(53 days)
Not Found
No
The summary describes a system that measures and computes a ratio based on CO2 isotopes. There is no mention of AI, ML, or any complex algorithms beyond basic computation of a ratio. The performance studies focus on standard clinical metrics like sensitivity and specificity, not metrics typically associated with AI/ML model evaluation.
No
The device is used for diagnosis and monitoring of a condition, not for treating it.
Yes
The intended use explicitly states that the system is "used to diagnose and monitor Helicobacter pylori infection" and "is to be used as an aid for initial diagnosis and post treatment monitoring of Helicobacter pylori infection."
No
The device description explicitly states the system consists of a "medical device (BreathID™ system) to measure and compute the ratio between 1202 and 13CO2" and a "Test Kit" which includes physical components like a nasal cannula and a tablet. This indicates the system includes 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 "diagnose and monitor Helicobacter pylori infection by measuring changes in the 1302/1202 ratio in a patient's breath". This involves analyzing a sample (breath) taken from the human body to provide information for diagnostic purposes.
- Device Description: The system includes a "Test Kit" with a "drug" (13C-urea) and other components used to perform a "test for the presence of Helicobacter pylori". This further reinforces the diagnostic nature of the device.
- Mechanism: The device measures the ratio of isotopes in exhaled breath, which is a biological sample. This measurement is then used to infer the presence of urease, which is indicative of H. pylori infection. This process falls under the definition of an in vitro diagnostic test.
- Performance Studies: The performance studies evaluate the device's ability to accurately diagnose H. pylori infection by comparing its results to established diagnostic methods (endoscopy, CLOtest®, histology). This is a key characteristic of an IVD.
Therefore, based on the provided information, the BreathID™ System clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
MSQ
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.
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:
-
- Oridion Nasal FilterLine™
-
- A packaged tablet of 13C-urea
-
- A package of powdered Citrica
-
- A drinking straw
-
- Package insert
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Stomach
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained operators under the supervision of physicians, nurses or other healthcare professionals.
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)
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: Sensitivity 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%.
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.
Conclusions: There were no false negatives reported for any of the subjects taking PPI or H².
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity 100% (Pre-therapy, compared to endoscopic results)
Specificity 99.2% (Pre-therapy, compared to endoscopic results)
Relative Sensitivity 100% (Pre-therapy, compared to CLOtest® results)
Relative Specificity 99.2% (Pre-therapy, compared to CLOtest® results)
Sensitivity 95.8% (Pre-therapy, compared to Histology results)
Specificity 97.7% (Pre-therapy, compared to Histology results)
Sensitivity 100% (Post-therapy, compared to Endoscopic results)
Specificity 100% (Post-therapy, compared to Endoscopic results)
Relative Sensitivity 100% (Post-therapy, compared to CLOtest® results)
Relative Specificity 100% (Post-therapy, compared to CLOtest® results)
Sensitivity 100% (Post-therapy, compared to Histology results)
Specificity 95.2% (Post-therapy, compared to Histology results)
Relative sensitivity 93.3% (Post-therapy, compared to Meretek results)
Relative specificity 100% (Post-therapy, compared to Meretek results)
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
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
1
Oridion
.
Table of comparison to legally marketed predicate devices
| Characteristics | BreathID™ System | CLOtest®
K882199 | MERETEK UBT®
Breath Test K952220 | MERETEK UBT® Breath
Test K K972352 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Test measurement
device | Oridion BreathID™ Test
Device | Visual observation
of color change | Gas Isotope Ratio Mass
Spectrometer | Gas Isotope Ratio Mass
Spectrometer |
| Test Sample | Gas Sample
continuously
transported to test
measurement device
by Oridion nasal
cannula Filterline
K980324 | Sample is biopsy
specimen | Gas sample stored in
specially designed
breath collection bag | Gas sample stored in
specially designed breath
collection bag |
| 13C-Urea | Raw material supplier
CIL, 75mg Tablet
dissolved in water.
Manufacturer and
Packager CIL (NDA
#21-314 submitted) | NA | Raw material supplier
ISOTEC, 125mg powder
(Pranactin®) (in a glass
vial) dissolved in water.
Manufacturer and
Packager unknown | Raw material supplier
ISOTEC, 125mg powder
(Pranactin®) (in a glass
vial) dissolved in water.
Manufacturer and
Packager unknown |
| Applicable pre and
post-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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Oridion Medical 1987 Ltd. • POB 45025 • Jerusalem 91450 Israel • Voice:+972 2 589-9115 • Fax:+972 2 582-8873
Page No. 5 of 11
3
Image /page/3/Picture/0 description: The image shows the logo for Oridion. The logo consists of a stylized globe made of horizontal lines, positioned above the word "Oridion" in a serif typeface. The globe is black and white, and the text is black.
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.
4
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:
-
- 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.
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:
-
- Oridion Nasal FilterLine™
-
- A packaged tablet of 13C-urea
-
- A package of powdered Citrica
-
- A drinking straw
-
- Package insert
5
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
6
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.
7
Image /page/7/Picture/0 description: The image shows the word "Oridion" in a bold, serif font. Above the word is a logo that resembles a sphere made of horizontal lines. The lines are not perfectly straight, giving the sphere a slightly organic or textured appearance. The logo is positioned directly above the center of the word "Oridion".
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
8
Image /page/8/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 black and white, and the text is black.
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.
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
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
10
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
11
Image /page/11/Picture/0 description: The image shows the word "Oridion" in a bold, serif font. Above the word is a logo that appears to be a sphere made of horizontal lines. The lines are not perfectly straight, giving the sphere a slightly organic or textured look. The logo is positioned directly above the word, centered horizontally.
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.
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.
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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