(65 days)
No
The summary describes a standard mobile C-arm X-ray system and its components. There is no mention of AI, ML, or any advanced image processing features that would typically indicate the use of such technologies.
No.
The device is used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures, which are primarily diagnostic or assistive functions rather than direct therapeutic treatments.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used for radiological guidance and visualization during diagnostic, interventional and surgical procedures." The term "diagnostic" directly indicates its use in identifying or determining the nature of a disease or condition.
No
The device description explicitly lists numerous hardware components, including a C-arm Stand, X-RAY MONOBLOC, Flat Panel Detectors, Monitor, Control Panel, X-RAY COLLIMATOR, and more. This is clearly a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ARCO FP-S is a mobile X-ray device. It uses X-rays to create images of the inside of the body for guidance and visualization during medical procedures. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "radiological guidance and visualization during diagnostic, interventional and surgical procedures." This involves imaging the patient directly, not testing samples.
Therefore, the ARCO FP-S falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
ARCO FP-S is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopaedic, neuro, abdominal, vascular, thoracic and cardiac procedures. ARCO FP-S device can be used on all patients except paediatric patients within the limit of the device.
Product codes
OWB, OXO
Device Description
ARCO FP-S is a mobile C-arm with the solid-state image detector "Flat Panel". It will be realized in 2 models, depending on the size of the detector:
Model: ARCO FP-SR21
Dual focus 0.3/0.6 mm, rotating anode X-Ray tube, generator nominal power 5 KW. Detector size 21x21 cm, 1024x1024 pixel.
Models: ARCO FP-SR30
Dual focus 0.3/0.6 mm, rotating anode X-Ray tube, generator nominal power 5 KW. Detector size 30x30 cm, 1536 x 1536 pixel.
The system consists of:
C-arm Stand:
- MECHANICAL STAND
- X-RAY MONOBLOC, rotating anode
- FLAT PANEL DETECTORS: 2121cm or 3030cm
- MONITOR LCD 27" QUAD HD format 16:9
- CONTROL PANEL
- X-RAY COLLIMATOR
- SYSTEM CONTROLLER
- X-RAY HAND SWITCH
- ARTICULATED ARM FOR MONITOR SUPPORT
- ANTISCATTERING GRID
Options:
- FOOTSWITCH, two-foot pedal
- LASER LOCALISER
- Dose Area Meter,
- DSA Packages
- I.R. remote controls.
- DICOM Classes
- EXTERNAL VIDEO OUTPUT-Wireless transmission
- DICOM DATA Wi-Fi transmission to Ethernet/PACS
- NFC LOGIN
- Wireless monitor trolley, model TROTTER W, for duplicating the image of the monitor on board.
The normal use allows for imaging in the following modes:
- Low Dose Fluoroscopy
- High Quality Fluoroscopy
- Digital radiography (Snapshot)
- Fluoroscopy in Road Mapping mode (optional)
- Fluoroscopy in DSA mode (optional)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
all patients except pediatric patients
Intended User / Care Setting
radiological guidance and visualization during diagnostic, interventional and surgical procedures.
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)
Non clinical testing:
Radiologist's Images evaluation: A Board Certified Radiologist reviewed the still and moving images acquired by the newer digital receptor panels and found them to be of good and acceptable diagnostic quality.
Clinical testing: Clinical Images are not necessary to establish substantial equivalence to the predicate. Adequate bench testing results should clearly indicate device safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
August 13, 2021.
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
A.T.S. Applicazione Tecnologie Speciali S.R.L % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K211777
Trade/Device Name: ARCO FP-S Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO Dated: June 2, 2021 Received: June 9, 2021
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211777
Device Name ARCO FP-S
Indications for Use (Describe)
ARCO FP-S is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures.
In particular, the device is to be applied during othopaedic, neuro, abdominal, vascular, thoracic and cardiac procedures. ARCO FP-S device can be used on all patients except paediatric patients within the limit of the device.
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) |
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3
510(k) Summary K211777
Image /page/3/Picture/1 description: The image shows a logo with the letters "ATS" in a stylized, bold, sans-serif font. The letters are a dark blue color against a light blue background. The letters are connected to each other, forming a single, unified shape.
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.. VIA A. VOLTA, 10 -TORRE DE' ROVERI (BG) 24060 ITALY -TEL. +39.035.584311 -FAX +39.035.580220 Date Prepared: July 19, 2021
1. Administrative Information
Submitter:
Submission contact person: Eng. Livia PILLITTERI, QMS & Regulatory Affairs Manager
Identification:
| Identification: | ARCO FP-S |
|---|---|
| Regulation Number: | 21 CFR 892.1650 |
| Regulation Name: | Image-intensified fluoroscopic x-ray system |
| Regulatory Class: | Class II |
| Product Code: | OWB, OXO |
This is a MODIFIED device. The digital x-ray receptor panels have changed.
Substantially equivalent device: K182086
| Manufacturer: | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L. |
|---|---|
| Trade/Device Name: | ARCO FP |
| Regulation Number: | 21 CFR 892.1650 |
| Regulation Name: | Image-intensified fluoroscopic x-ray system |
| Regulatory Class: | Class II |
| Product Code: | OWB, OXO |
REFERENCE Device: (New digital x-ray receptor panels) K200022 submitted by Livermoretech Trade/Device Name: FLUSION-9001 Fluoroscopic C-arm Mobile X-ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA, IZI
-
- Indications for Use: ARCO FP-S is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. ARCO FP-S device can be used on all patients except pediatric patients within the limit of the device.
-
- Device description: ARCO FP-S is a mobile C-arm with the solid-state image detector "Flat Panel" It will be realized in 2 models, depending on the size of the detector: Model: ARCO FP-SR21
4
Dual focus 0.3/0.6 mm, rotating anode X-Ray tube, generator nominal power 5 KW. Detector size 21x21 cm, 1024x1024 pixel.
Models: ARCO FP-SR30
Dual focus 0.3/0.6 mm, rotating anode X-Ray tube, generator nominal power 5 KW. Detector size 30x30 cm, 1536 x 1536 pixel.
Image /page/4/Picture/3 description: The image shows two medical devices, a C-arm and a mobile monitor stand. The C-arm is a medical imaging device used in surgical procedures, and it has a large, C-shaped arm that houses an X-ray tube and detector. The image also has labels indicating the stand, footswitch, and remote control. The mobile monitor stand is a device used to display medical images during surgical procedures.
Photo: ARCO FP-S
OPTIONAL STAND: Wireless Monitor
The system consists of:
C-arm Stand:
- MECHANICAL STAND
- X-RAY MONOBLOC, rotating anode
- FLAT PANEL DETECTORS: 2121cm or 3030cm
- MONITOR LCD 27" QUAD HD format 16:9
- CONTROL PANEL
- X-RAY COLLIMATOR
- SYSTEM CONTROLLER
- X-RAY HAND SWITCH
- ARTICULATED ARM FOR MONITOR SUPPORT
- ANTISCATTERING GRID
Options:
- FOOTSWITCH, two-foot pedal
- LASER LOCALISER
- Dose Area Meter,
- DSA Packages
5
- I.R. remote controls.
- DICOM Classes
- EXTERNAL VIDEO OUTPUT-Wireless transmission
- DICOM DATA Wi-Fi transmission to Ethernet/PACS
- NFC LOGIN
- Wireless monitor trolley, model TROTTER W, for duplicating the image of the monitor on board.
Technology Employed
ARCO FP-S is a mobile C-arm unit for fluoroscopy and radiography designed for a wide rangeof surgical applications.
The normal use allows for imaging in the following modes:
- Low Dose Fluoroscopy -
- -High Quality Fluoroscopy
- Digital radiography (Snapshot) l
- -Fluoroscopy in Road Mapping mode (optional)
- -Fluoroscopy in DSA mode (optional)
The image acquisitions employ X-rays emitted by an X-ray generator which can produce upto 5 kW. The X-rays, attenuated in different ways depending on the tissue they have to pass through, leave an impression on a detector and then they are converted into electrical signal, which forms the image. The main differences from the predicate device are:
The image detectors are new. The Pixium detectors (used in the predicate device) were replaced with Paxscan (used with the subject device, cleared under K200022).
Only the 5 kW power generator is now available.
The software has been upgraded from the predicate software functionality remains the same. The original software (SYSTEMA dRF- software ISIX) and the modified software (SYSTEMA DRF-S software) are FUNCTIONALLY IDENTICAL.
The workstation image display monitor is being upgraded to a higher resolution.
The operating system is upgraded (Windows 7 is no longer supported).
| Comparison Chart | PROPOSED DEVICE
ARCO FP-S | PREDICATE DEVICE
ARCO FP K182086 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS FOR USE | ARCO FP-S is a mobile X-ray device used for
radiological guidance and visualization
during diagnostic, interventional and
surgical procedures. In particular, the
device is to be applied during orthopedic,
neuro, abdominal, vascular,thoracic and
cardiac procedures. ARCO FP-S device can
be used on all patients except pediatric
patients, within the limits ofthe device. | ARCO FP is a mobile X-ray device used for
radiological guidance and visualization
during diagnostic, interventional and
surgical procedures. In particular, the
device is to be applied during orthopedic,
neuro, abdominal, vascular,thoracic and
cardiac procedures. ARCO FP device can be
used on all patients except pediatric
patients, within the limits ofthe device. |
| CLASS | 2 | 2 |
4. Technological characteristics: Comparison Table
6
| Comparison Chart | PROPOSED DEVICE
ARCO FP-S | PREDICATE DEVICE
ARCO FP K182086 |
|--------------------------------------------|------------------------------------------------------|------------------------------------------------------|
| Product code | OWB; OXO | OWB: OXO |
| Photo | Image: PROPOSED DEVICE ARCO FP-S | Image: PREDICATE DEVICE ARCO FP K182086 |
| PERFORMANCE SPECIFICATION | | |
| A. C-arm | | |
| C-Arm Weight | 310 kg | 280 kg |
| B. Power Supply | | |
| Supply type | Single phase (live/neutral,separate
earth) | Single phase (live/neutral,separate earth) |
| Input Voltage | 100, 110, 120, 130, 210, 220, 230, 240 V
@50-60Hz | 100, 110, 120, 130, 210, 220, 230, 240 V
@50-60Hz |
| X-ray Generator
Maximum power | 5kW | 5kW; 20kW |
| C. X-ray tube | | |
| Type | Rotating anode | Rotating anode |
| Nominal voltage | 120 kV | 120 kV |
| Nominal focal
spot valuesinput
power | 0.3 mm = 6.0kW
0.6 mm = 25 kW | 0.3 mm = 6.0kW
0.6 mm = 25 kW |
| Maximum heat
dissipation | 750 W | 750 W |
| Maximum
anode heat | 225 kJ | 225 kJ |
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| Comparison Chart | PROPOSED DEVICE
ARCO FP-S | PREDICATE DEVICE
ARCO FP K182086 | | | |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------|---------------------------------|--|
| content | | | | | |
| Anode material | Rhenium-Tungsten-Molybdenum | Rhenium-Tungsten-Molybdenum | | | |
| Filtration | Possible Filters To Apply:
- none
- 2mmAl
- 1mmAl + 0,1mmCu
- 1mmAl + 0,2mmCu | Possible Filters To Apply:
- none
- 2mmAl
- 1mmAl + 0,1mmCu
- 1mmAl + 0,2mmCu | | | |
| D. Detector | | | | | |
| | PaxScan
2121DXV | PaxScan
3030DXV | PIXIUM 2121S | PIXIUM 3030S | |
| Active
detector
size /
Sensitive
area | 1024x1024 pixel
205x205 mm | 1516x1516 pixel
294x294 mm | 1344 x 1344 pixel
207x207 mm | 1956 x 1956 pixel
301x301 mm | |
| Pixel size | 205 μm | 194 μm | 154 μm | 154 μm | |
| Cooling | Passive | | Passive | | |
| Detective | 0 –80% | 0 –80% | 0 –77% | 0 –77% | |
| Quantum
Efficiency,
RQA5
[ Lp/mm@2uGy ] | 1.0 - 65% | 1.0 - 65% | 1.0 - 56% | 1.0 – 57% | |
| | 2.0 - 40% | 2.0 - 44% | 2.0 - 46% | 2.0 - 48% | |
| Modulation
Transfer
Efficiency
(MTF)
[ Lp/mm@2uGy ] | 1.0 - 50% | 1.0 – 55% | 1.0 – 59% | 1.0 – 59% | |
| | 2.0 – 22% | 2.0 – 23% | 2.0 – 29% | 2.0 – 29% | |
| | Nyquist - 15% | Nyquist - 15% | Nyquist-11% | Nyquist-11% | |
| Maximum frame per
second | 30 | | 25 | | |
| | E. Anti-Scattering Grid | | | | |
| Material | Aluminum | | Aluminum | | |
| Lines/cm | 80 | | 80 | | |
| Grid focus distance | 100 cm | | 100 cm | | |
8
| Comparison Chart | PROPOSED DEVICE
ARCO FP-S | PREDICATE DEVICE
ARCO FP K182086 |
|---------------------------------|--------------------------------------------------|-------------------------------------|
| Ratio | 8:1 | 8:1 |
| F. Workstation monitor | | |
| Size / Type | 21.7" / LCD | 21.5" / LCD |
| Resolution | 2560 x 1440 (4K) | 1920 x 1080 |
| Nominal light output | 350 cd/m² | 1000 cd/m² |
| G. Control panel monitor | | |
| Size / Type | 12.5" / LCD touch | 12.5" / LCD touch |
| Resolution | 1920 x 1080 | 1920 x 1080 |
| H. Workstation Operating system | | |
| Windows version | Windows 10 (Windows 7 is no longer
supported) | Windows 7 or Windows 10 |
- Non clinical testing: In order to demonstrate the EMC and Electrical safety of the proposed device ARCO FP-S, the manufacturer A.T.S. Applicazione Tecnologie Speciali Srl. has performed safety tests incompliance with the standards listed here below:
- IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basicsafety and essential performance;
- IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests;
- IEC 60601-1-3: Medical Electrical Equipment - Part 1-3: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Radiation ProtectionIn Diagnostic X-Ray Equipment;
- IEC 60601-1-6: Medical Electrical Equipment - Part 1-6: General Requirements ForBasic Safety And Essential Performance - Collateral Standard: Usability;
- IEC 60601-2-43: Medical Electrical Equipment - Part 2-43: Particular RequirementsFor The Safety And Essential Performance Of X-Ray Equipment For Interventional Procedures;
- IEC 60601-2-54: Medical Electrical Equipment - Part 2-54: Particular RequirementsFor The Basic Safety And Essential Performance Of X-Ray Equipment For Radiography And Radioscopy.
- IEC 60825-1: Safety of laser products - Part 1: Equipment classification andrequirements
- IEC 62304: Medical device software - Software life cycle processes
- ETSI EN 301 489-17: ElectroMagnetic Compatibility (EMC) standard for radio equipment and services - Part 17: Specific conditions for Broadband Data Transmission Systems; Harmonised Standard for Electro Magnetic Compatibility
In order to demonstrate the performance of the ARCO FP-S, the following quality testing has been performed by A.T.S. Applicazione Tecnologie Speciali Srl:
- Radiologist's Images evaluation. A Board Certified Radiologist reviewed the still and moving images ●
9
acquired by the newer digital receptor panels and found them to be of good and acceptable diagnostic quality.
The software remains at a MODERATE LEVEL OF CONCERN, and software was validated according to the FDA Software Guidance at that level.
The following FDA guidance was employed in regard to cybersecurity concerns: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff. Our labeling and internal procedures were updated to reflect the recommendations of this guidance.
- Clinical testing. Clinical Images are not necessary to establish substantial equivalence to the predicate. Adequate bench testing results should clearly indicate device safety and effectiveness.
7. Substantial Equivalence Discussion.
The ARCO FP-S performs the same functions as the predicate using the same technological methods to produce and store diagnostic x-ray images. In all material aspects, the A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L. devices are substantially equivalent to each other. The detector technological characteristics (resolution, MTF and DQE performance, see comparison table above) all point to substantial equivalence
8. Substantial Equivalence Conclusion:
After analyzing bench test results, risk analysis, and standards compliance, it is the conclusion of A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.. that the ARCO FP-S is as safe and effective as the predicate device, has few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.