(86 days)
None
No
The document describes image processing and data analysis but does not mention AI, ML, or any related terms like deep learning or neural networks. The performance studies focus on standard verification and validation, not AI/ML model performance metrics.
No
The device is described as an "Imaging System" with the primary purpose of providing "imaging of coronary arteries" and "detection of lipid core containing plaques," which are diagnostic functions, not therapeutic.
Yes
The device is intended for "imaging of coronary arteries," "detection of lipid core containing plaques," "assessment of coronary artery lipid core burden," and "identification of patients and plaques at increased risk of major adverse cardiac events," all of which are diagnostic purposes. The device combines OCT and NIRS capabilities to assess vessel composition and structure.
No
The device description explicitly lists multiple hardware components (Console, Catheter Interface Unit, Imaging Catheter) in addition to the software. The performance studies also mention benchtop testing of the entire device, which includes hardware.
Based on the provided information, the HyperVue™ Imaging System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for the imaging of coronary arteries and is used in patients during transluminal interventional procedures. This indicates direct interaction with the patient's body.
- Device Description: The description details an intravascular imaging device with a catheter that is inserted into the body.
- Anatomical Site: The device is used within the coronary arteries, which are internal to the patient.
- IVD Definition: An IVD device is defined as a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
The HyperVue™ Imaging System operates in vivo (within the living body) to acquire images and assess vessel characteristics directly, rather than examining specimens in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The HyperVue™ Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.
The Starlight™ Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.
The Starlight Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.
The NIRS capability of the HyperVue Imaging System is intended for the detection of lipid core containing plaques of interest.
The NIRS capability of the HyperVue Imaging System is intended for the assessment of coronary artery lipid core burden.
The NIRS capability of the HyperVue Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
Product codes
NQQ, ORD, OGZ, IYO
Device Description
The HyperVue™ Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system.
The HyperVue™ Imaging System consists of the following components:
- Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface.
- Software: A proprietary application software that orchestrates the control, acquisition, processing, and display of the OCT-NIRS data.
- Catheter Interface Unit (CIU): A tethered CIU that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console.
- Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS)
Anatomical Site
coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians and healthcare professionals in a Cardiac catheterization laboratory
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
Design verification and validation (V&V) of the HyperVue™ Imaging System with the updated software were performed in compliance with external standards and internal design control procedures. V&V testing comprised of system/software verification and summative usability testing to confirm device performance.
Benchtop testing of the entire device was conducted to evaluate certain system-level features, such as measurements, that require both hardware and software to evaluate. The results of this testing conclude the system has met these requirements.
Usability evaluation was conducted to establish that the updated software for the HyperVue™ Imaging System meets the needs of the intended users to perform OCT-NIRS imaging safely and effectively according to ANSI/AAMI/IEC 62366-1.
No animal testing was necessary to demonstrate equivalence.
No clinical testing is provided in this pre-market notification.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
June 7, 2023
SpectraWAVE, Inc. Farzad Parsaie VP, Quality Assurance & Regulatory Affairs 12 Oak Park Drive Bedford, Massachusetts 01730
Re: K230691
Trade/Device Name: HyperVue™ Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NQQ, ORD, OGZ, IYO Dated: March 13, 2023 Received: March 13, 2023
Dear Farzad Parsaie:
We have reviewed vour 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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 medical devices and radiation-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,
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
HyperVue™ Imaging System
Indications for Use (Describe)
The HyperVue™ Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.
The Starlight™ Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.
The Starlight Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.
The NIRS capability of the HyperVue Imaging System is intended for the detection of lipid core containing plaques of interest.
The NIRS capability of the HyperVue Imaging System is intended for the assessment of coronary artery lipid core burden.
The NIRS capability of the HyperVue Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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
Traditional 510(k) Summary
1. Submitter Name & Address:
| 510(k) Owner: | SpectraWAVE, Inc. |
|---|---|
| Address: | 12 Oak Park Drive |
| Bedford, MA 01730 | |
| (781) 701-8148 | |
| Official Contact: | Farzad Parsaie |
| VP, Quality Assurance & Regulatory Affairs | |
| (781) 701-8148 | |
| fparsaie@spectrawave.com | |
| Date Prepared: | 6/5/2023 |
2. Device Name:
| Trade Name: | HyperVue™ Imaging System |
|---|---|
| Model Number: | System: 931 |
| Common Name: | Optical Coherence Tomography Imaging System |
| Classification Name: | System, Imaging, Optical Coherence Tomography |
| Diagnostic intravascular catheter | |
| Regulation Numbers: | 21 CFR 892.1560, 21 CFR 870.1200 |
| Product Code: | NQQ, ORD, OGZ, IYO |
| Classification: | Class II |
3. Predicate Device:
- . K221257, SpectraWAVE Imaging System and Catheter
Device Description: 4.
The HyperVue™ Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system.
The HyperVue™ Imaging System consists of the following components:
4
- . Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface.
- Software: A proprietary application software that orchestrates the control, . acquisition, processing, and display of the OCT-NIRS data.
- . Catheter Interface Unit (CIU): A tethered CIU that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console.
- . Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath.
5. Indications for Use Statement:
The HyperVue™ Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.
The Starlight™ Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.
The Starlight Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.
The NIRS capability of the HyperVue Imaging System is intended for the detection of lipid core containing plaques of interest.
The NIRS capability of the HyperVue Imaging System is intended for the assessment of coronary artery lipid core burden.
The NIRS capability of the HyperVue Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
6. Technological Characteristics:
Three of the four system components in the HyperVue™ Imaging System - Console, CIU and Imaging Catheter - are the same as the predicate device. The subject of this application is for the Software module which contains updates with similar technological characteristics and substantially equivalent performance to the cited predicate. Table 1 below provides a comparative summary (predicate vs proposed device) for the relevant system characteristics/features.
5
| Predicate Device Comparison | |||
|---|---|---|---|
| Manufacturer | |||
| & Model | PREDICATE DEVICE | ||
| SpectraWAVE, Inc. | |||
| SpectraWAVE Imaging System (K221257) | PROPOSED DEVICE | ||
| SpectraWAVE, Inc. | |||
| HyperVue™ Imaging System | Discussion of | ||
| Equivalence & | |||
| Differences | |||
| Product Code | NQQ - System, imaging, optical coherence | ||
| tomography | |||
| ORD - Optical Coherence Tomography, | |||
| Intravascular Catheter | |||
| OGZ - Catheter, Intravascular, Plaque | |||
| Morphology Evaluation | |||
| IYO - System, Imaging, Pulsed Echo, | |||
| Ultrasonic | NQQ - System, imaging, optical coherence | ||
| tomography | |||
| ORD - Optical Coherence Tomography, | |||
| Intravascular Catheter | |||
| OGZ - Catheter, Intravascular, Plaque | |||
| Morphology Evaluation | |||
| IYO - System, Imaging, Pulsed Echo, | |||
| Ultrasonic | Same | ||
| Intended Use | The SpectraWAVE Imaging System and the | ||
| SpectraWAVE Imaging Catheter are intended | |||
| for the imaging of coronary arteries. | The HyperVue™ Imaging System and the | ||
| Starlight™ Imaging Catheter are intended for | |||
| the imaging of coronary arteries. | Same | ||
| Added tradenames | |||
| only | |||
| Intended | |||
| Users | Physicians and healthcare professionals | Physicians and healthcare professionals | Same |
| Operational | |||
| Environment | Cardiac catheterization laboratory | Cardiac catheterization laboratory | Same |
| Indications | |||
| For Use | The SpectraWAVE Imaging System is intended | ||
| for the imaging of coronary arteries and is | |||
| indicated in patients who are candidates for | |||
| transluminal interventional procedures. | |||
| The SpectraWAVE Imaging Catheter is | |||
| intended for use in vessels 2.0 to 5.2 mm in | |||
| diameter. | |||
| The SpectraWAVE Imaging Catheter is not | |||
| intended for use in a target vessel which has | |||
| undergone a previous bypass procedure. | The HyperVue™ Imaging System is intended | ||
| for the imaging of coronary arteries and is | |||
| indicated in patients who are candidates for | |||
| transluminal interventional procedures. | |||
| The Starlight™ Imaging Catheter is intended | |||
| for use in vessels 2.0 to 5.2 mm in diameter. | |||
| The Starlight Imaging Catheter is not intended | |||
| for use in a target vessel which has undergone | |||
| a previous bypass procedure. | |||
| The NIRS capability of the HyperVue Imaging | |||
| System is intended for the detection of lipid | |||
| core containing plaques of interest. | Same | ||
| Added tradenames | |||
| only | |||
| Predicate Device Comparison | |||
| Manufacturer | |||
| & Model | PREDICATE DEVICE | ||
| SpectraWAVE, Inc. | |||
| SpectraWAVE Imaging System (K221257) | PROPOSED DEVICE | ||
| SpectraWAVE, Inc. | |||
| HyperVue™ Imaging System | Discussion of | ||
| Equivalence & | |||
| Differences | |||
| The NIRS capability of the SpectraWAVE | |||
| Imaging System is intended for the detection of | |||
| lipid core containing plaques of interest. | |||
| The NIRS capability of the SpectraWAVE | |||
| Imaging System is intended for the | |||
| assessment of coronary artery lipid core | |||
| burden. | |||
| The NIRS capability of the SpectraWAVE | |||
| Imaging System is intended for the | |||
| identification of patients and plaques at | |||
| increased risk of major adverse cardiac events. | The NIRS capability of the HyperVue Imaging | ||
| System is intended for the assessment of | |||
| coronary artery lipid core burden. | |||
| The NIRS capability of the HyperVue Imaging | |||
| System is intended for the identification of | |||
| patients and plaques at increased risk of major | |||
| adverse cardiac events. | |||
| Primary | |||
| Functions | Delivers energy (infrared light) to the tissue. | ||
| Measures the depth and pattern of reflections | |||
| from the tissue from the return near-infrared | |||
| light to create high-resolution, real-time | |||
| images. | |||
| Stores images for evaluation and review. | Delivers energy (infrared light) to the tissue. | ||
| Measures the depth and pattern of reflections | |||
| from the tissue from the return near-infrared | |||
| light to create high-resolution, real-time | |||
| images. | |||
| Stores images for evaluation and review. | Same | ||
| Image | |||
| Creation. | |||
| Display and | |||
| Storage | Process reflected optical signals to construct | ||
| images. | |||
| Display images. | |||
| Store images. | Process reflected optical signals to construct | ||
| images. | |||
| Display images. | |||
| Store images. | Same | ||
| Measure | |||
| Vessel Cross | |||
| Sectional Area | Calculate and report vessel cross-sectional | ||
| area | Calculate and report vessel cross-sectional | ||
| area | Same | ||
| Measure | |||
| Vessel Linear | |||
| Dimensions | Calculate and display vessel diameter at user | ||
| specified locations within the displayed image | Calculate and display vessel diameter at user | ||
| specified locations within the displayed image | Same | ||
| Predicate Device Comparison | |||
| Manufacturer | |||
| & Model | PREDICATE DEVICE | ||
| SpectraWAVE, Inc. | |||
| SpectraWAVE Imaging System (K221257) | PROPOSED DEVICE | ||
| SpectraWAVE, Inc. | |||
| HyperVue™ Imaging System | Discussion of | ||
| Equivalence & | |||
| Differences | |||
| Calculate | |||
| Vessel | |||
| Physical | |||
| Parameters | Calculate and display mathematical | ||
| comparisons of image data such as % | |||
| reduction from average, length of narrowing. | Calculate and display mathematical | ||
| comparisons of image data such as % | |||
| reduction from average, length of narrowing. | Same | ||
| Procedural | |||
| Steps | System set-up, patient data entry, catheter | ||
| preparation insertion of catheter into the artery | |||
| under fluoroscopic guidance, proper | |||
| positioning of the catheter distal to the target | |||
| vessel, image acquisition, and evaluation of the | |||
| acquired images. | System set-up, patient data entry, catheter | ||
| preparation insertion of catheter into the artery | |||
| under fluoroscopic guidance, proper | |||
| positioning of the catheter distal to the target | |||
| vessel, image acquisition, and evaluation of the | |||
| acquired images. | Same | ||
| Use of Results | Physicians evaluate the images in combination | ||
| with other tests and evaluations to assess the | |||
| patient's coronary arteries. | Physicians evaluate the images in combination | ||
| with other tests and evaluations to assess the | |||
| patient's coronary arteries. | Same | ||
| Operating | |||
| System (OS) | Windows-based (Windows Professional | ||
| Desktop) | Windows-based (Windows Enterprise IoT) | ||
| Windows Enterprise IoT OS provides | |||
| configurability for deploying a single- | |||
| purpose dedicated system. | Substantially | ||
| equivalent | |||
| There is no | |||
| difference in the | |||
| fundamental | |||
| performance and | |||
| intended use of the | |||
| software due to | |||
| change to OS | |||
| User | |||
| Convenience | |||
| Features | Computer-aided measurement tools, such as | ||
| border contours, computation of cross- | |||
| sectional area, and percent stenosis. | |||
| Display of live angiography imagery on the | |||
| SpectraWAVE Imaging System display | |||
| monitors. | Computer-aided measurement tools, such as | ||
| border contours, computation of cross- | |||
| sectional area, and percent stenosis. | |||
| Display of live angiography imagery on the | |||
| HyperVue™ Imaging System display monitors. | Substantially | ||
| equivalent | |||
| The additional | |||
| features are minor | |||
| changes compared | |||
| to the predicate and | |||
| were added to the | |||
| Predicate Device Comparison | |||
| Manufacturer | |||
| & Model | PREDICATE DEVICE | PROPOSED DEVICE | Discussion of |
| Equivalence & | |||
| Differences | |||
| SpectraWAVE, Inc. | |||
| SpectraWAVE Imaging System (K221257) | SpectraWAVE, Inc. | ||
| HyperVue™ Imaging System | proposed device to | ||
| provide user- | |||
| selectable and | |||
| optional user | |||
| convenience | |||
| features. | |||
| No changes were | |||
| made to the | |||
| intended use or | |||
| indications of use of | |||
| the device. | |||
| The following updates have been added | |||
| compared to the predicate device: | |||
| • Addition of new user-selectable and | |||
| optional image overlays on the displayed | |||
| viewports (Angiography & OCT-NIRS) to | |||
| highlight OCT/NIRS-derived features. | |||
| • Update to User Interface (UI) look-and-feel | |||
| and clinical workflow |
6
7
8
9
7. Performance Testing:
7.1 Summary of Performance Testing:
Design verification and validation (V&V) of the HyperVue™ Imaging System with the updated software were performed in compliance with external standards and internal design control procedures. V&V testing comprised of system/software verification and summative usability testing to confirm device performance.
7.2 Sterilization and Shelf Life:
No change from K221257. Sterilization and shelf life are not impacted since this 510(k) submission covers only a software update for the HyperVue™ Imaging System.
7.3 Biocompatibility:
No change from K221257. Biocompatibility is not impacted since this 510(k) submission covers only a software update for the HyperVue™ Imaging System.
7.4 Software:
HyperVue™ Imaging System and Application Software were developed and tested in compliance with IEC 62304. Software verification and validation were conducted to FDA requlations, standards, and quidance document requirements. The results of this testing conclude the software has met these requirements.
7.5 EMC/Basic Electrical Safety:
No change from K221257. This 510(k) submission covers only a software update package for the HyperVue™ Imaging System. EMC & Basic Electrical Safety are not impacted by this software update.
7.6 Bench testing:
In addition to the software verification testing described above, benchtop testing of the entire device was conducted to evaluate certain system-level features, such as measurements, that require both hardware and software to evaluate. The results of this testing conclude the system has met these requirements.
7.7 Animal Testing:
Not applicable. No animal testing was necessary to demonstrate equivalence.
7.8 Human Factors Engineering (HFE) Usability Study:
Usability evaluation was conducted to establish that the updated software for the HyperVue™ Imaging System meets the needs of the intended users to perform OCT-NIRS imaging safely and effectively according to ANSI/AAMI/IEC 62366-1.
10
The updated software for the HyperVue™ Imaging System has been found to be safe and effective for the intended users, uses, and use environments.
7.9 Clinical Testing:
No clinical testing is provided in this pre-market notification.
8. Conclusion and Statement of Equivalence:
Modifications to the software of the device presented in this 510(k) submission do not raise new questions of safety or effectiveness. As demonstrated by risk management activities, software verification, and HFE usability study testing, the proposed HyperVue™ Imaging System does not raise new questions of safety or effectiveness and is therefore considered substantially equivalent to the predicate device.