The BreathID™ System is used to diagnose and monitor Helicobacter pylori infection by measuring changes in the 1302/1202 ratio in a patient's breath following the ingestion of 13C urea.

The Oridion BreathID™ system continually and non-invasively measures changes in the 130% 200 exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori infection in the stomach. The Oridion BreathID™ System is to be used as an aid for initial diagnosis and post treatment monitoring of Helicobacter pylori infection.

Device Description

The BreathID™ system is a non-invasive breath test system for detecting urease associated with Helicobacter pylori. The system consists of:

A medical device (BreathID™ system) to measure and compute the ratio between 1202 and 13CO2 in the patient's exhalation.
A Test Kit.

Test Device: The BreathID™ system is based on Oridion's proprietary CO2 measurement technology. The device will be used to measure and compute changes in the ratio between 1202 and 1302 in the patient's exhalation. The Oridion BreathID test device measurement is made by continuous sampling of the breath.

Test Kit: Part of the BreathID™ system is the Test Kit (IDkit™). The Test Kit is used to perform the test for the presence of Helicobacter pylori. The drug in the Test Kit is 13 - Urea. The nasal cannula device used in the kit is an Oridion Nasal Filterline.

The Test Kit consists of:

Oridion Nasal FilterLine™
A packaged tablet of 13C-urea
A package of powdered Citrica
A drinking straw
Package insert

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the BreathID™ System, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets in the document. However, the reported device performance and the determination of the cut-off point imply the clinical thresholds for satisfactory performance.

Acceptance Criteria (Implied)	Reported Device Performance (BreathID™ System)
Pre-treatment
Sensitivity (vs. Endoscopic)	100%
Specificity (vs. Endoscopic)	99.2%
Relative Sensitivity (vs. CLOtest®)	100%
Relative Specificity (vs. CLOtest®)	99.2%
Sensitivity (vs. Histology)	95.8%
Specificity (vs. Histology)	97.7%
Post-treatment
Sensitivity (vs. Endoscopic)	100%
Specificity (vs. Endoscopic)	100%
Relative Sensitivity (vs. CLOtest®)	100%
Relative Specificity (vs. CLOtest®)	100%
Sensitivity (vs. Histology)	100%
Specificity (vs. Histology)	95.2%
Relative Sensitivity (vs. Meretek)	93.3%
Relative Specificity (vs. Meretek)	100%

Note: The cut-off point (threshold) for the BreathID™ System test was determined to be 5 DOB (Delta Over Baseline). This threshold was confirmed to optimize sensitivity (100% pre-therapy, 95.5% post-therapy) and specificity (99.2% pre-therapy, 100% post-therapy).

Study Details

Sample sizes used for the test set and the data provenance:
- Pivotal Study:
  - Pre-therapy: 315 subjects
  - Post-therapy: 77 subjects
- Reference Studies: One additional study included 36 Helicobacter pylori positive patients and 247 negative patients.
- Data Provenance: Not explicitly stated regarding country of origin, but the manufacturer is based in Jerusalem, Israel. The study dates (September 1999 - June 2000) indicate it was a prospective study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications.
- Ground truth definitions are provided based on endoscopic results, CLOtest®, and histology. These procedures are typically performed and interpreted by medical professionals, implicitly including gastroenterologists/endoscopists and pathologists, but specific expert involvement or their numbers are not detailed.
Adjudication method for the test set:
- The document does not specify an adjudication method. The ground truth was established by comparing BreathID™ system results to various diagnostic methods (CLOtest®, histology, endoscopic results), which serve as accepted clinical standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable as the BreathID™ System is a diagnostic device that directly measures a physiological change (13CO2/12CO2 ratio), not an imaging-based AI system that assists human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance metrics reported (Sensitivity, Specificity, Relative Sensitivity, Relative Specificity) are for the BreathID™ System in standalone mode. The device measures and computes the ratio without human interpretation influencing the diagnostic outcome provided by the device. The system is for "use by trained operators under the supervision of physicians, nurses or other healthcare professionals," but this refers to the operation of the device and supervision of patient care, not to the interpretation of the device's diagnostic output for a positive/negative H. pylori infection.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established using a combination of pathology (histology) and clinical diagnostic tests (CLOtest® and endoscopic results).
- Specifically:
  - Helicobacter pylori positive: defined as positive CLOtest® AND positive histology.
  - Helicobacter pylori negative: defined as negative CLOtest® AND negative histology.
- Endoscopic results were also used as a comparator.
The sample size for the training set:
- The document does not explicitly state a separate training set size. The reported study appears to be the pivotal clinical validation study. It's possible that the cut-off point (5 DOB) was determined using a portion of the data or in prior internal studies, but this is not detailed in the provided text. The text mentions "The threshold level of 5 DOB was confirmed to be the optimal Cut-off point (COP) for the BreathID System in a multi-center study," suggesting a validation of this threshold within the clinical study data rather than just pre-defined.
How the ground truth for the training set was established:
- As a separate training set is not explicitly mentioned, the method for establishing ground truth for any potential internal training/optimization would likely be similar to the pivotal study: using established clinical diagnostic methods like CLOtest® and histology. However, the document does not provide details on a specific training set or its ground truth establishment.

Summary

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K011668

JUL - 9 2001

Image /page/0/Picture/2 description: The image shows the logo for Oridion. The logo consists of a stylized globe made of swirling lines above the word "Oridion" in a serif font. The globe is black and white, and the word "Oridion" is in black.

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92

The assigned 510(k) number is

PRODUCT NAME

TRADE/PROPRIETARY NAME

BreathID™ System

COMMON NAME

13C-Urea Breath Test for the Presence of Helicobacter pylori

CLASSIFICATION NAME

MSQ Campylobacter pylori. The urea breath test was recently reclassified from LYR to MSQ

ESTABLISHMENT ADDRESS:

Oridion Medical 1987 Ltd. 7 HaMarpe St. Har Hotzvim Science Based Industrial Park POB 45025 91450 Jerusalem, Israel

ESTABLISHMENT REGISTRATION NUMBER

NUMBER: 8044004

DEVICE LISTING FDA FORM 2892:

B073773

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Oridion

Table of comparison to legally marketed predicate devices

Characteristics	BreathID™ System	CLOtest®K882199	MERETEK UBT®Breath Test K952220	MERETEK UBT® BreathTest K K972352
Test measurementdevice	Oridion BreathID™ TestDevice	Visual observationof color change	Gas Isotope Ratio MassSpectrometer	Gas Isotope Ratio MassSpectrometer
Test Sample	Gas Samplecontinuouslytransported to testmeasurement deviceby Oridion nasalcannula FilterlineK980324	Sample is biopsyspecimen	Gas sample stored inspecially designedbreath collection bag	Gas sample stored inspecially designed breathcollection bag
13C-Urea	Raw material supplierCIL, 75mg Tabletdissolved in water.Manufacturer andPackager CIL (NDA#21-314 submitted)	NA	Raw material supplierISOTEC, 125mg powder(Pranactin®) (in a glassvial) dissolved in water.Manufacturer andPackager unknown	Raw material supplierISOTEC, 125mg powder(Pranactin®) (in a glassvial) dissolved in water.Manufacturer andPackager unknown
Applicable pre andpost-treatment	Yes	Yes	No	Yes
Characteristics	BreathID™ System	CLOtest® K882199	MERETEK UBT® Breath Test K952220	MERETEK UBT® Breath Test K K972352
Test Meal	Citrica 4.5 gr dissolved in water	NA	Ensure pudding	Ensure pudding
Test results time	10-30 minutes	NA	Sample must be sent to lab for measurement, could be hours to days	Sample must be sent to lab for measurement, could be hours to days
Breath collection	Continuous over test time of 10-30 minutes	NA	One sample before ingestion of 13C-Urea and one sample after 30 minutes.	One sample before ingestion of 13C-Urea and one sample after 30 minutes.
Cut off point	5.0 delta per mil above baseline (post dose minus pre dose)	NA	2.4 delta per mil above baseline (post dose minus pre dose)	2.4 delta per mil above baseline (post dose minus pre dose)
Intended use	See Below (page 16)	See Below (page 16)	See Below (page 16)	See Below (page 16)
Organism	Hp in vivo	Hp in tissue biopsy	Hp in vivo	Hp in vivo
Reagent	13C-Urea	Urea	13C-Urea	13C-Urea
Result	13CO2/12CO2 ratio – Molecular Correlation Spectroscopy (MCS)	CO2+NH3 Color change	13CO2+NH3 Gas Isotope Ratio Mass Spectrometer	13CO2+NH3 Gas Isotope Ratio Mass Spectrometer

Page No. 4 of 11

Oridion Medical 1987 Ltd. • POB 45025 • Jerusalem 91450 Israel • Voice:+972 2 589-9115 • Fax:+972 2 582-8873

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の
Oridion

Oridion Medical 1987 Ltd. • POB 45025 • Jerusalem 91450 Israel • Voice:+972 2 589-9115 • Fax:+972 2 582-8873

Page No. 5 of 11

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Intended Use

Oridion BreathID™ system .
The intended use of the Oridion BreathID™ system is to non invasively measure, in a The intended ase of the Ondion Broad.nl " of catio of exhaled breath after drinking a test drink which includes 13C enriched urea. The system measures urease associated with Helicobacter pylori infection in the stomach to aid in the initial diagnosis and post treatment monitoring of Helicobacter pylori.infection. The detection is accomplished by measuring monitoring of Hollobactor ps 1302 and 1202 using Oridion proprietary (MCS) gas onanges in the ratio botwoon - ove of change in the 1302/202 ratio may be indicative of a physiological or metabolic change in the patient's condition. The system is for use by trained operators under the supervision of physicians, nurses or other healthcare professionals.

The Meretek UBT® Breath test (K972352) e

The intended use of the Meretek test is for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. This test is essentially equivalent to the test described in Meretek K952220 except that the intended use labeling has been expanded to include post-treatment monitoring of Helicobacter pvlori.

Intended Use (Meretek)K952220 .

The intended use is to non invasively detect urease associated with Helicobacter pylori infection in the stomach, and to aid in the initial diagnosis and post treatment monitoring of Helicobacter pylori. infection.

Intended Use (CLOtest®) .

The intended use is to detect urease associated with Helicobacter pylori infection in the stomach, and to aid in the initial diagnosis and post treatment monitoring of Helicobacter pylori.infection.

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Image /page/4/Picture/0 description: The image shows the word "Oridion" in a serif font, with a stylized globe-like symbol above it. The globe is made up of horizontal lines that curve around to create a spherical shape. The text is in a dark color, likely black, and the globe symbol has a similar dark tone.

ORIDION BreathID™ SYSTEM DESCRIPTION

The BreathID™ system is a non-invasive breath test system for detecting urease associated with Helicobacter pylori. The system consists of:

1. A medical device (BreathID™ system) to measure and compute the ratio between 1202 and 13CO2 in the patient's exhalation.
1. A Test Kit.

Test Device

The BreathID™ system is based on Oridion's proprietary CO2 measurement technology. The device will be used to measure and compute changes in the ratio between 1202 and 1302 in the patient's exhalation. The Oridion BreathID test device measurement is made by continuous sampling of the breath.

The CO2 produced in normal breathing contains approximately 99% 12O2 and 1% 13CO2 (12C and 13C are stable isotopes of carbon). The Oridion BreathID™ system measures the changes in ratio between 1302 and 1202 using our proprietary technology. The system is for use by trained operators under the supervision of physicians, nurses or other healthcare professionals.

Test Kit

Part of the BreathID™ system is the Test Kit (IDkit™). The Test Kit is used to perform the test for the presence of Helicobacter pylori. The drug in the Test Kit is 13 - Urea. The nasal cannula device used in the kit is an Oridion Nasal Filterline.

The Test Kit consists of:

1. Oridion Nasal FilterLine™
1. A packaged tablet of 13C-urea
1. A package of powdered Citrica
1. A drinking straw
1. Package insert

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Image /page/5/Picture/0 description: The image shows the logo for Oridion. The logo consists of a stylized globe made up of horizontal lines, positioned above the word "Oridion" in a serif typeface. The globe is textured with varying line thickness, giving it a three-dimensional appearance.

CLINICAL STUDY SUMMARY

Dates: (Pivotal study)

September 1999-June 2000

Subjects:

315 subjects pre-therapy and 77 subjects post-therapy

Objective:

To evaluate the sensitivity and specificity of the BreathID™ system to detect . the presence of Helicobacter pylori pre-treatment.

Results:

Comparison of BreathID™ system results to endoscopic results -- Pre-therapy 1Sensitivity 100%

Specificity 99.2%

Helicobacter pylori positive is defined as positive CLOtest® and positive histology; Helicobacter pylori negative is defined as negative CLOtest® and negative histology. 24 hr CLOtest® results were used to evaluate efficacy.

Comparison of BreathID™ system results to CLOtest® results -- Pre-therapy

Relative Sensitivity 100%

Relative Specificity 99.2%

Comparison of BreathID™ system results to Histology results - Pre-therapy Sensitivity 95.8%

Specificity 97.7%

Objective:

To evaluate the sensitivity and specificity of the BreathID™ system to detect . the presence of Helicobacter pyfori post- treatment, and to evaluate the ability of Oridion's BreathID™ system to monitor the efficacy of treatment.

Results:

Comparison of BreathID™ system results to Endoscopic results - Post-therapy Sensitivity 100%

Specificity 100%

Comparison of BreathID™ results to CLOtest® results - Post-therapy

Relative Sensitivity 100%

Relative Specificity 100%

Comparison of BreathID™ results to Histology results - Post-therapy Sensitivity 100%

Specificity 95.2%

1 The limits of the 95% 2 sided confidence interval are calculated using exact method Oridion Medical 1987 Ltd. • POB 45025 • Jerusalem 91450 Israel • Voice:+972 2 589-9115 • Fax:+972 2 582-8873

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Image /page/6/Picture/0 description: The image shows the logo for Oridion. The logo consists of a stylized globe made up of horizontal lines, positioned above the word "Oridion" in a serif typeface. The globe is shaded to give it a three-dimensional appearance, and the word "Oridion" is in a relatively large font.

Comparison of BreathID™ results to Meretek results – Post-therapy

Relative sensitivity 93.3% Relative specificity 100%

Objective:

To evaluate the sensitivity and specificity of the BreathID™ system to detect . the presence of Helicobacter pylori with a "variable time" breath test procedure.

Results :

Clinical data demonstrated the equivalence of the standard test to the varying time tests regarding the diagnostic results. These results did not depend on clinical stage or on the specific medical center.

Analysis of the influence of PPI and H2

This multi-site study had no exclusionary criteria for and was indifferent to PPI/H² therapy. No difference was noted between the predicate devices and the experimental device (BreathID™ system), regarding testing accuracy and concurrent therapy. Out of 317 diagnostic patients, 233 (73.5%) were using PPI/H2. Amongst all Helicobacter pylori-positive test results (32), 61.5% were being therapeutically treated by PPI/H². Of these Helicobacter pylori-positive patients using PPI/H², 48.4% had taken the PPI/H² 24 hours prior to testing, while 71.0% had taken their medication within 48 hours of testing.

Percentage of Helicobacter pylori Positive Pre-Therapy Patients According to Days without Medication

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Conclusions:

There were no false negatives reported for any of the subjects taking PPI or H². The results for subjects taking either PPI or H2 therapy (shown according to therapy) are shown in the tables above.

ADVERSE EVENTS:

There were only two adverse events in two subjects in this study, both of which were judged as mild. One adverse event was judged not to be related to the device, and possibly related to the procedure; and the other was judged as possibly related to the device and the procedure. Both subjects recovered without treatment.

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CUT-OFF POINT (THRESHOLD) DETERMINATION

The cut-off point (COP) is the level (threshold) used to discriminate between H. pylori infected and non-infected individuals. The threshold value (COP) for the BreathID™ System test is 5 DOB.

The threshold level of 5 DOB was confirmed to be the optimal Cut-off point (COP) for the BreathID System in a multi center study . The sensitivity and specificity achieved with this COP were found to be 100% and 99.2%, respectively, for pre-therapy patients and 95.5% and 100% for post-therapy patients.

Image /page/7/Figure/4 description: This image is a scatter plot titled "Values of 'Last-Delta' in Clinically Negative and Positive Subjects". The y-axis is labeled "Last Delta Units" and ranges from -1 to 59. The x-axis has two categories: "Negative" and "Positive", with data points scattered above each category. The data points for the "Positive" category are clustered much higher than those for the "Negative" category.

Figure 1 Cut-off point histogram

The histogram in Figure 1 shows graphically that the 5 DOB can distinguish very clearly between the infected (positive) and the uninfected (negative) populations.

Oridion Medical 1987 Ltd. • POB 45025 • Jerusalem 91450 Israel • Voice: +972 2 589-9115 • Fax: +972 2 582-8873

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Reference Studies

In addition to the Pivotal study there were several reference studies (one still in addition to the 1 frotar other and 247 negative patients. The results reported were supportive of the conclusions reached in the pivotal study.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 9 2001

Mr. Sandy Brown Regulatory Affairs Manager Oridion Medical 1987 Ltd. 7 HaMarpe Street Har Hotzvim Industrial Park P.O. Box 45025 Jerusalem, Israel

Re: K011668

Trade Name: Oridion BreathID™ System for Helicobacter pylori Regulation Number: 866.3110 Regulatory Class: I Product Code: MSQ Dated: May 14, 2001 Received: May 17, 2001

Dear Mr. Brown:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have and we have determined the device is substantially equivalent (for the indications for use above into we introllosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, provision in the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

In addition, we have determined that your product contains the following component subject to regulation as drugs: 13C-enriched urea tablet-75mg.

Our substantially equivalent determination does not apply to the drug component (NDA 21-314) Our product. For information on applicable Agency requirements for marketing this product, we suggest you contact:

Mark Goldberger, M.D., M.P.H. Director Division of Special Pathogens and Immunologic Drug Products Center for Drug Evaluation and Research Food and Drug Administration 9201 Corporate Blvd. Rockville, Maryland 20850

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If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification although we recommend that you first contact the Center for Drug Evaluation and Research before marketing your drug component[s]. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device or your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Kano Aza

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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June 10, 2001

Indications For Use

510(k) Number (if known): K011668

BreathID™ System Device Name:

Indications For Use:

The BreathID™ System is used to diagnose and monitor Helicobacter pylori infection by measuring changes in the 1302/1202 ratio in a patient's breath following the ingestion of 13C urea.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Woody Dubois

Division of Clinical Laboratory Devices 510(k) Number

Oridion Medical 1987 Ltd. • POB 45025 • Jerusalem 91450 Israel • Voice: +972 2 582-8873

Regulation Number and Section

§ 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).