(90 days)
Not Found
No
The description focuses on the measurement of CO2 ratios using spectroscopy and computation of a Delta over Baseline (DOB) value, which is a direct calculation based on measured values, not an AI/ML algorithm. There is no mention of AI, ML, or related concepts like training/test sets.
No
The device is used for diagnosis and monitoring of H. pylori infection, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection".
No
The device description explicitly states that the system consists of an "electro-optical medical device with embedded software" and an "Auto Sampler," in addition to the Lab Application and test kit. 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 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 involves testing a sample (exhaled breath) taken from the human body to provide information about a physiological state (H. pylori infection).
- Indications for Use: It is indicated for use "as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients." Diagnosis and monitoring of a disease are key functions of IVDs.
- Device Description: The description details a system that "measures and computes the changes in ratio between 1302 and 12CO2 concentrations in the patient's exhalation." This is a measurement performed on a biological sample (breath).
- Test Kit: The system includes a "test kit" with components like 13C-urea and citric acid, which are reagents used in the diagnostic process.
- Performance Studies: The document describes a validation study comparing the device's results to "composite biopsy results (histology and RUT)," which are other diagnostic methods. The study evaluates the device's sensitivity and specificity in detecting H. pylori infection.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for 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. The Exalenz BreathID® Hp Lab System consists of the IDkit:Hp™ kits, 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)
MSO, 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 13CO2 and 12CO2 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 Collection Bags (Baseline and Post Ingestion) with bar code labels and a . 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 CO2 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 current and the cleared versions of the BreathID® Hp 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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Validation:
A multi-center, non-randomized, open label validation study was completed to confirm the safety and efficacy of the BreathID® Hp Lab System, when used together with the IDkit Hp™ Two kit, for initial diagnosis and post-treatment monitoring of H. pylori infection versus composite biopsy results (histology and RUT). The study evaluated 179 adult initial diagnosis patients and 68 post-treatment patients.
For the initial diagnosis cohort, the sensitivity in comparison to composite biopsy results was 100% [95% CI (90.60; 100.00)] and specificity was 97.9% [95% CI (93.97; 99.28)]. For the posttreatment cohort, the sensitivity was 92.3% [95% CI (66.69; 98.63)] and the specificity was 100% [95% CI (93.47; 100.00)]. Therefore, the study demonstrated that breath samples can be successfully collected in the Exalenz breath sample bags and accurately tested using the BreathID® Hp Lab System. There were no reportable major safety concerns due to adverse events.
Analytical Studies (Bench):
Precision testing conducted to evaluate variability across different operators, test devices, sites, and days.
Carry over testing designed in compliance with the recommendations of the CLSI EP-10 standard and successfully demonstrated that there was no sample carry over for the BreathID Hp Lab System.
Specimen storage conditions testing successfully demonstrated that the Breath Sample Bags maintain their performance characteristic when under their end limits storage conditions of temperature and relative humidity and for the maximal allowed storage time of 14 days.
System operating conditions for Auto Sampler: Testing successfully demonstrated that the Auto Sampler operates according to its specifications while operating within the defined environmental conditions.
Software Verification and Validation: Software testing 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Initial diagnosis cohort: sensitivity of 100% [95% CI (90.60; 100.00)] and specificity of 97.9% [95% CI (93.97; 99.28)].
Post-treatment cohort: sensitivity of 92.3% [95% CI (66.69; 98.63)] and specificity of 100% [95% CI (93.47; 100.00)].
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31, 2016
EXALENZ BIOSCIENCE LTD. C/O ORNA OZ BIOMEDICAL STRATEGY LTD. 155 BIALIK ST. RAMAT-GAN, IL 5252346
Re: K162150
Trade/Device Name: BreathID Hp Lab System Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: I Product Code: MSO, JJO Dated: July 28, 2016 Received: August 2, 2016
Dear Ms. Oz:
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162150
Device Name BreathID® Hp Lab system
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:Hp™ kits, 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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See PRA Statement below.
3
510(K) SUMMARY
510(K) Number K162150
Applicant's Name:
Exalenz Bioscience Ltd. 4 Ha'Maayan Street Modiin, 7177872, Israel Tel: +972-8-9737502 Fax: +972-8-9737501
Contact Person:
Orna Oz, Ph.D. Biomedical Strategy (2004) Ltd. 10 Ha'ta'as Street Ramat Gan, 5252346, Israel Tel: +972-3-6123281 Fax: +972-3-6123282 Mail: orna@ebms.co.il
Date Prepared:
July, 2016
Trade Name:
BreathID® Hp Lab System
Classification Name:
Test, urea (breath or blood)
Product Code:
MSQ, JJQ
Device Class: I
Regulation Number: 866.3110
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Panel:
Microbiology
Predicate Device:
Exalenz BreathID® Hp System [Exalenz Bioscience Ltd.] cleared under K130524
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 1302 and 12CO2 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 Collection Bags (Baseline and Post Ingestion) with bar code labels and a . 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 1302 and 12 CO2 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 current and the cleared versions of the BreathID® Hp 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 1300/1202 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 Hp™ kits, and the BreathID® Hp device, Auto Sampler and Lab Application.
5
To be administered by trained personnel as ordered by a licensed healthcare practitioner.
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® Hp System cleared under K130524 (the predicate).
| BreathID® Hp Lab System | BreathID® Hp System | |
|---|---|---|
| 510(k) Number | K162150 | K130524 |
| Product | ||
| Code/Class | MSQ/Class I | Same |
| Regulation | Campylobacter fetus | |
| serological reagents, 866.3110 | Same | |
| Manufacturer | Exalenz Bioscience Ltd. | Same |
| Intended Use | The Exalenz BreathID® Hp | |
| 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. | The Exalenz BreathID® Hp | |
| System is intended for use to | ||
| continually and 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 | ||
| 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 System consists | ||
| of the IDkit HpTM and the | ||
| BreathID® Hp test device. | ||
| The device is for use by | ||
| trained health care | ||
| professionals. To be | ||
| administered under a | ||
| physician's supervision. | ||
| BreathID® Hp Lab System | BreathID® Hp System | |
| System | ||
| Hardware | ||
| Components | BreathID® Hp Lab device Auto Sampler IDkit HpTM Two | BreathID® Hp device IDkit:HpTM One |
| System | ||
| Software | ||
| Components | BreathID® Hp Lab device embedded SW BreathID® Hp Lab Application Auto Sampler embedded SW | BreathID® Hp device embedded SW |
| Test Sample | Human breath exhaled into breath sample bags | Human breath collected using a nasal cannula |
| Sample | ||
| Collection | ||
| Method | Two breath sample bags: for baseline and for post ingestion | Continual collection over the test duration through a nasal cannula |
| Organism | Helicobacter pylori | Same |
| Reagent | 13C Urea (NDA 21-314) | Same |
| Test Duration | 15-20 minutes | 10-30 minutes |
| 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 |
6
Comparison of Intended Use:
The intended use and indications for use of the BreathID® Hp Lab System are substantially equivalent to those of its predicate; both are indicated for the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients, and both are prescription devices. The BreathID® Hp Lab System uses breath bags for collection of the breath sample, unlike its predicate. These differences, however, have
7
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 System kit.
Comparison of Technological Characteristics:
The BreathID® Hp Lab System shares with its predicate device the same underlying 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 1302/1202 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 cutoff (≥5 DOB).
Like its predicate device, the BreathID® Hp Lab System includes an analyzer device with embedded SW and a test kit. In addition, unlike its predicate, the subject 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 commonly used in other FDA cleared H. pylori breath test devices that collect breath into bags (K011668, K130524).
The subject system uses breath bags, hence the breath is exhaled through the mouth into the bag, unlike the nasal cannula used in the predicate device, which transfers breath exhaled from the nose. Yet, as demonstrated in the analytical and clinical testing, the underlying technology similarly applies to both systems as well as the diagnostic specifications (i.e., the light absorbance similarly correlates to the concentration of 1302 and 1202 regardless of the breath source, and the same cut-off and accuracies apply to both systems). It is also important to note that the actual measurement by the predicate device (i.e., the BreathID® Hp System) is performed in an intermittent fashion, at timed intervals, despite the continuous transfer of the breath sample through the nasal cannula. Consequently, the absorbance measurement of the two discrete breath collection bags in the subject BreathID® Hp Lab System may be considered substantially equivalent to the intermittent measurement of the light absorbance in the predicate device. Finally, any additional differences between the
8
subject and predicate systems were evaluated in the performance testing, as briefly described below, all demonstrating comparable safety and efficacy characteristics of the BreathID® Hp Lab System, subject of this 510(k) submission, and its predicate, the BreathID® Hp System.
Summary of Performance Testing:
Exalenz has performed extensive and well-executed verification and validation for demonstration of substantial equivalence of the BreathID® Hp Lab System to the cleared BreathID® Hp System. The following key verification and validation tests were used to establish substantial equivalence:
- · Analytical Studies (Bench)
- O Precision testing
The precision/repeatability testing was conducted using the complete BreathID® Hp Lab System, hence evaluating all system components concomitantly. The reproducibility testing was conducted in two parts: The first part tested the precision/repeatability and reproducibility of the entire System while a dedicated, additional, test focused on the reproducibility of the Auto Sampler. The testing evaluated variability across different operators, test devices, sites, and days.
-
Carry over testing O
Cary over testing was designed in compliance with the recommendations of the CLSI EP-10 standard and successfully demonstrated that there was no sample carry over for the BreathID Hp Lab System. -
Specimen storage conditions O
Testing successfully demonstrated that the Breath Sample Bags maintain their performance characteristic when under their end limits storage conditions of temperature and relative humidity and for the maximal allowed storage time of 14 days. -
System operating conditions O Auto Sampler: Testing successfully demonstrated that the Auto Sampler operates according to its specifications while operating within the defined environmental conditions.
-
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.
9
● Clinical Validation
A multi-center, non-randomized, open label validation study was completed to confirm the safety and efficacy of the BreathID® Hp Lab System, when used together with the IDkit Hp™ Two kit, for initial diagnosis and post-treatment monitoring of H. pylori infection versus composite biopsy results (histology and RUT). The clinical study was conducted in compliance with its protocol and in accordance with the ethical principles under Investigational Review Board (IRB) approval consistent with Good Clinical Practice (GCP) and with applicable regulatory requirements. All endpoints in the protocol were met. The study evaluated 179 adult initial diagnosis patients and 68 post-treatment patients who were positive for infection and who had completed eradication therapy at least six weeks prior to participation in the study. For the initial diagnosis cohort, the sensitivity in comparison to composite biopsy results was 100% [95% CI (90.60; 100.00)] and specificity was 97.9% [95% CI (93.97; 99.28)]. For the posttreatment cohort, the sensitivity was 92.3% [95% CI (66.69; 98.63)] and the specificity was 100% [95% CI (93.47; 100.00)]. Therefore, the study demonstrated that breath samples can be successfully collected in the Exalenz breath sample bags and accurately tested using the BreathID® Hp Lab System. There were no reportable major safety concerns due to adverse events. It can thus be concluded that the BreathID® Hp Lab System can successfully be used for initial diagnosis and post-eradication monitoring, similar to the predicate device.
The results of analytical and clinical studies demonstrate that the BreathID® Hp Lab System performs according to its specifications and to the requirements established for devices for the detection of H. pylori without raising new questions regarding their safety or efficacy.
Conclusion:
The Exalenz BreathID® Hp Lab System has been demonstrated to be as safe and effective as its predicate device, the cleared Exalenz BreathID® Hp System (K130524), for its intended use, and it is substantially equivalent to its predicate device without raising new safety and/or effectiveness issues.