VS3-IR system

K152204 · Visionsense, Ltd. · OWN · Oct 28, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K152204
• Device Name: VS3-IR system
• Applicant: Visionsense, Ltd.
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: Oct 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The 3D Endoscope Module of the VS3-IR System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures. The MMS configuration of the Iridium Module of the VS3-IR System is intended for capturing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic. micro- and reconstructive surgical procedures. The Endoscope configuration of the Iridium Module of the VS3-IR System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. Iridium Endoscope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infrared imaging during minimally invasive surgery.

Device Story

VS3-IR System provides real-time 3D visible light and near-infrared (NIR) fluorescence endoscopic imaging. System components include HD3D camera, laser light source (805nm), xenon light source, CCU, display monitor, and Iridium endoscope. During minimally invasive surgery, device illuminates surgical field with white and laser light; ICG dye (administered to patient) fluoresces under 805nm excitation. Left channel of 3D endoscope captures visible light; right channel captures NIR emission (825-850nm). Images are processed and fused into a composite display for the surgeon. Used in OR by surgeons to visualize anatomy and assess blood flow/tissue perfusion. Benefits include enhanced intraoperative visualization of vessels and tissue health, aiding surgical decision-making.

Clinical Evidence

Bench testing only. System validated for fluorescence mode performance using simulated surgical field. Testing confirmed successful detection of ICG fluorescence, fusion of visible and IR channels, and adherence to performance acceptance criteria. No clinical data presented.

Technological Characteristics

System utilizes proximal stereoscopic camera block with dual-channel imaging (visible/NIR). Materials: Reusable endoscope (steam autoclave). Energy: 805nm laser (excitation) and Xenon (visible). Connectivity: Integrated system (camera, CCU, light sources). Standards: IEC 60601-1, 60601-1-2, 60601-1-4, and laser safety standards. Dimensions: 5.5mm diameter, 0°/30° view. Software: Validated for image fusion and system control.

Indications for Use

Indicated for patients undergoing general, neurological, spinal, shoulder, or knee arthroscopic surgical procedures requiring internal visualization. Also indicated for patients undergoing plastic, micro-, or reconstructive surgery requiring visual assessment of blood flow and tissue perfusion via ICG fluorescence imaging during minimally invasive procedures.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Novadaq Technologies SPY Imaging System (K063345 / K091515)

Reference Devices

• VS3 3D Endoscopes (K123467, K141002, K131434)
• VS3-IR-MMS & ICG Kit (K150018)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Visionsense Ltd. % Mr. Raymond Kelly Licensale Incorporated 57 Lazy Brook Road Monroe, Connecticut 06468

October 28, 2015

Re: K152204

Trade/Device Name: VS3-IR Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OWN, GCJ, HRX, GWG Dated: August 5, 2015 Received: August 6, 2015

Dear Mr. Kelly:

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 Part 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

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applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (21CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K152204

Device Name

VS3-IR

Indications for Use (Describe)

The 3D Endoscope Module of the VS3-IR System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures.

The MMS configuration of the Iridium Module of the VS3-IR System is intended for capturing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic. micro- and reconstructive surgical procedures.

The Endoscope configuration of the Iridium Module of the VS3-IR System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. Iridium Endoscope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infrared imaging during minimally invasive surgery.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) Summary Visionsense VS3-IR System

#### Submitter's Name, Address, Telephone Number,

Visionsense Ltd. 20 Hamagshimim Street, Petach Tikva 49348 Israel Phone: [phone] Facsimile: [phone]

#### Contact Person and Date Prepared

Raymond Kelly 57 Lazy Brook Rd Monroe, CT 06468 USA Phone: [phone]

Date Prepared: August 11, 2015

#### Name of Device

VS3-IR System

#### Common or Usual Name / Classification Name

Endoscopes and Accessories / Infrared Microscope / Angiographic X-ray System

#### Predicate Device

Novadaq Technologies SPY Imaging System (K063345 / K091515)

#### Intended Use / Indications for Use

The 3D Endoscope Module of the VS3-IR System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, and foraminotomy, and shoulder and knee arthroscopic procedures.

The MMS configuration of the Iridium Module of the VS3-IR System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

The Endoscope configuration of the Iridium Module of the VS3-IR System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. Iridium Endoscope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess yessels, blood flow and related tissue perfusion with near infrared imaging during minimally invasive surgery.

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## Principles of Operation / Conditions of Use

The VS3-IR System is made up of the following components:

- VS3 3D Endoscope (K123467, K141002, K131434) .
- VS3-IR-MMS & ICG Kit (K150018)
- . VS3-IR-Endoscope & ICG Kit (not yet assigned).

The following table summarizes FDA clearance history for the VS3-IR system:

| Component | FDA Clearance # | Indication |
|-----------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VS3 3D<br>Endoscopes | K123467 (Laparoscope)<br>K141002 (Arthroscope)<br>K131434 (Neurological) | Intended for viewing internal surgical<br>sites during general surgical<br>procedures, for use in visualization of<br>ventricles and structures within the<br>brain during neurological surgical<br>procedures, viewing internal surgical<br>sites during anterior and posterior<br>spinal procedures, such as<br>nucleotomy, discectomy, and<br>foraminotomy, and shoulder and knee<br>arthroscopic procedures. |
| VS3-IR-MMS<br>& ICG Kit | K150018 | Intended for capturing and viewing<br>fluorescent images for the visual<br>assessment of blood flow, as an<br>adjunctive method for the evaluation<br>of tissue perfusion, and related tissue-<br>transfer circulation in tissue and free<br>flaps used in plastic, micro- and<br>reconstructive surgical procedures. |
| VS3-IR-<br>Endoscope<br>& ICG Kit | Not yet assigned | Intended to provide real-time<br>endoscopic visible and near infrared<br>fluorescence imaging. Iridium<br>Endoscope enables surgeons to<br>perform routine visible light<br>endoscopic procedures as well as<br>further visually assess vessels, blood<br>flow and related tissue perfusion with<br>near infra-red imaging during<br>minimally invasive surgery. |

This premarket notification adds the IR endoscope to the FDA cleared devices in K123467 (Laparoscope), K141002 (Arthroscope), K131434 (Neurological), and K150018 (MMS), and to change the family brand name to VS3-IR system.

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The VS3-IR system includes:

- . HD3D camera (cleared K123467, K141002, and K131434)
- Laser Light Source (cleared K123467, K141002, K131434, and K150018)
- CCU (cleared K123467, K141002, K131434. and K150018) .
- Display monitor (cleared K123467, K141002, K131434, and K150018)
- MMS-IR (cleared K150018)
- . VS3-IR Endoscope (subject of this premarket notification)
- 3rd party Xenon light source (cleared K123467, K141002, K131434, and K150018) .
- . 3rd party endoscopic light cable (cleared K123467, K141002, K131434, and K150018)
- . Light Integrator for white (Xenon) light and IR light from the LLS (cleared K150018)
- . ICG Kit (cleared K150018)

The VS3 3D endoscopes (cleared in K123467, K131434, and K141002) are based on the proximal camera concept with a stereoscopic camera block on the proximal side of the endoscope (the handle). The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block through an optical transmission system to PC workstations or external display monitors for enhanced viewing or capturing. VS3 includes reusable endoscopes which are cleaned and sterilized using the same methods and are indicated for the same lifecycle.

In addition to traditional endoscopic procedures, VS3-IR system includes support for Infrared (IR) Fluorescence visualization (hereafter referred to as Iridium utilizes the VS3 system with scopes that support IR fluorescence visualization. VS3 Iridium Miniature Microscope (VS3-IR-MMS) which was cleared in K150018 is positioned 20cm to 45cm above the patient during an open procedure. The proposed Iridium Endoscopes (VS3-R-Endoscope) is used during laparoscopic minimally invasive procedures. VS3 Iridium MMS and Endoscopes are designed to work with an approved IR fluorescence dve (Indocvanine Green or ICG), which has excitation at 805nm and emission band between 825nm and 850nm. VS3 Iridium (VS3-IR) provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera.

Both the Iridium MMS and Iridium Endoscope utilize the left channel of the VS3 imaging system (camera and image processor) for IR fluorescence imaging and the right channel for visible light imaging. This structure allows fluorescence imaging to use the same acquisition and processing pathways as the approved 3D endoscopes (cleared in K123467, K131434, and K141002).

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## Technological Characteristics

Requirements for the Iridium Endoscope assume that the Iridium Scope is used with the Iridium Camera, CCU, and Laser Light source. Stand-alone functionality of the Iridium Scope is not supported.

| # | Feature/Parameter | Value/Description |
|---|------------------------------------|-----------------------|
| 1 | Able to function with no<br>camera | No |
| 2 | Working distance | 2cm – 7cm from tissue |
| 3 | Direction Of View | 0°, 30° |

### Performance Data

The subject device conforms to the following recognized standards:

| Standards<br>No. | Standards<br>Organization | Standards Title |
|------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 60601-1-2 | IEC | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance -<br>collateral standard: electromagnetic compatibility -<br>requirements and tests (Edition 3). |
| 60601-1 | IEC | Medical electrical equipment - Part 1: General requirements<br>for basic safety and essential performance. |
| 60601-1-4 | IEC | Medical electrical equipment - Part 1: General requirements<br>for safety, Collateral standard: Programmable electrical<br>medical systems. |
| 60601-1-4 | IEC | Safety of laser products - Part 1: equipment classification,<br>and requirements. |

The system software was validated and performs as intended per the pre-specified requirements.

In addition, bench testing was conducted to verify that the subject device can detect and visualize anatomy and blood flow per the proposed indications for use of the Iridium Module.

The Visionsense VS3 system with ICG fluorescence endoscope (VS3 Iridium Endoscope) was bench tested in fluorescence mode so that the endoscope light sources provided both IR (laser light source) and Visible (xenon light source) light to illuminate the simulated surgical field. The left channel of the 3D endoscope was dedicated to visible light imaging, while the right channel of the scope was dedicated to IR imaging during the testing the laser excitation light triggered IR fluoresce in ICG molecules as intended. The fluorescence light was detected by one of the image sensors in the PHD camera to produce an IR image. The other sensor was used to capture a visible light image of the same scene. The two images were fused together to produce a composite image showing blood flow.

In all instances, the VS3-IR System using the VS3-IR-Endoscope functioned as intended and met all performance acceptance criteria.

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## Substantial Equivalence

The VS3-IR-Endoscope as part of the VS3-IR System is substantially equivalent to other legally marketed surgical endoscopes. Specifically, the VS3-IR-Endoscope is substantially equivalent to the cleared Novadaq SPY Imaging device (K091515). As explained in more detail below, the subject VS3-IR-Endoscope has been added to the cleared VS3 base system and VS3-IR-MMS to create the VS3-IR-Endoscope and has the same indications for use and substantially similar technological characteristics and principles of operation as the identified predicate device. A substantial equivalence chart comparing the similarities and differences between the subject and predicate device is provided below

All the components of the subject device and associated software have been cleared in the original VS3 base system 510(k) notices (K123467, K131434, K141002) and the Infrared Iridium VS3-IR-MMS submissions (K150018) including the ICG Kit (K150018) and are included in this submission by reference for purposes of completeness in describing the updated VS3-IR System that the company plans to market.

| | VS3-IR IR Endoscope<br>(proposed) | Novadaq Endoscopic SPY<br>(K091515) |
|---------------------------------------|-----------------------------------------------------|-----------------------------------------------------|
| Manufacturer | Visionsense Ltd. | Novadaq Technologies Inc |
| Sterilization | Steam Autoclave | Steam Autoclave |
| Imaging Agent | IR fluorescence dye (i.e.<br>Indocyanine Green-ICG) | IR fluorescence dye (i.e.<br>Indocyanine Green-ICG) |
| Imaging Head | Silicon Image Sensor in the<br>camera | Silicon Image Sensor in the<br>camera |
| Light Source | Infrared Laser | Infrared Laser |
| Excitation Wavelength | 805nm | 805nm |
| Scope Diameter | 5.5mm | 10mm |
| Angles of View | 0°, 30° | 0°, 30° |
| Imaging | Fluorescent and White Light<br>Imaging | Fluorescent and White Light<br>Imaging |
| Emission Band | 825nm to 850nm | 825nm to 850nm |
| Emission Capture | IR camera | IR camera |
| Display both Visible<br>and IR images | Yes | Yes |

# Conclusions

The VS3-IR System is substantially equivalent to the predicate device. Performance testing demonstrates that the newly added components to the VS3-IR-System performs substantially equivalent to the predicate device, and any differences in technological characteristics do not raise different questions of safety or efficacy compared to the predicate device.