Citrica (citric acid) .
- One drinking straw .
- One drinking cup .
- One Package Insert (Instructions for Use) .
- One Quick User Guide ●
- Two Breath Sample Bags (one Baseline and one Post Ingestion) .
- Four bar code labels ●
- One large Sample Transport Bag ●
Using bags for breath collection enables off-site and deferred testing as well as testing of multiple breath sample bags sequentially in a batch. The BreathID® Hp Lab System and the BreathID® Smart System measure and compute the ratio between 13CO2 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 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
To be administered by 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance characteristics remain unchanged.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 the seal 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.
Meridian Bioscience Israel Ltd. Raffi Werner VP Meridian Bioscience Israel 4 Ha'Maayan st. Modiin. 7177872 Israel
June 23, 2022
Re: K220494
Trade/Device Name: BreathID Hp Lab System, BreathID Smart System Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter Fetus Serological Reagents Regulatory Class: Class I, reserved Product Code: MSQ Dated: February 16, 2022 Received: February 22, 2022
Dear Raffi Werner:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kristian Roth, Ph.D. Deputy Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220494
Device Name
BreathID Hp Lab System and BreathID Smart System
Indications for Use (Describe)
The BreathID Hp Lab System or BreathID Smart 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 BreathID Hp Lab System or BreathID Smart 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 BreathD Hp Lab System consists of the appropriate IDkit Ho kit, and the BreathID Hp device, Auto Sampler and Lab Application. The BreathID Smart System consists of the appropriate IDkit Hp kit and the BreathID Smart device. To be administered by trained personnel as ordered by a licensed healthcare practitioner.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Special 510(k) Summary
Purpose of this 510(k)
The purpose of this Special 510(k) submission is to obtain marketing clearance for a labeling modification of the BreathID® Hp Lab System (K173777) and the BreathID® Smart System (K193610). This labeling modification is solely to the package insert which is included in the IDkit Hp™ Two, the test kit used as part of these two cleared 510(k) devices while the Intended Use and Indication for Use remain unchanged. The modified labeling informs clinicians that they may act upon positive results for the Urea Breath Test with the BreathID® Hp Lab System or the BreathID® Hp Smart System for patients taking proton pump inhibitors (PPIs), a family of prescription and over-the-counter drugs that help alleviate the symptoms caused by H. pylori infection.
Applicant's Name
Meridian Bioscience Israel Ltd. 4 Ha'Maayan Street Modiin, 7177872, Israel Tel: +972-8-9737502 Fax: +972-8-9737501
Contact Person
Raffi Werner Meridian Bioscience Israel Ltd. 4 Ha'Maayan Street Modiin, 7177872, Israel Tel: +972-8-9737502 Fax: +972-8-9737501 Raffi.werner@meridianbioscience.com
Date Prepared
June 10, 2022
4
Trade Name
BreathID® Hp Lab System; BreathID® Smart System
Classification Name
Test, urea (breath or blood)
Product Code
MSQ, IJQ
Device Class
I
Regulation Number
866.3110
Panel
Microbiology
Predicate Devices
BreathID® Hp Lab System [Meridian Bioscience Israel Ltd.] cleared under K173777
and
BreathID® Smart System [Meridian Bioscience Israel Ltd.] cleared under K193610
Device Description (unchanged from cleared devices)
The BreathID® Hp Lab System and the BreathID® Smart System are two non-invasive breath test systems for detecting the presence of Helicobacter pylori (H. pylori) based on the same technology. The systems consist of an electro-optical medical device designed to measure and compute the changes in the ratio between 13CO2 and 12CO2 concentrations in the patient's exhalation, an Auto Sampler, software, and a test kit.
The IDkit Hp™ Two test kit consists of:
- One 75mg 13C-urea tablet .
- One packet of 4.3g powdered Citrica (citric acid) .
5
- One drinking straw .
- One drinking cup .
- One Package Insert (Instructions for Use) .
- One Quick User Guide ●
- Two Breath Sample Bags (one Baseline and one Post Ingestion) .
- Four bar code labels ●
- One large Sample Transport Bag ●
Using bags for breath collection enables off-site and deferred testing as well as testing of multiple breath sample bags sequentially in a batch. The BreathID® Hp Lab System and the BreathID® Smart System measure and compute the ratio between 13CO2 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 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 (unchanged from cleared devices)
The BreathID® Hp Lab System or BreathID® Smart System is intended for use to non-invasively measure changes in the '3CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp Lab System or BreathID® Smart 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 BreathID® Hp Lab System consists of the appropriate IDkit Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application. The BreathID® Smart System consists of the appropriate IDkit Hp™ Two and the BreathID® Smart device.
To be administered by trained personnel as ordered by a licensed healthcare practitioner.
Substantial Equivalence
The device and kit of the BreathID® Hp Lab System and the BreathID® Smart System that are subject of this Special 510(k) labeling modification request are identical to the device and kit of the cleared predicate BreathID® Hp Lab System (K173777) and the cleared predicate BreathID® Smart System (K193610). They use the exact same technology and the same principles of
6
operation, including the same test kit, utilizing the same test substrate and same method to collect patient's exhaled breath samples for the test, as the predicate devices.
There are additional minor changes to the Package Insert that did not require a 510(k) submission and that have been previously implemented in accordance with design control requirements as specified in 21 CFR 820.30 and based on FDA Guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device", issued on October 25th, 2017.
The labeling modification in this submission is specifically related to the current limitation for those patients taking proton pump inhibitors (PPIs) and performing the breath test and is reflected in changes to the package insert of the test kit, IDkit Hp™ Two, that is used as part of the BreathID® Hp Lab System or the BreathID® Smart System. This labeling modification informs clinicians that they may act upon positive breath test results in patients using PPIs, a family of prescription and over-the-counter drugs that helps alleviate the symptoms caused by H. pylori infection. The changes in the Package Insert are described below:
-
- In Section 5.2 of the package insert "Warnings and Precautions", item 7 is revised to remove the following statement:
"Antimicrobials, proton pump inhibitors, and bismuth preparations are known to suppress H. pylori. Ingesting these medications within two weeks prior to performing the breath test may produce false negative test results."
- In Section 5.2 of the package insert "Warnings and Precautions", item 7 is revised to remove the following statement:
The following statements will replace the removed warning:
"False negative test results may be caused by:
- Ingestion of antimicrobials or bismuth preparations within two weeks prior to • performing the breath test.
- . Ingestion of proton pump inhibitors (PPIs) within two weeks prior to performing the breath test.
Note: If a negative result is obtained from a patient ingesting a PPI within two weeks prior to the breath test, the results cannot be considered indicative of the absence of urease associated with H. pylori and the test should be repeated two weeks after discontinuing the PPI treatment. A positive result for a patient on a PPI could be considered as indicative of the presence of urease associated with H. pylori."
-
- In Section 7.4 of the package insert "Operational Precautions and Limitations", item 4 is revised and items 5 and 6 are added to accept positive breath test results in patients using PPIs as follows:
7
"4. The patient should not have taken antimicrobials, proton pump inhibitors (PPI) or bismuth preparations within two weeks prior to administering the test.
-
If the test is negative and it is determined that the subject has used PPIs within two weeks prior to taking the breath test, the test may provide a false negative result. The test needs to be repeated two weeks post discontinuation of PPI treatment.
-
A positive result for a patient on PPI could be considered as indicative of the presence of urease enzyme associated with H. pylori."
-
- Section 8.1 of the package insert "Patient Preparation" is revised to accept positive breath test results in patients using PPIs as in the following statement:
"The patient should have fasted at least one hour before administering the solution. The patient should not have taken antimicrobials, proton pump inhibitors (PPI) or bismuth preparations within two weeks prior to administering the test. If PPIs are used within two weeks of breath testing, false negative test results may occur, and the test should be repeated two weeks after discontinuation of PPI treatment. A positive result for a patient on PPI could be considered as indicative of the presence of urease enzyme associated with H. pylori."
- Section 8.1 of the package insert "Patient Preparation" is revised to accept positive breath test results in patients using PPIs as in the following statement:
Test Kit and Ingested Drug
The IDkit Hp™ Two test kit that includes the 13C urea tablet and citric acid powder approved in NDA-21-314. the procedure for ingestion of test substrate, and the breath collection method remain unchanged. The drinking cup has been changed to a drinking cup with a lid, thereby providing a more efficient means of dissolving the substrate, by sealing the cup and shaking it.
Comparison of Technological Characteristics
Technological characteristics remain unchanged.
Summary of Performance Testing
Performance characteristics remain unchanged.
Conclusion:
The information submitted in this premarket notification is complete and supports a finding of substantial equivalence.